PRESS RELEASE 

H1 2024 RESULTS

• Several agreements signed in July 2024 with Edwards Lifesciences for an initial amount of €15m and an option to acquire the rights for Kalios^TM
• Positive feedback from the Food & Drug Administration (FDA) to accelerate access to the US market for Kalios^TM through a simple De Novo or 510K pathway
• Progress in the ‘Dry’ pilot study with the Artus urinary sphincter, with 7 patients implanted by mid-September

Aix-en-Provence, September 26, 2024 – 5:45 p.m. CEST – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME – “Affluent”), a French clinical-stage medical technology company specializing in the international development and industrialization of implantable innovative medical devices, is today publishing its financial results for H1 2024 and providing an update on its clinical and operational progress and the extension of its financial horizon until July 2025.

Strong progress with all three clinical programs

Since January 1, 2024, Affluent Medical has taken several major steps in the development of its three medical devices. At the same time, and to meet its operational needs, the Company has secured several financings and signed a strategic partnership with the leader in this space, Edwards Lifesciences. 

MITRAL RING KALIOS^TM: Positive feedback from the FDA to quickly access the US market

Kalios^TM is the only mitral annuloplasty device that can be simply adjusted percutaneously by a cardiologist to treat both residual or recurrent mitral valve insufficiency, at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart surgery. Affluent Medical believes that Kalios^TM would avoid further intervention for potentially 30% to 40% of patients over a five-year horizon. The global market for mitral valve repair surgery was estimated to be $1.5 billion in the US-Europe region in 2023, growing at 3.5% per year.

In line with the US market access strategy announced in Q3 2023, the Company made several pre-submissions to the FDA to assess the marketing authorization process for its medical device as a class 2 device, which is faster than the registration process in Europe.

In September 2024, Affluent Medical received positive feedback from the FDA on this approach and the Agency indicated that no additional patients would be required beyond the 26 patients already treated in the Optimise II study. The FDA also shared its recommendations for the long-term follow-up of patients in preparation for the future submission.

Affluent Medical’s objective is to submit a De Novo application with current clinical data at the end of 2025/early 2026, followed by commercial launch, subject to Edwards’ decisions. 

MITRAL VALVE EPYGON: Acceleration of patient assessments and of activating clinical centers

Epygon is the only biomimetic mitral heart valve that mimics the anatomy of the native mitral valve and physiological blood flow, able to be implanted via a transcatheter route. This transcatheter approach avoids an invasive open-heart procedure and associated complications to treat mitral valve insufficiency.

This serious and potentially fatal disease affects 2% of the world’s population, or approximately 160 million people. However, fewer than 4% of patients with a severe form are able to have open heart surgery, which poses a high risk of death and hospitalization.

In 2024, the company began a collaboration with Prof. Mohammad Sarraf, MD, interventional cardiologist at the Mayo Clinic in the US, to evaluate the benefits of the biomimetic design of the Epygon valve. This innovative design aims to replicate the anatomy and natural physiology of the native mitral valve to enable patients to recover good cardiac function more quickly.

During the first half of 2024, Affluent Medical accelerated patient evaluations, achieving a fourfold increase in the number of patients included by the end of June 2024. The Company has increased the number of activated centers, with currently 11 centers in Europe. The selection criteria for this type of clinical study are highly stringent. As a result, Affluent Medical continues to work to increase the number of centers and has submitted applications for five new centers (in Austria, Italy, Germany and Spain), with the target of activating these sites in the coming months. The goal is to implant up to 10 patients to complete the pilot phase.

URINARY SPHINCTER ARTUS: seven patients already received implants; completion of pilot phase of study planned for Q4 2024

Artus is the first artificial urinary sphincter that can be activated by the patient with a simple remote control for the treatment of moderate to severe urinary incontinence. Urinary incontinence is a major public health problem for over 400 million people worldwide without any innovation in the last 40 years, causing patients to suffer a reduced quality of life associated with the psychological disorders related to the disease.

In March 2024, the first implant of the Artus next-generation urinary sphincter was successfully performed by Roman Zachoval, MD, PhD, Head of the Department of Urology at Thomayer University Hospital in Prague, Czech Republic.

At the end of June, the safety criteria were met in the first two patients, who did not report any discomfort or inconvenience during the use of the device. A performance assessment will be conducted in the pivotal phase of the study, evaluating reduction in urinary leakage at three months post implantation.

As of mid-September 2024, seven patients had received an implant, representing over half of the planned patients for the pilot phase of the study. The Company plans to implant a total of 10 patients by Q4 2024 and then launch the pivotal phase of the study. An additional 60 patients are planned to be enrolled in the pivotal phase of the study, which will assess performance based on at least a 50% reduction in incontinence pads.

Ongoing support from major shareholders with two successive financings

€3.5 million capital increase subscribed by main shareholders

At the end of January 2024, Affluent Medical announced the completion of a €3.5 million bridge financing from its main shareholders (Truffle Capital, LCEA, Ginko Invest, Denos and Hayk Holding), in the form of a capital increase with cancellation of preferential subscription rights of shareholders in favor of a category of beneficiaries. The transaction enables the Company to finance operations, in particular the costs related to regulatory support for interactions with the FDA for Kalios^TM, the initiation of the pilot study for Artus and the continuation of the pilot study for Epygon. 

Current account advances granted by reference shareholders

In April 2024, to finance its short-term operational needs, Affluent Medical carried out another bridge financing with its main shareholders in the amount of €3.5m. In the form of current account advances, the Company was able to extend its financial horizon until the end of July 2024 and explore various additional financing options. The shareholders that participated in this financing were Truffle Capital and Ginko Invest.

Signing in July 2024 of several strategic agreements with Edwards Lifesciences, a global leader in innovative solutions for cardiovascular diseases, which becomes a reference shareholder

On July 11, 2024, the Company entered into several agreements with Edwards Lifesciences relating to its interventional cardiology products (Kalios™ adjustable mitral ring) and technologies (mitral valve technology). Under these agreements, Affluent Medical received an initial cash payment of €15 million.

The three agreements break down as follows:

• An initial payment of €5 million for an exclusive purchase option for Kephalios, the wholly owned subsidiary of Affluent Medical developing the innovative adjustable mitral ring Kalios™, based on the results of its clinical study. Operational activities for the development of Kalios™ will continue to be managed exclusively by Affluent Medical during the life of the option.

• An initial payment of €5 million for Affluent’s global, non-exclusive intellectual property license on the biomimetic heart valve replacement technology. The agreement is limited to open-heart surgery, enabling Affluent Medical to retain its right for the transcatheter pathway. Affluent Medical is eligible to receive future royalties on all products that may be marketed using the licensed patents throughout the lifetime of these patents. Affluent Medical retains all rights to the transcatheter valve patents, including those for its Epygon mitral valve, which is currently in clinical development.
   
• A €5 million payment as part of Edwards Lifesciences’ acquisition of a stake in Affluent. Edwards Lifesciences invested €5 million to acquire a stake in Affluent Medical, becoming a 9.21% shareholder. This investment was made as part of a capital increase with cancellation of preferential subscription rights of shareholders through an offer reserved for certain categories of beneficiaries. The unit subscription price, set at €1.38 per share (including a par value of €0.10 and an issue premium of €1.28), reflected a 15% discount on the weighted average price over the last 20 trading sessions before July 11, 2024. This strategic investment by Edwards Lifesciences marked an important step in the development of Affluent Medical, recognizing the innovation of its products.

With the initial cash payment of €15 million received under these agreements, Affluent Medical’s financial runway was extended by more than one year to July 2025.

In addition to this initial payment, in accordance with the agreements, new payments could be made to Affluent, in particular, related to the exercise of the exclusive purchase option for Kephalios, which would be triggered based on the results of the ongoing Optimise II pivotal clinical study with Kalios^TM, as well as royalty payments on the sales of surgical valves using Affluent’s technology.

FINANCIAL STATEMENTS FOR H1 2024

The main financial items under IFRS are presented in the table below and were approved by the Board of Directors at its meeting on Tuesday, September 24, 2024. The Statutory Auditors conducted a limited review of the half-year financial statements.

The full financial statements are available on the Company’s website: www.affluentmedical.com.

 During H1 2024, consumed purchases decreased by €119,000 compared with H1 2023, with a decrease of €141,000 in external study expenses.

The change in external costs between the two periods was mainly due to consulting, engineering and recruitment fees, up by €901,000.

The €405,000 increase in personnel expenses in the first half of 2024 was due to the increase in the Group’s workforce in research and development, clinical activities and management functions.

The Group had an average headcount of 66 employees at the end of H1 2024, compared with 52 one year previously.

In the first half of 2024, financial income included: accrued interest of €618,000 on repayable advances (Mivana and PIAVE Artus); accrued interest of €38,000 on current account advances received in May 2024 from certain shareholders; interest paid of €63,000 (€27,000 in the first half of 2023) in connection with the pre-financing of research tax credit receivables; financial interest on leases of €21,000; the accretion of repayable advances in accordance with IAS 20 “Accounting for Government Grants and Disclosure of Government Assistance” of €7,000; and changes in the fair value of liabilities derivatives amounting to +€100,000 (+€53,000 in the first half of 2023).

The Company reported a net loss of €9.4 million in H1 2024, compared to a net loss of €8.0 million in the prior year period.

Availability of the 2024 half-year financial report

The interim financial report for 2024 is available to the public and was filed with the French Financial Markets Authority on September 26, 2024. It is also available on the company’s website in the Investors section.
 

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

Contacts:

Gerresheimer, Stevanato Group and SCHOTT Pharma Announce Strategic Industry “Alliance for RTU”

•  Market advances adoption of ready-to-use containers
• Improved operational efficiency in pharmaceutical manufacturing processes
• Increased patient safety with high-quality sterile primary packaging

Düsseldorf, September 26, 2024. Gerresheimer AG (MDAX: GXI), an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, together with Stevanato Group S.p.A. (NYSE: STVN), and SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP), announced today that they have entered into a strategic industry alliance (“Alliance for RTU”) to support market adoption of Ready-to-Use (RTU) vials and cartridges.

The Alliance for RTU aims to share with pharmaceutical companies, CMOs and CDMOs expertise and technical knowledge in high-quality sterile primary packaging, specifically ready-to-fill vials and cartridges, highlighting RTU configurations’ advantages over conventional bulk packaging.

Reduced risks and lower total cost of ownership

Traditional fill & finish processes present several operational risks and require increased efficiency. By adopting an industrial ready-to-use (RTU) setup, pharmaceutical companies and Contract Manufacturing Organizations (CMOs) can benefit from reduced operational risks, enhanced flexibility and efficiency, and lower waste. RTU technology can help streamline processes, increase productivity, and thus lower total cost of ownership (TCO) while reducing contamination risks and easing EU GMP Annex 1 compliance.

Pharmaceutical companies, CMOs and CDMOs opting for ready-to-use containers can benefit from higher-quality products, which helps minimize the release of glass particles and risks of breakage or rejection while preserving the drug inside throughout its entire life cycle.

Open expert platform for RTU industry standard

Additionally, the market is driving investment in advanced aseptic filling technologies due to increasing demand for injectable medicines and regulatory pressure to meet safety standards. In this context, the Alliance for RTU aims to create an expert platform open to other industry players to help industry manufacturers learn about the key benefits of RTU processes and products and to better evaluate investments for transitioning to efficient filling systems and meeting their unique needs from clinical applications to widespread commercial use.

“As an industry, we are fully prepared for the transition to RTU vials and cartridges,” said Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. “With recent advancements, RTU processing is now a mature technology which will improve our customers operations in terms of efficiency, cost and time to market.”

“RTU vials and cartridges represent a significant advancement in product quality, offering enhanced reliability and efficiency in pharmaceutical processes. This alliance allows us to highlight further how RTU solutions elevate standards across the industry, ensuring safer and more effective delivery of medications to patients worldwide” said Franco Stevanato, CEO at Stevanato Group.

“The shift towards ready-to-use vials and cartridges reflects a collective industry move to advance quality and efficiency in aseptic filling processes and this alliance shows readiness by expanding capacity and thereby supporting this market trend,” said Andreas Reisse, CEO at SCHOTT Pharma. “Ready-to-use solutions can reduce complexities and better meet the stringent requirements of modern pharmaceutical production.”

The Alliance for RTU will be officially presented at the CPHI in Milan on October 8, 2024 during a dedicated event at the tradeshow fairground.

For more information, visit www.alliance-for-rtu.com.

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as 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, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).  
www.gerresheimer.com 

About Stevanato Group
Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. www.stevanatogroup.com.

About SCHOTT Pharma
Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations work at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the MDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.
www.schott-pharma.com

Contacts

Gerresheimer AG

Media
Jutta Lorberg
T +49 211 6181 264
jutta.lorberg@gerresheimer.com

Investor Relations
Guido Pickert
T +49 152 900 14145
gerresheimer.ir@gerresheimer.com

SCHOTT Pharma

Media Relations
Joana Kornblum
T +49 151 29223552
joana.kornblum@schott.com

Investor Relations
Jasko Terzic, CFA
ir.pharma@schott.com

Stevanato Group

Media
media@stevanatogroup.com
Cassie Gonzalez
stevanatoUS@teamlewis.com

Investor Relations
Lisa Miles
lisa.miles@stevanatogroup.com

SCHOTT Pharma, Gerresheimer, and Stevanato Group announce strategic industry “Alliance for RTU”

• Market advances adoption of ready-to-use containers
• Improved operational efficiency in pharmaceutical manufacturing processes
• Increased patient safety with high-quality sterile primary packaging

SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP), a pioneer in pharma drug containment solutions and delivery systems, together with Gerresheimer AG (MDAX: GXI) and Stevanato Group S.p.A. (NYSE: STVN), announced today that they have entered into a strategic industry alliance (“Alliance for RTU”) to support market adoption of Ready-to-Use (RTU) vials and cartridges.

The Alliance for RTU aims to share with pharmaceutical companies, CMOs and CDMOs expertise and technical knowledge in high-quality sterile primary packaging, specifically ready-to-fill vials and cartridges, highlighting RTU configurations’ advantages over conventional bulk packaging.

Reduced risk and lower total cost of ownership
Traditional fill-and-finish processes present several operational risks and require increased efficiency. By adopting an industrial ready-to-use (RTU) setup, pharmaceutical companies and Contract Manufacturing Organizations (CMOs) can benefit from reduced operational risks, enhanced flexibility and efficiency, and lower waste. RTU technology can help streamline processes, increase productivity, and thus lower total cost of ownership (TCO) while reducing contamination risks and easing EU GMP Annex 1 compliance.

Pharmaceutical companies, CMOs and CDMOs opting for ready-to-use containers also can benefit from higher-quality products, which helps minimize the release of glass particles and risks of breakage or rejection while preserving the drug inside throughout its entire life cycle.

Open expert platform for RTU industry standard
Additionally, the market is driving investment in advanced aseptic filling technologies due to increasing demand for injectable medicines and regulatory pressure to meet safety standards. In this context, the Alliance for RTU aims to create an expert platform open to other industry players to help industry manufacturers learn about the key benefits of RTU processes and products and to better evaluate investments for transitioning to efficient filling systems and meeting their unique needs from clinical applications to widespread commercial use.

“The shift towards ready-to-use vials and cartridges reflects a collective industry move to advance quality and efficiency in aseptic filling processes and this alliance shows readiness by expanding capacity and thereby supporting this market trend,” said Andreas Reisse, CEO at SCHOTT Pharma. “Ready-to-use solutions can reduce complexities and better meet the stringent requirements of modern pharmaceutical production.”

“RTU vials and cartridges represent a significant advancement in product quality, offering enhanced reliability and efficiency in pharmaceutical processes. This alliance allows us to highlight further how RTU solutions elevate standards across the industry, ensuring safer and more effective delivery of medications to patients worldwide,” said Franco Stevanato, CEO at Stevanato Group.

“As an industry, we are fully prepared for the transition to RTU vials and cartridges,” said Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. “With recent advancements, RTU processing is now a mature technology which will improve our customers operations in terms of efficiency, cost and time to market.”

The Alliance for RTU will be officially presented at the CPhI in Milan on October 8 during a dedicated event at the tradeshow fairground.

For more information, visit www.alliance-for-rtu.com.

About SCHOTT Pharma
Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the MDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023. Further information at www.schott-pharma.com.

About Gerresheimer
Gerresheimer is an innovative systems and solutions provider and a global partner to the pharma, biotech, and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as 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, ampoules, tablet containers, infusion, dropper and syrup bottles, and more. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6). www.gerresheimer.com

About Stevanato Group
Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: stevanatogroup.com.



Press contact

SCHOTT Pharma
Media Relations
Joana Kornblum
Tel.: +49 151/29223552
E-Mail: joana.kornblum@schott.com
 
Investor Relations
Jasko Terzic, CFA
E-Mail: ir.pharma@schott.com

Gerresheimer AG
Media Relations
Jutta Lorberg
T +49 211 6181 264
E-Mail: jutta.lorberg@gerresheimer.com  

Investor Relations
Guido Pickert
Vice President Investor Relations
T +49 152 900 14145
E-Mail: gerresheimer.ir@gerresheimer.com

Stevanato Group
Media Relations
Stevanato Group
E-Mail: media@stevanatogroup.com
Cassie Gonzalez
E-Mail: stevanatoUS@teamlewis.com  

Investor Relations
Lisa Miles
E-Mail: lisa.miles@stevanatogroup.com

Abivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024

• Professor Bruce E. Sands, MD to present oral presentation of Phase 2b, open-label, maintenance efficacy and safety data at weeks 48 and 96 among week 8 induction non-responders in obefazimod-treated patients with moderately to severely active ulcerative colitis (UC)
• Two moderated poster presentations highlighting corticosteroid-free efficacy and safety data of obefazimod at weeks 48 and 96 of an open-label maintenance trial, as well as the impact of obefazimod induction therapy on combined histologic and endoscopic outcomes at week 8 in patients with UC

PARIS, France, September 26, 2024 – 08:30 a.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX; NASDAQ: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced that three scientific abstracts on its lead drug candidate, obefazimod, will be presented during the United European Gastroenterology (UEG) Week meeting, Oct. 12-15, 2024, in Vienna, Austria.

“We look forward to returning to UEGW to share new analysis of our Phase 2b trial data on obefazimod in patients with moderately to severely active ulcerative colitis,” said Abivax Chief Medical Officer Fabio Cataldi, MD. “With this presentation, we have observed additional evidence that obefazimod has the potential to advance the treatment paradigm, designed to be a once-daily oral therapy, for people living with ulcerative colitis.”

For more information on the Abivax clinical program and company updates, please see the conference program at the UEG website.

Obefazimod data to be presented:

*****

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q3 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and X, formerly Twitter, @ABIVAX.

Contact:

Patrick Malloy
SVP, Investor Relations Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “forward”,” will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, as well as the timing of initiation of a Phase 2b clinical trial of obefazimod in Crohn’s disease. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Hamburg, Germany, 26 September 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that Evotec has entered a technology development partnership with Novo Nordisk in cell therapy.

Both Evotec and Novo Nordisk have significant expertise and a strategic focus to support stem cell-based therapies. In order to provide next-generation off-the-shelf cell therapy products for clinical development and possible commercialisation thereafter, the companies will collaborate on development of advanced technologies in support thereof.

Under the collaboration agreement, Novo Nordisk will provide funding for technology development activities at Evotec’s R&D site in Göttingen, Germany and at Evotec’s certified cell therapy manufacturing facility in Modena, Italy. Novo Nordisk has an option to obtain exclusive rights to utilise the results of the collaboration for a pre-defined therapeutic area. Evotec receives R&D funding, an undisclosed upfront and possible milestone and royalty payments.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: “Cell therapies have already proven to be highly effective and have the potential to become functional cures in many disease areas. Stem cell-based cell therapy is a promising approach to modulate and scale cell therapies to ultimately provide tailor-made, off-the-shelf cell therapies at reasonable costs. Together with Novo Nordisk, we are confident to be able to generate novel and robust technologies that will help deliver on the promise of stem cell-based therapies.”

Dr Joachim Fruebis, Corporate Vice President, Cell Therapy R&D, at Novo Nordisk, added: “We are excited to join forces with Evotec on our cell therapy initiatives. We hope that this collaboration will enable us to bring cutting-edge, stem cell-based therapies to patients more efficiently. By integrating our strengths, we are setting the stage for significant breakthroughs to more efficiently advance our cell therapies. This partnership holds great promise, and I am confident it will lead to significant advancements in realising our full potential “

About Cell Therapy at Evotec
Cell therapy, one of the most promising regenerative medicine approaches, replaces a patient’s missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patient’s own material, or from stem cells. Stem cell research has opened up an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

Building on Evotec’s industrialised induced pluripotent stem cell (“iPSC”) platform, Evotec has built up a proprietary cell therapy with broad and deep capacity and capabilities. Evotec’s initiatives include proprietary and partnered cell types currently in pre-clinical development for a broad range of indications including diabetes, oncology, cardiology, and ophthalmology.

About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Media

Gabriele Hansen
SVP Head of Global Corporate Communications
Gabriele.Hansen@evotec.com

Hinnerk Rohwedder
Director of Global Corporate Communications
Hinnerk.Rohwedder@evotec.com

Investor Relations

Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model

• Abivax is actively conducting preclinical studies with multiple oral and injectable therapies and will report additional data in Q4 2024.
• Pre-clinical evaluation of obefazimod combined with etrasimod improved body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each treatment alone.

PARIS, France, September 25, 2024, 10:00 p.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced today results of initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD. 

“Despite progress and development of multiple new advanced targeted therapies in IBD, efficacy rates appear to have reached a ceiling. Fewer than half of patients achieve clinical remission, and many of those lose response over time. It is imperative for our field to explore rational and scientifically driven combination therapies to break through the efficacy ceiling, which in turn will lead to improved long-term outcomes for patients,” said David Rubin, MD Professor of Medicine and Chief, Gastroenterology, Hepatology and Nutrition at The University of Chicago. 

“Our goal for this program is to develop a fixed-dose combination therapy for UC patients that delivers best-in-disease state induction and maintenance efficacy, a safety profile on par with obefazimod, and an IP runway into the late 2040’s”, said Marc de Garidel, CEO of Abivax. He went on to say, “We believe that obefazimod’s emerging safety and efficacy profile, with potentially best-in-disease maintenance efficacy, could provide a meaningful benefit to patients when taken as a monotherapy. Additionally, since obefazimod is an oral therapy that has thus far demonstrated a favorable safety profile, it is an attractive candidate to be combined with other mechanisms of action to attempt to break through the efficacy ceiling observed with advanced therapies.”

Fabio Cataldi, MD Chief Medical Officer of Abivax provided key elements of the combination therapy program. “This program involves multiple stages.  First, we will perform additional pre-clinical experiments evaluating the efficacy of obefazimod in combination with several other mechanisms of action. Based on our findings, we plan to select a candidate in 2025 and work towards developing a fixed dose combination to move into clinical development.”

“We are setting a high bar for success and are excited about the promising data we are generating with this preclinical combination program,” Mr. de Garidel said. “We are planning to present this data at an upcoming scientific conference and are actively conducting additional combination studies that address various disease pathways. We look forward to providing an update on our progress by year end.”

Pre-Clinical Program and Initial Findings

Preclinical evaluation of obefazimod combined with etrasimod, was conducted in the T-cell adoptive transfer mouse model. In this study, CD4+CD45high or CD4+CD45low cells were intraperitoneally injected to 6-week-old male C57BL/6NRj-Rag2^tm1Ciphe/Rj mice (10 mice per group). The mice were then orally treated for 55 days with obefazimod or etrasimod alone or with the combination of both compounds. The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each drug alone.

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q3 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “plan,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, the availability and timing of preclinical data to support decision-making on therapy candidates for use in combination with obefazimod in UC, as well as the availability and timing of disclosure of preclinical data of any such combination therapy, the timing of initiation of clinical trials, obefazimod’s potential, as monotherapy or in combination with other therapies, to provide meaningful benefit to patients suffering from UC, Crohn’s disease, IBD or other indications, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Current results are not necessarily indicative of future results. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Press Release – Ad-hoc announcement pursuant to Art. 53 LR                          

Medacta Group SA reports revenue growth of 14.3% at constant currency and adjusted EBITDA¹ margin 26.9%, or 28.1% at constant currency in 1H 2024.

First Capital Markets Day on 25 September 2024 to showcase the business strategy and mid-term outlook.

• 1H 2024 revenue increased to EUR 288.6 million, or 14.3% at constant currency¹ (13.1% reported) from 1H 2023;
• Adjusted EBITDA grew to EUR 77.5 million, corresponding to 28.1% margin in constant currency, or 26.9% reported;
• 1H 2024 profit increased to EUR 38.0 million (13.2% of revenue), representing a growth of 30.4% compared to 1H 2023;
• Outlook FY 2024: guidance confirmed – revenue growth at constant currency in the range of 13% to 15%, and Adjusted EBITDA margin at constant currency improving around 50 bps from 2023 reported, subject to unforeseen events;
• Mid-term Outlook: revenue Compound Annual Growth Rate (CAGR) at constant currency is expected to be in the low double-digits region, and Adjusted EBITDA targeted to be around the 2024 result, before any currency effects.

CASTEL SAN PIETRO, 25 September 2024 – Medacta Group SA (“Medacta”, SIX:MOVE) today reported financial results for the Half-Year ending 30 June, 2024 and hosts the first edition of the Capital Markets Day.

Francesco Siccardi, CEO of Medacta, commented: “The first half of 2024 delivered strong revenue growth, driven by our balanced geographical footprint and an effective marketing strategy to seize new opportunities. We are particularly pleased with this outstanding performance, which, in the year of our 25th anniversary celebration, further confirms the strength of our strategy and values, as well as the company’s ability to significantly outpace the market growth. Thanks to our continued focus on cost control, we were also able to defend our profitability despite higher sales and marketing expenses in the early part of the year.”

Our Achievements 

In 2024, Medacta is celebrating its 25^th anniversary with a World Tour that features a series of global scientific events, starting in April with the 10^th M.O.R.E. International Symposium held in Switzerland, followed by events in Australia, the U.S., and Japan. These events underscore our commitment to medical education by fostering the exchange of experience and knowledge among distinguished surgeons worldwide, focusing on how to improve patient outcomes through the sustainability of personalized medicine and technology in orthopedics and spine surgery.

• On the Knee side, after the 2023 launch, in the first semester of 2024, we continued introducing SpheriKA in Europe. Preliminary studies have successfully confirmed the initial positive results in terms of patient outcomes of the GMK SpheriKA^2,3, the first knee implant specifically designed for Kinematic Alignment procedures. It adds further value to Medacta’s MyKA platform, the most comprehensive solution for accurately and reproducibly performing Kinematic Alignment in Total Knee Replacement. Moreover, a new version of NextAR Knee was released, featuring significant enhancements to the user experience with a simplified workflow and improved intraoperative planning and soft tissue assessment interface, facilitating tailoring the surgeons decision-making process to the actual soft-tissue behavior of each patient, driving further market adoption.

• For the Hip, we focused on optimizing different tissue-sparing surgical approaches. This has led to the creation of the Medacta MIS Platform in hip replacement. This formula follows the same successful pathway used with AMIS, supporting each surgical technique across the platform with a complete set of advanced instruments, appropriate implants, and hi-tech enabling tools underpinned by effective and continuous medical education. In addition, the market positively received new options for Medacta’s revision platform, designed to address even the most complex cases.

• NextAR Shoulder Augmented Reality application was enhanced with new features, including the intraoperative guidance in anatomic cases and an improved registration path, potentially leading to a reduced O.R. time. These updated functionalities are currently available in the United States and Australia, with plans to expand further worldwide.

• In Spine surgery, we launched the NextAR Rod Optimizer, which is unique on the market and a disruptive technology that is quickly redefining rod management. This sustainable and personalized real-time system provides surgeons with a selection of around thousand combinations⁴ of pre-bent rods for a tailored fit to each patient’s unique anatomy, avoiding manual rod bending or custom-made rods which require production and long wait times with significant advantages for surgeons and patients. The NextAR Rod Optimizer has been awarded the 2024 Spine Technology Award from Orthopedics This Week, the third Medacta product to receive this prestigious honor after NextAR Spine and MySpine.

• In the nascent Sports Medicine business line, Medacta introduced a simplified approach to M-ARS ACL at the AGA Congress 2024 in Zürich, Switzerland. This optimized technique streamlines the natural anatomy reconstruction of ACL, enhancing knee biomechanics to help restore the patient’s natural joint motion.

During the semester, 96 new jobs were added to support operations and a continued salesforce expansion across all geographies and business lines.

Reported Performance Measures

* Adjusted in 2024 for provision on litigations for patent matter with Mighty Oak Medical (Euro 2.1 million), extraordinary legal expenses (Euro 0.4 million) and MDR transition costs (Euro 0.2 million). The reconciliation is provided in the “Alternative Performance Measures” section of 2024 Half-Year Report.

** Adjusted in 2024 for extraordinary legal expenses (Euro 0.4 million), for the settlement of legal claims (Euro 1.9 million), MDR transition costs (Euro 0.2 million), non-recurring investments for corporate land acquisition and plant expansion (Euro 5.5 million) and international advances and deposits for future logistic expansion (Euro 0.2 million). Please see the “Alternative Performance Measures” section of 2024 Half Year Report for the reconciliation of the “Adjusted Free Cash Flow”.

Growth in all regions and business lines

In the first semester 2024, revenue increased 14.3% at constant currency and 13.1% on reported currency over the prior period, at EUR 288.6 million. We delivered robust organic growth, progressing with the acquisition of new customers across all geographies and business lines. In every region, the increase was sustained by a continued expansion of our salesforce and customer base, together with some new product introductions, particularly in the Knee business line through GMK SpheriKA, the shoulder with NextAR Shoulder for anatomic cases, and the introduction of the NextAR Rod Optimizer for Spine. Currency development had a negative impact on our top line with a headwind of 1.2%, mainly due to the strengthening of the Euro against the Australian Dollar and the Japanese Yen, only partially compensated by the Euro weakening against the Swiss Franc.

Gross Profit margin

The Gross Profit was EUR 197.7 million compared to EUR 175.9 million in the previous period. The Gross Profit margin was equal to 68.5% compared to 68.9% in the first semester of 2023. This change is primarily due to negative currency developments. Part of the impact stems from the effect on our revenue, as previously mentioned, while the weakening of the Euro against the Swiss Franc negatively affected the translation of our cost of sales. However, this was partially offset by the natural hedging by purchases in Euro and improvements in the industrial efficiency, which helped mitigate the FX driven increase in standard costs.

Adjusted EBITDA margin

Adjusted EBITDA reached EUR 77.5 million, up from EUR 71.9 million in H1 2023, representing a margin of 26.9%, including 1.2% headwind from FX. Net from FX effect, the EBITDA was in line compared to 1H23 result (28.2%). Additionally, the increase in sales and marketing expenses was mainly explained by the unusual concentration of marketing events in the first semester, particularly those related to Medacta’s 25^th Anniversary celebrations. This increase was partially offset by greater efficiency in G&A expenses.

Adjusted EBIT margin

The Adjusted EBIT amounted to EUR 45.5 million, 15.8% on revenue, compared to EUR 43.8 million, 17.2% on revenue, in the first semester 2023. The change of margin was due to the decrease of EBITDA and a negative contribution in currency development for additional 30 basis points.

Profit for the period

The Profit for the period was EUR 38.0 million, or 13.2% on revenue, representing an increase of 30.4% vs prior period.

Solid Balance Sheet

Medacta’s balance sheet has further strengthened, with total assets increasing to EUR 731.9 million and an equity ratio of 47.0% at the end of the reporting period. In the first semester of 2024, we generated a cash flow from operating activities of EUR 41.8 million. This robust cash flow generation was invested to sustain the short-term growth, primarily new instruments for Euro 34.2 million, and long-term growth for EUR 19.8 million, primarily buildings and product developments. As a result, we reported a negative free cash flow of EUR 12.2 million, compared to a negative EUR 5.3 million in the first half of 2023.

2024 Outlook

We confirm the existing guidance: revenue growth at constant currency in the range of 13% to 15% and Adjusted EBITDA margin at constant currency improving around 50 bps from 2023 reported, subject to unforeseen events.

Capital Markets Day and Mid-term Outlook

Medacta today holds its first Capital Markets Day and welcomes the financial community to its cutting-edge innovation hubs in Rancate and Castel San Pietro. The event will be hosted by Francesco Siccardi, CEO of Medacta, together with the senior management team. The program features a company overview followed by an outline of its strategy implementation through responsible and sustainable innovation, together with world-class medical education, indispensable for transforming innovation into benefits for patients, surgeons and the healthcare system. The success of this strategy is closely linked to Medacta’s continuous growth, with a direct presence in the most attractive markets and full control over the supply chain.

In the mid-term, revenue Compound Annual Growth Rate (CAGR) at constant currency is expected to be in the low double-digits region, and Adjusted EBITDA targeted to be around the 2024 result, before any currency effects. 

Francesco Siccardi, CEO of Medacta, commented: “I’m delighted to host our first Capital Markets Day, meeting the financial community on-site. It will be a great opportunity to share our dedication to advancing orthopedic care for improved patient outcomes worldwide and describe the main components of our strategy and our expectations in the mid-term”.

Webcast Today at 2:00 pm (CEST)

The presentation, held in English, will start at 2:00 pm (CEST) and it will be divided in two parts, the first part related to the 1H Results presentation and the second to the Capital Markets Day. The slide presentation, as well as the live online webcast, are accessible from Medacta website: https://www.medacta.com/EN/home-investors-global. Those who are not interested in participating in the Capital Markets Day may log off Zoom immediately after the 1H results presentation.

Contact

Medacta Group SA

Corrado Farsetta, CFO

investor.relations@medacta.ch

About Medacta

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

Disclaimer

This press release has been prepared by Medacta Group SA (‘Medacta’ and together with its subsidiaries, ‘we’, ‘us’ or the ‘Group’). The information contained in the press release does not purport to be comprehensive and is not to be taken as containing any securities advice, recommendation, offer or invitation to subscribe for, purchase or redeem any securities regarding Medacta.

Forward-looking information

This press release has been prepared by Medacta and includes forward-looking information and statements concerning the outlook for our business. These statements are based on current expectations, estimates and projections about the factors that may affect our future performance. These expectations, estimates and projections are generally identifiable by statements containing words such as “expects”, “believes”, “estimates”, “targets”, “plans”, “outlook” or similar expressions. There are numerous risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from the forward-looking information and statements made in this press release. Important factors that could cause such differences include: changes in the global economic conditions and the economic conditions of the regions and markets in which the Group operates; changes in healthcare regulations (in particular with regard to medical devices); the development of our customer base; the competitive environment in which the Group operates; manufacturing or logistics disruptions; the impact of fluctuations in foreign exchange rates; and such other factors as may be discussed from time to time. Although we believe that our expectations reflected in any such forward-looking statement are based upon reasonable assumptions, we can give no assurance that those expectations will be achieved.

¹ Alternative Performance Measures

This press release contains certain financial measures of historical performance that are not defined or specified by IFRS, such as “constant currency”, “EBITDA”, “Adjusted EBITDA” or “CORE EBITDA”, “Free Cash Flow”, “Adjusted Free Cash Flow”, “Net Debt” and “Leverage”. Reconciliation of these measures as well as “CORE” financial measures is provided in the “Alternative Performance Measures” of our 2024 First Half Report. These Alternative Performance Measures (APM) should be regarded as complementary information to, and not as a substitute for, the IFRS beginning performance measures. For definitions of APM, together with reconciliations to the most directly reconcilable IFRS line items, please refer section headed “Alternative Performance Measures” of the 2024 First Half Report. The 2024 First Half Report is available at https://www.medacta.com/EN/financial-reports .

² Sappey-Marinier E, Howell SM, Nedopil AJ, Hull ML. The Trochlear Groove of a Femoral Component Designed for Kinematic Alignment Is Lateral to the Quadriceps Line of Force and Better Laterally Covers the Anterior Femoral Resection Than a Mechanical Alignment Design. J Pers Med. 2022 Oct 16;12(10):1724. doi: 10.3390/jpm12101724. PMID: 36294863; PMCID: PMC9605321.

³https://10more.medacta.com/assets/pages/video/?w=6c865c55-a98a-442f-b22b-51b17d25cbb5.mp4

⁴ Data on file Medacta

 Related Trademarks

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The below products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts.

MyShoulder®, NextAR™, NextAR™ Knee, NextAR™ Shoulder, NextAR™ Spine, GMK® Sphere, MyKA™, AMIS®, GMK® SpheriKA, AMIS®, MySpine®.

• BfArM and lead ethics committee approve early end of recruitment
• Last patient included on 6 August 2024;
• A total of 202 patients were included in the study;
• Start of the MDR registration phase

aap Implantate AG (“aap” or “Company”) informs that due to the ongoing good results the patient recruitment of the human clinical trial could be terminated early. After the incidence rate remained at a very low level and more than 200 patients were recruited for the study, an application to discontinue patient recruitment was submitted in July 2024. This application was approved by the Federal Office for Drugs and Medical Devices (BfArM) and the lead ethics committee. The study has a follow-up period of one year and will end in August 2025. aap would like to thank all participating clinics for their excellent performance in the context of patient recruitment and the very good cooperation to date. 

The decision represents a milestone for aap after the company has invested around EUR 15 million in development work and associated costs in the years since the start of the project. This makes aap the only company with a nearly completed human clinical study on an antibacterial trauma implant, which puts it in an excellent starting position in a market worth billions.

Rubino Di Girolamo (CEO) comments on this success: “We are very pleased about the approval granted by the BfArM and the leading ethics committee. This underlines a successful intermediate step, which was achieved after several obstacles through persistent adherence to the goal and brings aap‘s opportunity to make a significant contribution to the fight against antibiotic resistance closer.”

In the next step, aap is preparing the MDR registration of the technology with the aim of authorising an initial product group in the 2026 – 2027 timeframe, depending on the regulatory requirements, and subsequently generating initial sales. The company anticipates that the funds required for product approval in the period 2025 – 2027 will amount to between EUR 1 million and EUR 2 million. With additional, manageable funds, aap can also initiate its own small series production, which will enable an adequate level of sales. Doctors and clinics that took part in the study have already signalled great interest in the product.  Depending on funding commitments or licence agreements with strategic market participants, the scope of product approvals and production capacities can be expanded considerably.

——————————————————————————————————————————————-

aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily utilises a broad network of distributors in around 25 countries. In the USA, the company utilises a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both via distribution agents and through partnerships with global orthopaedic companies. The aap Implantate AG share is listed in the General Standard segment of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore only apply on the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

Contact:

aap Implantate AG; Rubino Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; 12099 Berlin
Phone: +49 (0)30 75019 – 170; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de

MEDIA RELEASE

Medacta NextAR Rod Optimizer, a Disruptive Technology Redefining Rod Management in Spine Surgery, wins the 2024 Spine Technology Award from Orthopedics This Week

CASTEL SAN PIETRO, September 24, 2024—Medacta Group SA (“Medacta,” SIX:MOVE) announced today its NextAR Rod Optimizer has been awarded the 2024 Spine Technology Award from Orthopedics This Week. This marks the third time a Medacta spine product has received this prestigious honor after the MySpine Platform, patient-matched technology, and the NextAR Spine, Augmented Reality Surgical Application.

The unique NextAR Rod Optimizer is a sustainable and personalized solution designed to enhance intraoperative planning and provide real-time selection starting from a dozen pre-bent rods that allow thousands of solutions¹ in both minimally invasive and open approaches. Spine surgeons can now benefit from an advanced solution that eliminates the need for manual rod-bending, significantly reducing the risk of breakage and subsequent revision surgeries. This innovative approach also provides a compelling alternative to systems that are based on custom-made rods, eliminating preoperative imaging, production and waiting time, with significant advantages for surgeons and patients.

“NextAR Rod Optimizer provides the most accurate and easy to deploy point of care solution for selecting personalized rods for long fusion constructs, providing the optimal rod length and contour for percutaneous or open deformity constructs,” states Lionel Metz, MD, University of California San Francisco Department of Orthopedic Surgery.

The NextAR Rod Optimizer is part of NextAR Spine and may also be used as a stand-alone technology. This innovative tool complements Medacta’s comprehensive spine offering by enhancing surgical procedures with cutting-edge precision and efficiency. NextAR Rod Optimizer aims to improve patient outcomes and streamline the surgical workflow. This advanced technology exemplifies Medacta’s commitment to developing innovative and sustainable solutions that support both surgeons and patients.

“The possibility of having an intraoperative planning tool to select a pre-bent rod among multiple solutions has enhanced my workflow and reduced potential complications associated with traditional techniques that require manual bending,” says Dr. Itsuo Shiina, from the Department of Orthopaedic Surgery, Moriya Daiichi Hospital, Japan.

The NextAR Rod Optimizer further expands the capabilities of the award-winning NextAR Spine, an innovative technology proven to be accurate in screw placement, and to seamlessly integrate into the OR workflow, enabling the surgeon to enhance efficiency, accuracy, and versatility in spine surgery².

NextAR Spine is a sustainable solution within Medacta’s NextAR Augmented Reality Surgical Platform for both joint replacement and spine procedures. This hardware system offers the ability to host software for multiple applications (NextAR Knee, NextAR Shoulder, NextAR Spine). It is a vital component of the MySolutions Personalized Ecosystem, a network of advanced digital solutions designed to enhance patient care and surgical outcomes.

The entire spine portfolio is supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

For more information about the NextAR Rod Optimizer, please visit https://nextar-rod-optimizer.medacta.com/.

Contact
Gianluca Olgiati
Group Vice President Marketing
+41 91 696 60 60
media@medacta.ch

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

RELATED TRADEMARKS
Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The below products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts. MySolutions™ Personalized Ecosystem, NextAR™, NextAR™ Spine, NextAR™ Rod Optimizer, M.U.S.T.^®.

REFERENCES
[1] Data on file Medacta

[2] Schwendner M, Ille S, Wostrack M, Meyer B. Evaluating a cutting-edge augmented reality-supported navigation system for spinal instrumentation. Eur Spine J. 2023 Nov 14. doi: 10.1007/s00586-023-08011-w. Epub ahead of print. PMID: 37962688.