Ipsen Announces Plan to Launch Four New Products and Indications in 2024 Following Strong 2023 Financial Performance

ParisFebruary 23, 2024PR Newswire -- Ipsen announces its financial results for the full year 2023 and the fourth quarter of 2023.

Excerpts from Consolidated Financial Results for Fiscal Year 2023 and Fiscal Year 2022^[6]：

Ipsen CEO David Loew said, "This year's strong performance has laid a solid foundation for Ipsen's development in 2024."2024The year will be an exciting one, with expectations of launching four new products and indications, and having the opportunity to further expand the R&D pipeline.. As Ipsen undergoes transformation, our execution capabilities continue to improve, providing a solid guarantee for the sustained growth in sales. Meanwhile, our continuously advancing R&D pipeline keeps bringing more encouraging news to patients.

Supported by a strong balance sheet, ourExternal Innovation Strategy is Expanding the Number of Potential Drugs in Three Therapeutic AreasFollowing the acquisition of Albireo and the successful launch of Bylvay in 2023, we look forward to achieving more milestones this year.Will continuously enrich the R&D pipeline through additional external innovation deals."I am confident that this strategy will bring more medicines to patients and ensure the sustainable growth of Ipsen."

2023Yearly Achievements

2023In the year, Ipsen continued to successfully advance the company's strategy."Focus, Win-Win, Serve Patients and Society". The growth platform achieved double-digit growth, with sales growth of Cabometyx and Dysport reaching as high as 22.9%, respectively.^[7]And 14.5%^[7]. New drug Bylvay^®（odevixibat）、Sohonos^®(Palovarotene) and Tazverik^®(tazemetostat) also contributed to the growth in sales, while Somatuline^®(Somatuline) sales continued to gradually decline (-10.4%).^[7]）, accounting for only 34% of total sales (Fiscal Year 2022: 40%).

Core operating profit margin fell to32.0%(Fiscal Year 2022: 36.9%), reflecting increased investments resulting from the acquisitions of Albireo and Epizyme, including higher R&D expenses to fund the new product pipeline. Ipsen's net cash at year-end was €65.1 million, primarily due to a steady free cash flow of €710.9 million.

In March 2023, Ipsen acquired Albireo, a leading innovator in bile acid modulators for the treatment of cholestatic liver diseases in children and adults, further expanding its rare disease portfolio and R&D pipeline. The primary focus of the transaction is Bylvay, a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor.

Pipeline Progress in 2023 Includes Positive Results from Phase III Trials of Elafibranor for Primary Biliary Cholangitis (PBC) and Cabometyx for Prostate Cancer. Regulatory Submissions for Onivyde (for first-line treatment of pancreatic ductal adenocarcinoma [1L PDAC]) and Elafibranor Accepted. In the same year, the U.S. Food and Drug Administration (FDA) also approved the marketing authorization applications for Sohonos and Bylvay, for the treatment of Fibrodysplasia Ossificans Progressiva (FOP) and Alagille Syndrome, respectively.

2024Annual Priorities and Financial Guidance

Ipsen is expected to2024Four New Products and Indications Launched in a YearPreviously, the marketing applications for Onivyde in the U.S. (H1) for the treatment of 1L PDAC, Elafibranor in the U.S. (H1) and EU (H2) for second-line PBC treatment, and Odevixibat in the EU (H2) for Alagille syndrome have all been approved by regulatory authorities. Sohonos was recently launched in the U.S. for the treatment of FOP.

The company will leverage its existing platform to continue driving global efficiency initiatives, providing substantial further investment for the launch of new products and pipelines.

Ipsen has set the following financial guidance for the 2024 fiscal year, excluding any potential impact from future external innovation transactions:

Total sales guidance includes expectations for the further launch of Somatuline lanreotide generics in the United States and the European Union.

Capital Markets Day and Mid-Term Financial Outlook

Ipsen Outlines Next Phase of Growth at Capital Markets Day Held in December 2023

The Company Outlined the Following Mid-Term Financial Outlook^[8]：

Environment, Social, and Governance:Generation Ipsen

At the aforementioned Capital Markets Day, Ipsen presented an ambitious sustainability roadmap, the strategy of which is based onGeneration IpsenBased on the foundation, with a focus on four key pillars: Environment, Patients, Employees, and Governance. Significant progress was achieved in 2023.

Ipsen is committed to scientifically reducing greenhouse gas emissions across the entire value chain.Compared with the 2019 baseline, the company achieved a 36% reduction in Scope 1 and Scope 2 emissions in 2023. Compared with the same baseline year, Scope 3 emissions decreased by 29% in 2023. Ipsen is confident in achieving carbon neutrality by the end of 2025 and net-zero emissions by 2045.

The company is patient-centered, integrating clinical trial results with non-FDA/EMA^[9]The time between regulatory submissions was reduced by 25%. In 2023, 53% of GLT members were women, compared to 48% in 2022; in 2023, 43% of colleagues worked on healthcare or environmental projects.

Renewal of ISO 37001 Anti-Bribery Management System Certification Obtained.

For complete information, please click [Read the Original Text], View Ipsen inReport released on February 8, 2024.

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, 2023 (Fiscal Year 2023) and the 3-month period ending December 31, 2023 (Q4 2023), with comparative data referring to the 12-month period ending December 31, 2022 (Fiscal Year 2022) and the 3-month period ending December 31, 2022 (Q4 2022). Additionally, unless otherwise noted, all commentary is based on the performance of Fiscal Year 2023.

About Ipsen

Ipsen is a global biopharmaceutical company focused on providing innovative drugs to patients in three therapeutic areas: oncology, rare diseases, and neuroscience.

Our R&D pipeline is driven by external innovation, backed by nearly a century of development experience and supported by global centers in the United States, France, and the United Kingdom. Our global team, spread across more than 40 countries, collaborates with our partnerships worldwide, enabling us to provide medicines to patients in over 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and traded in the United States through a sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information about Ipsen, please visit ipsen.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. Ipsen set up its China headquarters in Shanghai in 2021, and in 2022, in line with the group’s business changes, simultaneously divested its diversified healthcare business to focus on specialty care. Targeting three major disease areas (oncology, rare diseases, neuroscience) and six key indications, Ipsen continues to introduce innovative treatment solutions in collaboration with the Innovation Center to meet the urgent unmet medical needs of Chinese patients.

Ipsen – Cautionary Statement Regarding Forward-Looking Statements

The forward-looking statements, objectives and targets contained in this document are based on the Group's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ significantly from those anticipated in this document. All of the above risks may affect the Group’s ability to achieve its financial targets in the future, which are set under reasonable macroeconomic conditions based on information available today. The use of words such as "believe," "expect," and "anticipate" and similar expressions is intended to identify forward-looking statements, including the Group’s expectations regarding future events, such as regulatory filings and decisions. Moreover, the formulation of the targets described herein does not take into account external growth assumptions or potential future acquisitions, both of which could lead to changes in metrics. The objectives are based on data and assumptions that the Group considers reasonable. Targets depend on conditions or facts that may occur in the future and not solely on historical data. Considering the occurrence of certain risks and uncertainties, actual results may differ significantly from these indicators, notably as promising products in early stages of development or clinical trials may ultimately never reach the market or achieve their commercial objectives, particularly due to registration or competitive reasons. The Group must face or may face competition from generic drugs, which could translate into a loss of market share. Additionally, the R&D process involves multiple stages, each with significant risks, meaning the Group may fail to achieve its goals and be forced to abandon efforts on products into which it has invested heavily. Therefore, the Group cannot guarantee that favorable results obtained in preclinical trials will be confirmed in subsequent clinical trials, nor can it ensure that the results of clinical trials will sufficiently demonstrate the safety and efficacy of the relevant products. There is no assurance that products will receive the necessary regulatory approvals or prove commercially successful. If underlying assumptions prove inaccurate or if risks or uncertainties do arise, actual results may differ significantly from those in the forward-looking statements. Other risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange fluctuations; the impact of pharmaceutical industry regulations and healthcare legislation; global trends toward healthcare cost containment; competitors obtaining technological advances, new products, and patents; inherent challenges in new product development, including obtaining regulatory approval; the Group’s ability to accurately predict future market conditions; production difficulties or delays; financial instability and sovereign risks in international economies; reliance on the validity of the Group’s patents and other protections for innovative products; and possible litigation, including patent litigation and/or regulatory actions. Furthermore, the Group relies on third parties to develop and market certain products, which may generate substantial royalty payments; the actions of these partners may adversely affect the Group’s activities and financial results. The Group cannot be certain that its partners will fulfill their respective obligations. The Group may not derive any benefit from these agreements. Any failure by the Group’s partners to meet their obligations would result in lower-than-expected revenues. Such situations could negatively impact the Group’s business, financial condition, or performance. The Group expressly disclaims any obligation, unless required by applicable law, to update or revise any forward-looking statements, objectives, or assumptions contained in this press release to reflect any change in the events, conditions, assumptions, or circumstances on which such statements are based, and makes no commitment to do so. The Group’s business is subject to the risk factors outlined in its Registration Document filed with the French financial markets authority (AMF). The risks and uncertainties listed in this document are not exhaustive, and readers are advised to consult the Group’s most recent Universal Registration Document available on its website (www.ipsen.com).

[1] At constant exchange rates (CER), which means recalculating the performance of the relevant period by applying the exchange rates used in the previous period, excluding any foreign exchange impact.

[2]Dysport^®(Botulinum Toxin Type A), Decapeptyl^®(Triptorelin), Cabometyx^®(cabozantinib) and Onivyde^®(Irinotecan).

[3] Exclude any potential impact of future external innovation transaction increments.

[4] Includes expectations for other lanreotide generics of Somatuline in the U.S. and EU, and excludes an estimated unfavorable currency impact of approximately 1% on total sales based on the average exchange rate level as of January 2024.

[5] Included additional R&D expenses generated by anticipated early and mid-stage external innovation opportunities.

[6] Consolidated Performance Summary. The company's auditors have audited the consolidated financial statements.

[7] Calculated in CER, which means recalculating the performance of the relevant period using the exchange rate from the previous period, excluding any foreign exchange impact.

[8] Exclude the impact of any potential additional future (Phase III clinical development or later) external innovation opportunities.

[9] European Medicines Agency.