On April 26, 2023 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its sales performance for the first quarter of 2023 (Press release, Ipsen, APR 27, 2023, View Source [SID1234630534]).

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Q1 2023 Q1 2022 % change
€m €m Actual CER1
Oncology 570.8 556.4 2.6% 1.1%
Neuroscience 156.4 120.2 30.2% 24.4%
Rare Disease 14.7 11.3 29.8% 29.0%
Total Sales2 741.9 687.9 7.8% 5.7%

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.