Gerresheimer builds new production capacities for glass syringes at Skopje site 

• Expansion of the site in the Republic of North Macedonia with a new production hall for glass syringes
• Total investment volume of over EUR 100 million
• Around 250 new jobs for skilled workers from the region
• Ramp-up of syringe production starting by the end of 2024

Düsseldorf/Skopje, December 2, 2024. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetics industries, is expanding its production capacity in Skopje, North Macedonia, with a new production hall for syringes. Since 2019, Gerresheimer has been producing drug delivery systems, diagnostic and medical products made of plastic on around 14,600 m² at this site. The new factory hall adds around 7,600 m² of production space for glass syringes. The company is investing over EUR 100 million in the construction and equipment of the new building. The expansion of the site will double the number of employees in Skopje from around 250 to 500 over the next three to five years. The new production hall in Skopje is currently one of the key projects in the global capacity expansion for drug delivery systems and syringes for long-term customer contracts.

 “Combining production capacities for plastic and glass at one location for the efficient production of integrated solutions for the pharma industry is a further step in the implementation of our corporate strategy formula g,” explains Dietmar Siemssen, CEO of Gerresheimer AG. “As a systems and solutions provider, our customers receive individually tailored, fully integrated solutions. In the future, for example, we will also supply ready-to-fill syringe systems from Skopje.”

New syringe production hall for the highest demands

The new production hall is specifically designed for the manufacture of syringes and other primary packaging made of tubular glass. The total area, including Good Manufacturing Practice (GMP) Class C and D clean rooms, covers around 7,600 square meters – roughly the size of a soccer field. The new hall provides space for the precision glass forming lines developed and manufactured by Gerresheimer itself, as well as specific assembly and ready-to-fill lines.

Glass and plastics production with growth reserve at one location

Since 2019, Gerresheimer has been producing drug delivery systems as well as diagnostic and medical products and components made of plastic on around 14,600 m² in Skopje, including ISO class 7, 8 and 9 clean rooms. This also includes syringe accessories such as the Gerresheimer Gx TELC syringe closure system and the Gx InnoSafe safety system, which protects against accidental needlestick injuries. 

One advantage of the plant in Skopje, with its 7,600 m² extension, is the combination of production capacities for pharmaceutical plastic and glass products at one location. This enables efficient production of integrated solutions with optimized logistics. For example, customers can obtain fully assembled ready-to-fill syringe systems in a wide variety of configurations from Skopje. The site in Skopje also offers growth potential. 100,000 m² of additional space is available on the site for future expansion.     

Quality assurance with state-of-the-art technology

Gerresheimer uses state-of-the-art inspection systems for quality assurance as part of its certified quality management system, including, for example, the Gx G3 inspection system with high-speed camera technology and AI-based image processing developed in-house by Gerresheimer for the syringe production. In addition, the plant in Skopje has two in-house laboratories with high precision measurement technology and laboratory equipment for optical, mechanical, chemical and microbiological testing.

Very good infrastructure and local specialists

Gerresheimer’s Skopje site is located in a well-connected industrial area close to the international airport of the North Macedonian capital. Larger Mediterranean ports in Greece and Albania are each around 250 km away. The country has a well-trained workforce. Around a quarter of Gerresheimer’s workforce at the site was trained by Gerresheimer experts in Germany. In addition, Gerresheimer cooperates with the University of Skopje in order to recruit qualified young talents. 

Ramp-up of syringe production in Skopje by the end of 2024
The first syringe production lines will ramp up in Skopje shortly, with more to be added in the course of 2025. This means that Gerresheimer is currently concentrating syringe production at its sites in Bünde (Germany), Querétaro (Mexico) and Skopje (Republic of North Macedonia).

 

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 

Contact Gerresheimer AG

Media
Jutta Lorberg Head of Corporate Communication T +49 211 6181 264 jutta.lorberg@gerresheimer.com	Marion Stolzenwald Senior Manager Corporate Communication T +49 172 2424185 marion.stolzenwald@gerresheimer.com
Investor Relations
Guido Pickert Vice President Investor Relations T +49 152 900 14145 gerresheimer.ir@gerresheimer.com	Thomas Rosenke Senior Manager Investor Relations T: +49 211 6181-187 gerresheimer.ir@gerresheimer.com

         2nd December 2024 –Uni-Bio Science Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce two significant milestones that demonstrate the Group’s continued growth and innovation in the field of medical aesthetics and dermatological solutions.

The Group’s strategic cooperation product with Chongqing Minji Medical Device Co., Ltd., recombinant collagen dressing, has successfully received Class II medical device approval, with the approval number “渝械注准 20242140377″. At the same time, the Group’s self-developed medical aesthetics product, 肌顏態®, was successfully launched, marked by a grand event held in Wuhan. The launch brought together industry experts, key opinion leaders,

（Photo: group photo of the launch of 肌顏態®）

media representatives, and other professionals to witness the Group’s entry into the rapidly growing medical aesthetics market, valued at hundreds of billions of RMB. This milestone signifies a bold new chapter for the Group as it continues to expand its presence in this high-potential sector.

Collagen, which is central to the newly approved recombinant collagen dressing, is the most abundant protein in the human body, comprising 25–35% of total protein content. It forms a network of elastic fibers that support the skin’s structure, maintain elasticity, and lock in moisture. However, collagen production decreases by approximately 1% annually after maturity (around age 21), leading to a loss of skin firmness and elasticity. Collagen-based products have a wide range of applications, including moisturizing, maintaining the skin barrier, and addressing signs of aging. In addition to dressing, microneedles for collagen are also being developed.

The launch of 肌顏態®, developed based on proprietary patents of Skbrella™ FN (Recombinant Human Fibronectin), marks another key milestone in the Group’s efforts to expand its portfolio. 肌顏態® is designed to provide safe, effective solutions for improving skin quality and repair, making it ideal for treating damaged skin, acne-prone skin, and for post-medical procedure care. Fibronectin, a multifunctional extracellular matrix glycoprotein, plays a vital role in cell migration, adhesion, proliferation, hemostasis, and tissue repair. It is worth mentioning that the Group is advancing the development of its fibronectin-based medical device.

（Photo left:肌顏態® Fibronectin Repair Solution; Photo right:肌顏態® Fibronectin Serum）

The debut of肌顏態® has attracted high recognition and attention from many dermatologists and medical aesthetics practitioners. At the launch, experts and scholars conducted professional academic exchanges and case sharing on the effects and clinical use of fibronectin from different perspectives “肌顏態®, a product designed for use throughout the entire cycle of preoperative and post-medical procedures, demonstrates significant effectiveness, particularly for patients with anesthetic allergies. It enables rapid skin repair and reduces redness efficiently. “

（Photo: Dermatology clinical practice sharing by Professor Yang Bin, President of Guangdong Dermatology Hospital, Southern Medical University）

（Photo: 肌顏態® use case sharing by Professor Shi Ge, Director of the Department of Plastic Surgery of the Sixth Affiliated Hospital of Sun Yat-sen University）

Mr. Frank Zhao, CEO of Uni-Bio Science Group, also said: “The Group will leverage its professional expertise in dermatology, nearly three decades robust clinical data from GeneTime , and its established sales network, adhering to the rigorous R&D standards of pharmaceutical companies, to build a diversified product portfolio across biological drugs, medical devices, and medical aesthetics, ultimately providing safer and more effective full-cycle skincare solutions for patients.”

（Photo left: Mr. Frank Zhao, CEO of Uni-Bio Science Group delivered opening speech for the launch of 肌顏態®; Photo right: Dr. Yu Shan, Deputy Director of R&D and Project of Uni-Bio Science Group, introduction of 肌顏態®）

The Group is well-positioned to capitalize on the growing opportunities in the market. Industry forecasts indicate that the medical aesthetic market is set to sustain a CAGR growth of 10% to 15% between 2024 and 2027, and is expected to exceed RMB 600 billion in 2030. The approval of collagen medical devices and the launch of 肌顏態® herald a new journey for the Group in the field of skin care.

（Photo: Mr. Kingsley Leung, Chairman of Uni-Bio Science Group, success entered in partnerships with various renowned medical aesthetics clinic chain and distributors）

These achievements reflect the Group’s strong commitment to innovation, strategic execution, and value creation. As the Group continues to execute its strategic vision, it remains focused on its goal of becoming China’s leading expert in dermatology, leveraging innovation, clinical expertise, and market insight to drive sustainable growth and long-term success.

 

 

End

Berlin, 02 December 2024. Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler) today celebrates the successful start of Actinium-225 (Ac-225) production, addressing the global shortage of this critical radionuclide. This milestone marks a major success of the common project with the Nuclear Physics Institute of the Czech Academy of Sciences (ÚJF). The test production demonstrated that the choice of technology was appropriate to achieve the expected parameters of the product.

In parallel with production, Eckert & Ziegler has commenced the validation process to produce GMP-grade Ac-225, crucial for clinical and commercial use. It is expected to become available in the first half of 2025, unlocking new opportunities for pharmaceutical companies developing alpha-emitting radiopharmaceuticals.

The production facility employs innovative cyclotron-based methods to generate Ac-225 from Radium-226, marking a pivotal advancement in isotope production. “This milestone underscores our commitment to advancing cancer treatment through the reliable supply of radioisotopes,” said Dr. Lutz Helmke, Managing Director of Eckert & Ziegler Radiopharma GmbH. “The commencement of Ac-225 production not only addresses the current shortage but also fortifies Eckert & Ziegler’s position as a key player in the future of radioligand therapy.”

The successful start of Ac-225 production is a direct result of the close collaboration between Eckert & Ziegler and the ÚJF. Drawing on decades of expertise in nuclear research and radiopharmaceutical development, ÚJF has played a crucial role in designing and optimizing this production pathway for Ac-225. Incorporating custom-engineered solutions by Isotope Technologies Dresden GmbH, Eckert & Ziegler’s hot cell division, the production process is designed to be efficient and sustainable.

The start of production positions Eckert & Ziegler at the forefront of the radiopharmaceutical industry’s transformation, offering a reliable and scalable source of Ac-225 for clinical development and commercial manufacturing.

About Eckert & Ziegler SE
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Contact
Eckert & Ziegler SE
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Jan Schöpflin, Marketing / Karolin Riehle, Investor Relations
jan.schoepflin@ezag.de / karolin.riehle@ezag.de
Tel.: +49 (0) 30 / 94 10 84-138; www.ezag.com

Mainz Biomed Announces Stock Split

BERKELEY, US and MAINZ, Germany – November 29, 2024 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a 1-for-40 reverse stock split of its issued and outstanding shares.  The reverse stock split was authorized by the Board of Directors of the Company pursuant to shareholder approval granted at its Extraordinary Shareholders Meeting on November 20, 2024.

The reverse stock split is expected to become effective on December 3, 2024 (the “Effective Date”), and the Company’s ordinary shares are expected to begin trading on the split-adjusted basis on the Nasdaq under the Company’s existing trading symbol “MYNZ” at market open on December 3, 2024, upon Nasdaq’s approval. The new CUSIP number for the Company’s ordinary shares following the reverse stock split will be N5436L119.

The reverse stock split is intended to increase the market price per share of its common stock to comply with the continued listing standards of the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) and to make investments in the Company more attractive to investors by increasing the trading price of the Company’s ordinary shares on such market.

Information for Stockholders

On the Effective Date, every 40 issued and outstanding ordinary shares of the Company will be converted automatically into one share of the Company’s ordinary shares without any change in the par value per share. Once effective, the reverse stock split will reduce the number of ordinary shares issued and outstanding from approximately 80.1 million shares to approximately 2.0 million.

Immediately after the reverse stock split, each stockholder’s percentage ownership interest in the Company and proportional voting power will remain unchanged, except for minor changes and adjustments that will result from the treatment of fractional shares. The Company will not issue fractional shares but will pay cash in lieu of fractional shares.  The rights and privileges of the holders of ordinary shares of the Company will be substantially unaffected by the reverse stock split.

Shareholders who hold their shares in brokerage accounts or in “street name” will have their positions automatically adjusted to reflect the reverse stock split, subject to each broker’s particular processes, and will not be required to take any action in connection with the reverse stock split.

Registered shareholders holding pre-split shares of the Company’s ordinary shares electronically in book-entry form are not required to take any action to receive post-split shares. Those shareholders holding shares of the Company’s ordinary shares in certificate form will receive a transmittal letter from our transfer agent, Transhare Corporation, with instructions as soon as practicable after the Effective Date.

Nasdaq Capital Market Compliance

Mainz Biomed’s securities are currently listed on Nasdaq. In May 2024, the Company received written notice (the “Notice”) from the Listing Qualifications Department of Nasdaq notifying that, based on the closing bid price of Mainz Biomed’s ordinary shares for the last 30 consecutive trading days, the Company no longer complied with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”), and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for a period of 30 consecutive trading days. Pursuant to the Nasdaq Listing Rules, Mainz Biomed were provided with an initial compliance period of 180 calendar days to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the closing bid price of ordinary shares has to be at least $1.00 per share for a minimum of 10 consecutive trading days prior to November 25, 2024. Additionally, the Company no longer meets the minimum $2,500,000 minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1).

On November 27, 2024, Mainz Biomed received a staff determination letter (the “Determination Letter”) from Nasdaq stating that the Company had not regained compliance with the Minimum Bid Price Requirement by November 25, 2024, and is not eligible for a second 180-day period The Determination Letter has no immediate effect on the listing of Mainz Biomed’s ordinary shares on the Nasdaq Capital Market. The Company intends to shortly file a hearing request that automatically stays any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Nasdaq Hearing Panel (the “Panel”) following the hearing.  In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the authority to grant an extension not to exceed 180 days from the date of the Determination Letter.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Viromed Medical AG will not acquire ActivCell Group AG and is focusing on another strategic option with greater added value

Pinneberg, 29 November 2024 – Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) has terminated negotiations for the planned acquisition of all shares in ActivCell Group AG, Switzerland, and will not pursue this opportunity further.

On 17 September, Viromed had originally announced its intention to acquire 100% of ActivCell Group AG. The purchase price for this was to be in the mid-single-digit million euro range and was to be paid exclusively by granting new shares in the company, making partial use of the authorized capital 2022, in the context of a capital increase against contributions in kind, excluding shareholders’ subscription rights.

In the course of further negotiations, Viromed’s management board has come to the conclusion that the added value of the proposed transaction in relation to the purchase price does not meet the company’s expectations. Therefore, the negotiations will not be continued.

Viromed Medical AG already has its own device, ViroCAP, which is by far the most advanced and innovative model in this field. The company has already made significant progress in the MDR 2a approval process with this device and is now focusing on bringing it to market on a broad scale.

 

Contact Viromed Medical AG

Uwe Perbandt
CEO
Flensburger Strasse 18
25421 Pinneberg
Germany
Email: kontakt@viromed-medical.de
www.viromed-medical-ag.de

Asklepios Group: Consistent growth in first nine months of 2024

• Consolidated revenue totals EUR 4,350.8 million
• Patient numbers up 6% at 2.7 million
• Refinancing as part of Social SSD issue

Hamburg, 28 November 2024. Asklepios Kliniken GmbH & Co. KGaA has generated stable growth over the first nine months of 2024. In a volatile macro-economic and healthcare policy environment, Asklepios has managed to increase its treatment numbers once more and to achieve positive consolidated earnings. The refinancing is an important step for further integrating sustainability initiatives into the Group’s financing strategy.

Between January and September 2024, Asklepios Group’s healthcare facilities treated a total of 2,742,439 patients (9M 2023: 2,587,813) – around 6% more than in the same period the previous year. This positive trend underlines the trust that patients have in the medical services provided by Asklepios Kliniken. The number of full-time employees was slightly up on the previous year’s level at 50,398 (9M 2023: 49,689).

The Asklepios Group generated consolidated earnings of EUR 4,350.8 million across the first nine months of 2024 (9M 2023: EUR 4,077.7 million). Consolidated earnings after tax (EAT) for the period January to September 2024 were slightly higher than in the same period the previous year at EUR 88.2 million (9M 2023: EUR 81.9 million). The EAT margin remained stable at 2.0% (9M 2023: 2.0%).

The Asklepios Group is employing new refinancing instruments as part of its Social Finance Framework in order to remain flexible in the face of changes in the market landscape. This move allows proceeds to be fed back into the social healthcare infrastructure. We were able to raise the issuing volume from EUR 250.0 million to a total of EUR 500.0 million. Hafid Rifi, CFO of Asklepios Kliniken: “Conducted within our Social Finance Framework, this round of financing will allow us to react flexibly in a volatile landscape. The high issuing volume indicates the trust investors have in our journey and strengthens Asklepios’ position as a trustworthy healthcare services provider.”

As part of a strong network with MEDICLIN and RHÖN, the Asklepios Group is confident about the remainder of the financial year 2024. The Group is in a solid position for pursuing its strategic goals with consistency.

Asklepios – Publications

About Asklepios

Asklepios Kliniken is one of the leading private operators of hospitals and healthcare facilities in Germany. The hospital group stands for highly qualified care for its patients with a clear commitment to medical quality, innovation and social responsibility. On the basis of this, Asklepios has developed dynamically since it was founded more than 35 years ago. The group currently has 164 healthcare facilities across Germany. These include acute hospitals at all levels of care, university hospitals, specialist clinics, psychiatric and forensic facilities, rehabilitation clinics, care homes and medical centres. In the financial year 2023, over 3.5 million patients were treated in Asklepios Group facilities. The company has more than 68,000 employees.

IR Contact:
Mirjam Constantin
Head of Corporate & ESG Reporting / Investor Relations
Asklepios Kliniken GmbH & Co. KGaA
Debusweg 3 – 61462 Königstein-Falkenstein
Tel: +49 61 74 90-1166
ir@asklepios.com

PR Contact:
Rune Hoffmann
Head of Corporate Communication & Marketing
Asklepios Kliniken GmbH & Co. KGaA
Rübenkamp 226 – 22307 Hamburg
Tel.: +49 40 1818-82 6630
Fax: +49 40 1818-82 6639 
presse@asklepios.com

Find Asklepios online, on Facebook or on YouTube:
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Care blog: “We Are Care”

Press Release // November 28, 2024
 

Formycon reports nine-month results for 2024 and continues growth trajectory with further operational success

• Excellent third quarter with product approvals for FYB202 in the key markets USA and Europe
• Keytruda^® biosimilar candidate FYB206 starts clinical development program (phase I and phase III study)
• Development of FYB210 officially started as seventh pipeline project
• Successful business performance is reflected in the financial results and confirms the guidance
• Invitation to today’s conference call at 3:00 p.m. (CET)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reported on the financial results and business performance of the Formycon Group for the first nine months of fiscal year 2024.

“We can look back on an extremely successful business performance in the first nine months of fiscal year 2024 and have met all operational, clinical and regulatory targets. In the third quarter of 2024, we were able to announce the EMA and FDA approvals for FYB202/Otulfi^®1, which followed in quick succession. This also triggered two milestone payments from our partner Fresenius Kabi. We are equally pleased about the EMA’s Committee for Medicinal Products for Human Use (CHMP) positive opinion for FYB203/AHZANTIVE^®2/Baiama^®3, which once again underscores the excellent quality of our data, processes and products. Our biosimilar FYB201, approved in 2022, was able to further expand its strong market position in the key markets USA and UK during the course of this financial year, gaining impressive market shares. At the same time, we achieved a groundbreaking development milestone with our Keytruda^®4 biosimilar candidate by including the first patients in our clinical program for FYB206, thereby consolidating our position among the leading developers for this product. Thanks to our development expertise and agility, we are ideally placed to position Formycon AG as a leading independent provider of high-quality biosimilars in the market,” says Dr. Stefan Glombitza, CEO of Formycon AG.

Enno Spillner, CFO of Formycon AG, adds: ”After a great deal of intensive preparation, we completed  the final step necessary for entry into the Prime Standard in the third quarter of 2024. This uplisting to the regulated market of the Frankfurt Stock Exchange in mid-November marks a significant chapter in our capital market strategy. It gives us access to a broader range of international and institutional investors. This increases our attractiveness to the capital market and strengthens our position in international competition.”

Operational success and progress in the second half of the year underpin growth strategy

FYB201 Lucentis^®5 biosimilar

Formycon’s FYB201 (ranibizumab), available in the United States under the tradename CIMERLI^®6, has captured a significant share of the overall U.S. Lucentis^® market. Following the strategic realignment of Formycon’s distribution partner Coherus BioSciences, Inc. (Coherus), the marketing rights for CIMERLI^®, including the Coherus ophthalmology sales team, were transferred to Sandoz AG on March 1, 2024. According to market reports, CIMERLI^®‘s market share in the US ranibizumab market was over 40% in August. In the United Kingdom, FYB201/ONGAVIA^®7 has a market share of over 80% based on indication-based market volume and thus has a dominant market position. In addition, further markets such as Canada and Saudi Arabia have been tapped in the current fiscal year. FYB201 is now available in a total of 20 countries worldwide.

FYB202 Stelara^®8 biosimilar

At the end of September 2024, both the U.S. Food and Drug Administration (FDA) and the European Commission granted approval for FYB202/Otulfi^®, Formycon’s ustekinumab biosimilar, for the treatment of severe inflammatory diseases such as Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. A settlement agreement had already been concluded between Formycon, Fresenius Kabi and Johnson & Johnson, granting Formycon’s marketing partner Fresenius Kabi the right to launch Otulfi^® in the USA no later than February 22, 2025. A further agreement governs the launch of the biosimilar in Europe and Canada, the terms of which remain confidential. The European Commission’s approval covers both subcutaneous and intravenous formulations and is valid in all countries of the European Economic Area (EEA), including the 27 EU member states, Iceland, Liechtenstein and Norway.

FYB203 Eylea^®9-Biosimilar

On November 15, 2024 (after the reporting period), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of FYB203, a biosimilar to Eylea^® (aflibercept), under the brand names AHZANTIVE^® and Baiama^®. The recommendation includes the treatment of neovascular age-related macular degeneration (nAMD) as well as other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR) and macular edema secondary to retinal vein occlusion (RVO). The final decision of the European Commission is expected in the second half of January 2025. The FDA had already approved FYB203/AHZANTIVE^® in the US for the same indications on June 28, 2024. With these advances, Formycon is on track to make FYB203 available in both the US and Europe as a cost-effective treatment alternative for patients with severe retinal diseases.

FYB206 Keytruda^® biosimilar candidate

Another important operational milestone was reached with the start of the clinical development program for FYB206, a biosimilar candidate for the immuno-oncology blockbuster drug Keytruda^®. The first patient was enrolled in the phase I study to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda^® in patients with malignant melanoma (black skin cancer) in June 2024. The parallel phase III study comparing the safety and efficacy of FYB206 with Keytruda^® in patients with non-small cell lung cancer (NSCLC) started at the end of July 2024. The scientific basis for the ongoing clinical trials is provided, among other things, by the results of an analytical study comparing FYB206 with Keytruda^®, which were published in October 2024 in the peer-reviewed journal Drugs in R&D. The results confirmed a high degree of structural and functional similarity between FYB206 and the reference medicine. With the start of the study, Formycon is consolidating its excellent position in the leading group of developers of pembrolizumab biosimilars.

FYB208 / FYB209 – early biosimilar candidates and further development of the pipeline

Formycon is continuously investing in the expansion of its biosimilar platform and has further expanded its product pipeline with the two younger biosimilar candidates FYB208 and FYB209. For both candidates, cell lines with convincing stability, productivity and quality have been identified and transferred to manufacturing partners for further process development and scale-up.

FYB210 – a new biosimilar candidate in the pipeline in the field of immunology

Following a complex selection process, a further biosimilar candidate FYB210 was recently launched (after the reporting period). Following the official start of the development process, FYB210 is now the seventh biosimilar project in Formycon’s development pipeline and is positioned in the immunology indication area. It addresses an attractive and strongly growing therapeutic area with the aim of commercialization after the loss of exclusivity rights after 2030.

Key personnel appointment and promotion to a higher stock exchange segment confirm strategic direction

Formycon has a highly experienced management team with many years of industry expertise. To ensure continuity in the company’s successful management, the management contract of CEO Dr. Stefan Glombitza has been extended until December 2027 (after the reporting period).

In addition, on November 11 (after the reporting period), Formycon successfully completed its uplisting to the Prime Standard of the Frankfurt Stock Exchange, the segment with the highest transparency requirements on the Deutsche Börse. This step marks a significant milestone in the company’s capital market strategy. The Prime Standard requires strict disclosure and reporting obligations and is an important prerequisite for investment decisions by institutional and international investors. This uplisting also lays the foundation for a potential inclusion in important indices, such as the SDax or TechDax; it strengthens the company’s visibility and transparency in the global capital markets.

Formycon Group revenue and EBITDA remain in line with planning

The Formycon Group’s revenue for the first nine months of 2024 was around €41.1 million (9M/2023: €60.2 million), in line with expectations. These revenues include both income from the marketing of FYB201 and revenues from development services for the partnered or out-licensed biosimilar candidates FYB201 and FYB203. In addition, milestone payments from the commercialization partnership for FYB202 with Fresenius Kabi AG (Fresenius Kabi) were recognized on a pro-rata basis, a portion of which had already been deferred in 2023.

The commercialization of the ranibizumab biosimilar FYB201, which was launched in further markets in the first nine months, is developing very positively in terms of sales figures. Revenues from the direct participation in the commercialization of this Lucentis^® biosimilar increased to around €6.0 million (9M/2023: €2.3 million). The significant portion of the contribution of earnings from FYB201 is realized in the context of the 50% at-equity investment in Bioeq AG and is therefore not directly reflected in revenues, but below EBITDA (see below). As of the September 30, 2024 reporting date, it amounted to a total of €20.6 million and is reflected accordingly in the adjusted EBITDA.

Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to around €-17.7 million in the first nine months (9M/2023: €5.2 million) and are in line with planning. This result was due to lower revenues, a planned and significant increase in research and development costs due to the rapid progress of FYB208 and FYB209, but also higher administrative costs due to the preparation and execution of the uplisting.

Adjusted group EBITDA reflects strong FYB201 performance

The adjusted Group EBITDA aims to present the total income from the FYB201 project, which is partially recognized as equity-accounted income below EBITDA due to the existing 50% stake in Bioeq AG, as regular operating income. It shows the direct financial contributions of FYB201 to the business success of the Formycon Group and the actual operating performance of the company.

Adjusted consolidated EBITDA for the first nine months of 2024 amounted to €2.9 million (9M/2023: €3.5 million). This is due in particular to the good performance of FYB201 and the resulting significant increase in the earnings contribution from Bioeq AG (at equity earnings) of €20.6 million (9M/2023: € -1.7 million).

Working capital increase due to higher cash and receivables

The net working capital of the Formycon Group amounted to €65.8 million as of September 30, 2024 (September 30, 2023: €41.3 million) and includes cash and cash equivalents of €33.8 million (September 30, 2023: €35.6 million). The working capital includes two milestone payments from Fresenius Kabi, which were recognized in receivables earlier than expected due to the already granted EU approval for FYB202 but are not due for payment until the fourth quarter.

The existing shareholder loan of €48.0 million was extended. The credit line remains fully available and can be utilized flexibly until May 2026.

 Forecast for the Formycon Group for the full year 2024 remains unchanged

For the fourth quarter, Formycon expects business to continue as planned. In addition to further operational progress with the biosimilar candidates, revenues are expected to be slightly higher than the average of the first three quarters. The milestone payments received from Fresenius Kabi for the approvals of FYB202 will lead to a stable cash position in the fourth quarter.

The guidance for the full year 2024, which was already revised upwards for adjusted EBITDA and working capital in the context of the half-year results, is thus confirmed.

Forecast in € million	Q1/2024	H1/2024	9M/2024
Revenue	55 to 65	55 to 65	55 to 65
EBITDA	-25 to -15	-25 to -15	-25 to -15
Adjusted EBITDA	-15 to -5	-5 to +5	-5 to +5
Working Capital	10 to 20	35 to 45	35 to 45

Conference Call and Webcast

The Executive Board of Formycon AG will discuss the company’s performance and key financial figures, as well as the recent uplisting to the Prime Standard of the Frankfurt Stock Exchange, in a conference call. The earnings call, which will be webcast live, will take place in English on November 28, 2024 at 3:00 p.m. (CET).

To participate in the conference call, please register at: https://webcast.meetyoo.de/reg/TkZPrWBERFjh

After registration, participants will receive a confirmation email with individual dial-in data.

The presentation and audio broadcast can be accessed via the following webcast link:
https://www.webcast-eqs.com/login/formycon-2024-q3

After a brief presentation, the Management Board will be available for analysts’ questions. The conference call will be recorded and can subsequently be accessed via the Formycon website at: https://www.formycon.com/en/investor-relations/publications/

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

2) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH

3) Baiama^® is a registered trademark of Klinge Biopharma GmbH

4) Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA

5) Lucentis^® is a registered trademark of Genentech Inc.

6) CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.

7) ONGAVIA^® is a registered trademark of Teva Pharmaceutical Industries

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

9) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

 

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 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.

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.

Korneuburg, Austria, 27. November 2024 – Marinomed Biotech AG (the “Company”) announces that it has signed a binding term sheet with the European Investment Bank (EIB) for the intended issuance of a convertible bond (registered bond in the name or order) with a nominal value of EUR 423,840, which is to be subscribed exclusively by the European Investment Bank (EIB) (excluding the statutory subscription rights of existing shareholders) against the contribution of a right of segregation. The convertible bond will evidence a conversion right in initially up to 84,768 shares of the Company at a conversion price of EUR 5 per share and will be issued in December 2024. In the event of conversion of the convertible bond, it is intended to issue the shares available from the conditional capital of the Company. A corresponding report on the planned exclusion of the statutory subscription rights of existing shareholders to convertible bonds will be published shortly. The required resolution of the Supervisory Board on the issuance of the convertible bond with the exclusion of subscription rights can be adopted at the earliest two weeks after publication of the report. The necessary consent of the insolvency administrator for the issuance of the convertible bond has not yet been obtained. 

+++ End of ad-hoc announcement +++ 
 

Korneuburg, Austria, 27. November 2024 –  As Marinomed Biotech AG (the “Company” or “Marinomed”) announced in its ad hoc announcement dated 18 September 2024 regarding the first cash capital increase of 154,053 new shares (the “First Cash Capital Increase”), the Company is negotiating with investors regarding a possible second cash capital increase, which would be carried out in accordance with the authorisation to exclude the subscription rights of existing shareholders (the “Second Capital Increase”). Marinomed is currently continuing to discuss with several investors such a Second Capital Increase, although no agreements or board resolutions have yet been reached.

The Company’s Management Board has resolved today to publish a report on the intended exclusion of subscription rights of existing shareholders for a possible cash capital increase of up to EUR 154,053 by issuing up to 154,053 new no-par value bearer shares against cash contribution (the “Report”). The Report on the exclusion of subscription rights is to be published as soon as possible on the electronic announcement and information platform of the Federal Government of Austria (“EVI”).

With the publication of the Report, the Company’s Management Board ensures that, in the event of a short-term financing requirement of the Company, the Company’s Management Board is legally in a position to resolve on a new cash capital increase from the authorised capital 2024 in accordance with § 5 para (6) of the Company’s Articles of Association (the “Authorised Capital 2024”) at short notice with the approval of the Supervisory Board. The background to this is that a report on the planned exclusion of subscription rights must be published at least two weeks prior to the required Supervisory Board resolution. Against the background of the cash ratio to be deposited in accordance with the adopted restructuring plan, the Company is creating the prerequisite for being able to raise necessary equity at short notice and not having to wait for the two-week period to expire in this case.

The actual implementation of a possible Second Capital Increase remains dependent on the outcome of negotiations with investors, the conclusion of the respective transaction documents and the adoption of resolutions by the Company’s Management Board and Supervisory Board. In addition, the restructuring proceedings (still needed for a Second Capital Increase) require the approval by the restructuring administrator.

+++ End of ad-hoc announcement +++