On February 9, 2023 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its financial results for the year and the fourth quarter of 2022 (Press release, Ipsen, FEB 9, 2023, View Source [SID1234626995]).

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Extract of consolidated results for FY 2022 and FY 20213:

FY 2022 FY 2021 %
change
€m €m Actual CER1
Total Sales 3,025.0 2,643.3 14.4% 8.5%
Core Operating Income 1,115.4 983.1 13.5%
Core operating margin 36.9% 37.2% -0.3% pts
Core Consolidated Net Profit 872.4 740.1 17.9%
Core earnings per share (fully diluted) 10.51 8.88 18.4%
IFRS Operating Income 729.9 824.7 -11.5%
IFRS operating margin 24.1% 31.2% -7.1% pts
IFRS Consolidated Net Profit 647.5 646.7 0.1%
IFRS earnings per share (fully diluted) 7.81 7.76 0.6%
Dividend per share €1.204 €1.20 —
Free Cash Flow 817.2 780.7 4.7%
Net cash5 398.8 28.06 n/a

David Loew, Chief Executive Officer, commented:

"2022 was a year of strong results and clear progress on our strategic roadmap. Improving execution supported another excellent sales performance from our growth platforms in Oncology and Neuroscience. I was particularly pleased with the progress of the pipeline, including the recent clinical-trial results for Onivyde, which could significantly benefit patients with pancreatic cancer. We have also been replenishing the pipeline at pace through the acquisition of Epizyme in Oncology and, more recently, the announcement of Albireo in Rare Disease.

Our external-innovation strategy, underpinned by a strong balance sheet and increasing cash generation, is expanding the number of potential medicines we have across our three therapy areas, and we have the ambition to enlarge the pipeline further. With the Company fully focused on Specialty Care, the outlook is promising, reflecting our commitment to bringing more medicines to patients and ensuring the sustainable growth of Ipsen."

Delivering on strategy

Ipsen delivered successfully on the second year of the implementation of its strategy: Focus. Together. For patients and society.

The divestment of the Consumer HealthCare (CHC) business in 2022 was a major step forward towards building a more focused Ipsen, centering on Specialty Care. The growth platforms produced a double-digit performance, including Dysport, which grew by 29.4%%7 and Cabometyx, up by 23.9%7. There were also favorable developments from the existing pipeline, including positive results from the Phase III trial of the Onivyde-based regimen in pancreatic cancer, as well as the initiation of new trials, including a Phase II trial of elafibranor in rare liver disease.

It was also a particularly strong period of replenishment of the pipeline, founded on the strong execution of Ipsen’s external-innovation model. Through a combination of in-licensing and acquisitions, the Company has added 20 new assets to the pipeline in the last two years across the three strategic therapy areas of Oncology, Rare Disease and Neuroscience. In 2022, Ipsen strengthened its position in Oncology by acquiring Epizyme, a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets for cancer patients. More recently, Ipsen announced its intention to acquire Albireo8, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. This anticipated acquisition is designed to enrich Ipsen’s Rare Disease portfolio and pipeline.

Finally, the Company continued to drive benefits from its global efficiencies program, yielding savings across the entire cost base, which enabled significant further investment in Ipsen’s priorities for growth.

Full-year 2023 guidance

Ipsen has set the following financial guidance for FY 2023, assuming the completion of the planned acquisition of Albireo, expected to close in the first quarter of the year:

Total-sales growth greater than 4.0%, at constant currency. Based on the average level of exchange rates in January 2023, an anticipated adverse impact on total sales of around 2% from currencies
Core operating margin around 30% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions
Ipsen intends to provide a mid-term outlook before the end of 2023, following the anticipated completion of the acquisition of Albireo8, as well as a number of pipeline milestones.

Business development update

In January 2023, Ipsen and Albireo announced that they had entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The anticipated acquisition will enrich Ipsen’s Rare Disease portfolio and pipeline. The lead medicine in Albireo’s pipeline is Bylvay (odevixibat), the first-approved treatment in progressive familial intrahepatic cholestasis in the U.S. and E.U., with potential in other rare diseases. The transaction is anticipated to close in the first quarter of 2023.

Pipeline update

In November 2022, Ipsen announced that the NAPOLI 3 Phase III trial of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen), compared to nab-paclitaxel plus gemcitabine in previously untreated patients with metastatic pancreatic ductal adenocarcinoma, met its primary endpoint, demonstrating a clinically meaningful and statistically significant improvement in overall survival. The full trial results were presented in January 2023 at the American Clinical Society of Oncology Gastrointestinal Cancers Symposium in San Francisco, U.S.

In December 2022, Ipsen announced that the CONTACT-01 Phase III trial of Cabometyx, in combination with atezolizumab, compared to docetaxel in patients with unmutated metastatic non-small cell lung cancer who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy, did not meet its primary endpoint of an improvement in overall survival.

In December 2022, the U.S. FDA issued a Complete Response Letter (CRL) regarding the New Drug Application for palovarotene, an investigational treatment for the reduction of new abnormal bone formation (heterotopic ossification) in people living with fibrodysplasia ossificans progressiva. The CRL was related to the regulatory agency’s previous request for additional information on palovarotene clinical-trial data communicated to Ipsen in October 2022, which was not a request for additional efficacy or safety data beyond existing studies. Ipsen anticipates responding to the request in the first quarter of 2023, with an expected six-month U.S. FDA review cycle. In January 2023, Ipsen received a negative opinion from the CHMP9 for palovarotene in the same indication. The Company will request a re-examination of the opinion, based on scientific data available from the existing palovarotene clinical-trial program.

Environment, Social and Governance: Generation Ipsen

Ipsen is committed to science-based reductions in greenhouse-gas emissions and its near-term climate targets were independently validated by the Science Based Target initiative in 2022. Ipsen now uses 100% green electricity for all operations in the U.K., the Republic of Ireland and France. This increased the Company’s use of electricity from renewable sources to 90%, in line with a commitment to 100% renewable-electricity use by 2025. Another action was a further decarbonizing of Ipsen’s processes that have traditionally used fossil fuels to produce heat and steam for the manufacturing process, while a new Fleet For Future program is focused on the transitioning of at least 30% of Ipsen’s vehicle fleet to battery-electric vehicles by 2025.

The Company is focused on patients’ access to medicines, including the provision in 2022 of humanitarian relief in response to the crisis in Ukraine via patient support, medicine donations and funding to the Red Cross and Tulipe charities. The partnership with Access Accelerated, a not-for-profit collective that works in communities that lack sufficient access to healthcare to address non-communicable diseases, also continued to thrive. Finally, Fondation Ipsen, under the aegis of the Fondation de France, again reached millions of people impacted by rare diseases, helping to improve lives across around 100 countries.

Consolidated financial statements

The Board of Directors approved the consolidated financial statements on 8 February 2023. 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).

Conference call

A conference call and webcast for investors and analysts will begin today at 1.45pm, Paris time. Participants can access the call and its details by registering here; webcast details can be found here.