Ipsen presents strong full-year 2022 results and guidance for 2023

• 2022 total sales up by 8.5% at CER¹ (14.4% as reported) with growth platforms’² sales increasing by 20.9%¹ and Somatuline^® (lanreotide) sales declining by 5.6%¹
• 2022 core operating margin of 36.9%, broadly in line with 2021; IFRS operating margin of 24.1%, down by 7.1% points, reflecting the impact of the acquisition of Epizyme and impairment losses on intangible assets
• Successful delivery of strategy, driving strong growth, advancement of the pipeline and further external-innovation transactions, including the acquisition of Epizyme and the divestment of Consumer HealthCare
• 2023 financial guidance: total-sales growth greater than 4.0% at CER¹; core operating margin around 30% of total sales

Paris (France), 9 February 2023

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, presents today its financial results for the year and the fourth quarter of 2022.

Extract of consolidated results for FY 2022 and FY 2021³:

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.

Calendar

Ipsen intends to publish its first-quarter sales update on 27 April 2023.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the twelve-month period to 31 December 2022 (the year or FY 2022) and the three-month period to 31 December 2022 (the fourth quarter or Q4 2022), compared to twelve-month period to 31 December 2021 (FY 2021) and the three-month period to 31 December 2021 (Q4 2021), respectively, unless stated otherwise. Commentary is based on the performance in FY 2022, unless stated otherwise. The performance of the CHC business, divested in July 2022, has been excluded from all commentary and comparisons to prior performance.

Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

Contacts