Ipsen to Host an Investor Day to Highlight Its Innovative R&D Pipeline and Provide Financial Outlook for 2022

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today will host an Investor Day in Paris to present a comprehensive corporate update, with a focus on its advancing R&D pipeline.

David Meek, Chief Executive Officer of Ipsen stated: “The business momentum of Ipsen is strong, delivering industry-leading top-line growth and investing to build an innovative and sustainable pipeline. The execution of our R&D strategy over the last two years through accelerating key internal programs and externally sourcing innovation has significantly strengthened the focus and value of our pipeline.

“Ipsen currently has five new chemical entities in clinical development, nine significant regulatory submissions planned from 2019 to 2022 and several mid-to-late-stage program readouts in the coming months. We remain committed to executing on our top-line, bottom-line and pipeline growth strategy to create and deliver long-term value to patients and shareholders.”

In Rare Diseases, palovarotene is a late-stage and largely de-risked drug candidate for the treatment of rare and extremely disabling bone disorders with no current treatment options. Palovarotene has Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations and is supported by robust clinical data. The company expects to submit an NDA to the FDA in the second half of 2019 for the first indication of fibrodysplasia ossificans progressiva (FOP).

In Neuroscience, Ipsen is pursuing two new therapeutic indications to maximize the potential of Dysport. The Company is also leveraging its research and development expertise building upon its neurotoxin franchise to advance its proprietary next-generation neurotoxin program with a fast-acting neurotoxin to enter Phase 2 clinical development in the second half of 2019 and a long-acting neurotoxin in preclinical development.

In Oncology, there are numerous ongoing mid-to-late-stage programs to broaden the scope of Cabometyx (cabozantinib) and Onivyde (irinotecan liposomal). The Phase 3 CheckMate 9ER trial in combination with nivolumab has the potential to strengthen Cabometyx^’s presence in the first-line renal cell cancer market, with top-line results expected in the first half of 2020. In addition, the Phase 3 trial in combination with atezolizumab for first-line hepatocellular carcinoma has the potential to expand the use of Cabometyx earlier in the treatment paradigm and to serve as the registrational trial to enter China.