Irinotecan Hydrochloride Lioposome

H1 total sales growth of 11.4% at CER1, or 9.7% as reported, driven by the three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology H1 core operating income of €656m, growing by 21.9% as reported, with a core operating margin of 36.0% of total sales, increasing by 3.6 points Upgraded FY 2025 financial guidance2: total-sales growth greater than 7.0% at CER (prior guidance: greater than 5.0% at CER); core operating margin greater than 32.0% of total sales (prior guidance: greater than 30%) Pipeline progression including regulatory filing of tovorafenib in Europe, and initiation of a Phase II trial of LANT3 (IPN10200) in cervical dystonia European Commission approval on 23 July 2025 of Cabometyx® in advanced neuroendocrine tumors (NETs), the sixth indication Key upcoming milestones with the pivotal FALKON trial results for fidrisertib in FOP4 and the Proof-of-Concept data readout for the LANT in aesthetics PARIS, FRANCE, 31 July 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the first half of 2025. “Our half year results reflect continued strong momentum, with growth across all three therapeutic areas, particularly in our rare liver disease franchise, which is expanding rapidly and progressing well,” said David Loew, Chief Executive Officer, Ipsen. “Building on that performance, I am pleased to increase our full year guidance in terms of sales and profitability.” “I’m also delighted to report robust progression in our pipeline and portfolio, including the recent European Commission approval of Cabometyx® in advanced neuroendocrine tumors, an area where Ipsen has a strong legacy. In the second half of the year, we are anticipating the readout of our pivotal study of fidrisertib in fibrodysplasia ossificans progressiva and the proof-of-concept trial of our long-acting neurotoxin in aesthetics. Our focused strategy, our culture of excellence in execution and our commitment to science with purpose position us to provide a positive impact for patients and society.” Full-year 2025 guidance Based on the strong performance in the first half, Ipsen upgrades its financial guidance for 2025: 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 Core operating margin greater than 32.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities Guidance includes a negative impact on Somatuline sales due to a potential increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions. Pipeline update since Q1 2025 In May 2025, Ipsen presented data on Iqirvo® (elafibranor) from the Phase II ELMWOOD study at the European Association for the Study of the Liver congress. It showed a favorable safety profile and demonstrated dose-dependent efficacy over 12 weeks for people living with PSC5, a rare liver disease with no approved treatment options. In June 2025, Ipsen initiated a Phase II study of LANT (IPN10200), in cervical dystonia. This marked the fourth study in the global long-acting neurotoxin development plan in therapeutics and aesthetics indications. On 23 July 2025, Ipsen received European Commission approval for Cabometyx® (cabozantinib) in previously treated advanced neuroendocrine tumors. This approval was based on positive outcomes from the Phase III CABINET trial. Consolidated financial statements The Board of Directors approved the condensed consolidated financial statements on 30 July 2025. The Company’s auditors performed a limited review of the H1 2025 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, 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 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 year-to-date and third-quarter sales update on 22 October 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2025 (H1 2025) and the three-month period to 30 June 2025 (Q2 2025), compared to the six-month period to 30 June 2024 (H1 2024) and the three-month period to 30 June 2024 (H1 2024), respectively, unless stated otherwise. Commentary is based on the performance in H1 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 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 80 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. IPSEN CONTACTS Investors Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com +1 857 32 00 517 Anne Liontas anne.liontas@ipsen.com +33 7 67 34 72 96 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 Long-acting neurotoxin. 4 Fibrodysplasia ossificans progressiva. 5 Primary sclerosing cholangitis Attachment H1 total sales growth of 11.4% at CER1, or 9.7% as reported, driven by the three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology H1 core operating income of €656m, growing by 21.9% as reported, with a core operating margin of 36.0% of total sales, increasing by 3.6 points Upgraded FY 2025 financial guidance2: total-sales growth greater than 7.0% at CER (prior guidance: greater than 5.0% at CER); core operating margin greater than 32.0% of total sales (prior guidance: greater than 30%) Pipeline progression including regulatory filing of tovorafenib in Europe, and initiation of a Phase II trial of LANT3 (IPN10200) in cervical dystonia European Commission approval on 23 July 2025 of Cabometyx® in advanced neuroendocrine tumors (NETs), the sixth indication Key upcoming milestones with the pivotal FALKON trial results for fidrisertib in FOP4 and the Proof-of-Concept data readout for the LANT in aesthetics PARIS, FRANCE, 31 July 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the first half of 2025. “Our half year results reflect continued strong momentum, with growth across all three therapeutic areas, particularly in our rare liver disease franchise, which is expanding rapidly and progressing well,” said David Loew, Chief Executive Officer, Ipsen. “Building on that performance, I am pleased to increase our full year guidance in terms of sales and profitability.” “I’m also delighted to report robust progression in our pipeline and portfolio, including the recent European Commission approval of Cabometyx® in advanced neuroendocrine tumors, an area where Ipsen has a strong legacy. In the second half of the year, we are anticipating the readout of our pivotal study of fidrisertib in fibrodysplasia ossificans progressiva and the proof-of-concept trial of our long-acting neurotoxin in aesthetics. Our focused strategy, our culture of excellence in execution and our commitment to science with purpose position us to provide a positive impact for patients and society.” Full-year 2025 guidance Based on the strong performance in the first half, Ipsen upgrades its financial guidance for 2025: 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 Core operating margin greater than 32.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities Guidance includes a negative impact on Somatuline sales due to a potential increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions. Pipeline update since Q1 2025 In May 2025, Ipsen presented data on Iqirvo® (elafibranor) from the Phase II ELMWOOD study at the European Association for the Study of the Liver congress. It showed a favorable safety profile and demonstrated dose-dependent efficacy over 12 weeks for people living with PSC5, a rare liver disease with no approved treatment options. In June 2025, Ipsen initiated a Phase II study of LANT (IPN10200), in cervical dystonia. This marked the fourth study in the global long-acting neurotoxin development plan in therapeutics and aesthetics indications. On 23 July 2025, Ipsen received European Commission approval for Cabometyx® (cabozantinib) in previously treated advanced neuroendocrine tumors. This approval was based on positive outcomes from the Phase III CABINET trial. Consolidated financial statements The Board of Directors approved the condensed consolidated financial statements on 30 July 2025. The Company’s auditors performed a limited review of the H1 2025 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, 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 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 year-to-date and third-quarter sales update on 22 October 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2025 (H1 2025) and the three-month period to 30 June 2025 (Q2 2025), compared to the six-month period to 30 June 2024 (H1 2024) and the three-month period to 30 June 2024 (H1 2024), respectively, unless stated otherwise. Commentary is based on the performance in H1 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 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 80 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. IPSEN CONTACTS Investors Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com +1 857 32 00 517 Anne Liontas anne.liontas@ipsen.com +33 7 67 34 72 96 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 Long-acting neurotoxin. 4 Fibrodysplasia ossificans progressiva. 5 Primary sclerosing cholangitis Attachment Cabometyx® approved in the EU for previously treated advanced neuroendocrine tumors Ipsen announces changes to its Executive Committee Ipsen receives positive CHMP opinion for Cabometyx® in previously treated advanced neuroendocrine tumors Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma Late-breaking exploratory data highlights the impact of IQIRVO® (elafibranor) on fatigue and provides mechanistic insights into anti-inflammatory and symptom-related effects in patients with primary biliary... Ipsen appoints Laura Réveillon as EVP, Strategy & Transformation Late-breaking elafibranor primary sclerosing cholangitis (PSC) data demonstrates favorable safety profile and significant efficacy in second potential rare liver disease indication Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance Ipsen publishes its 2024 Universal Registration Document Ipsen announces issuance of €500 million inaugural Rated Public Bond You are now leaving the Ipsen group website. To continue, please click on Continue? These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. 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Phase III NAPOLI 3 trial is the largest and has the longest follow-up for an interventional study in metastatic pancreatic adenocarcinoma1 Post-hoc analysis of NAPOLI 3 study determined characteristics associated with long-term survival, with median overall survival of 19.5 months amongst long-term survivors receiving Onivyde® plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy2 Dose reductions and/or treatment delays for the management of adverse events enabled patients to stay on treatment longer and achieve high cumulative doses of liposomal irinotecan and oxaliplatin2 31 May 2025 – Late-breaking (LBA4175) post-hoc analysis data from the Phase III NAPOLI 3 study were presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These results found a median overall survival (mOS) of 19.5 months among long-term survivors (n=15) with metastatic pancreatic adenocarcinoma (mPDAC) treated with the Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line treatment (n=120), with younger age at diagnosis, and certain tumor and metastasis locations associated with long-term survivorship.2 Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed annually in the U.S. and nearly 500,000 people globally.3,4 It is often detected after the disease has spread to other parts of the body (metastatic or stage IV)5 and fewer than 20% of people diagnosed with metastatic pancreatic adenocarcinoma (mPDAC) survive longer than one year.5,6 Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.5,6 “When people are diagnosed with metastatic pancreatic adenocarcinoma, the most important question remains: how long will they have with their loved ones,” said Dr. Vincent Chung, Medical Oncologist, City of Hope. “Findings from the NAPOLI 3 post-hoc analysis provide important context on long-term overall survival with the Onivyde (NALIRIFOX) treatment regimen.” The analysis included patients who survived for 18 months or longer (N=15), with findings showing long-term survivors living with mPDAC had a mOS of 19.5 months (interquartile range [IQR]: 18.8–22.6).2 Clinical and pathological factors of long-term survivors included younger than average age at time of diagnosis (median age 61.0 (IQR: 49.0–70.5) as well as tumor location.2 Fewer patients had tumors in the head or tail of the pancreas (53.3% had the main pancreatic tumor located in the body of the pancreas), a substantial proportion had liver metastasis (66.7%) and ≥3 metastatic sites (53.3%).2 Additionally, findings indicate dose reduction and treatment delays resulted in prolonged exposure and higher cumulative doses of the Onivyde (NALIRIFOX) regimen.1 Liver metastasis and ≥3 metastatic sites, dose modifications and an otherwise good clinical profile enabled people to achieve a long mOS.2 Consideration should be taken when interpreting these results as a post-hoc analysis with a small sample size. "Data from the Phase III NAPOLI 3 trial were the first positive data of its kind in a decade and continue to reinforce the potential for long-term outcomes with the Onviyde (NALIRIFOX) regimen,” said Sandra Silvestri, MD, PhD, Executive Vice President, Chief Medical Officer, Ipsen. “With people on average living just 4-6 months following diagnosis with pancreatic adenocarcinoma, these data help us to understand the characteristics associated with long-term survival seen in the NAPOLI trial, an important advancement for this difficult-to-treat cancer where data of this kind are scarce.” Onivyde is a long-circulating liposomal topoisomerase inhibitor. In Onivyde, irinotecan is enclosed in tiny fat particles called liposomes which accumulate in the tumor and release slowly over time. Onivyde is administered via intravenous infusion over 90 minutes every two weeks with recommendations on dosing modifications. Onivyde, as part of the NALIRIFOX regimen (combined with oxaliplatin, fluorouracil (FU) and leucovorin (LV)), is for people living with mPDAC who are treatment naïve or used in combination with FU and LV following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of adult patients with metastatic pancreatic adenocarcinoma. Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company governed by a foundation and with an international presence in 140 countries, is responsible for the commercialization of Onivyde outside of the U.S., Taiwan and Canada. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan. NAPOLI 3 is a randomized, open-label Phase III trial of an Onivyde treatment regimen (NALIRIFOX) in treatment-naïve mPDAC. NAPOLI 3 enrolled 770 patients across 187 trial site locations in 18 countries across Europe, North America, South America, Asia, and Australia. Patients were randomized to receive Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle). 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 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. References 1 Wainberg et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. 2 Chung et al. NAPOLI 3 phase 3 study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): final overall survival (OS) analysis and characteristics of the long-term survivors. As presented at ASCO Congress 2025 Chicago, USA 3 American Cancer Society – Cancer Facts and Figures 2024. Available : https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf 4 https://www.cancer.net/cancer-types/pancreatic-cancer/statistics 5 Orth, M., Metzger, P., Gerum, S. et al. Pancreatic ductal adenocarcinoma: biological hallmarks, current status, and future perspectives of combined modality treatment approaches. Radiat Oncol 14, 141 (2019). https://doi-org.libproxy1.nus.edu.sg/10.1186/s13014-019-1345-6 The content above comes from the network. if any infringement, please contact us to modify.