On October 23, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its performance for the year to date and the third quarter of 2024 (Press release, Ipsen, OCT 23, 2024, View Source [SID1234647337]).
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YTD 2024 YTD 2023 % change Q3
2024 Q3
2023 % change
€m €m Actual CER1 €m €m Actual CER1
Oncology 1 829,8 1 744,1 4,9% 5,8% 604,0 574,5 5,1% 5,6%
Neuroscience 536,4 489,0 9,7% 11,8% 181,9 164,8 10,4% 10,1%
Rare Disease 129,7 76,0 70,7% 71,3% 50,8 33,2 53,1% 54,4%
Total Sales 2 495,9 2 309,1 8,1% 9,2% 836,6 772,4 8,3% 8,6%
Highlights
Total-sales growth in the year to date of 9.2% at CER1, or 8.1% as reported, with notable performances from Dysport (abobotulinumtoxinA), Cabometyx (cabozantinib) and Bylvay (odevixibat), with robust Somatuline (lanreotide) sales, as well as the increasing contribution from the launches of Iqirvo (elafibranor) in 2L PBC2 and Onivyde (irinotecan) in 1L mPDAC3
Regulatory approvals in the E.U. of Iqirvo and Kayfanda (odevixibat)
Increased 2024 financial guidance: total-sales growth greater than 8.0% at CER1 (prior guidance: greater than 7.0% at CER1); core operating margin greater than 31.0% of total sales (prior guidance: greater than 30.0%)
"Since the launch of our strategy in 2020, we have enjoyed uninterrupted growth. This quarter was no exception and was accompanied by further progress in the pipeline", commented David Loew, Chief Executive Officer. "We have also continued to launch across several indications and lines of therapy, including the recent rollouts of Iqirvo and Onivyde, which are progressing well. Supported by the performance so far this year, we are further increasing our 2024 sales and margin guidance."
"We have built a track record of delivery, grounded in a strong foundation of external innovation, commercial excellence and our ongoing mission to offer more choices for patients."
Full-year 2024 guidance
Based on the strong performance in the third quarter, Ipsen has further increased its financial guidance for 2024:
Total-sales growth greater than 8.0%, at constant currency (prior guidance of greater than 7.0%). Based on the average level of exchange rates in September 2024, an adverse impact on total sales of around 1.5% from currencies is expected
Core operating margin greater than 31.0% of total sales (prior guidance of greater than 30.0%)
Pipeline update
In September 2024, the European Commission conditionally approved Iqirvo 80mg tablets for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in patients unable to tolerate UDCA. Iqirvo was approved in the same setting by the U.S. FDA in June 2024.
In September 2024, the European Commission also approved Kayfanda as a treatment for pruritus in children from as young as six months of age who have Alagille syndrome (ALGS). Odevixibat, under the brand name Bylvay, is already marketed in the E.U. for the treatment of progressive familial intrahepatic cholestasis (PFIC), and in the U.S. and E.U. for PFIC, and in the U.S. for ALGS.
In the same month, final results from the CABINET Phase III trial were presented at the 2024 European Society for Medical Oncology Congress and were published in the New England Journal of Medicine, reinforcing the efficacy benefits of Cabometyx in advanced neuroendocrine tumors. It was announced at that time that Ipsen had submitted an extension of indication Marketing Authorization to the European Medicines Agency.
Business development
In August 2024, Ipsen entered into an agreement to sell its rare pediatric disease Priority Review Voucher. As part of the agreement, Ipsen received a cash payment of $158m in the third quarter.
In October 2024, Eton Pharmaceuticals entered into an agreement with Ipsen to acquire Increlex (mecasermin injection). The transaction is expected to close before the end of 2024.
Arbitration proceedings with Galderma
As of 30 September 2024, two arbitration proceedings initiated by Galderma against Ipsen at the International Chamber of Commerce (ICC) were ongoing. The first dispute, initiated by Galderma in 2021, pertains to the territorial scope of the commercial partnership related to Azzalure (abobotulinumtoxinA) and Dysport under an agreement signed in 2007 in the E.U., in certain Eastern European countries, and in Central Asia. The Tribunal of the ICC Internal Court of Arbitration issued a final award, in October 2024, dismissing most, if not all, of Galderma’s claims in this first arbitration and ordered that Galderma bear the majority of the legal fees and arbitration costs incurred by Ipsen.
A second dispute was initiated by Galderma in November 2023, related to the validity of Ipsen’s 2023 termination of a joint R&D collaboration agreement entered into in 2014 under the parties’ respective early-stage neurotoxin programs, including the development of IPN10200. At this stage, Ipsen cannot reasonably predict any potential financial impact from this final remaining arbitration process, for which it intends to fully defend and vindicate its rights.
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