On October 26, 2023 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its sales performance for the year to date and the third quarter of 2023 (Press release, Ipsen, OCT 26, 2023, View Source [SID1234636374]).

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YTD
2023 YTD
2022 % change Q3
2023 Q3
2022 % change
€m €m Actual CER1 €m €m Actual CER1
Oncology 1,744.1 1,767.2 -1.3% 0.8% 574.5 603.1 -4.7% 0.8%
Neuroscience 489.0 407.7 19.9% 24.5% 164.8 160.7 2.5% 13.7%
Rare Disease 76.0 33.6 n/a n/a 33.2 11.0 n/a n/a
Total Sales 2,309.1 2,208.5 4.6% 7.1% 772.4 774.8 -0.3% 6.5%

Sales and pipeline highlights

Total-sales growth in the year to date of 7.1% at CER1, or 4.6% as reported, driven by the performance of the growth platforms2, up by 16.1%1, with Dysport (abobotulinumtoxinA) up by 24.7%1 and Cabometyx (cabozantinib) up by 24.4%1, respectively. The performance included contributions from new medicines Bylvay (odevixibat), Tazverik (tazemetostat) and Sohonos (palovarotene)
Further pipeline progress, including the regulatory approval and launch in the U.S. of Sohonos in Rare Disease and initial results from the CONTACT-02 Phase III trial of Cabometyx plus atezolizumab in Oncology
David Loew, Chief Executive Officer, commented:
"Ipsen’s strategic success has been reflected in further sales and pipeline progress so far this year. Our portfolio has performed well across the three therapy areas, driven by strengthened commercial execution and the results of our external-innovation strategy. Based on the solid sales momentum, today we are confirming our guidance for the full year.

Further good news from the pipeline, including the regulatory approval of Sohonos in the U.S., continue to provide additional options for patients with real unmet medical needs. In the final quarter of the year, we look forward to regulatory steps for elafibranor in primary biliary cholangitis, as well as sharing further details on sustainable growth opportunities across our portfolio and pipeline at our forthcoming capital-markets day."

Full-year 2023 guidance
Ipsen has confirmed its financial guidance for FY 2023:

Total-sales growth greater than 6.0%, at constant exchange rates. Based on the average level of exchange rates in September 2023, an adverse impact on total sales of around 3.5% from currencies is expected
Core operating margin greater than 30% of total sales
Pipeline development

In August 2023, it was announced that the U.S. Food and Drug Administration (FDA) had approved Sohonos, the first and only treatment for people with fibrodysplasia ossificans progressiva.

It was also announced that the global CONTACT-02 pivotal Phase III trial of Cabometyx plus atezolizumab in metastatic castration-resistant prostate cancer met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival at the primary analysis.

In October 2023, the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products confirmed its negative opinion recommending not to maintain the orphan designation for Bylvay in Alagille syndrome (ALGS). This was despite a positive opinion from the Committee for Medicinal Products for Human Use in July 2023. To maintain Bylvay’s orphan designation in the approved treatment of progressive familial intrahepatic cholestasis, Ipsen is planning to resubmit to the EMA under a new brand name for the treatment of ALGS by the end of 2023.

Galderma partnership

In September 2023, the Arbitral Tribunal of the International Chamber of Commerce issued a final decision following a difference of opinion on the regulatory-submission strategy for the liquid botulinum toxin type A, QM1114. In October 2023, Ipsen announced that its partner, Galderma, had received a Complete Response Letter from the U.S. FDA related to its Biologics License Application for QM1114.

A second arbitration proceeding, related to the territorial scope of the Dysport/Azzalure aesthetics’ partnership, is anticipated to conclude next year.

AASLD call
To accompany the presentation of the ELATIVE Phase III trial results at the American Association for the Study of Liver Diseases (AASLD) 2023 Annual World Congress, Ipsen plans to host a conference call for analysts and investors on 14 November 2023, at 4.30pm CET. 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.

Capital-markets day
The Company is planning to host a capital-markets event, starting at 12.30pm GMT on 7 December 2023 in London. The event will be webcast live and details will be available on ipsen.com in due course. In-person attendance will be by invitation only.

Calendar
Ipsen intends to publish its full-year and fourth-quarter results on 8 February 2024.

Conference call: YTD 2023
A conference call and webcast for investors and analysts will begin today at 2pm CET. 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.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2023 (YTD 2023) and the three-month period to 30 September 2023 (Q3 2023), compared to nine-month period to 30 September 2022 (YTD 2022) and the three-month period to 30 September 2022 (Q3 2022), respectively, unless stated otherwise. Commentary is based on the performance in YTD 2023, unless stated otherwise.