On February 8, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the year and final quarter of 2023 (Press release, Ipsen, FEB 8, 2024, View Source [SID1234639941]).

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Extract of consolidated results for FY 2023 and FY 20226:

FY 2023 FY 2022 % change
€m €m Actual CER1
Total Sales 3,127.5 3,025.0 3.4% 6.7%
Core Operating Income 1,001.0 1,115.4 -10.3%
Core operating margin 32.0% 36.9% -4.9% pts
Core Consolidated Net Profit 765.5 872.4 -12.3%
Core earnings per share (fully diluted) €9.15 €10.51 -13.0%
IFRS Operating Income 816.0 729.9 11.8%
IFRS operating margin 26.1% 24.1% 2.0% pts
IFRS Consolidated Net Profit 647.2 647.5 –
IFRS earnings per share (fully diluted) €7.73 €7.81 -1.0%
Free Cash Flow 710.9 817.2 -13.0%
Closing net cash 65.1 398.8 -83.7%

"Solid results in the year have provided an excellent platform for Ipsen in 2024, an exciting period in which we anticipate four launches and further opportunities to expand the pipeline", commented David Loew, Chief Executive Officer, Ipsen. "As Ipsen transforms, improving execution is supporting consistent sales growth, while the productive pipeline is yielding further encouraging results for patients.

"Our external-innovation strategy, underpinned by a strong balance sheet, continues to extend the number of potential medicines across our three therapeutic areas. Following the acquisition of Albireo in 2023 and the successful launch of Bylvay, we look forward to more milestones this year and enriching the pipeline over time through additional external-innovation transactions. I am confident that this strategy will deliver more medicines for patients and ensure the sustainable growth of Ipsen."

2023 progress

Ipsen continued to deliver successfully in 2023 on its strategy, Focus. Together. For patients and society. The growth platforms produced a further double-digit performance, with Cabometyx and Dysport up by 22.9%7 and 14.5%7, respectively. There were contributions from the new medicines, Bylvay (odevixibat), Sohonos (palovarotene) and Tazverik (tazemetostat), while Somatuline (lanreotide), continuing its gradual erosion (-10.4%7), represented only 34% of total sales (FY 2022: 40%).

The decline in the core operating margin to 32.0% (FY 2022: 36.9%) reflected enhanced investment from the acquisitions of Albireo and Epizyme, including a higher level of R&D expenses to fund the new pipeline. Ipsen ended the year with net cash of €65.1m, driven by solid free cash-flow generation of €710.9m.

In March 2023, Ipsen enriched its Rare Disease portfolio and pipeline by acquiring Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The primary focus of the transaction was Bylvay, a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor.

Favorable pipeline developments in 2023 included positive results from the Phase III trials of elafibranor in primary biliary cholangitis (PBC) and Cabometyx in prostate cancer, respectively. Regulatory submission acceptances were received for Onivyde in first-line pancreatic ductal adenocarcinoma
(1L PDAC), as well as for elafibranor. Sohonos and Bylvay were also granted approval during the year by the U.S. Food and Drug Administration (FDA) in fibrodysplasia ossificans progressiva (FOP) and Alagille syndrome, respectively.

2024 priorities and financial guidance
Ipsen anticipates four commercial launches in 2024, following regulatory decisions for Onivyde in 1L PDAC in the U.S (H1), elafibranor in second-line PBC in the U.S. (H1) and in the E.U. (H2), as well as odevixibat in Alagille syndrome in the E.U. (H2). Sohonos, in FOP, was recently launched in the U.S.

The Company will continue to drive benefits from its global efficiencies program, leveraging its current platform, which provide significant further investment for launches and the pipeline.

Ipsen has set the following financial guidance for FY 2024, which excludes any impact from potential late-stage external-innovation transactions:

Total-sales growth greater than 6.0%, at constant currency. Based on the average level of exchange rates in January 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.

Capital-markets day and mid-term financial outlook

Ipsen outlined its next phase of growth at its capital-market day, held in December 2023. Several current and potential near-term launches are set to be complemented by many pipeline milestones over the mid-term to build a strengthened and diversified business, including a combination of seven anticipated and current medicines, each with expected peak sales of at least €500m. This will be augmented by an active external-innovation strategy, designed to provide a platform to drive sustainable pipeline growth.

The Company outlined the following mid-term financial outlook8:

Total-sales average growth of at least 7% per year for the period 2023-2027 at constant exchange rates
A core operating margin in 2027 of at least 32% of total sales
Environment, Social and Governance: Generation Ipsen
Ipsen presented an ambitious sustainability roadmap at the aforementioned capital-markets day, based on Generation Ipsen, the strategy focused on four pillars: Environment, Patients, People and Governance. Good progress was made in 2023.

Ipsen is committed to science-based reductions in greenhouse-gas emissions across the entire value chain. The Company achieved a 36% reduction in Scope 1 & 2 emissions in 2023 vs the 2019 baseline. Scope 3 reductions in 2023, against the same baseline year, amounted to 29%. Ipsen has the ambition to be carbon-neutral by the end of 2025 and reach net-zero emissions by 2045.

With a key focus on patients, the Company has made progress to reduce the length of time between clinical-trial readouts and non-FDA/EMA9 regulatory submissions by 25%. In 2023, 53% of the GLT was comprised of women versus 48% in 2022, while 43% of colleagues were engaged in healthcare or environmental projects in 2023.

Finally, ISO37001 certification for anti-corruption management was renewed in the year.

Consolidated financial statements

The Board of Directors approved the consolidated financial statements on 7 February 2024. The consolidated financial statements have been audited and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available in due course on ipsen.com (regulated-information section).

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