Ipsen Reports Solid Sales Growth in First Nine Months of 2023 and Reaffirms Full-Year Guidance

Paris, November 3, 2023 /PR Newswire/ --2023Year10Month26DayIpsen (Euronext: IPN; ADR: IPSEY), a global biopharmaceutical company in the specialty medicines field, announced its sales performance for the first three quarters of 2023 and the third quarter of 2023.

2023The first three quarters of the year

2022The first three quarters of the year

Percentage Change%

2023Year

The Third Quarter

2022Year

Q3

Percentage Change%

Million euros

Million euros

Actual

At a fixed exchange rate^[1]

Million euros

Million euros

Actual

At a fixed exchange rate^[1]

Tumor

1,744.1

1,767.2

-1.3 %

0.8 %

574.5

603.1

-4.7 %

0.8 %

Neuroscience

489.0

407.7

19.9 %

24.5 %

164.8

160.7

2.5 %

13.7 %

Rare Diseases

76.0

33.6

n/a

n/a

33.2

11.0

n/a

n/a

Total Sales

2,309.1

2,208.5

4.6 %

7.1 %

772.4

774.8

-0.3 %

6.5 %

Key Highlights of Sales and R&D Pipeline

David Loew，Global CEO of Ipsen

"Up to now, this year's sales and R&D pipeline have made further progress, confirming the success of Ipsen's strategy. Driven by the results of strengthening commercial execution and external innovation strategies, our product portfolio has performed well in all three therapeutic areas. Based on this robust sales momentum, we are reaffirming our full-year guidance for 2023."

The R&D pipeline has once again delivered good news, including the regulatory approval of Sohonos in the United States, allowing it to continue providing additional treatment options for patients with unmet medical needs. In the last quarter of this year, we look forward to regulatory progress in the indication of elafibranor for the treatment of primary biliary cholangitis and plan to share more details on how to identify sustainable growth opportunities within our portfolio and R&D pipeline at the upcoming Capital Markets Day.

2023Full-year Guidance for the Year

Ipsen Confirms Financial Guidance for Fiscal Year 2023:

R&D Pipeline Progress

In August 2023, Ipsen announced that the U.S. Food and Drug Administration (FDA) had approved Sohonos, the first and only drug available to treat patients with fibrodysplasia ossificans progressiva.

Ipsen also announced that the global CONTACT-02 pivotal Phase III trial of Cabometyx in combination with atezolizumab for the treatment of metastatic castration-resistant prostate cancer met one of the two primary endpoints, demonstrating a statistically significant improvement in progression-free survival at the interim analysis.

In October 2023, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a negative opinion, recommending not to maintain the orphan drug designation for Bylvay in the treatment of Alagille syndrome (ALGS). This occurred despite the Committee for Medicinal Products for Human Use issuing a positive opinion in July 2023. To retain the orphan drug designation for Bylvay in its already approved indication for progressive familial intrahepatic cholestasis, Ipsen plans to resubmit the application for Bylvay in treating ALGS to the EMA under a new brand name by the end of 2023.

PartnerGalderma

In September 2023, the ICC arbitration tribunal issued its final ruling following a disagreement over the regulatory submission strategy for liquid A-type botulinum toxin QM1114. In October 2023, Ipsen announced that its partner Galderma had received a complete response letter from the U.S. FDA regarding its Biologics License Application for QM1114.

The Second Arbitration Procedure and Dysport/Azzalure^®The market share region of medical beauty product partners is expected to conclude by next year.

Instructions

All financial data is in millions of euros (€m). Unless otherwise stated, the performance in this report covers the nine months prior to September 30, 2023 (the first three quarters of 2023) and the three months prior to September 30, 2023 (the third quarter of 2023), with comparative data referring to the nine months prior to September 30, 2022 (the first three quarters of 2022) and the three months prior to September 30, 2022 (the third quarter of 2022). Unless otherwise noted, comments are based on the performance of the first three quarters of 2023.

About Ipsen

Ipsen is a mid-sized global biopharmaceutical company focused on innovative drugs in the fields of oncology, rare diseases, and neuroscience. In the 2022 fiscal year, Ipsen's total sales of specialty medicines exceeded 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 in Paris, France; Oxford in the UK; Cambridge in the US; and Shanghai in China. Ipsen currently has approximately 5,200 employees worldwide 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. Ipsen set up its China headquarters in Shanghai in 2021 and, in accordance with the group's business changes in 2022, simultaneously divested its diversified health business to focus on specialty care. Targeting three major disease areas (oncology, rare diseases, neuroscience) and six indications, Ipsen continues to introduce innovative treatment solutions in collaboration with the Innovation Center to meet the urgent treatment 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 could 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. Furthermore, the targets outlined herein were established without considering external growth assumptions or potential future acquisitions, both of which could alter the indicators. The objectives are based on data and assumptions deemed reasonable by the Group. Targets depend on conditions or facts that may occur in the future, not solely on historical data. Considering the occurrence of certain risks and uncertainties, actual results may differ significantly from these indicators, notably where products showing promise in early-stage development or clinical trials may ultimately never reach the market or achieve their commercial goals, 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 carrying significant risks, meaning the Group may fail to achieve its objectives and be forced to abandon efforts on products into which it has invested substantial resources. As a result, the Group cannot guarantee that favorable results obtained in preclinical trials will be confirmed in subsequent clinical trials or that clinical trial results will be sufficient to demonstrate the safety and efficacy of the relevant products. There can be 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 materialize, actual results may differ significantly from those projected 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 gaining technological advances, new products, and patents; inherent challenges in developing new products, including obtaining regulatory approval; the Group’s ability to accurately forecast 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. Moreover, the Group relies on third parties to develop and market certain products that may generate substantial royalty payments; the actions of these partners could adversely affect the Group’s activities and financial results. The Group cannot guarantee 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 could 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 changes in the events, conditions, assumptions, or circumstances on which such statements are based, nor will it make any 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 latest Universal Registration Document available on its website (www.ipsen.com).

^[1] Calculated at constant exchange rates (CER), which recalculates the performance of the relevant period using the exchange rates from the previous financial period to exclude any foreign exchange impact.

^[2] Dysport, Decapeptyl^®(Triptorelin), Cabometyx, and Onivyde^®(Irinotecan)