On July 27, 2023 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2023 (Press release, Ipsen, JUL 27, 2023, View Source [SID1234633457]).

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H1 2023 total sales up by 7.4% at CER1 (7.2% as reported), with growth-platforms’2 sales increasing by 17.7%1 and a strong contribution from newly acquired medicines, Bylvay (odevixibat) and Tazverik (tazemetostat). Somatuline (lanreotide) sales, now comprising around a third of the total, fell by 12.0%1
H1 2023 core operating margin of 34.0%, a decline of 5.6% points, driven by investment in the pipeline, mainly from Bylvay and Tazverik. IFRS operating margin of 19.2%, down by 15.7% points, including the integration costs and amortization of intangible assets from Albireo and Epizyme
Acquisition of Albireo accompanied by several favorable developments in the pipeline, including Onivyde (irinotecan), Bylvay, palovarotene and elafibranor
Upgraded 2023 financial guidance: total-sales growth greater than 6.0% at CER1 (prior guidance: greater than 4.0% at CER1); core operating margin greater than 30.0% of total sales (prior guidance: around 30%)
Extract of consolidated results for H1 2023 and H1 20223:

H1 2023 H1 2022 % change
€m €m Actual CER1
Total Sales 1,536.6 1,433.7 7.2% 7.4%
Core Operating Income 523.2 568.0 -7.9%
Core operating margin 34.0% 39.6% -5.6% pts
Core Consolidated Net Profit 393.0 420.5 -6.5%
Core earnings per share (fully diluted) €4.73 €5.06 -6.6%
IFRS Operating Income 295.6 501.3 -41.0%
IFRS operating margin 19.2% 35.0% -15.7%
IFRS Consolidated Net Profit 195.1 394.3 -50.5%
IFRS earnings per share (fully diluted) €2.35 €4.74 -50.5%
Free Cash Flow 371.5 339.0 9.6%
Closing net cash/(debt)4 (272.2) 168.2 n/a

David Loew, Chief Executive Officer, commented:

"The successful delivery on our strategic roadmap is yielding more top-line growth, advancements in the pipeline and further positive developments from external innovation. Improving execution supported another strong performance from our growth platforms in Oncology and Neuroscience in the first half of the year, while I was particularly pleased with the Rare Disease progress of the pipeline, including another regulatory approval for Bylvay in the U.S., positive clinical-trial results for elafibranor and a favorable regulatory step for palovarotene in the U.S. These developments have the potential to significantly benefit patients across a range of indications.

The performance in the first half of the year is reflected in today’s upgrade to our full-year guidance. We look forward to more milestones and further expansion of the pipeline over time through additional external-innovation transactions. I am confident, as we continue to deliver more medicines to patients, in ensuring the sustainable growth of Ipsen."

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

Total-sales growth greater than 6.0%, at constant currency (prior guidance: greater than 4.0% at constant currency). Based on the average level of exchange rates in June 2023, an adverse impact on total sales of around 3% from currencies is expected
Core operating margin greater than 30.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions (prior guidance: around 30%)
Pipeline update
Several announcements regarding Ipsen’s pipeline were published in June 2023:

The U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application for Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (the NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma. The Prescription Drug User Fee Act (PDUFA) goal date is
13 February 2024
The U.S. FDA approved Bylvay for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). In July 2023, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Bylvay for the treatment of cholestatic pruritus in patients with ALGS aged six months or older. The Committee for Orphan Medicinal Products (COMP), a scientific committee of the EMA, concurrently issued a negative opinion for the maintenance of Bylvay’s orphan drug designation in ALGS. This latter opinion prevents the retention of orphan-drug status in Bylvay’s marketing authorization in ALGS and might delay a final European Commission decision. Ipsen plans to submit an appeal in respect of the COMP opinion
The U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). The PDUFA goal date is 16 August 2023. In May 2023, the CHMP confirmed the negative opinion on palovarotene as a potential treatment for FOP, and it was therefore not subsequently approved by the European Commission
Positive top-line data from the pivotal ELATIVE Phase III trial were published. In the trial, the efficacy and safety of elafibranor was assessed for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis, who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid. The trial met its primary endpoint, and full trial data will be presented at a future scientific congress
Update on Galderma partnership

In July 2023, Ipsen notified Galderma of the termination of the July 2014 R&D collaboration related to the parties’ respective neurotoxin programs.

Ipsen will retain all rights and obligations related to its early-stage R&D neurotoxin pipeline, including the development of IPN10200 (longer-acting neurotoxin). This decision does not impact the two ICC arbitrations initiated by Galderma. Ipsen intends to fully defend and vindicate its rights against Galderma’s allegations.

Consolidated financial statements

The Board of Directors approved the condensed consolidated financial statements on 26 July 2023. The Company’s auditors performed a limited review of the H1 2023 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section.

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.

Calendar
Ipsen intends to publish its year-to-date and third-quarter sales update on 26 October 2023. The Company also anticipates hosting a capital-markets event on 7 December 2023 in London. It will be webcast live and details will be available in due course.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2023 (H1 2023) and the three-month period to 30 June 2023 (Q2 2023), compared to six-month period to 30 June 2022 (H1 2022) and the three-month period to 30 June 2022 (Q2 2022), respectively, unless stated otherwise. Commentary is based on the performance in H1 2023, unless stated otherwise. The performance of the Consumer HealthCare (CHC) business, divested in July 2022, has been excluded from all commentary and comparisons to prior performance.