Ipsen Reports Strong 2022 Financial Results and Provides 2023 Guidance

ParisFebruary 20, 2023PR Newswire -- Ipsen (Euronext: IPN; ADR: IPSEY), a global biopharmaceutical company in the specialty medicines field, announced its financial results for the full year and fourth quarter of 2022.

Excerpts from the Condensed Consolidated Financial Statements for the Fiscal Years 2022 and 2021^[3]：

2022Finance
Year

2021Finance
Year

Percentage Change%

Million Euros
Yuan

Million Euros
Yuan

Actual

Fixed
Exchange Rate^[1]Plan
Calculate

Total Sales

3,025.0

2,643.3

14.4 %

8.5 %

Core Operating Profit

1,115.4

983.1

13.5 %

Core Operating Profit Margin

36.9 %

37.2 %

-0.3% pts

Consolidated Core Net Profit

872.4

740.1

17.9 %

Core earnings per share fully diluted

10.51

8.88

18.4 %

IFRS Operating Profit

729.9

824.7

-11.5 %

IFRS Operating Profit Margin

24.1 %

31.2 %

-7.1% pts

IFRS Consolidated Net Profit

647.5

646.7

0.1 %

Fully Diluted International Financial Reporting Standards
Earnings per share

7.81

7.76

0.6 %

Dividend per share

€1.20^[4]

€1.20

—

Free Cash Flow

817.2

780.7

4.7 %

Net Cash^[5]

398.8

28.0^[6]

n/a

Global Chief Executive OfficerDavid LoewIndicates:

"2022The year was exceptionally strong for Ipsen in terms of performance, and our strategic roadmap has taken a solid step forward. At the same time, the sales performance of our growth platforms in oncology and neuroscience was also outstanding, mainly due to our continuously improving execution. In addition, the progress in the R&D pipeline has brought me great surprises, including recently...OnivydeThe clinical trial results indicate that this drug may greatly benefit pancreatic cancer patients. Compared withEpizymeThe transaction will further expand our product pipeline in the oncology field, while the recent collaboration withAlbireoThe merger agreement is expected to significantly enhance Ipsen's performance in the rare disease field.

Backed by a strong balance sheet and increasing cash flow, our external innovation strategy is expanding the potential drug categories in three key therapeutic areas, and we will strive to further expand the R&D pipeline. With the growing focus on specialty care business, the development prospects are encouraging, reflecting our commitment to providing more medicines for patients and ensuring Ipsen's sustainable growth.

Strategy Implementation

Ipsen Achieves Success in the Second Year of Implementing Its Strategy "Focus. Together. For Patients and Society."

The divestment of the Consumer Healthcare (CHC) business in 2022 marked an important step in Ipsen's strategic blueprint to build a more focused Ipsen centered on specialty medicines. The growth platform achieved double-digit growth, with Dysport sales increasing by 29.4%.^[7]Cabometyx sales grow by up to 23.9%^[7]The current R&D pipeline has also shown a promising situation, including the positive results achieved in the Phase III trial of the Onivyde-based regimen for the treatment of pancreatic cancer, as well as the launch of new trials, including the Phase II trial of elafibranor for the treatment of rare liver diseases.

This is also an important period for the expansion of the R&D pipeline, mainly due to the effective execution of Ipsen's external innovation model. In the three strategic therapeutic areas of oncology, rare diseases, and neuroscience, the company has added 20 new assets to its R&D pipeline in the past two years through a dual approach of licensing and acquisitions. In 2022, Ipsen strengthened its position in the field of oncology by acquiring Epizyme (a fully integrated, commercial-stage biopharmaceutical company dedicated to developing and delivering novel epigenetic therapies for cancer patients). Recently, Ipsen also announced plans to acquire Albireo.^[8], a company that uses bile acid modulators to treat cholestatic liver disease in children and adultsTheLeading Innovator. This anticipated acquisition aims to further enrich Ipsen's rare disease portfolio and R&D pipeline.

Finally, the company continues to benefit from its global efficiency program, saving overall costs, thereby enabling further increased investment in growth priorities.

2023Full-year Guidance for [Year]

Ipsen has set the following financial guidance for the 2023 fiscal year, assuming Ipsen completes its acquisition of Albireo (expected to be completed in the first quarter of this year):

Upon completion of the review of Albireo^[8]Following the acquisition and some R&D pipeline milestones, Ipsen plans to release a mid-term outlook report by the end of 2023.

Business Development Update

In January 2023, Ipsen and Albireo announced that they had reached a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile acid modulators for the treatment of cholestatic liver diseases in children and adults. This anticipated acquisition will further enhance Ipsen's rare disease portfolio and R&D pipeline. Bylvay^®(Odevixibat) is the leading product in Albireo's R&D pipeline and the first drug approved in the United States and the European Union for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC). It also shows potential for treating other rare diseases. This transaction is expected to be completed in the first quarter of 2023.

R&D Pipeline Update

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

In December 2022, Ipsen announced that the Phase III trial CONTACT-01 did not meet its primary endpoint of extending overall survival. The trial aimed to evaluate the efficacy and safety of Cabometyx (cabozantinib) in combination with atezolizumab versus docetaxel in patients with metastatic non-small cell lung cancer who had disease progression during or after treatment with immune checkpoint inhibitors and platinum-based chemotherapy.

In December 2022, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for palovarotene, an investigational drug used to reduce new abnormal bone formation (heterotopic ossification) in patients with fibrodysplasia ossificans progressiva. The CRL is related to a request made by the regulatory agency to Ipsen in October 2022, which involved submitting additional clinical trial data for palovarotene that is unrelated to efficacy and safety. Ipsen is expected to respond to this request in the first quarter of 2023, with the FDA’s review cycle anticipated to last six months. In January 2023, Ipsen received the CHMP opinion.^[9]A negative opinion on palovarotene for the treatment of the same indication. The company will request a re-examination of this opinion based on scientific data from the existing palovarotene clinical trial program.

Environment, Social and Governance:Generation Ipsen

Ipsen is committed to scientifically reducing greenhouse gas emissions, and its recent climate targets were independently validated by the Science Based Targets initiative in 2022. Currently, all operations of Ipsen in the UK, the Republic of Ireland, and France are powered 100% by green electricity. This brings the company’s renewable energy electricity usage rate to 90%, aligning with its commitment to achieve 100% renewable energy electricity usage by 2025. Another initiative involves further decarbonizing the traditional process where Ipsen uses fossil fuels to generate heat and steam for production. Meanwhile, the new "Future Fleet" program focuses on transitioning at least 30% of Ipsen's fleet to fully electric vehicles by 2025.

The company has been highly attentive to patients' medication issues, including providing humanitarian aid in 2022 to those affected by the Ukraine crisis through patient support programs, drug donations, and financial contributions to the Red Cross and Tulipe charities. Ipsen's partnership with Access Accelerated continues to thrive; Access Accelerated is a non-profit organization working in communities with insufficient healthcare services, focusing on addressing non-communicable diseases. Finally, with the support of the Fondation France, the Ipsen Foundation has assisted millions of patients impacted by rare diseases, with a charitable presence in approximately 100 countries.

Instructions:

All financial data is in millions of euros. Unless otherwise stated, the performance in this report covers the 12-month period ending December 31, 2022 (Fiscal Year 2022) and the 3-month period ending December 31, 2022 (Q4 2022), with comparisons made against the 12-month period ending December 31, 2021 (Fiscal Year 2021) and the 3-month period ending December 31, 2021 (Q4 2021). Additionally, unless otherwise noted, all commentary is based on the performance of Fiscal Year 2022. The performance of the CHC business, which was divested in July 2022, has been excluded from all commentary and comparisons with prior performance.

About Ipsen

Ipsen is a mid-sized international biopharmaceutical company focused on innovative medicines in oncology, rare diseases, and neuroscience. In the 2022 fiscal year, Ipsen’s total specialty care sales reached 3 billion euros, with a sales network covering more than 100 countries worldwide. In addition to its external innovation strategy, the company's R&D activities are carried out on innovative and differentiated technology platforms located in leading biotechnology and life sciences hubs: Saclay near Paris, France; Oxford, UK; Cambridge, USA; and Shanghai, China. Ipsen (excluding the Consumer Healthcare business) has approximately 5,000 employees globally and is listed in Paris (Euronext: IPN) and the United States through a sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more detailed information, please visitipsen.com。

About Ipsen China

Ipsen Group entered China in 1992 and established an innovation center in Shanghai in 2019, which is one of the four global research and development centers. In 2021, Ipsen set up its China headquarters in Shanghai, focusing on the fields of oncology, rare diseases, and neuroscience. Together with the innovation center, Ipsen continues to introduce innovative treatment solutions to meet the urgent medical needs of Chinese patients.

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