Adjustment of 2025 financial targets
Villepinte, 2 December 2025, 5.45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is announcing a downward revision to its financial targets for full-year 2025.
Following an inspection by the U.S. Food and Drug Administration (FDA) during the first half of the year, the Guerbet Group developed and initiated the implementation of a compliance plan at its Raleigh site in the United States. This plan has been reinforced over the past weeks in response to FDA’s observations1.
Guerbet always puts the patient front and centre of its commitments and affirm its determination to ensure production meets the highest regulatory and quality standards.
Guerbet mobilised human, financial and technical internal resources and hired external experts to conduct comprehensive assessments and take other interim measures under the compliance plan, in alignment with FDA guidance to industry. The implementation of the compliance plan has delayed the release of batches manufactured at the site, and this is expected to result in a loss of revenue for the Group in the 2025 financial year. The implementation of compliance plan activities will also give rise to exceptional costs.
Under these conditions, Guerbet will not be able to meet its 2025 targets and now anticipates:
- A decrease in revenue of between -4 % and -5 % at constant exchange rates and on a like-for-like basis, compared with a slight decrease of -1% previously announced;
- A restated EBITDA margin of between 10,5% and 12% of revenue, compared with between 12% and 13% previously announced;
- Free cash flow of between -5M€ and -15M€, versus slightly negative previously announced
The operational consequences and financial impact for the 2026 financial year are currently being analysed. The company will inform the market as soon as it has additional information.
About Guerbet
At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 99 years, with more than 2,905 employees worldwide, we continuously innovate and devote 9% of our revenue to Research and Development in four centers in France and the United States. Guerbet (GBT) is listed in compartment B of Euronext Paris and generated revenue of €841m in 2024. For more information, please visit www.guerbet.com.
Forward-looking statements
Certain information contained in this press release is not historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts and assumptions including, without limitation, assumptions regarding the Group’s current and future strategy and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties and other factors, which may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly in these forward-looking statements.
These forward-looking statements are only valid as of the date of this press release and the Group expressly disclaims any obligation or commitment to issue an update or revision of the forward-looking statements contained in this press release to reflect changes in the assumptions, events, conditions or circumstances on which such forward-looking statements are based. Forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and generally beyond the control of the Group.
These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing analyses, decisions by regulatory authorities, such as the Food and Drug Administration or the European Medicines Agency, whether or not to approve, and when, the application for a drug, process or biological product for one of these candidate products, as well as their labeling decisions and other factors that may affect the availability or commercial potential of these candidate products. A detailed description of the risks and uncertainties related to the Group’s activities can be found in chapter 4.8 “Risk factors” of the Group’s Universal Registration Document registered by the AMF under number D.25-0220 on April 3, 2025, available on the Group’s website (www.guerbet.com).
1 Warning Letter dated 17 October 2025
Contacts:
Guerbet
Christine Allard, SVP Public Affairs and Corporate Communications +33 6 30 11 57 82 / christine.allard@guerbet.com
Seitosei.Actifin
Marianne Py, Financial Communication + 33 6 85 52 76 93 / marianne.py@seitosei-actifin.com
Jennifer Jullia, Press +33 6 02 08 45 49 / jennifer.jullia@seitosei-actifin.com
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