aap Implantate AG (“aap” or “Company”) informs:

• Human Clinical Trial of Silver Antibacterial Technology Successfully Nears Completion and Opens Next Step to Regulatory Approval;
• Existing customer business EMEA grows normalized by 11%, total aap 3% after excluding one-time UN order;
• US tariff impact successfully mitigated;
• APAC region strong growth driver

The first half of 2025 was marked by geopolitical uncertainties, fragile supply chains and new US tariffs. Despite these challenges, the company succeeded in strengthening its operating base and consistently driving forward strategic initiatives.

The introduction of US import tariffs (“Liberation Day”) at the beginning of April represented a turning point. Operational adjustments in supply chains and targeted price adjustments in the USA have reduced the impact of tariffs to a minimum.

Regionally, we were able to further expand our position in important markets:

• EMEA: The EMEA region, which accounts for over 50% of total sales, maintained a solid baseline. Adjusted for one-off effects from the previous year, the region even recorded strong growth of 11% in existing customer business. Germany (+8% despite hospital structural reform), South Africa (+36%) and the MEA markets as a whole performed particularly well.

• LATAM: The region stabilized in Q2 but was unable to close the Q1 gap. Brazil stands out with +37% growth, driven by the successful launch of the first LOQTEQ® foot systems after certification. Mexico and Colombia, on the other hand, fell short of expectations – Mexico due to delayed customer contract processes, Colombia due to structural challenges due to financing bottlenecks in the healthcare sector.

• APAC: Successful market development continues. With initial activities in the new markets of South Korea and Taiwan as well as strong growth in Thailand (+26%), the customer base was significantly expanded. The region achieved an impressive growth of 82% and promises further growth in the future.

• USA: The strategic transformation was initially slower than expected, but the implemented strategies and intensified customer activities are now starting to take effect. In June, monthly sales of over USD 0.3 million were achieved – a clear signal that the reorganization and targeted customer relationships initiated in 2023 are bearing fruit.

Revenue Q2/HY 2025/2024

With regard to the USA, the success story of the strategic realignment is somewhat clearer when viewed after adjusting for currency effects. The operating decline decreased continuously from -9% in the first half of the year to only -1% in the second quarter – clear evidence that the transformation initiated in 2023 is taking effect.

Due to the continuously growing customer base and simultaneous investments by existing customers in the aap portfolio, the company plans to increase orders on the revenue side for the second half of 2025 compared to the first 6 months.

Key financial figures for the first half of 2025 aap Group (unaudited)

*(Gross margin = sales +/- inventory changes – material expenses / sales revenues)

Key financial figures for the first half of 2025 aap by segment (unaudited)

The measures taken at the end of 2023, ongoing optimizations and the organic increase in sales are showing financial success in the first half of the year. aap achieved an almost break-even result in consolidated earnings at EBITDA level, while the positive trend was confirmed in the trauma business at EBITDA level. The EBITDA difference compared to the previous year is primarily related to the deviation in sales and the reduced other operating income.

Cashflow (unaudited)

The significant improvement in operating cash flow was mainly due to a stable gross margin of over 85% (despite inflation-related increases in material prices), lower personnel costs compared to the previous year (mainly reduction in vacation provisions), and an improved margin and cost situation in the United States (higher margins with stable fixed costs).

Financing
In July 2025, the company was able to conclude a lease-sale back agreement with NordLeasing company to secure liquidity. The company thus received EUR 725 thousand. The leasing contract has a term of four years.

Operational activities

Bottlenecks at our notified body delayed the expected MDR approvals for plates and screws, which had a negative impact on sales planning and production. On the other hand, the MDR approvals for products of classes Im, Ir and IIa were successfully completed, which confirms the high quality of our submitted documents. These successes make us confident that the remaining registrations will follow soon.

Regarding the human clinical trial with antibacterial implants, we refer to the most recent press release of September 09, 2025. The Internet address contained in the press release regarding the guideline of the study has changed due to a name change of the funding agency. It has been updated in the following text.

The clinical trial is funded by the German Federal Ministry of Education and Research (“BMBF”). The grant granted to the company (funding codes 13GW0313A+B, 13GW0449A+B) is part of the BMBF’s field of action “Healthcare Economics in the Health Research Framework Program” (= funding body). According to the BMBF, funding is provided for projects on the topic of “Transferring medical technology solutions into patient care – proving clinical evidence without delay”. For further information, please refer to the corresponding guideline on the BMBF website: https://www.bmftr.bund.de/SharedDocs/Bekanntmachungen/DE/2024/07/2024-07-29-Bekanntmachung-L%c3%b6sungen.html.

Outlook for the second half of 2025

For the second half of 2025, in addition to the forecasts already formulated in the 2024 annual financial statements, the focus is on several important milestones: the stabilization of liquidity for ongoing investments, the completion of the human clinical trial, the preparation of the study report by the end of the year for our antibacterial implant technology and the completion of the MDR approval work. At the beginning of September, we had already very successfully passed the MDR recertification of the company and the US FDA inspection.

On the revenue side, the Management Board plans to increase sales for the second half of the year compared to the first six months and maintains its forecast for the year as a whole.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

About aap Implantate AG

 aap Implantate AG is a global medical technology company headquartered in Berlin, Germany. The company develops and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovative pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical and not yet adequately solved problems in traumatology.  In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while on an international level, it primarily uses a broad network of distributors in around 25 countries. In the USA, the company and its subsidiary aap Implants Inc. rely on a distribution agent and selective direct sales strategy. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Board of Directors/CEO; Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 170; Email: r.digirolamo@aap.de

Newron presents H1 2025 results and provides business update 

Milan, Italy, September 16, 2025, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half-year ended June 30, 2025, and provided a business update for 2025 and beyond.

Highlights H1 2025:

Evenamide

Clinical trials:

• In May, the Company announced regulatory approval for its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with treatment-resistant schizophrenia (TRS). The program consists of two pivotal studies:
  • ENIGMA-TRS 1, an international, one-year, double-blind, placebo-controlled Phase III study in at least 600 patients. Following a successful screening period, patient enrolment began post-period, in August 2025, with 12-week study results expected in Q4 2026
  • ENIGMA-TRS 2, approved by the US Food and Drug Administration, to be performed at centers in the US and selected additional countries. This 12-week, double-blind, placebo-controlled Phase III study in at least 400 patients is expected to start by October 2025

Strategic licensing and partnerships:

• In January, the Company announced a licensing agreement with Myung In Pharm to develop, manufacture and commercialize evenamide in South Korea
  • Under the terms of the agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming Phase III ENIGMA-TRS 1 study and will cover the costs related to this population
• Following the execution (in December 2024) of the licensing agreement with EA Pharma, a subsidiary of Eisai, to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories, Newron in the reporting period received the upfront payment of EUR 44 million and invoiced the first milestone achievement
• Newron continues to actively explore additional partnership opportunities for the global development and commercialization of evenamide in other territories

Industry engagement and scientific exchange:

• In January, evenamide’s exceptional results in study 014/015 and study 008A were published in the peer reviewed International Journal of Neuropsychopharmacology
• Post-period, in August 2025, new preclinical data from researchers at the University of Pittsburgh was published in the peer-reviewed journal Neuropsychopharmacology. The research suggests that evenamide ameliorates schizophrenia-related dysfunction, targeting the key site of schizophrenia pathology in the hippocampus, and so could be an ideal therapeutic agent for the treatment of schizophrenia

Corporate

• In April, Dr. Chris Martin was elected as the Chairman of Newron’s Board of Directors, succeeding Dr. Ulrich Köstlin who served as Chairman of the Company from 2013

Stefan Weber, CEO of Newron, commented: “Since the beginning of the year, Newron has continued to make exciting progress in the development of our novel drug candidate evenamide. Most notably, we announced the approval of our pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy in patients with treatment-resistant schizophrenia (TRS) and recently we began enrolling patients into the first study from the program, ENIGMA-TRS 1. We’re delighted to have achieved this crucial milestone on evenamide’s clinical development journey and continue to believe that this new chemical entity has blockbuster potential and could bring enormous benefits to patients who are insufficiently served by the treatments currently available.”

Evenamide – advancing schizophrenia treatment

In January, Newron announced its licensing agreement with Myung In Pharm to develop, manufacture and commercialize evenamide as an add-on therapy for TRS and poorly responding patients with schizophrenia in South Korea. Under the terms of the agreement, Myung In Pharm, besides the usual financial terms for such agreement, will contribute 10% of the total patient population to be enrolled into Newron’s pivotal ENIGMA-TRS 1 clinical trial and cover the costs related to this population.

There has also been strong progress from EA Pharma, who Newron has entered into a license agreement with to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories. EA Pharma expects to initiate its clinical development program for evenamide in Japan. Also, the first milestone under the license agreement became due and was invoiced in the reporting period.

In May, Newron announced the regulatory approval of its pivotal Phase III ENIGMA-TRS program with evenamide as add-on therapy in patients with TRS. More than one third of schizophrenia patients suffer from TRS and are not responding to the existing second-generation antipsychotics on the market. Consequently, these patients are in great need of the development and approval of new therapeutic treatments. If approved, evenamide would be the first medication added to existing antipsychotics that improves the symptoms of TRS.

The ENIGMA-TRS Phase III development program consists of two pivotal studies, ENIGMA-TRS 1 and ENIGMA-TRS 2:

• ENIGMA-TRS 1 is an international, 52-week, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide as an add-on treatment to current antipsychotics, compared to placebo. Patients on second-generation antipsychotics (SGAs), including clozapine, will meet Treatment Response and Resistance Psychosis (TRRIP) international consensus criteria for TRS. The study will enroll at least 600 patients at study centers in Europe, Asia, Latin America and Canada.
• The primary assessment of efficacy and safety of ENIGMA-TRS 1 will be performed 12 weeks after randomization to treatment. Following this initial period, the study will continue double-blind and placebo-controlled until the 52-week time point. The primary efficacy endpoint of the trial will be the change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Newron expects to announce 12-week results from the study in Q4 2026.
• ENIGMA-TRS 1 is actively screening across all target continents. Post-period, in August 2025, Newron announced that the first patients have been successfully enrolled following the completion of a 42-day screening period. Newron’s partner Myung In Pharm has also received the necessary approvals in South Korea to move towards enrolling patients in this region.
• ENIGMA-TRS 2, the second study in Newron’s pivotal Phase III development program, has been approved by the US Food and Drug Administration (FDA), and will be performed at centers in the US and selected additional countries. ENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase III study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide as an add-on treatment to current antipsychotics, compared to placebo.
• Patients will undergo the same screening as the ENIGMA-TRS 1 trial. The efficacy and safety analysis will be performed at the 12-week point following successful completion of the study. US investigational centers are expected to initiate the study by October 2025.

Shortly after the reporting period, in August 2025, new preclinical data from Dr. Anthony Grace and other researchers at the University of Pittsburgh was published in the peer-reviewed journal Neuropsychopharmacology. The data suggests that evenamide ameliorates schizophrenia-related dysfunction, and for the first time demonstrates that evenamide targets the key site of schizophrenia pathology in the hippocampus. Using the neurodevelopmental MAM model of schizophrenia, researchers demonstrated that evenamide could offer a novel therapeutic strategy capable of addressing the positive, cognitive, and negative symptoms of schizophrenia, a key advantage over existing antipsychotic drugs which only target positive symptoms.  Importantly, time-course analysis indicates effects of a single dose of evenamide last long after elimination of drug, suggesting effect on neuronal plasticity. These findings help explain the robust and sustained symptom improvements observed in Newron’s Phase II and Phase III studies in patients with chronic schizophrenia, reinforcing evenamide’s potential as a transformative therapy for treatment-resistant and poorly responding patients, and offering a promising alternative to traditional dopamine D2-based antipsychotics.

Xadago®/safinamide – Parkinson’s disease

In partnership with Zambon and Meiji Seika, Newron continues to develop and market its product, Xadago®/safinamide.

Corporate

At the Annual General Meeting 2025, Dr. Chris Martin was elected as the new Chairman of the Board following his nomination by the Company. Chris Martin took over from Dr. Ulrich Köstlin, who served as Chairman of Newron’s Board since 2013. Dr. Martin is a recognized leader in the biopharma industry who has taken therapeutic technology from the lab bench through to regulatory approval and global market sales. He co-founded ADC Therapeutics in 2012 and served as its CEO from its inception until 2022, growing the company from a private biotech start-up to a New York Stock Exchange listed leader in the field of antibody-drug conjugates with products marketed worldwide. Chris Martin also co-founded and was the CEO of Spirogen, an innovator of antibody-drug conjugate payload technology, which was subsequently sold to AstraZeneca for a total of up to $440 million.

Outlook

Following the approval of the pivotal Phase III ENIGMA-TRS program for evenamide and the subsequent initiation of the ENIGMA-TRS 1 study, Newron’s key focus for the coming months is on progressing this study and initiating ENIGMA-TRS 2, initially in the US study centers.

In addition to its licensing agreements with Myung In Pharm and EA Pharma, Newron continues to be supported by one of world’s leading full-service investment banking and capital markets firms in a structured process to secure the most attractive, value creating transactions for the Company’s shareholders.

Furthermore, to comprehensively protect the future value of evenamide for shareholders and new investors, Newron is currently in the process of filing additional patent applications to further extend the Intellectual Property protection around evenamide as a novel treatment for schizophrenia. Additionally, the existing patent applications pertaining to evenamide continue to be granted within the European Union and the US.

Newron CEO Stefan Weber concluded: “We are very excited about our continued achievements, and we are one step closer to potentially bringing enormous benefits to schizophrenia patients who are insufficiently served by the treatments currently available. The financial position of our Company remains strong – Newron’s total available cash resources are expected to fund our planned development programs and operations well towards the end of the year 2026.”

Financial Summary (IFRS) H1 2025 and 2024:

In thousand EUR (except per share information)

Newron’s Half-Year Report 2025 is available for download on the Company’s website at: www.newron.com/investors/reports-and-presentation/year/2025

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system.

Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications.

Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea.

Newron has a proven track record in bringing CNS therapies to market. Its Parkinson’s disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika.

For more information, please visit: www.newron.com 

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com  

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com
 

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

MPH Health Care AG publishes figures for the first half-year of 2025:

 Equity (net asset value) amounts to EUR 205.1 million, which corresponds to EUR 47.91 per share. The equity ratio fell slightly to 93.7% (31 December 2024: 95.5%)

Berlin, 16^th September 2025 – MPH Health Care AG (ISIN: DE000A289V03) announces the preliminary IFRS consolidated results for the first half-year of 2025. Accordingly, equity decreased by 26% from EUR 277.9 million as of 31 December 2024 to EUR 205.1 million as of 30 June 2025. The net asset value (NAV) per share fell from EUR 64.90 (31 December 2024) to EUR 47.91 as of 30 June 2025.

The IFRS result for the period decreased from EUR 74.5 million as of 30 June 2024 to EUR -72.7 million as of 30 June 2025. This result is due to the accounting valuations of the investments as at the reporting date, which do not affect cash flow. MPH AG is an investment company whose investments are reported as financial assets under the balance sheet item ‘Financial investments’ and are measured at fair value through profit or loss on the balance sheet date.

The equity ratio fell slightly from 95.5% to 93.7% and remains at a very high level.

The financial position has improved compared to the previous year. From 1 January to 30 June 2025, an operating cash flow of kEUR 1,016 was generated (previous year: kEUR -895) and a net cash flow of kEUR 261 (previous year: kEUR -2,781).

The fair value losses are mainly due to the sharp decline in the share price of our listed investment CR Energy AG, which unexpectedly filed for (preliminary) insolvency proceedings with the competent local court in Potsdam in June 2025. The price of CR shares fell from EUR 4.78 on 31 December 2024 to EUR 0.54 on 30 June 2025.

The M1 Kliniken AG investment continued its growth trajectory in the first half of 2025, once again increasing both revenue and earnings. IFRS consolidated revenue in the first half of 2025 amounted to EUR 183.5 million, compared with EUR 167.7 million in the first half of 2024. This represents an increase of 9.4%. The Group EBIT margin increased by approximately 14% to 9.8% in the first half of 2025 (same period last year: 8.6%). Operating profit (EBIT) increased to EUR 18.0 million (previous year: EUR 14.5 million). Net profit (before minority interests) as of 30 June 2025 rose by around 19% to EUR 12.5 million.

M1 Kliniken AG continues to grow and aims to increase revenue in the high-margin beauty segment to EUR 200–300 million per year by 2029, with a sustainable EBIT margin of at least 20%. With a dividend payment of EUR 0.50 per share, M1 Kliniken AG is reaffirming its distribution policy.

At this year’s Annual General Meeting of MPH Health Care AG on 17 July 2025, it was resolved to distribute a dividend of EUR 1.20 per dividend-bearing share, as in the previous year, and to carry forward the remaining amount of the 2024 net profit of EUR 72.5 million to new account.

The half-yearly report of MPH Health Care AG is available for download under Financial Reports – MPH Health Care AG.

About MPH Health Care AG:

MPH Health Care AG is an investment company with a strategic focus on the acquisition, development and sale of companies and company shares, particularly in growth segments of the healthcare market. This includes both insurance-financed and privately financed segments. However, MPH also aims to exploit potential opportunities in high-growth and high-yield sectors outside the healthcare market.

Contact:
Patrick Brenske, Management Board
Corporate Communications
E-Mail: ir@mph-ag.de

Gerresheimer delivers solid results in the financial year 2024 despite market headwinds

• Organic growth: revenue +2.9%, adjusted EBITDA +4.1%
• Destocking in vial business partially offset by strong growth in medical devices
• Growth strategy execution: capacity expansions and higher revenue share from solutions for biologics
• Bormioli Pharma to boost revenues and adjusted EBITDA from 2025 with integration well underway

Duesseldorf, February 26, 2025: Gerresheimer, an innovative systems and solutions provider and global partner for the pharma, biotech and cosmetics industries, achieved solid results and continued to grow profitably in financial year 2024. Revenues reached EUR 2,035.9m (2023: EUR 1,990.5m), while adjusted EBITDA amounted to EUR 419.4m (2023: EUR 404.5m). Organic sales grew by +2.9% and adjusted EBITDA by +4.1%. The adjusted EBITDA margin improved to 20.6% (2023: 20.3%). The Plastics & Devices Division benefited from the strong growth in medical devices, partially offsetting the destocking effects in the vial business in the Primary Packaging Glass Division. The first signs of a market recovery in the vial business were seen in the fourth quarter of 2024, but destocking effects at customers weighed on the results of the Primary Packaging Glass Division in the full year 2024. Bormioli Pharma will contribute significantly to the Group’s revenues and Adjusted EBITDA from the financial year 2025 while the integration into the Gerresheimer Group is well underway. For the financial year 2025, the combined group of companies including Bormioli Pharma now expects organic revenue growth of 3-5% compared to combined pro forma figures of the previous year. The adjusted EBITDA margin is expected to improve further to around 22%. The Group anticipates profitable growth in the coming years through the consistent execution of its growth strategy.

“2024 was characterized by temporary market effects in one of our submarkets,” says
Dietmar Siemssen, CEO of Gerresheimer AG. “Our long-term growth prospects remain positive. We are growing strongly in systems and solutions for large-molecule biologics for which we are systematically expanding our production capacities. With the acquisition of Bormioli Pharma, we have expanded our product portfolio and created the basis for new, integrated high value plastic solutions. All of this will help us to continue our profitable growth in the coming years.”

Plastics & Devices: Significant growth with improved margin
The Plastics & Devices Division generated revenue of EUR 1,141.3m in the financial year 2024 (2023: EUR 1,065.1m). Organic revenue growth amounted to 8.0%. The main driver of this positive development was the strong demand for drug delivery systems. Demand for plastic containment solutions also remained at a high level. Adjusted EBITDA reached EUR 293.7m (2023: EUR 270.0m). Adjusted EBITDA grew organically by 8.8% compared to the same period of the previous year. The division also increased its Adjusted EBITDA margin to 25.7% (2023: 25.3%). The positive development was driven by a higher proportion of specially tailored solutions for biologics, including GLP-1 products for the treatment of obesity.

Primary Packaging Glass: Destocking effects moderating
The first signs of a market recovery became visible in the fourth quarter of 2024, but business development in the Primary Packaging Glass Division in the financial year 2024 was still significantly influenced by destocking effects at pharmaceutical customers, particularly in the area of standard vials (“bulk vials”). Sales revenues reached EUR 898.6 million (2023: EUR 927.3 million). In organic terms, they were thus 2.6% below the same period of the previous year. Adjusted EBITDA amounted to EUR 177.2m (2023: EUR 182.5m). In organic terms, adjusted EBITDA was 2.4% below the prior-year period. The adjusted EBITDA margin remained stable at 19.7% (2023: 19.7%). Gerresheimer expects that destocking effects for standard vials will continue to moderate in the course of 2025.

High dividend continuity – dividend proposal of EUR 1.25
Gerresheimer’s adjusted net income increased to EUR 164.6m in the financial year 2024 (2023: EUR 158.0m). Adjusted EPS at constant currency rose to EUR 4.67 (2023: EUR 4.62). The Executive Board and Supervisory Board will therefore once again propose a dividend of EUR 1.25 per share for the financial year 2024 at the Annual General Meeting. This corresponds to a payout ratio of 26.0%. The proposed dividend is therefore within the payout range of 20% to 30%.

Bormioli Pharma – new category of high value plastic solutions through system integration

At the beginning of December 2024, Gerresheimer successfully completed the acquisition of the Bormioli Pharma Group. Bormioli Pharma will thus be fully consolidated in the Gerresheimer Group from the financial year 2025. The integration of the company is one of Gerresheimer’s focus topics of the financial year 2025 in order to seize the opportunities of the expanded product portfolio and the possibilities of system integration for new high-value plastic solutions. The acquisition also enables the formation of a stand-alone global moulded glass powerhouse.

Profitable growth expected in subsequent years

In view of the strong growth in systems and solutions for biologics, the successful execution of the growth projects in this area and the expanded portfolio of high value solutions, Gerresheimer expects profitable growth in the coming years.

Guidance for FY 2025 (organic)

• Revenue growth: 3-5%
• Adjusted EBITDA margin: around 22%
• Adjusted EPS growth: high single-digit percentage range

Mid-term guidance (organic)

• Revenue growth: 8-10 % CAGR
• Adjusted EBITDA margin: 23 – 25%
• Adjusted EPS growth: ≥ 10% CAGR

The Annual Report 2024 is available on the Gerresheimer website here:

https://www.gerresheimer.com/en/company/investor-relations/reports

About Gerresheimer
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.  Together with Bormioli Pharma 2024, the Group generated revenues of around EUR 2.4bn and currently employs around 13,400 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).
www.gerresheimer.com

Contact Gerresheimer AG

 Affluent Medical appoints Liane Teplitsky – a senior executive in the medical device industry as a new member of the Board of Directors

Aix-en-Provence, February 25, 2025 – 5:45 p.m. CET – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME – “Affluent”), a French clinical-stage medical technology company specializing in the international development and industrialization of innovative implantable medical devices, today announced it has coopted Liane Teplitsky as a new Board member.

Recently appointed CEO of Artedrone, the first autonomous robotic solution for Mechanical Thrombectomy, Liane Teplitsky is a successful seasoned senior executive in the medical device with achievements in building, leading, and growing innovative businesses that elevate the standard of patient care.

With an extensive background in R&D and a passion for advancing intelligent and life-changing medical technologies, Liane has cultivated an expertise in leading business strategy, clinical data development and commercialization for multimillion-dollar global medical technology franchises. Additionally, Liane has demonstrated excellence in building and leading highly functioning, highly engaged teams.

Most recently she was President, Global Robotics, Technology & Data Solutions at Zimmer Biomet where she led the global growth and development of the company’s portfolio of robotics and digital health technologies. Prior to Zimmer Biomet, Liane spent nearly a decade in executive leadership roles at Abbott as Vice President Sales & Division Vice President Marketing for Cardiac Arrhythmia & Heart Failure division and at St Jude Medical, with different strategic roles across multiple product and sales divisions.

Liane holds a Master of Science in Biomedical Engineering from Duke University and a Bachelor of Science in Electrical Engineering and a Bachelor of Science in Physiology from the University of Saskatchewan – Canada.

Sébastien Ladet, Affluent Medical CEO declares: “We are excited to welcome Liane to our board of Directors. Her extensive experience in both the healthcare and technology sectors, combined with her proven track record in leading market development and sales for medical devices, will be invaluable as we continue to advance in the clinical development of our 2 cutting-hedge medical devices to treat mitral valve regurgitation and prepare for their commercialisation.”
 

About Affluent Medical

Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases, one of the world’s leading causes of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, designed to restore essential physiological functions. The candidate products developed by the Company are all undergoing clinical studies in humans.

Subject to raising the funds necessary to finance its strategy and the positive results of ongoing clinical studies, the Company aims to gradually market its products from 2026, directly or indirectly.

For more information, please visit www.affluentmedical.com