Ipsen delivers robust sales growth in the first quarter of 2023 and confirms its full-year guidance

Paris (France), 27 April 2023

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today presents its sales performance for the first quarter of 2023.

Highlights

• Total-sales growth of 5.7% at CER¹, or 7.8% as reported, driven by the performance of the growth platforms³, up by 14.7%¹, with Dysport^® (abobotulinumtoxinA) up by 25.2%¹ and Cabometyx^® (cabozantinib) up by 31.0%¹, respectively. The performance included contributions from newly acquired Tazverik^® (tazemetostat) and Bylvay^® (odevixibat)
• Completion of the definitive merger agreement for the acquisition of Albireo, expanding Ipsen’s scope in Rare Disease
• Regulatory-decision dates in the U.S. confirmed for Bylvay in Alagille syndrome and palovarotene in fibrodysplasia ossificans progressiva (FOP), respectively
• Full-year 2023 guidance confirmed, with total-sales growth greater than 4.0% at CER¹ and a core operating margin of around 30% of total sales

David Loew, Chief Executive Officer, commented:

“Ipsen continues to make excellent progress in its transformation. We delivered further robust sales growth in the quarter, led by the standout performances of Dysport and Cabometyx. Based on the continued sales momentum, we are confirming our guidance for the full year. I was also delighted by the further enhancement of our pipeline, portfolio and organization as a result of the recent acquisition of Albireo; through our global presence, we will continue to meet the unmet medical needs of an increasing number of patients. As we replenish the pipeline and execute on recent transactions, we look forward to several milestones for our business, including the Phase III data readout for elafibranor and anticipated regulatory developments for Onivyde, palovarotene and Bylvay.”

Full-year 2023 guidance

Ipsen has confirmed its financial guidance for FY 2023⁴:

• Total-sales growth greater than 4.0%, at constant exchange rates. Based on the average level of exchange rates in Q1 2023, an adverse impact on total sales of around 2% from currencies is expected
• Core operating margin around 30% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions

Business development

In March 2023, Ipsen announced that it had completed the acquisition of Albireo Pharma, Inc., a leading innovator in bile-acid modulators to treat rare liver conditions. Ipsen acquired all issued and outstanding shares at a price of $42.00 per share in cash, plus one non-transferable contingent value right of $10.00 per share.

Pipeline development

In February 2023, it was announced that the U.S. Food and Drug Administration had accepted the supplemental New Drug Application for a second Bylvay indication, for patients with Alagille syndrome. The administration also issued a Prescription Drug User Fee Act (PDUFA) action date of 15 June 2023.

In March 2023, it was announced that the PDUFA action date in the U.S., for the resubmitted New Drug Application for palovarotene as a potential treatment for FOP, will be 16 August 2023. The Company also recently requested a re-examination of the negative opinion from the CHMP⁵ for palovarotene, received in January 2023.

Conference call

A conference call and webcast for investors and analysts will begin today at 2pm, Paris time. Participants can access the call and its details by registering here; webcast details can be found here. A recording will be available on ipsen.com.

Calendar

Ipsen intends to publish its half-year and second-quarter results on 27 July 2023.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the three-month period to 31 March 2023 (the first quarter or Q1 2023), compared to the three-month period to 31 March 2022 (Q1 2022), unless stated otherwise.

Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,400 colleagues worldwide and 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.