Live-nyheter • Jul 25
Ipsen Phase III Bylvay Trial in Biliary Atresia Fails to Meet Main Goal Ipsen reported that its Phase III BOLD trial of Bylvay (odevixibat) in children with biliary atresia who had undergone Kasai hepatoportoenterostomy did not meet the primary endpoint of improving native liver survival.
The company stated that topline data from BOLD are consistent with the known safety profile of odevixibat in its approved uses, but the result is significant because BOLD is described as the largest disease-modification study conducted in this rare pediatric liver condition, where options beyond surgery or transplant are limited.
Ipsen’s share price is around €158.40, with the stock up 36.4% year to date, while the session’s move was a decline of 2.8%.
This outcome raises questions about how much value investors assign to Bylvay’s potential in additional indications and may shift attention back to Ipsen’s already approved uses for the drug and to other late-stage pipeline assets. Tillkännagivande • Jul 24
Ipsen Provides Update On Phase III BOLD Trial In Biliary Atresia Ipsen announced that the Phase III BOLD trial evaluating Bylvay versus placebo for patients living with biliary atresia (BA) who have already undergone a Kasai hepatoportoenterostomy (HPE) did not meet the primary endpoint of improvement in native liver survival vs placebo. Current topline data is in line with the well-established safety profile of odevixibat in approved indications. Characterized as a rapidly progressive and complex condition, BA is the leading cause of paediatric liver transplant, with no approved therapeutic options beyond Kasai HPE or liver transplant surgery. BOLD has generated the most comprehensive dataset ever assembled in this disease. Although the study did not meet its primary endpoint, the commitment of participating children and families has produced valuable insights that will deepen our understanding of biliary atresia and provide a crucial basis for future research and patient care. As biliary atresia is a heterogeneous disease with variable clinical presentation and progression, further analyses of this comprehensive dataset may provide important insights into disease biology and help us better understand whether outcomes differ across patient subgroups. These results reflect the significant challenge biliary atresia presents as a complex, rare paediatric cholestatic liver disease which has so far evaded all therapeutic attempts beyond surgery. Their commitment has been instrumental in helping advance our understanding of biliary atresia and the needs of those living with this challenging disease. Odevixibat is a once-daily selective and potent ileal bile acid transport (IBAT) inhibitor that reduces bile acid reabsorption in the intestine. Through IBAT inhibition, the bile acids are instead diverted and excreted with faeces. Bylvay (odevixibat) is approved in the U.S. as the first treatment for cholestatic pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC) across all types, and for pruritus in patients with Alagille Syndrome (ALGS). In the EU Bylvay is approved for the treatment of PFIC, with orphan exclusivity granted, and is additionally marketed as KAYFANDA for ALGS. BOLD is a Phase III randomized, double-blind, placebo-controlled, trial (NCT04336722) investigating the efficacy and safety of odevixibat compared to placebo in patients with biliary atresia who have undergone a Kasai hepatoportoenterostomy (HPE). It is the largest trial evaluating disease modification in biliary atresia. The trial enrolled 254 patients across 19 countries who had undergone Kasai HPE surgery within the first 90 days of life. Patients received oral odevixibat 120mcg/kg/day or placebo once daily for up to 104 weeks. The primary endpoint was native liver survival, defined as time from randomization to first occurrence of liver transplant or death at week 104. An open-label extension study currently ongoing (BOLD-EXT) is evaluating the longer-term safety and efficacy of odevixibat in patients who have completed the BOLD trial. A decision regarding the continuation of patients in the open-label extension will be made following a comprehensive review of the full trial data. Biliary atresia (BA) is a rare, serious pediatric cholestatic liver disease affecting 1 in 5,000-20,000 newborns in which the bile ducts inside and/or outside the liver are blocked, absent, or scarred, preventing bile from draining from the liver into the intestine. Bile then builds up in the liver, causing progressive inflammation, fibrosis, cirrhosis and ultimately liver failure if untreated. The condition appears in newborns and young infants, typically within the first weeks to months of life, often through persistent jaundice, pale stools and dark urine. Biliary atresia is the most common cause of pediatric liver transplantation worldwide. While an early Kasai HPE surgical procedure can restore bile flow and delay disease progression, it does not always cure the condition and many patients will require a liver transplant. Currently there are no approved medical treatments options for BA. Live-nyheter • Jul 24
Ipsen Finalizes Memo Therapeutics Acquisition Adding Late-Stage BK Virus Antibody to Pipeline Ipsen has completed the acquisition of Memo Therapeutics AG, bringing in potravitug, a late-stage monoclonal antibody that targets BK polyomavirus reactivation in kidney transplant recipients and has shown significant anti-viral response and resolution of related nephropathy in clinical trials.
The deal adds a first-in-class rare disease asset to Ipsen’s Rare Disease pipeline, expanding its presence in treatments for transplant-related complications based on a candidate with existing clinical data.
Ipsen’s share price is around €163.00, with the stock up 40.4% year to date, reflecting recent share price momentum as the company adds late-stage pipeline assets.
This acquisition gives Ipsen a differentiated therapy in a highly specific transplant complication, but outcomes still depend on further clinical progress, regulatory decisions and eventual commercial uptake. Live-nyheter • Jul 21
Ojemda Undergoes EU’s First Joint Clinical Review Under New Health Assessment Rules Ipsen’s oncology drug Ojemda has become the first product to undergo a joint clinical assessment under the EU’s new Health Technology Assessment Regulation, focused on its relative effectiveness and safety in pediatric low-grade glioma.
The debut assessment is expected to serve as a reference point for how future therapies are clinically appraised under the HTAR, while gaps in comparator data for Ojemda could complicate pricing and reimbursement talks across different EU member states.
Ipsen’s shares trade at around €162.00, with the stock up about 39.5% year to date.
This early test of the HTAR process puts Ipsen in the spotlight, creating potential upside if Ojemda’s profile is viewed favorably across Europe while also adding policy and reimbursement risk if national payers rely on the missing comparator data to push back on terms. Live-nyheter • Jul 09
Dysport Hits Phase III Migraine Milestone With Significant Reduction in Monthly Attacks Ipsen reported that Dysport achieved statistically significant topline Phase III results in both episodic (E-BEOND) and chronic (C-BEOND) migraine, meeting primary endpoints and showing a significant reduction in monthly migraine days, with safety in line with its known profile.
The company highlighted that Dysport is the first botulinum toxin in episodic migraine to show a statistically significant reduction in monthly migraine days in a Phase III setting. This may support a broader treatment label if regulators approve the data.
Ipsen’s share price is €166.00, with the stock up 43.0% year to date, and the news adds a clinical milestone around a marketed product.
The key read-through is that positive Phase III results in a major indication like migraine could expand Dysport’s addressable use. However, regulators still need to review the data, and any label changes would involve timing and reimbursement uncertainties. Tillkännagivande • Jul 09
Ipsen Reports Positive Topline Phase III Results for Dysport in Both Episodic and Chronic Migraine Ipsen announced positive topline results from its Phase III BEOND migraine program evaluating Dysport (abobotulinumtoxinA) for the prevention of episodic (E-BEOND) and chronic migraine (C-BEOND) in adults. Both the E-BEOND and C-BEOND trials met their primary endpoints, a reduction in monthly migraine days versus placebo. The E-BEOND results represent the first Phase III trial in which a botulinum toxin has demonstrated statistically significant efficacy in episodic migraine. Together with the positive C-BEOND results, BEOND is the first Phase III clinical program to demonstrate efficacy of a botulinum toxin in the prevention of both episodic and chronic migraine. Dysport was well-tolerated. Safety findings observed across both trials were consistent with well-established use of Dysport in approved indications, with no new or unexpected signals identified. Detailed findings from the BEOND program will be presented at a future scientific congress. The BEOND Phase III program included two randomized, multi-center, placebo-controlled trials, C-BEOND (NCT06047444) and E-BEOND (NCT06047457). The trials enrolled 1,510 patients across 120 centers. The primary endpoint for both trials was the change from baseline in the number of monthly migraine days at week 24 (measured over weeks 21 to 24). The Extension Phase of the BEOND trials, where all participants receive Dysport for two treatment cycles, will continue to week 48. Migraine is a complex neurological disease characterized by recurrent attacks of headache and migraine, and is estimated to impact approximately 14% of the world’s population. People living with migraine experience symptoms that include recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch and smell. Migraine can be categorized as episodic migraine or chronic migraine. People living with chronic migraine experience 15 or more headache days per month, of which at least 8 are migraine days. People living with episodic migraine can experience up to 14 headache days per month of which at least 6 are migraine days (as defined in the E-BEOND trial). Dysport (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in approximately 90 countries, more than 30 years of clinical experience and >21 million treatment years of patient experience. The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics (SmPC) and the U.S. Prescribing Information (PI) for Dysport (300 units) Powder and Dysport (500 units) Powder. Dysport labels and approved indications may vary from country to country. Live-nyheter • Jul 02
Ipsen to Acquire Memo Therapeutics for $800 Million Kidney Transplant Drug Deal Ipsen has agreed to acquire Swiss biotech Memo Therapeutics AG, paying €200 million upfront and up to more than €700 million in milestones, to secure potravitug, a BK polyomavirus monoclonal antibody in Phase II for kidney transplant patients.
The lead asset potravitug targets BK polyomavirus-associated nephropathy, an unmet complication in kidney transplants, and holds FDA fast-track status plus EU orphan drug designation, with Phase II SAFE KIDNEY II data backing Ipsen’s plan for a pivotal Phase II/III trial expected to start later this year.
Ipsen shares trade around €165.80, with the stock up about 42.8% year to date.
This deal deepens Ipsen’s rare disease pipeline but also commits it to significant development and milestone outlays, so trial progress and regulatory outcomes for potravitug will be central to how the acquisition is ultimately viewed. Live-nyheter • Jun 30
Ipsen Agrees to Acquire Kartos Therapeutics in $1.75 Billion Myelofibrosis Deal Ipsen agreed to acquire Kartos Therapeutics for up to $1.75 billion, including $450 million upfront and up to $1.3 billion in milestones, adding navtemadlin, an oral MDM2 inhibitor in Phase III POIESIS trials for myelofibrosis, to its hemato-oncology pipeline.
The deal gives Ipsen a late-stage asset targeting patients with inadequate responses to ruxolitinib. The acquisition is expected to close by the end of Q3 2026, and top-line Phase III data is anticipated in 2027.
Ipsen’s share price is around €165.00, with the stock up 42.1% year to date.
The key read-through is that Ipsen is committing significant capital to expand in rare blood cancers, with future value hinging on clinical trial outcomes for navtemadlin and on whether regulatory and commercial milestones are ultimately achieved. Tillkännagivande • Jun 29
Ipsen S.A. (ENXTPA:IPN) entered into a definitive merger agreement to acquire Kartos Therapeutics, Inc. for $1.8 billion. Ipsen S.A. (ENXTPA:IPN) entered into a definitive merger agreement to acquire Kartos Therapeutics, Inc. for $1.8 billion on June 29, 2026. Under the terms of the agreement and plan of merger, Ipsen through a fully-owned subsidiary, will pay $450 million upfront at closing. Kartos Therapeutics shareholders are also eligible to receive additional milestone payments of up to $1.3 billion including a significant regulatory approval milestone and sales-based milestones.
The transaction is subject to customary closing conditions including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is anticipated to close by the end of the third quarter of 2026. This late-stage transaction is expected to be accretive to Ipsen’s core operating income from 2029, with limited dilution to 2026 full-year guidance.
Orrick, Herrington & Sutcliffe LLP acted as legal advisor for Ipsen S.A. Goldman Sachs & Co. LLC acted as financial advisor for Kartos Therapeutics, Inc. PJT Partners Limited acted as financial advisor for Kartos Therapeutics, Inc. DLA Piper LLP acted as legal advisor for Kartos Therapeutics, Inc. Tillkännagivande • May 28
Ipsen Presents New Late-Breaking Results and Real-World Evidence for IQIRVO in Primary Biliary Cholangitis Ipsen announced the presentation of new late-breaking results from the ELATIVE Phase III trial and two real-world studies at the European Association for the Study of the Liver congress. Together, these data further strengthen the growing body of evidence establishing IQIRVO as the only second-line primary biliary cholangitis (PBC) treatment providing rapid and robust alkaline phosphatase (ALP) reduction with fatigue improvement (in patients with moderate-to-severe fatigue at baseline) and pruritus relief. In a post hoc analysis of the pivotal ELATIVE study, patients with moderate-to-severe fatigue at baseline experienced greater fatigue reductions with IQIRVO compared to placebo across 52 weeks. A clinically meaningful improvement in fatigue was achieved in 67% of patients on IQIRVO vs 31% on placebo (p=0.020) at Week 52, with improvements observed as early as Week 4. The benefits of IQIRVO vs placebo were observed across multiple dimensions of physical and mental fatigue, including extreme exhaustion (62% vs 31%), too tired to think clearly (57% vs 31%) and too tired to bath or shower (55% vs 25%), highlighting the breadth of improvement across several symptom domains. In a second late-breaking presentation, a U.S. real-world analysis using the Health Verity database, evaluated outcomes in patients with ALP elevated between 1-1.67 times the upper limit of normal (ULN). These data showed that improvements were observed through to month 6 in patients who were naïve to second-line treatment with 72% of patients having a =15% ALP reduction, a decline in mean ALP from 174 U/L to 131 U/L and 59% of patients achieving ALP normalization. Normalization of ALP is recognized as a key treatment goal for improved long-term prognosis and slowing disease progression in PBC. These data are the first real-world evidence establishing the benefit of IQIRVO on ALP normalization within this patient population. In a third late-breaker, interim month 3 findings from the global Phase IV ELFINITY study, conducted in routine clinical practice, showed IQIRVO delivered rapid and sustained reductions in ALP for three months, with biochemical response achieved in 55% of patients. More than half of patients with baseline moderate-to-severe fatigue experienced clinically meaningful improvements by month 3 as well as clinically important improvements in pruritus. IQIRVO demonstrated a favorable tolerability profile consistent with previous studies, with no serious or severe treatment-emergent adverse events reported. IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist. Activation of PPARa and PPARd decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. IQIRVO is the first approved PPAR agonist with dual a and d activation, shown to have complementary anti-inflammatory, anti-cholestatic, anti-fibrotic and metabolic effects. In 2019, IQIRVO was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. IQIRVO was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA and EMA approvals are contingent on the further verification of clinical benefit. In addition to the U.S., E.U. and UK, IQIRVO is approved in Canada, Australia, Brazil and 13 other countries and is in regulatory processes with other authorities. IQIRVO was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026. Upcoming Dividend • May 27
Upcoming dividend of €1.60 per share Eligible shareholders must have bought the stock before 03 June 2026. Payment date: 05 June 2026. Payout ratio is a comfortable 26% and this is well supported by cash flows. Trailing yield: 0.9%. Lower than top quartile of French dividend payers (5.6%). Lower than average of industry peers (4.6%). Tillkännagivande • May 22
Ipsen Announces Late-Breaking Data from First Head-To-Head Study Comparing Dysport and Botox in Adults with Upper Limb Spasticity Ipsen announced results from the only prospective, head-to-head Phase IV DIRECTION trial comparing Dysport (abobotulinumtoxinA) to Botox (onabotulinumtoxinA) in adults living with upper limb spasticity will be presented as a late-breaking presentation at the International Society of Physical and Rehabilitation Medicine world congress in Vancouver on May 19, 2026. The trial showed that patients treated with Dysport had a non-inferior safety profile to Botox and achieved longer-lasting symptom control (based on a pre-specified 80% confidence interval). The DIRECTION trial addresses decades-long evidence gaps by delivering the first head-to-head, double-blind, comparative data between Dysport and Botox in adult spasticity. For the primary endpoint of the trial, Dysport demonstrated non-inferiority compared with Botox with a treatment-emergent adverse event rate of 20.3% vs 23.0%, respectively (adjusted difference (aboBoNT-A – onaBoNT-A) was -2.7% (80%CI: -6.2%, 0.9%)). The results support the well-established safety profiles of these treatments. In addition, the secondary efficacy endpoint was met: patients treated with Dysport experienced a longer duration of effect compared with those treated with Botox (14.2 vs 13.8 weeks, respectively; adjusted difference favoring Dysport (80%CI: 0.2, 5.9) with a pre-specified significance threshold for statistical significance (p=0.17; significance threshold, p=0.20). Evidence of longer duration was consistent across most demographic and clinical subgroups which is important as published research shows that over 80% of patients experience breakthrough symptoms between injection cycles and more than 70% of patients express a need for longer lasting treatment. DIRECTION is the first ever spasticity trial to compare Dysport (abobotulinumtoxinA) and Botox (onabotulinumtoxinA) directly in adults with upper limb spasticity. It is a Phase IV, randomized, double-blind, crossover trial involving 464 people living with upper limb spasticity at 72 sites across the USA, France, and Canada. Patients in the trial had an average age of 57 years, two-thirds were male, and most patients had spasticity because of a stroke. Each participant received one treatment cycle with each toxin, administered using standardized, instrument-guided techniques to ensure fairness and comparability. The trial used a rigorous design, controlling for factors that could affect treatment outcomes including volume, dilution, dose, muscles treated, and the use of guidance. The trial was powered to detect differences in safety (primary endpoint), duration of response (a key secondary endpoint) and functional outcomes. Upper limb spasticity can significantly impair function, mobility, and quality of life. Botulinum toxin type A injections are a recommended first-line treatment. Many patients express frustration with waning treatment effect before their next scheduled injection, impacting daily function and increasing caregiver burden. Dysport (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in approximately 90 countries, more than 30 years of clinical experience and >18 million treatment years of patient experience. The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics for Dysport (300 units) Powder and Dysport (500 units) Powder, and the U.S. Prescribing Information. Tillkännagivande • May 18
Ipsen Presents First-In-Class Phase II Corabotase Data In Glabellar Lines Ipsen presented the first corabotase data (n=183) for moderate-to-severe glabellar lines at the 2026 Scale Symposium in Nashville, TN. Corabotase is Ipsen’s first-in-class recombinant neuroinhibitor, RNITM. Built from engineered functional domains of A (catalytic) and B (binding), every element of its structure has been deliberately optimized to increase receptor affinity, enhance uptake, and improve resistance to degradation. In the trial, at Week 4, 66% of patients treated with corabotase (50ng) showed a statistically significant =2-grade improvement (composite response) vs 0% with placebo, p=0.0001 (primary endpoint). 54.3% of patients treated with Dysport showed a >2-grade improvement (composite response) at Week 4. At Week 24, 60.8% of patients treated with corabotase (50ng) experienced clinically significant sustained duration of effect vs placebo (0.2%) and vs Dysport (36.7%), defined as an investigator-assessed score of “none” or “mild” of line severity. These results were reinforced by patient satisfaction scores with 82.8% of those treated with corabotase (50ng) rating “very satisfied” or “satisfied” on the Subject Level of Satisfaction (SLS) 4-point categorical scale. Patient reported data also showed a rapid onset of action with corabotase (50ng) of 0.84 days and was well-tolerated with no significant safety concerns with any of the evaluated doses of corabotase across Stage 1. Frequency of adverse events was comparable across all treatment arms of corabotase, Dysport and placebo. Corabotase continued to show a greater response in line severity vs Dysport at Week 36. In this trial, Dysport was shown to perform consistently with its clinical profile. Following evaluation of these data, the 50ng dose was selected for further evaluation in our Phase III LAURITE program. Doses of corabotase are expressed in nanograms (ng) and are not directly comparable with unit-based dosing of naturally occurring toxins. The Phase II LANTIC trial remains ongoing with proof-of-concept data expected for two further aesthetic indications in forehead and lateral canthal lines. Corabotase (IPN10200) is a purposefully engineered recombinant neuroinhibitor, RNITM, designed through advanced protein engineering and Ipsen’s proprietary manufacturing platform. Built from engineered functional domains of A (catalytic) and B (binding), every element of its structure has been optimized to increase receptor affinity, enhance uptake, and improve resistance to degradation. This enables long lasting inhibition of neurotransmitter release and sustained reduction in muscle activity. LANTIC (n=727) is a Phase I/II trial evaluating the safety and efficacy of corabotase in three aesthetic indications of moderate to severe upper facial lines: glabellar lines, forehead lines and lateral canthal lines, across 3 Stages. Stage 1 (data presented at the SCALE symposium) included patients evaluating safety and efficacy of corabotase in a dose finding and dose escalation stage in glabellar lines, with three defined steps including multiple doses of corabotase; dose-escalation (step 1: Phase Ib), dose finding vs placebo and vs Dysport (step 2: Phase II) and additional dose finding vs placebo and vs Dysport (step 3: Phase II). Different doses of corabotase were evaluated within each step. Step 3 is the basis of the proof-of-concept data for corabotase in glabellar lines including 183 patients. Stages 2 and 3 (Phase II) will evaluate corabotase in all three upper facial indications vs placebo. The LANTIC trial is one of several ongoing trials within Ipsen’s broader corabotase development programs. Tillkännagivande • May 15
Ipsen Unveils Corabotase, First-In-Class Recombinant Neuroinhibitor RNI Ipsen announced the presentation of the Phase II LANTIC trial for the first aesthetic glabellar lines indication with corabotase, a custom-designed molecule recognized as the first in a newly designated class at the SCALE 2026 symposium on May 16, 2026. The Phase I/II trial evaluates the safety and efficacy of corabotase in three aesthetic indications of moderate to severe upper facial lines: glabellar lines, forehead lines and lateral canthal lines. Corabotase is the first investigational molecule in a newly designated class of recombinant neuroinhibitors, RNITM, as recognized by the WHO and USAN. Phase II data in glabellar (frown) lines to be featured as a late-breaking presentation at the SCALE Symposium. A broad Phase II and Phase III clinical program is advancing corabotase across multiple aesthetic and therapeutic indications. Corabotase is currently being evaluated as an investigational treatment in aesthetic indications. In September 2025, Ipsen reported positive Phase II data from the LANTIC trial, confirming a differentiated clinical profile for corabotase in glabellar lines, with a rapid onset of action and clinically sustained duration of effect. The trial remains ongoing with proof-of-concept data expected later this year for two further aesthetic indications in upper facial lines (forehead lines and lateral canthal lines). Corabotase (IPN10200) is a purposefully engineered recombinant neuroinhibitor, RNITM, designed through advanced protein engineering and Ipsen’s proprietary manufacturing platform. Built from engineered functional domains of A (catalytic) and B (binding), every element of its structure has been deliberately optimized to increase receptor affinity, enhance uptake, and improve resistance to degradation. This enables long lasting inhibition of neurotransmitter release and sustained reduction in muscle activity. LANTIC (n=727) is a Phase I/II trial evaluating the safety and efficacy of corabotase in three aesthetic indications of moderate to severe upper facial lines: glabellar lines, forehead lines and lateral canthal lines, across 3 Stages. Stage 1 included patients evaluating safety and efficacy of corabotase in a dose finding and dose escalation stage in glabellar lines, with three defined steps including multiple doses of corabotase; dose-escalation (step 1: Phase Ib), dose finding vs placebo and vs Dysport (step 2: Phase II) and additional dose finding vs placebo and vs Dysport (step 3: Phase II). Different doses of corabotase were evaluated within each step. Step 3 is the basis of the proof-of-concept data for corabotase in glabellar lines including 183 patients. Stages 2 and 3 (Phase II) will evaluate corabotase in all three upper facial indications vs placebo. The LANTIC trial is one of several ongoing trials within Ipsen’s broader corabotase development programs. Live-nyheter • May 15
Ipsen Unveils New IQIRVO Phase III Results and Strengthens Focus on Liver Disease at EASL 2026 Ipsen presented late-breaking Phase III ELATIVE trial data on IQIRVO at the EASL Congress 2026, reinforcing its role as a second-line treatment option for Primary Biliary Cholangitis (PBC).
Two real-world studies showed that 59% of patients on IQIRVO achieved alkaline phosphatase normalization at six months, alongside reported improvements in fatigue and pruritus.
Together with GENFIT, Ipsen also highlighted growing focus on Acute-on-Chronic Liver Failure (ACLF), signaling broader engagement in liver disease research.
The new IQIRVO data and real-world evidence point to deeper clinical adoption potential in PBC and a stronger clinical profile that may matter for physician choice in second-line treatment.
Ipsen’s visibility at a major liver congress and its involvement in the ACLF research ecosystem provide additional datapoints to watch around pipeline execution, while also underlining the usual development and regulatory risks tied to complex liver indications. Tillkännagivande • Apr 06
Ipsen S.A., Annual General Meeting, May 13, 2026 Ipsen S.A., Annual General Meeting, May 13, 2026. Location: 9 bis avenue d iena, paris France Declared Dividend • Apr 06
Dividend increased to €1.60 Dividend of €1.60 is 14% higher than last year. Ex-date: 3rd June 2026 Payment date: 5th June 2026 Dividend yield will be 1.0%, which is lower than the industry average of 3.9%. Payout Ratios Payout ratio: 26%. Cash payout ratio: 14%. Tillkännagivande • Mar 18
Ipsen Showcases Transformative Potential of Early Immuno-Oncology Pipeline At AACR Ipsen announced the presentation of new preclinical data across multiple early development programs currently in Phase I clinical trials, at the American Association of Cancer Research (AACR) congress. These latest data include an oral presentation for T cell activator (TCA) IPN01203 to be presented during the coveted New Drugs on the Horizon program session, highlighting the differentiated mode of action, activating Vß6/Vß10 T cells. These latest preclinical data will expand the growing evidence base, reinforcing the first-in-class potential of IPN01203 to improve outcomes where there are significant unmet needs for people living with solid tumors. Additionally, Ipsen revealed ITGA2 as the novel target for innovative antibody-drug conjugate (ADC) IPN60300, now in active Phase I evaluation. Preclinical findings showed pronounced over-expression of ITGA2 across multiple solid tumors—including pancreatic, gastric and colorectal cancers—with clear differential expression when compared to normal tissues. These results confirmed that IPN60300 binds specifically and with high affinity to ITGA2, enabling efficient internalization and accumulation of the exatecan payload. Further preclinical tumor model data showed dose-dependent anti-tumor activity and favorable tolerability, suggesting a promising first-in-class therapy with the potential to improve clinical outcomes. IPN01203 and IPN60300 combine precision targeting with innovative mechanisms of action with the aim of delivering strength of efficacy where few other treatments exist. IPN01203 is a first-in-class T cell activator which selectively activates a group of Vß6 T cells through the TCR and IL-15R pathways, enhancing their ability to recognize and target tumors. IPN01203 was generated by Marengo’s Selective T Cell Activation Repertoire (STAR) platform, a multi-specific fusion protein library that targets specific TCR Vß variants fused to different co-stimulate moieties to develop potent T cell activators. A Phase I/II dose escalation and expansion trial is ongoing. IPN60300 is a first-in-class antibody-drug conjugate targeting the novel tumor antigen ITGA2 known to be overexpressed in many solid tumors, including pancreatic, gastric and colorectal cancers. This novel tumor antigen was identified using Foreseen’ Biotechnology’s high throughput, integrated translational proteomics, and artificial intelligence (AI)-powered screening platforms. Comprised of an ITGA2-targeting antibody, exatecan payload and innovative linker from Escugen Biotechnology’s EZWi-Fit, IPN60300 is optimally designed to allow for a wide therapeutic index, with potential for improved efficacy over standard of care as well as a favorable safety profile. A Phase I/II dose escalation and expansion trial is ongoing. Tillkännagivande • Mar 13
Ipsen Announces Executive Changes Ipsen announced the appointment of Michelle C. Werner as Executive Vice President (EVP), President of North America, effective March 23, 2026. Michelle will serve on the Executive Leadership Team (ELT) and will report directly to Ipsen’s Chief Executive Officer (CEO), David Loew. Michelle joins us from Alltrna, a U.S.-based biotech, where she has served as President and CEO since 2022. Michelle has spent her 25+ year career in the pharmaceutical industry, starting at Bristol Myers Squibb (BMS) first in the sales and commercial teams in UK at country level and then marketing for the EMEA region within their Oncology division. In 2009 she was appointed Director for Global Market Access for their Oncology & Virology portfolios, back in the U.S. In 2011 she was appointed Global Brand Lead for their Non-Small Cell Lung Cancer (NSCLC) portfolio and in 2014 she became the U.S. Brand Lead for their Reyataz and Evotaz franchises. In 2015 Michelle moved to AstraZeneca to serve as Head of the Immuno-Oncology franchise & Oncology business unit in the U.S. where she oversaw several major product launches. In 2018 she was appointed Country President for the Nordics & Baltics based in Sweden. In 2020 Michelle came back to the U.S. as Global Franchise Head for Hematology. Shortly after, she moved to Novartis Oncology where she served as Global Franchise Head for Solid Tumors starting in July 2020, before joining Alltrna. Keira Driansky, EVP and President for North America, is leaving the company to pursue external opportunities. Tillkännagivande • Mar 10
Ipsen Voluntarily Withdraws Tazverik in Follicular Lymphoma and Epithelioid Sarcoma Ipsen announced that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen markets. Ipsen’s decision to withdraw is based on emerging data from the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab (R) vs R in follicular lymphoma). The Independent Data Monitoring Committee (IDMC) advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma (FL) and epithelioid sarcoma (ES). In addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrolment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the United States (U.S.) Food and Drug Administration (FDA) on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process. Tazverik is marketed in the U.S. by Ipsen in FL and ES. Tazverik received accelerated approval from the U.S. FDA in 2020 for adults with relapsed or refractory FL whose tumors are positive for an EZH2 mutation and who have received at least two prior therapies as well as relapsed or refractory FL adult patients who have no satisfactory alternative treatment options. Tazverik also received U.S. FDA accelerated approval in 2020 for the treatment of adults and adolescents aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Buy Or Sell Opportunity • Mar 09
Now 20% undervalued Over the last 90 days, the stock has risen 25% to €154. The fair value is estimated to be €193, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 7.2% over the last 3 years. Earnings per share has declined by 9.2%. For the next 3 years, revenue is forecast to grow by 3.9% per annum. Earnings are also forecast to grow by 11% per annum over the same time period. Price Target Changed • Feb 25
Price target increased by 7.1% to €143 Up from €134, the current price target is an average from 15 analysts. New target price is 10% below last closing price of €159. Stock is up 44% over the past year. The company is forecast to post earnings per share of €9.95 for next year compared to €5.37 last year. Major Estimate Revision • Feb 19
Consensus EPS estimates increase by 10% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has improved. 2026 revenue forecast increased from €3.99b to €4.12b. EPS estimate increased from €9.03 to €9.95 per share. Net income forecast to grow 90% next year vs 60% growth forecast for Pharmaceuticals industry in France. Consensus price target up from €134 to €141. Share price rose 7.2% to €158 over the past week. Reported Earnings • Feb 15
Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2025 results: EPS: €5.37 (up from €4.30 in FY 2024). Revenue: €3.93b (up 9.9% from FY 2024). Net income: €443.5m (up 25% from FY 2024). Profit margin: 11% (up from 10.0% in FY 2024). Revenue exceeded analyst estimates by 4.2%. Earnings per share (EPS) missed analyst estimates by 38%. Revenue is forecast to grow 3.3% p.a. on average during the next 3 years, compared to a 4.2% growth forecast for the Pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has increased by 13% per year, which means it is well ahead of earnings. Tillkännagivande • Feb 12
Ipsen S.A. Provides Earnings Guidance for the Full Year 2026 Ipsen S.A. provided earnings guidance for the full year 2026. For the year, 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. Tillkännagivande • Jan 29
Ipsen Nominates Peter Guenter to its Board of Directors, Effective January 28, 2026 Ipsen announced the co-optation of Peter Guenter to its Board as a Director, effective January 28, 2026, further to the vacancy of Mr. Henri Beaufour’s position. Peter Guenter holds nearly 40 years of experience as an executive leader in the global pharmaceutical industry. Most recently, he served as Chief Executive Officer of Merck Healthcare and member of the Executive Board of Merck Group from 2021 to 2025. Prior to that, Peter was CEO at Almirall, where from 2017 onward, he led the company’s strategic refocus on medical dermatology. He also spent more than 20 years at Sanofi across numerous leadership roles and joined Sanofi's Executive Committee in 2013. Throughout his career, Peter has had a proven track record of success in partnerships, and excellence in execution. Beyond these executive leadership roles, Peter is an active contributor to a variety of boards across the healthcare and private equity landscapes. Following this co-optation, Ipsen’s Board of Directors will remain composed of 14 directors: seven women and seven men, including five independent directors and two directors representing employees. At the next Shareholders’ meeting, there will be a request for ratification of this decision, which would remain in effect for the remainder of Henri Beaufour’s term of office, until the 2027 Shareholders’ meeting. Tillkännagivande • Jan 27
Ipsen Announces Executive Changes Ipsen announced that Pierrick Lefranc will be appointed as Executive Vice President (EVP) Technical Operations and member of the Executive Leadership Team (ELT), effective April 1, 2026. Pierrick will succeed Aidan Murphy, EVP Technical Operations and Member of the ELT, who will retire in March 2026. Pierrick brings over 30 years of experience in the pharmaceutical industry. Throughout his career, he has led manufacturing operations and large-scale industrial projects, consistently driving improvements in productivity, quality, and regulatory compliance. Since July 2019, Pierrick has served as Senior Vice President at Ipsen overseeing global manufacturing activities, engineering, and enterprise excellence. He joined the company in 2013 and was appointed as Head of the signs site in France in 2016. Pierrick will be based in Paris and report directly to David Loew, CEO. Tillkännagivande • Dec 20
Ipsen Announces Pivotal Phase II FALKON Trial Do Not Meet Its Primary Endpoint of Reducing New Heterotopic Ossification in Adults and Children Living with Fibrodysplasia Ossificans Progressiva Ipsen announced that the pivotal Phase II FALKON trial did not meet its primary endpoint of reducing new heterotopic ossification (HO) in adults and children living with fibrodysplasia ossificans progressiva (FOP) vs. placebo, as a result the study will be closed. The investigational medicinal product (fidrisertib) was generally well tolerated, with no safety concerns in the trial. Tillkännagivande • Dec 16
Ipsen S.A. (ENXTPA:IPN) completed the acquisition of ImCheck Therapeutics SAS from Kurma Partners SA, Gimv NV (ENXTBR:GIMB) and others. Ipsen S.A. (ENXTPA:IPN) entered into a definitive share purchase agreement to acquire ImCheck Therapeutics SAS from Kurma Partners SA, Gimv NV (ENXTBR:GIMB) and others for €1.4 billion on October 22, 2025. Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a €350 million payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to €1 billion. As a result of this transaction, Gimv will receive an upfront cash payment that represents a realized money multiple of 2.6x on our total investment and a positive impact of approximately €0.4 per share compared to the unaudited NAV communicated in the trading update at the beginning of September. Should all regulatory and sales-based milestones be achieved, this could result in a potential total money multiple of 7.1x, subject to the successful completion of these milestones.
The transaction is expected to close by the end of first quarter of 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations.
Marc Castagnède, Olivier Picquerey, Laëtitia Bénard, Charles Tuffreau, Luc Lamblin, Laurie-Anne Ancenys and Charles del Valle of Allen & Overy France acted as legal advisor for Ipsen S.A. Centerview Partners acted as financial advisor for ImCheck Therapeutics SAS. Graham Defries and Kenny Walker-Durrant of Goodwin Procter Llp acted as legal advisor for ImCheck Therapeutics SAS. Dentons Europe, Association d'Avocats à Responsabilité Professionnelle Individuelle acted as legal advisor for ImCheck Therapeutics SAS. Allen & Overy LLP acted as legal advisor for Ipsen S.A.
Ipsen S.A. (ENXTPA:IPN) completed the acquisition of ImCheck Therapeutics SAS from Kurma Partners SA, Gimv NV (ENXTBR:GIMB) and others on December 15, 2025. Tillkännagivande • Dec 01
Ipsen Announces Demise of Board Member Henri Beaufour on November 28, 2025 Ipsen announced that Henri Beaufour, Ipsen Board Member and a representative of the founding family, passed away on Friday, 28 November 2025. Beaufour, together with his sister Anne Beaufour, played a pivotal role in supporting the company’s strategic direction and upholding the values established by the Beaufour family. The Board of Directors and Executive Leadership Team extend their heartfelt condolences to the Beaufour family and all who were touched by his life and work. In their capacity as controlling shareholders, Beech Tree and Highrock reiterate their intent to continue to act together in the best interests of the Ipsen group and to support its ongoing development. Buy Or Sell Opportunity • Nov 26
Now 21% undervalued Over the last 90 days, the stock has risen 6.0% to €125. The fair value is estimated to be €158, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 7.2% over the last 3 years. Earnings per share has declined by 13%. For the next 3 years, revenue is forecast to grow by 3.8% per annum. Earnings are also forecast to grow by 9.3% per annum over the same time period. Major Estimate Revision • Oct 23
Consensus EPS estimates increase by 21% The consensus outlook for fiscal year 2025 has been updated. 2025 EPS estimate increased from €7.80 to €9.41. Revenue forecast steady at €3.76b. Net income forecast to grow 68% next year vs 44% growth forecast for Pharmaceuticals industry in France. Consensus price target of €129 unchanged from last update. Share price rose 5.9% to €121 over the past week. Tillkännagivande • Sep 20
Ipsen Announces That Japan's Ministry of Health, Labour and Welfare Grants Regulatory Approval for Bylvay®? (Odevixibat) for the Treatment of Pruritus Associated with Progressive Familial Intrahepatic Cholestasis Ipsen announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval for Bylvay®? (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC). PFIC is a group of rare genetic disorders in which bile acid accumulates in the liver, leading to progressive liver damage and potentially liver failure. The condition severely impacts quality of life through debilitating symptoms such as severe itching (pruritus), caused by the bile accumulation in the liver and bloodstream, which can cause skin mutilation, sleep disruption, irritability, and impaired cognitive and social development. The approval from the MHLW was based on data from a Phase III, open-label study conducted in Japan, which evaluated the efficacy and safety of odevixibat in pediatric patients with PFIC types 1 and 2. The study confirmed improvements in serum bile acid levels and pruritus consistent with the global Phase III PEDFIC results. The Phase III clinical development plan for Bylvay in Japan was managed by Jadeite Medicines Inc. and as part of the strategic collaboration, the new drug application for this indication was transferred to Ipsen headquartered in Tokyo, Japan. Ipsen will also be responsible for commercialization of Bylvay in Japan. Ipsen will also been responsible for commercialization of Bylvay in Japan. Tillkännagivande • Sep 10
Medison and Ipsen Announces Health Canada Approves Bylvay™? (odevixibat) for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome Medison and Ipsen announced that Health Canada has approved Bylvay™ (odevixibat) for the treatment of cholestatic pruritus in patients 12 months and older with Alagille Syndrome (ALGS). Bylvay was first approved in Canada in 2023 for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease. ALGS is a rare genetic disorder that can affect multiple organ systems, including the liver, heart, skeleton, eyes and kidneys.i It is estimated that ALGS is present in 1 in every 30,000 live births.ii Most of those living with ALGS experience cholestatic pruritus which can significantly impair sleep and quality of life. Health Canada's approval of Bylvay for ALGS was supported by data from the global Phase III ASSERT study, which demonstrated the efficacy of Bylvay in reducing cholestatic pruritus associated with ALGS within weeks of treatment. ASSERT is the world's first and only Phase III trial completed in patients with ALGS.iii The study also revealed secondary benefits, including improvements in sleep quality and reductions in bile acid levels, with a favorable safety profile. Medison and Ipsen are part of a multiregional partnership in both Canada and Israel to bring Bylvay to patients suffering from these rare diseases and their families. About Bylvay (odevixibat): Bylvay is a once-daily non-systemic ileal bile acid transport inhibitor (IBATi). Bylvay works in the small intestine and has minimal systemic exposure. It helps reduce itching and lower bile acid levels, two key challenges often faced by ALGS patients. Bylvay allows for flexible dosing based on body weight. Bylvay is available as capsules which can be swallowed whole with a glass of water or opened and sprinkled on soft food or in a liquid. Bylvay was first launched as a treatment option for patients with PFIC in the U.S. in 2021. Bylvay also received regulatory approval in the E.U. in 2021 for the treatment of PFIC in patients aged six months or older. In June 2023, Bylvay was also approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome. Odevixibat received regulatory approval in the E.U. for treating cholestatic pruritus in Alagille syndrome in patients aged six months and older in September 2024 and is marketed under the brand name Kayfanda®. Reported Earnings • Aug 01
First half 2025 earnings: EPS and revenues miss analyst expectations First half 2025 results: EPS: €4.04 (up from €2.92 in 1H 2024). Revenue: €1.94b (up 11% from 1H 2024). Net income: €334.0m (up 38% from 1H 2024). Profit margin: 17% (up from 14% in 1H 2024). Revenue missed analyst estimates by 4.2%. Earnings per share (EPS) also missed analyst estimates by 5.9%. Revenue is forecast to grow 4.5% p.a. on average during the next 3 years, compared to a 4.3% growth forecast for the Pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has increased by 3% per year, which means it is well ahead of earnings. Tillkännagivande • Jul 31
Ipsen S.A. Revises Earnings Guidance for the Year 2025 Ipsen S.A. revised earnings guidance for the year 2025. For the year, total-sales growth greater than 7.0%, at CER. Based on the average level of exchange rates in June 2025, an adverse impact on total sales of around 2% from currencies is expected (prior guidance: greater than 5.0% at CER). Tillkännagivande • Jul 25
Exelixis, Inc. Partner Ipsen Receives European Commission Approval for CABOMETYX®? (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors Exelixis Inc. announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX®? (cabozantinib) for the treatment of adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. The EC approval is based on results from the phase 3 CABOMETYX pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. CABINET was the basis for the U.S. Food and Drug Administrationapproval of CABOMETyX in March 2025 for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well- differentiated epNET; and 2) adult and pediatric patients 12 year of age and older with previously treatment, unresectable, locally Advanced or metastatic, well- Differentiated epNET. CABINet (Randomized, Double-Blinded, Phase III Study of CABOMETY X versus Placebo In Patients with Advanced Neuroendocrine Tumors After Progression on Prior Therapy) is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded National Clinical Trials Network, as part of Exelixis' collaboration through a Cooperative Research and Development Agreement with the NCI's Cancer Therapy Evaluation Program. CABINET is a multicenter, randomized, double-blinded, placebo-controlled phase 3 pivotal trial that enrolled a total of 298 patients in two separate cohorts (pNET and epNET) in the U.S. at the time of the final analysis. Patients were randomized 2:1 to cabozantinib (60 mg) or placebo; each cohort was randomized separately and had its own statistical analysis plan. The trial was stopped early after an interim analysis showed superior efficacy associated with cabozantinib as compared to placebo in each of the two cohorts. Patients with epNET had primary tumors arising in the gastrointestinal (GI) tract, lung, unknown primary sites and other organs. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression or intolerance after at least one U.S. FDA-approved line of prior systemic therapy other than som atostatin analogues. Tillkännagivande • Jul 23
Ipsen S.A. Announces New Appointments to Its Executive Committee Ipsen S.A. announced the following changes to its Executive Committee: Mari Scheiffeleis appointed to EVP, Chief Product Officer . Andreas Gerberis appointed to EVP, Head of International. Caroline Sitbonis appointed to EVP, General Counsel. Mari, Andreas and Caroline will report to Ipsen’s Chief Executive Officer, David Loew, beginning September 1, 2025. After 4 years successfully leading the commercial operations for the International Region at Ipsen, Mari Scheiffele will now lead all medicines in Oncology and Rare Disease at Ipsen. In the new role, Mari will focus on driving product development and pipeline innovation for new medicines and lead globally, brands and life cycle management. Mari succeeds Bartek Bednarz who will now lead the newly created Asia, Pacific & China region at Ipsen. Andreas Gerberjoins Ipsen from Johnson & Johnson where he most recently served as Worldwide Vice-president and Head of the Oncology Franchise. In his new role as Head of International, Andreas will lead Ipsen’s operations in all geographies excluding North America. Andreas’s extensive business acumen and commercial operations experience will support driving growth in Ipsen’s three therapeutic areas: Oncology, Rare Disease and Neuroscience across the International region. Andreas succeeds Mari Scheiffele. Finally, Caroline Sitbon has been promoted to the role of Ipsen’s General Counsel. Caroline joined the company from GSK in 2024 as Senior Vice President, Legal Affairs. In her new role, Caroline will lead legal and business ethics and will also serve as the Board of Directors’ General Secretary. Caroline succeeds François Garnier who will be retiring after a very successful career, including his tenure as Ipsen’s General Counsel and General Secretary to the Board of Directors. Upcoming Dividend • May 28
Upcoming dividend of €1.40 per share Eligible shareholders must have bought the stock before 04 June 2025. Payment date: 06 June 2025. Payout ratio is a comfortable 33% and the cash payout ratio is 87%. Trailing yield: 1.4%. Lower than top quartile of French dividend payers (5.4%). Lower than average of industry peers (3.9%). Tillkännagivande • Apr 24
Ipsen to Present Data from the Late-Breaking Elafibranor in the Investigational Phase II ELMWOOD Study at the European Association for the Study of the Liver (EASL) Congress Ipsen will be presenting data from the late-breaking abstract on elafibranor in the investigational Phase II ELMWOOD study at the European Association for the Study of the Liver (EASL) congress as an oral presentation, on 10 May at 11.15 CET. For the first time data highlighting the potential of elafibranor in treating people living with primary sclerosing cholangitis (PSC) will be presented. PSC is a rare liver disease that currently has no approved treatment options. Symptoms of PSC can include switching, fatigue, jaundice, and abdominal pain. Over time, PSC can result in complications like bile duct infections, liver cirrhosis, and an increased risk of liver cancer. Currently, there are no FDA or EMA approved therapies for the treatment of PSC. The ELMWOOD phase II study is a randomized, double-blind, placebo-controlled study which evaluated the safety and efficacy of elafibranor In treating PSC, a rare liver disease. Conducted over 12 weeks, the trial involved 68 patients who were randomized to receive either elafibranor (80 mg or 120 mg) or a placebo. Activation of PPARa and PPARd decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. Activation of PPAR a and PPARd also has anti-inflammatory effects by acting on different pathways. In 2019, elafibranor was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with Primary Biliary Cholangitis (PBC) who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC. Elafibranor under the brand name IQIRVO®? was granted U.S. FDA accelerated approval in June 2024, EU conditional approval by the European Commission (EC) in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) approval in October 2024, for the treatment of PBC in combination with ursodeoxycholic Acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA, EC and MHRA approvals are contingent on the further verification of clinical benefit. Elafibranor was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021. Tillkännagivande • Apr 17
Ipsen S.A. Confirms Guidance for the Full-Year 2025 Ipsen S.A. confirmed guidance for the full-year 2025. Total sales growth greater than 5.0%, at constant currency. Based on the average level of exchange rates in March 2025, a limited effect on total sales 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. Declared Dividend • Apr 14
Dividend increased to €1.40 Dividend of €1.40 is 17% higher than last year. Ex-date: 4th June 2025 Payment date: 6th June 2025 Dividend yield will be 1.5%, which is lower than the industry average of 3.9%. Sustainability & Growth Dividend is covered by both earnings (33% earnings payout ratio) and cash flows (87% cash payout ratio). The dividend has increased by an average of 5.1% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 50% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Tillkännagivande • Feb 15
Ipsen S.A. Provides Earnings Guidance for the Year 2025 Ipsen S.A. provided earnings guidance for the year 2025. Financial guidance for 2025 including 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. Reported Earnings • Feb 14
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: EPS: €4.30 (down from €7.46 in FY 2023). Revenue: €3.57b (up 8.1% from FY 2023). Net income: €355.9m (down 42% from FY 2023). Profit margin: 10.0% (down from 19% in FY 2023). Revenue missed analyst estimates by 2.4%. Earnings per share (EPS) also missed analyst estimates by 45%. Revenue is forecast to grow 5.0% p.a. on average during the next 3 years, compared to a 5.3% growth forecast for the Pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has fallen by 10% per year but the company’s share price has increased by 4% per year, which means it is well ahead of earnings. Tillkännagivande • Feb 14
Ipsen S.A., Annual General Meeting, May 21, 2025 Ipsen S.A., Annual General Meeting, May 21, 2025. Major Estimate Revision • Feb 13
Consensus EPS estimates fall by 11% The consensus outlook for fiscal year 2025 has been updated. 2025 EPS estimate fell from €8.54 to €7.59 per share. Revenue forecast steady at €3.72b. Net income forecast to grow 2.1% next year vs 13% growth forecast for Pharmaceuticals industry in France. Consensus price target broadly unchanged at €128. Share price fell 7.1% to €113 over the past week. Tillkännagivande • Sep 16
Ipsen Provides Update on CONTACT-02 Phase III Trial in Metastatic Castration-Resistant Prostate Cancer Following Final Overall Survival Analysis Ipsen announced detailed final overall survival (OS) data from the Phase III CONTACT-02 trial investigating the combination of Cabometyx® (cabozantinib) and atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). The trial investigated the combination regimen versus a second novel hormonal therapy (NHT) in men previously treated with one NHT and measurable soft-tissue disease. At a median follow-up of 24.0 months, these data demonstrated a numerical but not statistically significant improvement in OS for the combination versus a second NHT (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296). As previously announced, the trial met the other primary endpoint of progression-free survival (PFS), demonstrating a statistically significant benefit in PFS. Safety for the combination appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified. Based on the results of the final OS analysis and anticipated challenging regulatory environment in the countries in which Ipsen has commercialization rights (outside the US and Japan), Ipsen will not pursue regulatory submissions for this combination regimen in mCRPC. Tillkännagivande • Jul 26
Ipsen Receives CHMPPositive Opinions for Iqirvo® (Elafibranor) in Primary Biliary Cholangitis and Kayfanda® (Odevixibat) in Alagille Syndrome, Two Rare Cholestatic Liver Diseases Ipse announced wo positive opinions by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for two different rare cholestatic liver disease medicines from the company’s growing portfolio. Iqirvo® (elafibranor) has been recommended for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Kayfanda® (odevixibat) has also received a positive opinion from CHMP as a treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older. The European Commission will now consider the CHMP recommendations. Final decisions on marketing authorization for Iqirvo and for Kayfanda are anticipated in third quarter of 2024. Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed by Ipsen from Genfit in 2021. The CHMP positive opinion is based mainly on data from the Phase III ELATIVE trial. The composite endpoint was achieved with results demonstrating statistically significant improvements in alkaline phosphatase (ALP) and total bilirubin (TB), biomarkers of PBC disease progression. For the key secondary endpoint using the PBC Worst Itch NRS score a trend towards improvement in pruritus (itch) was observed for elafibranor versus placebo, which was not statistically significant. Two other secondary patient-reported outcome measures were used to assess itch, and greater reductions were observed with Iqirvo compared with placebo at Week 52, according to the itch domain of PBC-40 quality of life questionnaire (LS mean difference -2.3; 95% CI, -4.0 to -0.7) and 5-D Itch total score (LS mean difference, -3.0; 95% CI, -5.5 to -0.5). Reported Earnings • Jul 26
First half 2024 earnings: EPS and revenues miss analyst expectations First half 2024 results: EPS: €2.92 (up from €2.36 in 1H 2023). Revenue: €1.75b (up 7.9% from 1H 2023). Net income: €242.0m (up 24% from 1H 2023). Profit margin: 14% (up from 12% in 1H 2023). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 3.9%. Earnings per share (EPS) also missed analyst estimates by 24%. Revenue is forecast to grow 5.2% p.a. on average during the next 3 years, compared to a 5.0% growth forecast for the Pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has increased by 4% per year, which means it is well ahead of earnings. Tillkännagivande • Jul 25
Ipsen S.A. Upgrades Earnings Guidance for the Full Year 2024 Ipsen S.A. upgraded earnings guidance for the full year 2024. For the year, the company expects total-sales growth greater than 7.0%, at constant currency (prior guidance: greater than 6.0% at constant currency). Based on the average level of exchange rates in June 2024, an adverse impact on total sales of around 1% from currencies is expected . 
