IPSEN SA S/ADR - IPSEY STOCK NEWS

Ipsen announced a positive recommendation from the European Medicines Agency's CHMP for Cabometyx as a treatment for locally advanced or metastatic differentiated thyroid cancer (DTC) in adults. This recommendation is based on the COSMIC-311 Phase III trial, where Cabometyx showed a 78% reduction in disease progression or death compared to placebo. The objective response rate was 15% for Cabometyx versus 0% for placebo. This follows prior FDA approval in September 2021. Cabometyx is marketed in over 60 countries worldwide, addressing a critical need for new treatment options.

Ipsen has announced the development of a new electronic autoinjector for Somatuline Autogel/Somatuline Depot, aiming to enhance the patient experience for those with gastroenteropancreatic neuroendocrine tumors, carcinoid syndrome, or acromegaly. The device, built in partnership with Phillips-Medisize, is part of a €60 million investment in innovation and manufacturing. Performance and safety studies are ongoing, with the first launches expected in 2024. This fourth-generation device promises improved injection comfort for patients and caregivers.

Ipsen has reported its share capital details as of February 28, 2022. The company has a total of 83,814,526 shares, resulting in a gross total of 132,100,358 voting rights. The net total of voting rights stands at 130,837,209, considering the deduction of shares without voting rights. This announcement adheres to the French Commercial Code and regulations established by the Autorité des Marchés Financiers.

Ipsen presented new data at the ENETS 2022 conference, highlighting the benefits of Somatuline Autogel/Somatuline Depot (lanreotide) over octreotide in patients with gastroenteropancreatic neuroendocrine tumors. The PRESTO 2 survey showed significantly fewer patients experienced injection-site pain lasting over two days with Somatuline (6.0%) vs. octreotide (22.8%). Additionally, HomeLAN survey participants reported high satisfaction (95.5%) with their at-home injection experience, indicating improved patient control and comfort in treatment.

Ipsen announced the appointment of Catherine Abi-Habib as EVP Strategy, Transformation, and Digital, effective March 1, 2022. She replaces Dominique Bery, who will head the Nordics & Baltics. With over 10 years of experience in life sciences, she previously worked at McKinsey, specializing in performance transformation. CEO David Loew emphasized her expertise in digital innovation as key to Ipsen's strategy. Ipsen reported €2.9bn in sales in FY 2021 and operates globally in oncology, rare diseases, and neuroscience.

Ipsen announced updated two-year results from the Phase III CheckMate -9ER trial, demonstrating significant efficacy of Cabometyx (cabozantinib) combined with Opdivo (nivolumab) for advanced renal cell carcinoma (aRCC). Follow-up data showed improved overall survival (37.7 months) and progression-free survival (16.6 months) compared to sunitinib. The safety profile remained consistent, with 97.2% experiencing treatment-related adverse events. Patients reported enhanced health-related quality of life benefits. The results will be presented at the ASCO GU symposium from February 17-19, 2022.

Ipsen reported robust FY 2021 results with total sales of €2.87bn, up 10.7% as reported and 12.3% at constant currency. Core operating margin improved to 35.2%, with net profit at €646.7m, a 17.8% increase. The company plans to divest its Consumer Healthcare business, valued at up to €350m, to focus on Specialty Care, which constituted 92.1% of sales. Guidance for FY 2022 anticipates over 2% sales growth, excluding Consumer Healthcare, with an updated outlook projecting a 4-6% CAGR from 2020-2024. A proposed dividend of €1.20 per share reflects a 20% increase from the previous year.

Ipsen reported on January 31, 2022, the total number of shares and voting rights regarding its share capital. The company has 83,814,526 shares outstanding, with a gross total of 132,120,082 voting rights and a net total of 130,802,629 voting rights. This update follows provisions under the French Commercial Code regarding voting rights disclosures. The gross total accounts for shares with double voting rights and treasury shares, whereas the net total excludes shares without voting rights.

Ipsen has received Health Canada approval for Sohonos (palovarotene capsules), the first treatment for fibrodysplasia ossificans progressiva (FOP), enabling chronic use and flare-up management for patients aged 8 and above. This marks Sohonos' first global approval, following the MOVE trial which evaluated its efficacy in reducing new bone formation. Ipsen plans to file for U.S. approval in H1 2022 and is in discussions with other global regulators. FOP is an ultra-rare genetic disorder affecting 1.36 per million individuals.