Novo Holdings announces 2025 Annual Results




Novo Holdings announces 2025 Annual Results

• Total Income and Investment Returns in 2025 were DKK 21 billion (€2.8 billion). For 2025, Total Income and Investment Returns consisted of Income from dividends from the Novo Group companies (DKK 15 billion or €2.0 billion) and Returns from the Investment Assets Portfolio¹ (DKK 5.8 billion or €0.8 billion).
• Novo Holdings generated returns on the Investment Portfolio² of 2.3% in DKK, and 9.2% in Constant Exchange Rates (CER). The return for 2024 in CER was 14.8%.

• Novo Holdings’ 5- and 10-year returns are at 8.0% and 8.9%, respectively, in CER and stand well above benchmark.
• Total Income and Returns were negatively affected by the lack of proceeds from a share buyback from Novo Nordisk A/S (Novo Nordisk A/S suspended its buyback in 2025), and the significant depreciation in the US Dollar.
• Total Assets under Management amounted to DKK 694 billion (€93 billion) in 2025, down from DKK 1,060 billion (€142 billion) in 2024, primarily reflecting the significant drop in the market value of Novo Nordisk A/S. The Investment Portfolio grew from DKK 216 billion (€29 billion) in 2024 to DKK 226 billion (€30 billion) in 2025.

COPENHAGEN, Denmark, March 12, 2026 (GLOBE NEWSWIRE) — Novo Holdings today announced its financial results for 2025. The Novo Holdings Investment Portfolio continued to perform well on both an absolute and relative basis, with a return of 9.2% in CER. However, the depreciation of the US dollar by more than 11% against the Danish krone materially offset performance in Danish kroner.

Kasim Kutay, CEO of Novo Holdings, said: “We delivered a strong performance during the year, driven by, among other things, significant monetisations such as the exit of Clario and KabaFusion.³ This was achieved against a backdrop of considerable headwinds for the life sciences industry.”

Novo Holdings’ Investment Portfolio comprises Life Science Investments, the investment activities that are focused on human and planetary health, making up 52% of the total portfolio, and Capital Investments, making up the remaining 48% of the portfolio.

Activity across all Novo Holdings’ Life Science Investments teams remained high in 2025; however, there was a stronger emphasis on asset management and exits than on acquisitions. The Principal Investments Team announced the successful exits of both KabaFusion and Clario³ from the private portfolio and fully exited its public positions in Convatec and Evotec.

Novo Holdings deployed DKK 13 billion (€1.8 billion) into life sciences in 2025. In total, 12 new companies were welcomed to the Investment Portfolio, and several existing portfolio companies were supported by additional investments. During the year, Novo Holdings exited 36 companies, and the Investment Portfolio included 170 companies by year-end.

Life Science Investments closed the year with DKK 124 billion (€17 billion) of Investment Assets and generated a return of -0.3% in DKK and 9.8% in CER, corresponding to DKK -422 million (€-57 million).

Capital Investments provides global exposure beyond the life science sectors and is actively expanding and diversifying the total portfolio.

Capital Investments delivered a strong performance in 2025, outperforming benchmarks despite strong currency headwinds and a market heavily concentrated on technology and artificial intelligence (AI).
A strategy of providing global exposure beyond the life sciences sector by investing in less cyclical, resilient businesses with a high degree of recurring revenue, served Novo Holdings well throughout the year.

In 2025, Capital Investments closed the year with DKK 114 billion (€15 billion) of Investment Assets and had returns corresponding to DKK 6.2 billion (€0.8 billion). The Capital Investments Portfolio generated a return of 6.4% in DKK and 9.8% in CER.

Reflecting on a year marked by fundamental shifts within geopolitics, technology and the global investment environment, Kasim Kutay added:

“As a response to market volatility, we took a cautious approach to new investments in early 2025. Gradually, we picked up the pace which resulted in the addition of 12 new portfolio companies. Given the extreme volatility we experienced in parts of the market, I am pleased with the strong 9.2% CER return Novo Holdings generated in 2025, which comes on the heels of a 14.8% CER return in 2024. Geographically, we strengthened our position in Asia by establishing a presence in Mumbai. With enhanced asset and geographic diversification in Novo Holdings’ Investment Portfolio, I believe we remain very well-positioned to continue delivering on our purpose of improving people’s health and the sustainability of society and the planet by generating attractive long-term returns for the Novo Nordisk Foundation.”

Learn more in the 2025 Performance Report

About Novo Holdings A/S
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2025, Novo Holdings had total assets of €93 billion.

About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.

Media enquiries
Marie-Louise Jersin, Senior Communications Lead, maj@novo.dk

___________________________

¹ The Investment Assets Portfolio includes all our Investment Assets.

² The Investment Portfolio excludes Special Investments, which comprise impact investments and Assets held for Novo Nordisk Foundation strategic purposes.

³ Both transactions signed in 2025 with KabaFusion closing in Q1 2026 and Clario expected to close in Q2 2026.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3c9b5534-9cfc-4810-9a21-235b6c6575b9

Dr. Teresa Montagut Appointed as Clinical Development and Medical Affairs Head at Mesoblast




Dr. Teresa Montagut Appointed as Clinical Development and Medical Affairs Head at Mesoblast

NEW YORK, March 11, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the appointment of Teresa Montagut MD, PhD in the newly established position of Head of Clinical Development and Medical Affairs reporting to the Chief Medical Officer Dr. Eric Rose. In this role, Teresa will lead Mesoblast’s medical affairs organization, fostering clinical collaborations and spearheading investigator-initiated trials, enhancing clinical and medical communications, and engaging with healthcare professionals. She will play a critical role in unlocking the value of Mesoblast’s cell therapy programs in new pediatric and adult inflammatory conditions in partnership with investigators and key opinion leaders.

Teresa brings extensive experience in medical leadership and pharmaceutical development, with a strong background in translating clinical science into meaningful patient outcomes. Teresa joined Mesoblast from Regeneron where she was Global Head of Early Pipeline Studies in Oncology and Head of Medical Affairs for Investigator Sponsored Studies in gastrointestinal and genitourinary areas. She previously led multiple cancer immunotherapy programs across Novartis, Genentech, and Atara Biotherapeutics.

Teresa earned her MD from Universidad Nacional Autónomade México and her PhD in Tumor Immunology from Memorial Sloan Kettering Cancer Center/Cornell University. She completed fellowships at Massachusetts General Hospital, Howard Hughes Medical Institute, and Rockefeller University. Teresa also serves on the Board of Directors of the Global Pediatric Alliance, supporting maternal and pediatric healthcare in under-served indigenous communities in Latin America, particularly Mexico.

“Teri’s commitment to scientific excellence and her expertise in investigator-initiated clinical trial execution is central to successful implementation of our strategy to expand the range of indications of our FDA approved product Ryoncil^® in pediatric and adult inflammatory conditions, as well as advancing our pipeline of transformative cellular therapies,” said Dr. Silviu Itescu, Chief Executive Officer of Mesoblast.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Release authorized by the Chief Executive.

For more information, please contact:

Nyxoah to Participate in the Oppenheimer 36th Annual Healthcare MedTech & Services Conference




Nyxoah to Participate in the Oppenheimer 36th Annual Healthcare MedTech & Services Conference

Nyxoah to Participate in the Oppenheimer 36^th Annual Healthcare MedTech & Services Conference

Mont-Saint-Guibert, Belgium – March 11, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company will participate in the Oppenheimer 36^th Annual Healthcare MedTech & Services Conference, which takes place March 16 – 19, 2026.

Olivier Taelman, Nyxoah’s Chief Executive Officer, will deliver a corporate presentation on Monday, March 16, 2026, at 8:40 am ET. A webcast of the presentation will be available in the Events section of Nyxoah’s Investor Relations website. The Company will be available for 1×1 meetings with institutional investors.

Nyxoah’s Investor Presentation can be accessed on the Shareholder Information section of the Company’s
Investor Relations page.

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; the Company’s results of operations, financial condition, liquidity, performance, prospects, growth, future revenue and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
Rémi Renard
Head of Investor Relations & Corporate Communication
IR@nyxoah.com

Attachment

• ENGLISH_Nyxoah to Participate in Oppenheimer 36th Healthcare Conference

Solid Biosciences Provides Interim Positive Clinical Update on Phase 1/2 INSPIRE DUCHENNE Trial




Solid Biosciences Provides Interim Positive Clinical Update on Phase 1/2 INSPIRE DUCHENNE Trial

– 40 participants have been dosed with SGT-003 in the INSPIRE DUCHENNE trial to date –

– Robust microdystrophin expression with consistent mechanistic evidence of dystrophin associated protein complex (DAPC) restoration and improvements in muscle integrity, including stabilization and improvement in cardiac function (LVEF) observed after treatment with SGT-003 –

– SGT-003 continued to demonstrate an encouraging safety profile and has been generally well tolerated in the 40 participants dosed as of March 11, 2026 –

– SGT-003 is administered using a lower-burden, steroid-only prophylactic immunomodulation regimen –

– The Company plans for additional meetings with the FDA in H1 2026 for guidance on a potential accelerated approval pathway for SGT-003 and expects to provide an update mid-2026 –

CHARLESTOWN, Mass., March 11, 2026 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today reported updated positive interim data from the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial of SGT-003. The new data, including additional muscle biopsy, serum biomarker, cardiac function, and safety analyses, add to a growing dataset that suggests the potential of the biological activity of SGT-003 microdystrophin therapy. The interim update was delivered in an oral presentation at the 2026 MDA Annual Meeting on March 11, 2026, by Aravindhan Veerapandiyan, M.D., Director of the Comprehensive Neuromuscular Program and Co-Director of the Muscular Dystrophy Association Care Center at Arkansas Children’s Hospital, and principal investigator in the INSPIRE DUCHENNE trial.

Bo Cumbo, President and CEO of Solid Biosciences commented, “These data continue to suggest that SGT-003 may be having a disease-relevant treatment effect, with observed robust microdystrophin expression, restoration of key components of the dystrophin-associated protein complex suggesting a direct biologic correlate of dystrophin activity, and improvements across multiple biomarkers of muscle integrity. Together with the promising safety and tolerability profile, these interim results reinforce our confidence in the potential of SGT-003 to meaningfully impact the disease course of Duchenne. Duchenne continues to have an unmet medical need. We are pursuing guidance on a potential accelerated approval pathway for SGT-003 and look forward to continued engagement with the FDA as we work toward that goal. Our focus remains on urgently advancing SGT-003 to provide the Duchenne community with an additional therapeutic choice.”

Dr. Veerapandiyan commented, “What stands out in these data is the biological consistency observed across multiple independent measures of muscle structure, health, and preservation. This, combined with an encouraging safety and tolerability profile, is compelling. Solid Biosciences’ uniquely comprehensive quantitative biomarker analyses provide critical insights into SGT-003, and based on these findings, I believe this therapy has the potential to become an important treatment option for patients living with Duchenne.”

INSPIRE DUCHENNE Updated Interim Clinical Data

INSPIRE DUCHENNE is a Phase 1/2 first-in-human, open-label, single-dose, multicenter trial designed to evaluate the safety, tolerability and efficacy of SGT-003 in pediatric participants with Duchenne at a dose level of 1E14vg/kg. SGT-003 is administered as a one-time intravenous infusion. The interim clinical data reported in this release are as of a February 23, 2026, data cutoff date.

SGT-003 has been generally well tolerated in the 40 participants dosed as of March 11, 2026. The safety and tolerability profile observed in the INSPIRE DUCHENNE trial continued to be promising; SGT-003 is administered using a low-burden, steroid-only prophylactic immunomodulation regimen. The trial is being conducted at 15 clinical sites across the US, Canada, Italy and the United Kingdom and participant dosing remains ongoing.

Microdystrophin transduction and expression levels, beta-sarcoglycan localization and nNOS activity were evaluated by biopsy in 20 participants (ages 1-10 years) at Day 90 and in 3 participants at Day 360 (Table 1). Results demonstrated robust mean vector copies per nucleus and microdystrophin expression as well as properly localized and restored beta-sarcoglycan-positive fibers and nNOS activity-positive fibers. Beta-sarcoglycan and nNOS are critical components of the dystrophin-associated protein complex (DAPC). In Duchenne, the absence of dystrophin destabilizes the DAPC, triggering a cascade of structural, signaling and metabolic defects that impair muscle integrity. Reconstituting critical components of the DAPC, including beta-sarcoglycan and nNOS, could suggest biologic correlation of SGT-003’s treatment effect. Solid’s microdystrophin construct is the only microdystrophin gene therapy, approved or investigational, that contains the R16/R17 binding domain, which uniquely localizes nNOS to the muscle.

Table 1: 90- and 360-day biopsy results

Additionally, Solid has identified an extensive biomarker panel to comprehensively evaluate treatment effect on muscle integrity. Collectively, these observed biomarker improvements at Day 90 and Day 360 suggest improved muscle fiber health and stability, reduced ongoing muscle damage, and an interruption of the chronic degeneration/regeneration cycle that is characteristic of Duchenne.

In particular, embryonic myosin heavy chain (eMHC) is an informative predictor of disease progression. eMHC is typically expressed during fetal development but is also expressed when muscle satellite cells differentiate into muscle fibers, which in Duchenne occurs in response to muscle fiber damage. In the absence of functional dystrophin, newly generated muscle fibers also fail, leading to continued but ultimately futile satellite cell activation. A mean 44% observed reduction in eMHC positive fibers seen at Day 90 (n=20) suggests that SGT-003 treatment has potentially disrupted this chronic and futile degeneration-regeneration cycle, stabilizing muscle fibers and preserving the reservoir of satellite cells.

Table 2: Improvements in multiple biomarkers of muscle integrity observed at Day 90 and Day 360

While cardiac assessments were initially included as safety evaluations, stabilization-to-improvement in systolic function continues to be observed as of the data cutoff date, as measured by left ventricular ejection fraction (LVEF). Observed improvements were driven largely by participants with low-normal baseline LVEF (defined as ≤ 60%¹). Cardiomyopathy is a leading cause of death in Duchenne, with 25% of individuals displaying evidence of cardiomyopathy by six years of age, increasing to 59% by 10 years of age.²

A presentation summarizing the interim data update can be accessed on the Presentations page of the Investors section of the Company’s website.

SGT-003 Regulatory Status

As announced on February 9, 2026, Solid has reached alignment with the FDA on the overall study design for the Company’s randomized, double-blind, placebo-controlled Phase 3 clinical trial of SGT-003, IMPACT DUCHENNE. The FDA agreed that the trial design was reasonable including: the patient population of ambulant participants 7 to <12 years of age, the primary endpoint of change from baseline in Time to Rise (TTR) velocity from supine position evaluated at 18 months and other key secondary endpoints. Participant screening is underway and the Company anticipates dosing the first participant in the IMPACT DUCHENNE trial in the first quarter of 2026.

The Company plans to have additional meetings with the FDA in the first half of 2026 to receive guidance on a potential accelerated approval pathway for SGT-003 and expects to provide additional regulatory and clinical updates mid-2026.

References
1. Romanowicz J, et al. J Am Soc Echocardiogr. 2023;36(3):310-323.
2. Gandhi S, et al. Cells. 2024;13(14):1168.

About Duchenne
Duchenne is a genetic muscle-wasting disease predominantly affecting boys, with symptoms usually appearing between three and five years of age. Duchenne is a progressive, irreversible, and ultimately fatal disease that affects approximately one in every 5,000 live male births and has an estimated prevalence of 5,000 to 15,000 cases in the United States alone.

About SGT-003
SGT-003 is an investigational gene therapy containing a differentiated microdystrophin construct and a proprietary, next-generation capsid, POLARIS-101™ (formerly known as AAV-SLB101), which was rationally designed to target integrin receptors, and has shown enhanced cardiac and skeletal muscle transduction with decreased liver targeting in data from the Phase 1/2 INSPIRE DUCHENNE clinical trial and in nonclinical studies. SGT-003’s microdystrophin construct uniquely includes the R16/17 domains, which localize nNOS to the muscle. Nonclinical studies have shown that nNOS can improve blood flow to the muscle thereby reducing muscle breakdown from ischemia and muscle fatigue. Together, these design features suggest that SGT-003 could be a potential best-in-class investigational gene therapy for the treatment of Duchenne.

About INSPIRE DUCHENNE
INSPIRE DUCHENNE is a first-in-human, open-label, single-dose, multicenter Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of SGT-003 in pediatric participants with a genetically confirmed Duchenne diagnosis with a documented dystrophin gene mutation. INSPIRE DUCHENNE is a multinational trial designed to enroll participants in the United States, Canada, the United Kingdom and Italy.

About IMPACT DUCHENNE
IMPACT DUCHENNE is a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a single dose of SGT-003 in ambulatory participants aged 7 to less than 12 with a genetically confirmed Duchenne diagnosis. IMPACT DUCHENNE is a multinational trial intended to support potential regulatory authorizations.

About Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit www.solidbio.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company’s goals; anticipated benefits of SGT-003; strategies and expectations for the company’s SGT-003 program; expectations for planned enrollment, planned regulatory interactions and the potential approval pathways for SGT-003; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company’s ability to advance SGT-003, SGT-212, SGT-501, SGT-601 and other preclinical programs, capsid libraries and other enabling technologies on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company’s product candidates; manufacture sufficient quantities of our drug product in a timely manner and maintain adequate supply to support our clinical development and potential commercialization; obtain, maintain or protect intellectual property rights related to its product candidates; replicate preliminary or interim data from clinicals trials in the final data of such trials; compete successfully with other companies that are seeking to develop Duchenne, FA, CPVT and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, SGT-212, SGT-501, SGT-601 and other candidates; achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.

Solid Biosciences Investor Contact:
Nicole Anderson
Senior Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
investors@solidbio.com

Media Contact:
Glenn Silver
FINN Partners
glenn.silver@finnpartners.com

GUERBET : Change in Guerbet’s Board of Directors.




GUERBET : Change in Guerbet’s Board of Directors.

Change in Guerbet’s Board of Directors

Villepinte, March 11th, 2026: Guerbet (FR0000032526 GBT), a global leader in contrast agents and solutions for medical imaging, today announced, at its Board of Directors’ meeting, the appointment of Mr. Antoine Fady as “censeur” (non-voting director) effective immediately.

The appointment of Mr. Antoine Fady as a Director will be submitted for approval at the next Shareholders’ Meeting. Following this Shareholders’ Meeting, it will be proposed that the Board of Directors of Guerbet appoint Mr. Antoine Fady as Chairman, succeeding Mr. Hugues Lecat, who has decided to step down from his duties for personal reasons.

The members of the Board of Directors stated:
“We are delighted to welcome Mr. Antoine Fady to the Guerbet Group as a Board Observer, with the objective—subject to Shareholders’ Meeting approval—of him becoming a director and subsequently Chairman of the Company. His experience leading large industrial companies, his strong understanding of governance issues, and his strategic vision will be valuable assets in supporting the Group through a successful transformation and toward new achievements. We would like to sincerely thank Mr. Hugues Lecat for his unwavering commitment alongside us over the past two years.”

Mr Antoine Fady commented:
“I am very pleased to join Guerbet’s Board of Directors, with the prospect, subject to shareholder approval, of assuming its Chairmanship, and I would like to thank the Board members for their trust. In this year when Guerbet is celebrating a highly symbolic milestone, its 100th anniversary, I am extremely enthusiastic about contributing to the Group’s development and working closely with Karim Boussebaa to develop and implement strategies that will strengthen our market position and promote long-term sustainable growth.”

Biography

A trained engineer, a graduate of the École Nationale Supérieure des Mines de Saint-Étienne and holder of an MBA from INSEAD, Mr. Antoine Fady has extensive experience as an international executive in specialty and process industries.

He served for more than ten years as Chief Executive Officer of Flint Group, a global provider of printing materials and solutions, leading the company through major phases of strategic transformation, restructuring, and value creation.

Previously, he held several general management positions at ICI and Akzo Nobel, notably within the paints and coatings businesses in Europe.

Mr. Antoine Fady also has recognized governance experience as a non-executive director and board chairman, notably at Roquette (current directorship) and XSYS (Chairman of the Board from 2021 to 2024).

His career is characterized by deep expertise in complex and highly regulated industrial environments, strong corporate governance experience, and an extensive international background.

Next Event:

Q1 2026 revenue publication
April 23, 2026, after market close

About Guerbet

At Guerbet, we build lasting relationships to enable better living. This 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. Pioneers in contrast agents for 100 years, with 2 746 employees worldwide, we continuously innovate and dedicate 10,3% of our revenue to Research & Development across four centers in France and the United States. Guerbet (GBT) is listed on Euronext Paris, Compartment B, and achieved €786 million in revenue in 2025. For more information, please visit www.guerbet.com.

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GUERBET : 2025 full-year results.




GUERBET : 2025 full-year results.

2025 full-year results

• Revenue: €786.4 million, down 3.5% at CER¹ and like-for-like², mainly due to the fall in activity in France
• Profitability: restated EBITDA margin³ of 12.0% (at the high end of the adjusted range communicated in December)
• Net Income: loss of €112.7 million, which includes a non-recurring impairment of €86 million
• Free cash flow: in positive territory at €19.2 million
• Indebtedness: net debt/EBITDA ratio of 4.0x, below the ceiling of 4.8x set in December 2025 under the waiver obtained by the Group from its lenders.

2026

• Significant negative impact expected from the situation in Raleigh on revenue, profitability, cash generation and group indebtedness with a probable risk of covenant breach on June 30, 2026
• No dividend distribution in respect of the 2025 fiscal year
• Continuation of the transformation plan and strategic focus on sustainably improving the Group’s sales momentum and competitiveness

Villepinte, March 11, 2026, 5.45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its consolidated financial statements for fiscal 2025.

Full-year revenue came to €786.4 million, down 6.5%. After excluding the currency effect (-€22.8 million), mainly due to the depreciation of the US dollar, the Brazilian real and the South Korean won, this decline narrows to 3.8% at constant exchange rates (CER)¹. At CER and on a like-for-like basis², Guerbet’s revenue fell by 3.5% in 2025.

This decline is mainly due to two factors: the contraction in activity in France, without which sales would have been stable in 2025, and the loss of revenue in the fourth quarter linked to the situation at the Raleigh site (North Carolina).

In EMEA, full-year sales were down 2.5% at CER and on a like-for-like basis. However, after stripping out France, the region posted growth of 7.6% for the year. In France, the completion of the adaptation of manufacturing processes in line with the switch in the mix to comply with supply chain reform (from single dose to large vials) led to a return to growth in the fourth quarter of 2025.

In the Americas, full-year revenue was down 3.8% at CER and like-for-like. This decline, concentrated in the fourth quarter of 2025, was due to the delay in the release of batches produced at the Raleigh site because of the work being carried out under the compliance plan following the recommendations of the Food and Drug Administration (FDA).

In Asia, revenue for the year was down 4.8% at CER and like-for-like, due in particular to the loss of a major call for tenders in Vietnam.

By business, full-year revenue in Diagnostic Imaging was down 5.3% at CER and like-for-like, due to:

• In the IRM division (-1.9%), an increase in the Dotarem^® / Elucirem^TM franchise over the first nine months, followed by a decrease in the fourth quarter linked to the situation at the Raleigh site.
• In the X-ray division (-7.2%), the decrease in volumes for Xenetix^® and Optiray^®, mainly in France.

In Interventional Radiology, revenue rose by 9.7% at CER and like-for-like in 2025, still driven by solid momentum in volumes and prices for Lipiodol^®, particularly in vascular embolization.

Net income includes a significant non-recurring impairment, with no impact on cash

In 2025, the Group generated an EBITDA margin rate representing 10.5% of revenue. Excluding non-recurring costs related to the optimization of the operating plan and the change in the sales model which totaled -€12.2 million (vs. -€6.0 million in 2024), the restated margin rate was 12.0%, at the high end of the adjusted range communicated on December 2 (between 10.5% and 12%), compared with 14.9% in 2024.

The fall in profitability is due to the decline in activity and pressure on prices, particularly in the United States where margins were penalized by the unfavorable increase in the weight of distributors in the customer mix. At the same time, the Group maintained good cost discipline, with a decrease in personnel expenses (-7.2%) and external expenses (-6.5%).

The Group made an operating loss for the year of -€88.2 million, after the recognition of €170.4 million in depreciation, amortization and provisions. This includes in particular a non-recurring impairment of €86 million recorded in relation to the current situation at the Raleigh site following the impairment tests carried out during the year, as well as a provision of €10 million relating to the future destruction of certain inventories at the Raleigh site. These two accounting items have no impact on the Group’s cash generation.

After taking into account lower financial expenses (-12.8%) of €19.4 million, and foreign exchange losses (€2.0 million) and tax (€3.1 million), the Group made a net loss of -€112.7 million, compared with a profit of €13.5 million in 2024. On the balance sheet, shareholders’ equity stood at €267 million at December 31, 2025, compared with €394 million a year earlier.

Free cash flow and Indebtedness

Free cash flow (FCF) was positive for the year at €19.2 million (versus -€9.1 million in 2024), driven by a significant improvement in working capital requirements (WCR), thanks in particular to the optimization of the average days sales outstanding (DSO).

Net debt came to €325.7 million (vs. €344.9 million in 2024), i.e. financial leverage⁴ (net debt/EBITDA) of 4.0x (compared with 2.9x in 2024), below the ceiling of 4.8x set in December 2025 under the waiver obtained by the Group for its covenant from its lenders.

In order to support Guerbet Group’s long-term development, the Board of Directors will propose at the General Shareholders’ Meeting of May 22, 2026 that no dividends be distributed to shareholders in respect of the 2025 fiscal year.

Update on the Raleigh site and significant negative impact expected in 2026 on revenue, profitability, cash generation and group indebtedness

At the Raleigh industrial site, the remediation plan initiated in the fourth quarter of 2025 is continuing with a new management team in place and the support of external experts. The corrective actions undertaken, including the modernization of equipment and processes, aim to respond as quickly as possible to the FDA’s requests, and thus allow a return to a normative release rate for batches produced at the plant. The batch release rate has increased compared to the fourth quarter of 2025 and will continue to increase throughout the 2026 fiscal year.

The Raleigh site plans to be ready for a new FDA inspection by the end of fiscal 2026.

It expects to return to a normative release rate by the end of 2026, allowing Guerbet to operate under normal conditions in full-year 2027.

The Group anticipates a significant negative financial impact in 2026 from the situation in Raleigh:

• On activity mainly in North America and Latin America;
• On profitability, due to expenses related to the compliance plan, the increase in unit costs caused by a lower level of production, and inventory destruction costs;
• On cash generation, with free cash flow expected to be negative for the year and net debt expected to increase.

Guerbet draws attention to the probable risk of non-compliance with the net financial debt to EBITDA ratio of x3.5 tested on June 30, 2026 under the terms of the €350 million syndicated credit agreement and the €50 million EuroPP bond issue agreement and €50 million Relance bond issue agreement. If this non-compliance materializes, it would give lenders the right, subject to certain majorities being reached, to declare their debt due and payable in advance from the second half of 2026.

The Board of Directors has approved the Group’s consolidated financial statements today in accordance with the going concern principle. The audit procedures on the consolidated financial statements have been carried out and the auditors’ report, which will mention a significant uncertainty related to the going concern assumption due to the probable risk of non-compliance with the debt ratio mentioned above, is currently being issued.

The going concern assumption is therefore based on the assumption that a waiver will be obtained from the lenders. If this assumption is not met, the going concern assumption used for the financial statements as of December 31, 2025 may not be appropriate.

Guerbet is confident in its ability to find a satisfactory solution within a timeframe that is compatible with its contractual commitments.

Pursuing its transformation plan and strategic priorities

Guerbet’s teams remain fully committed to implementing the transformation plan launched in autumn 2025, aimed at strengthening sales momentum and restoring long-term profitability. This plan is based on three strategic priorities:

• Strengthen operational efficiency in Diagnostic Imaging by improving the competitiveness of the X-ray activity – in particular by streamlining the reference portfolio, promoting multi-dose (large) vials and optimizing industrial processes – while continuing to gain market share in MRI thanks to the Dotarem®/Elucirem™ franchise, with a ramp-up for the latter through geographical expansion and new indications.
• Support the strong momentum in Interventional Radiology (average full-year growth of +16.1% since 2012) by capitalizing on the positioning of Lipiodol® as the reference treatment for HCC (liver cancer), the growth in its use for vascular embolization, and the potential of Lipiojoint in the management of osteoarthritis.
• Improve productivity and cash generation by focusing on the twin aims of reducing fixed costs by implementing a plan to completely overhaul the support functions across the Group’s entire geographical scope, improving commercial and industrial efficiency and strengthening the financial structure through cash generation, based on rigorous management of working capital requirements (control of payment deadlines, optimization of inventories) and strict control of purchases. The full effect of this transformation plan is expected to be visible in fiscal 2027. The implementation of these measures in the French scope will be subject to consultation with the employee representative bodies for projects falling within their remit.

In this environment, the Group will communicate its 2026 targets at the latest when it presents its first-half revenue on July 23, 2026.

Next event:

Q1 2026 revenue
April 23, 2026 after market close

Glossary

Net debt: Net financial debt is defined as the sum of current and non-current borrowings less cash and cash equivalents and marketable securities.

EBITDA: EBITDA is defined as operating income plus net depreciation, amortization, impairment and provisions for risks.

Restated EBITDA: Restated EBITDA is defined as EBITDA minus non-recurring expenses related to reorganizations of the operational model.   

Free cash flow (FCF): Free cash flow is defined as the change in net debt from one year to the next.

Like-for-like basis: Like-for-like basis refers to the scope excluding the urology and Accurate businesses, sold in July 2024 and January 2025 respectively.

At constant exchange rates: At constant exchange rates means the impact of exchange rates is eliminated by recalculating sales for the period based on the exchange rates used for the previous year.

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 100 years, with 2,746 employees worldwide, we continuously innovate and devote 10% 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 €786 million in 2025. 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 At constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous fiscal year.

² Excluding the urology and Accurate activities (including sales in 2025 of inventories of components and finished products), which were sold in July 2024 and January 2025 respectively.
³ Excluding non-recurring costs related to the optimization of the operational framework and changes to the sales model.
⁴    This covenant applies to the bank debt and bonds negotiated in 2023.

Attachment

• 260311 CP GBT RA_Final_EN