MEDIA RELEASE

Medacta Hosts Inaugural Capital Markets Day, Showcasing Responsible Innovation and Effective Growth Strategy

CASTEL SAN PIETRO, Switzerland, September 30, 2024 – Medacta Group SA (SIX:MOVE) held its first Capital Markets Day on September 25, 2024, at its headquarters in Switzerland. The event attracted over 100 participants, both in-person and online, providing a comprehensive overview of the company’s history and patient focus, growth strategy, innovative product portfolio, and financial outlook.

“Welcoming the financial community to our headquarters has been a pleasure,” said Francesco Siccardi, CEO of Medacta. “Bringing together investors, analysts, and stakeholders in person allows us to foster deeper connections and share our vision for the future. It was a unique opportunity to share our story, our values, and our patient-focused commitment. We presented our strategic initiatives and the innovative, personalized, and minimally invasive solutions we are developing to continue to serve the surgeon community to improve patient outcomes. We value the insights and perspectives of our financial partners, and we look forward to continue collaborating with them as we drive sustainable growth and responsible innovation in the orthopedic market.”

Dr. Alberto Siccardi, Founder and President of Medacta, welcomed attendees and set the stage for the day’s presentations, sharing the story of his family as experienced entrepreneurs in the medical field and his personal story as a hip surgery patient. 

Francesco Siccardi, CEO of Medacta, highlighted the company’s strong market position and growth opportunities in key geographic areas, including the US, EMEA, Japan, and Australia. He emphasized Medacta’s commitment to continuous product development, fostered by efficient R&D activities, ongoing collaboration with surgeons, and the adoption of cutting-edge technologies, such as the MySolutions Personalized Ecosystem and NextAR, Augmented Reality Surgical Platform. 

Attendees had the opportunity to visit Medacta’s advanced production facilities, including recent expansions in Castel San Pietro and Rancate.

Medacta’s CFO, Corrado Farsetta, announced the mid-term guidance: “top line growth Compound Annual Growth Rate (CAGR) at constant currency is expected to be in the low double-digits region”, and the Adjusted EBITDA margin, he added, “targeted to be around the 2024 result, before any currency effects.” 

The CEO and the Management Team presented the innovative product portfolio and technologies across all business lines, emphasizing its focus on sustainable innovation and world-class global medical education platform, tailored to individual surgeon needs. The company’s commercial strategy centers on increasing market penetration and geographical footprint and expanding its sales force. Medacta’s product expansion strategy includes further development of its established Hip and Knee portfolio, as well as growth in Shoulder, Spine, and Sports Medicine product lines.

Moreover, participants learned more about the company’s strong commitment to corporate social responsibility and community engagement, demonstrating how Medacta strives to make a positive difference in the lives of individuals and communities worldwide. Through the Medacta for Life Foundation, Medacta supports a wide array of impactful projects that address both local and global needs.

The company has reaffirmed the importance of patients, emphasizing how they are the priority in each phase of its product development strategy.

The Capital Markets Day presentation recordings can be found here.

 

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.

 

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™.

 

Press Release // September 30, 2024

Formycon and Fresenius Kabi receive FDA approval for FYB202/ Otulfi^TM (ustekinumab-aauz)

• Otulfi^TM received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara^®
   
• Approval represents the third successful FDA approval for a Formycon biosimilar, two of them in 2024
   
• In accordance with the patent settlement between Formycon, Fresenius Kabi and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi^TM in the US no later than February 22, 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the U.S. Food and Drug Administration (FDA) has approved FYB202/Otulfi^TM1 (ustekinumab-aauz), a biosimilar to Stelara^®2, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. FYB202/ustekinumab is the third Formycon biosimilar successfully approved by the FDA.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the U.S.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “After FYB203 end of June, this marks our second FDA approval this year and we are very proud of achieving this milestone in line with our plans. Our ustekinumab biosimilar FYB202 exemplifies Formycon´s technical expertise and capabilities in developing high-quality, safe and affordable biologics. Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment. It is important to us to improve access to biosimilars as quickly and broadly as possible.

Beyond that, FYB202 represents a key pillar of Formycon’s commercial and financial development going forward. In this context, we are very pleased with the settlement, as it allows our biosimilar to enter the market earlier than previously announced, improving our competitive positioning even further.”

Enno Spillner, CFO of Formycon AG, added: “The U.S. approval is an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon. We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.“

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The FDA approval of FYB202, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). With global sales of more than USD 10 billion in 2023³, Stelara^® is one of the best-selling immunological drugs. The U.S. market accounted for the largest share of these sales at around USD 6 billion.

————————————————————————————-

 

¹⁾ Otulfi^TM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries

²⁾ Stelara^® is a registered trademark of Johnson & Johnson

³⁾ https://www.investor.jnj.com/news/news-details/2024/Johnson–Johnson-Reports-Q4-and-Full-Year-2023-Results/default.aspx

 

About Formycon:

Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

 

About Biosimilars:

Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

 

About Fresenius Kabi:

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com. For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com

 

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

 

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

 

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014

FDA grants approval for Stelara^® Biosimilar FYB202/Otulfi^TM (ustekinumab-aauz)

Planegg-Martinsried, Germany, September 27, 2024 – Formycon AG (FSE: FYB, “Formycon“) announces that the U.S. Food and Drug Administration (“FDA”) today approved FYB202/Otulfi^TM1 (ustekinumab-aauz), a biosimilar to Stelara^®2.

FYB202/Otulfi^TM obtained FDA approval for the treatment of patients with Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The approval for FYB202/Otulfi^TM is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/Otulfi^TM demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

—————————————————————————————————————————————————————

¹⁾ Otulfi^TM is a Trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered Trademark of Johnson & Johnson

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com
www.formycon.com

Disclaimer
Certain statements contained in this release may constitute “forward-looking statements” that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” or “aim,” or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change.

Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.

 

Classification of First Berlin Equity Research GmbH to Sernova Corp

Company Name:	Sernova Corp
ISIN:	CA81732W1041
Reason for the research:	Update
Recommendation:	Buy
from:	27.09.2024
Target price:	CAD1.90
Target price on sight of:	12 months
Last rating change:	–
Analyst:	Christian Orquera

First Berlin Equity Research has published a research update on Sernova Corp. (ISIN: CA81732W1041). Analyst Christian Orquera reiterated his BUY rating and decreased the price target from CAD 3.80 to CAD 1.90.

Abstract:
Sernova has presented interim data from the phase 1/2 clinical trial of its Cell Pouch for treating type 1 diabetes (T1D) at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting in Madrid, Spain. All six patients in Cohort A achieved sustained insulin independence following islet transplantation, with the first patient maintaining insulin independence for over four years before the Cell Pouch was removed due to unrelated health issues. Importantly, the removed device demonstrated safety, with no signs of fibrosis, tissue degradation, or structural changes over the long term. This makes Sernova’s Cell Pouch the only device that can harbour functioning islets (capable of producing insulin, glucagon, and somatostatin) that have remained healthy and active for more than five years after initial transplantation into the Cell Pouch. Unfortunately, there were delays in Cohort B due to immunosuppression issues in the first six patients. The company now plans to report interim results by YE 2024 following the first implantation in a recently enrolled patient and final data towards the end of Q1/25 or beginning of Q2/25; three additional patients will also be enrolled over the next few months. In addition, the company is on track to file an IND for the Cell Pouch in the indication hypothyroidism towards year-end. Following recent developments at Sernova (i.e. focus on 1G and 2G of T1D and hypothyroidism programmes, delay in closing a non-dilutive strategic deal), we have updated our SOTP valuation model and now see fair value for the share at CAD1.90 (previously CAD3.80). We maintain our Buy rating. 

First Berlin Equity Research hat ein Research Update zu Sernova Corp. (ISIN: CA81732W1041) veröffentlicht. Analyst Christian Orquera bestätigt seine BUY-Empfehlung und senkt das Kursziel von CAD 3,80 auf CAD 1,90.

Zusammenfassung:
Sernova hat auf der Jahrestagung 2024 der European Association for the Study of Diabetes (EASD) in Madrid, Spanien, Zwischenergebnisse aus der klinischen Phase 1/2-Studie mit dem Cell Pouch zur Behandlung von Typ-1-Diabetes (T1D) vorgestellt. Alle sechs Patienten in Kohorte A erreichten nach der Inseltransplantation eine dauerhafte Insulinunabhängigkeit, wobei der erste Patient mehr als vier Jahre lang insulinunabhängig blieb, bevor der Cell Pouch aufgrund nicht damit zusammenhängender gesundheitlicher Probleme entfernt wurde. Wichtig ist, dass sich das entfernte Device als sicher erwies, ohne Anzeichen von Fibrose, Gewebeabbau oder strukturellen Veränderungen über einen langen Zeitraum. Damit ist der Cell Pouch von Sernova das einzige System, das funktionierende Inseln beherbergen kann (die in der Lage sind, Insulin, Glukagon und Somatostatin zu produzieren), die mehr als fünf Jahre nach der ersten Transplantation in den Cell Pouch gesund und aktiv geblieben sind. Leider kam es in der Kohorte B aufgrund von Problemen mit der Immunsuppression bei den ersten sechs Patienten zu Verzögerungen. Das Unternehmen plant nun, nach der ersten Implantation bei einem kürzlich aufgenommenen Patienten bis Ende 2024 Zwischenergebnisse und gegen Ende des ersten oder Anfang des zweiten Quartals 2025 endgültige Daten vorzulegen; drei weitere Patienten werden in den nächsten Monaten ebenfalls aufgenommen. Darüber hinaus ist das Unternehmen auf dem besten Weg, gegen Ende des Jahres einen IND-Antrag für den Cell Pouch in der Indikation Hypothyreose zu stellen. Nach den jüngsten Entwicklungen bei Sernova (d.h. Fokussierung auf 1G und 2G der T1D- und Hypothyreose-Programme, Verzögerung beim Abschluss eines nicht verwässernden strategischen Deals) haben wir unser SOTP-Bewertungsmodell aktualisiert und sehen den fairen Wert der Aktie nun bei CAD1,90 (zuvor CAD3,80). Wir behalten unser Buy-Rating bei.

Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des Haftungsausschlusses siehe die vollständige Analyse.
 

You can download the research here: http://www.more-ir.de/d/30961.pdf

Contact for questions:
First Berlin Equity Research GmbH
Herr Gaurav Tiwari
Tel.: +49 (0)30 809 39 686
web: www.firstberlin.com
E-Mail: g.tiwari@firstberlin.com

The Annual General Meeting of SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) has confirmed the strategic growth course of the European industrial hemp and cannabis company group with an overwhelming majority. At the virtual Annual General Meeting on Friday, 20 September 2024, the shareholders unreservedly approved the plans for the current and coming year.

The Annual General Meeting chaired by Oliver Conrad, Chairman of the Board of Directors of SYNBIOTIC, lasted just two hours. The items put to the vote received over 99 percent approval across the board. In addition to Oliver Conrad and Daniel Kruse, CEO of SYNBIOTIC, multi-entrepreneur Frank Otto, a member of SYNBIOTIC’s Board of Directors, naturally also attended the Annual General Meeting. SYNBIOTIC had once again decided to hold the Annual General Meeting virtually in order to make it easier for as many shareholders as possible to attend.

Black figures in 2025

The report by CEO Daniel Kruse, who took office at the end of August 2023, shows a clearly discernible turnaround thanks to disciplined cost optimisation, efficient synergy measures and targeted investments. Thanks to reduced costs for personnel and service providers as well as the acquisition of three strategically important companies, Kruse expects to be in the black by 2025: “Since the fourth quarter of 2023 and especially in 2024, we have seen a significant increase in demand in all business areas. These increases in turnover, coupled with cost efficiency, are expected to lead us to profitability as early as 2025.”

For the 2024 financial year, SYNBIOTIC is forecasting sales of EUR 16.6 million at Group level, with gross profit of EUR 8.4 million – and rising sales of EUR 26.2 million for 2025. This corresponds to an increase of almost EUR 10 million, i.e. an increase of 57 per cent compared to 2024. For 2026, the Group is forecasting sales revenue of EUR 33.6 million and an increase of 28 per cent.

Share price target 12.50 euros

Macroeconomic influences caused by the coronavirus pandemic and the Russian war of aggression against Ukraine, as well as arbitrary behaviour by the authorities towards hemp and CBD products, have put the economic environment for industrial hemp and cannabis products under extreme pressure. The removal of cannabis from the Narcotics Act, on the other hand, has had an extremely positive effect as expected, with sales figures for medicinal cannabis increasing many times over. However, there are also positive signals from the political arena. The entire hemp industry and of course SYNBIOTIC, thanks to its strategic positioning, will benefit greatly from the planned and now adopted (editor’s note) Industrial Hemp Liberalisation Act, or NLG for short.

These are reasons for a good share price outlook, says Daniel Kruse: “The share price is very volatile compared to other stocks. After we had a share price of less than EUR 3 at the end of 2023, it rose to almost EUR 14 at the end of March this year, particularly due to the news surrounding legalisation. The share price has currently levelled off at around EUR 6, which in the opinion of analysts, and of course also in our opinion, represents a significant undervaluation of the share. The price target until mid-2025 is around EUR 12.50 per share.” The corresponding analyst reports are available for download on the website www.SYNBIOTIC.com.

New members of the Board of Directors, new seat, new spelling

At the Annual General Meeting of SYNBIOTIC SE, Mr Malte Johannes and Mr Daniel Kruse were elected as new members of the Board of Directors. In addition, the company’s registered office was moved from Munich to Düsseldorf. Even if it is only a “cosmetic change”, the spelling of the company has been changed from SynBiotic to SYNBIOTIC in capital letters.

Diversity advantage

As a European industrial hemp and cannabis group, SYNBIOTIC has a decisive unique selling point: no market competitor offers investors a comparably high degree of diversification in the industrial hemp and cannabis sector. Through its investments, SYNBIOTIC covers the entire value chain of the industrial hemp and cannabis sector. The successful continuation of the buy and build strategy will further extend this advantage.

Publisher
SYNBIOTIC SE
Daniel Kruse
Managing Director
Münsterstraße 336
40470 Düsseldorf
Germany

Media contact
Rüdiger Tillmann
SYNBIOTIC
Public Relations Manager
E-mail ruediger.tillmann@synbiotic.com
Mobile +49 170 9651451
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a listed group of companies in the hemp and cannabis sector and pursues a buy and build investment strategy focussed on the EU. The Group covers the entire value chain from cultivation to production and retail – from the field to the shelf. The core businesses of the vertically integrated subsidiaries are research and development, production and the commercialisation of hemp, CBD and cannabis products. SYNBIOTIC has a clear pan-European strategy to further expand along the value chains of its business areas – hemp and CBD, medical cannabis and consumer cannabis.

Press Release // September 27, 2024

Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi^® (ustekinumab) for the treatment of serious inflammatory diseases

• FYB202/Otulfi^® received European Commission (EC) approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European patients treated with ustekinumab
   
• FYB202/Otulfi^® is approved in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi^®1, a biosimilar to Stelara^®2. The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The European Commission’s decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) adopted a positive opinion in July 2024 to approve FYB202/Otulfi^® in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis. The EC decision is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights for FYB202 in key global markets. Semi-exclusive commercialization rights that cover Germany, parts of the MENA region and Latin America remain with Formycon. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential. Stelara^® ranks among Europe’s top-10 medicine brands by value with annual sales in Europe in excess of €2.5 billion.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB202/ustekinumab is our second biosimilar with market approval in Europe, and this marks another very important step on our way to a leading, profitable and sustainable pure-play biosimilar company. Chronic inflammatory diseases are globally on the rise and negatively impact the quality of life of millions of people. This especially relates to Europe, which has the highest prevalence of psoriatic diseases in the world.³ With FYB202/Otulfi^® we are – together with our partner Fresenius Kabi – committed to providing a safe, effective and cost-efficient treatment option for this large number of patients.”

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “With the approval of Otulfi^® in Europe, we expand our biosimilar portfolio with the fourth biosimilar to better support patients’ treatment experience and clinical outcomes. Our ustekinumab biosimilar is a testament to our dedication and commitment to patients across Europe, and we are proud to continue to deliver high-quality and affordable therapies for autoimmune diseases, while striving to ease the burden on local healthcare systems.”

¹⁾ Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson
³⁾⁾ https://cms.ifpa-pso.com/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. FYB203/aflibercept-mrbb received FDA approval, and FYB202/ustekinumab was approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

About Fresenius Kabi:
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com. For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

 

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.

Consolidated income statement (in thousands of euros)		6/30/2024		6/30/2023
		6 months		6 months
Other operating income		661		590
Purchases consumed		(918)		(1,037)
External costs		(3,721)		(2,828)
Personnel expenses		(3,691)		(2,996)
Taxes and duties		(36)		(49)
Provisions net of reversals		11		–
Other current operating income and expenses		89		101
Depreciation and amortization		(1,202)		(1,206)
CURRENT OPERATING INCOME		(8,807)		(7,425)
OPERATING INCOME after share of net income of equity affiliates		(8,807)		(7,425)
Net financial income		(638)		(633)
Income taxes		77		78
NET INCOME (LOSS)		(9,368)		(7,980)
Cash flow from operating activities		(3,702)		(8,531)
Cash flow from investing activities		(64)		(34)
Cash flow from financing activities		3,023		12,531
Increase (decrease) in cash		(743)		3,966
Cash and cash equivalents		914		6,545

 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:

AFFLUENT MEDICAL   Sébastien LADET Chief Executive Officer investor@affluentmedical.com	SEITOSEI.ACTIFIN Financial communications / Press relations Ghislaine Gasparetto / Jennifer Jullia +33 (0)6 21 10 49 24 / +33 (0)1 56 88 11 19 ghislaine.gasparetto@seitosei-actifin.com / jennifer.jullia@seitosei-actifin.com
PRIMATICE Public Relations France Thomas ROBOREL de CLIMENS +33 (0)6 78 12 97 95 thomasdeclimens@primatice.com	MC SERVICES AG Media relations Europe Caroline BERGMANN / Kirsten RÜHL +49 (0)211 529252 20 / +49 (0)211 529252 16 affluent@mc-services.eu

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