On April 23, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its sales for the first quarter of 2024 (Press release, Ipsen, APR 24, 2024, View Source [SID1234642251]).

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Q1 2024  Q1 2023  % change 
€m  €m  Actual CER1
Growth platforms2 509.7 452.0 12.8% 16.2%
New medicines3 45.5 14.3 n/a n/a
Somatuline 257.8 263.2 -2.0% -1.3%
Other 9.5 12.4 -23.8% -20.5%
Total Sales 822.4 741.9 10.9% 13.3%
Highlights

Total-sales growth of 13.3% at CER1, or 10.9% as reported, driven by the 16.2%1 increase in sales of the growth platforms2 and the increased contributions from new medicines, while Somatuline sales declined by only 1.3%1
Regulatory approval and launch of Onivyde in the U.S. as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC)
Confirmation of financial guidance for 2024
"An excellent first-quarter performance has laid a solid foundation for Ipsen’s growth in 2024", commented David Loew, Chief Executive Officer, Ipsen. "The delivery of our strategic plan continues to be evidenced by a strong top line, supported by the success of the growth platforms and the increased contribution of the new medicines. Moreover, the pipeline continues to deliver, illustrated this quarter by the regulatory approval in the U.S. of Onivyde as a first-line treatment for pancreatic cancer.

"This year marks a pivotal period for our growth plans, with the launches of four new medicines or indications. Our focus remains on the performance of our portfolio and the expansion of our pipeline, and a well-defined strategy for sustainable growth centred on enhancing the lives and medical outcomes of patients."

Full-year 2024 guidance

Ipsen has confirmed its financial guidance for 2024, which excludes the impact of any potential additional late-stage4 external-innovation opportunities:

Total-sales growth greater than 6.0%, at constant currency. Based on the average level of exchange rates in March 2024, an adverse impact on total sales of around 1% from currencies is expected
Core operating margin around 30% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities
Guidance on total sales incorporates expectations for Somatuline of further generic-lanreotide products in the U.S and E.U.

Business update

In February 2024, Ipsen announced that the U.S. Food and Drug Administration (FDA) had approved the supplemental new drug application for Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment for adults living with mPDAC. This was the second approval for an Onivyde regimen in mPDAC, after the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin, following disease progression with gemcitabine-based therapy. In conjunction with the approval in the U.S. of Onivyde as a first-line treatment in adults living with mPDAC, Orphan Drug Exclusivity was awarded and regulatory exclusivity was extended to 2031, driven by the automatic seven-year exclusivity period upon approval.

In April 2024, Ipsen announced an exclusive global licensing agreement for STRO-003, an antibody-drug conjugate (ADC) targeting the ROR1 tumor antigen. STRO-003 is in the final stages of pre-clinical development. The agreement gives Ipsen exclusive worldwide rights to develop and commercialize STRO-003 and is the first ADC candidate to join Ipsen’s expanding pipeline.

Ipsen and Skyhawk Therapeutics announced, in April 2024, the signing of an exclusive worldwide collaboration to discover and develop novel small molecules that modulate RNA for rare neurological diseases. The agreement includes an option pursuant to which Ipsen would acquire an exclusive licence for the worldwide rights to develop successful development candidates.

Onivyde litigation

In March 2024, Ipsen received a Paragraph IV notice letter regarding a 505(b)(2) submission to the U.S. FDA by Conjupro Biotherapeutics, Inc. (Conjupro), requesting approval to market an irinotecan hydrochloride liposome injection for the treatment of patients with mPDAC, following gemcitabine-based therapy. The letter challenges various patents that protect Onivyde and its use. In response, Ipsen filed in April 2024 a patent infringement lawsuit against Conjupro and certain related corporate entities in the U.S. District Court for the District of New Jersey and will fully defend its rights as its patent portfolio includes U.S. patent protection for the liposome composition to expire in 2027, with additional patents covering the formulation and approved use in the treatment of patients with mPDAC following gemcitabine-based therapy having expiration dates up to 2033, with additional protection on the first-line use until 2036.

Conference call

A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

Calendar

Ipsen intends to publish its half-year and second-quarter results on 25 July 2024.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the three-month period to 31 March 2024 (Q1 2024, the quarter), compared to the three-month period to 31 March 2023 (Q1 2023).