Berlin, 13 December 2024. Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler), a leading provider of isotope technology for nuclear medicine and radiopharmaceutical applications, announces the submission of its GalliaPharm® ⁶⁸Ge/⁶⁸Ga Radionuclide Generator for approval in Japan. This will pave the way for broader access to cutting-edge diagnostic tools including ⁶⁸Ga-PSMA-11 in Japan. For GalliaPharm®, Novartis Pharma K.K., will manage safety information and distribution of the product in Japan.

GalliaPharm® is widely used as a high-quality GMP grade generator for Gallium-68, supporting the production of radiopharmaceuticals for positron emission tomography (PET) imaging, particularly in oncology including the diagnosis of prostate cancer through PSMA imaging. An approval in Japan will provide the local healthcare community with an accessible and reliable tool to label Gallium-68 radiopharmaceuticals, offering new precision in diagnostic imaging that may improve early disease detection and patient outcomes.

“This step with the MHLW for us is a critical one,” stated Dr. Deljana Werner, Head of QA and Regulatory Affairs for the Medical Division of Eckert & Ziegler SE. “As a company committed to advancing nuclear medicine globally, we see GalliaPharm®’s entry into the Japanese market as a pivotal opportunity to support medical professionals in enhancing patient care through precise and innovative imaging solutions.”

By seeking approval in Japan, Eckert & Ziegler reinforces its commitment to meeting the specific needs of diverse healthcare markets, tailoring its innovations to support local advancements in nuclear medicine. This step not only underscores the company’s dedication to providing advanced radioisotopes for medical applications worldwide, but also strengthens its position as a trusted partner in the evolving landscape of radiopharmaceuticals.

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; https://ezag.com

Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England

First patients implanted with Genio at UCLH, London

Mont-Saint-Guibert, Belgium – December 13, 2024, 08:05am CET / 2:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced the commercial launch of its Genio system in England, marked by the first successful implants performed at University College London Hospitals (UCLH).

Genio is now covered under the NHS Specialised Services Devices Programme (SSDP), enabling access to innovative therapies through specialized centers of excellence.

The first two patients were successfully implanted by Mr. Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon at UCLH. Commenting on the milestone, Mr. Cheong said: “We are proud to be the first hospital in the UK to offer Genio to our OSA patients. Genio is a groundbreaking, clinically proven therapy that addresses the unmet needs of individuals suffering from Obstructive Sleep Apnea.”

Olivier Taelman, CEO of Nyxoah, added: “Today represents an important milestone for Nyxoah as we introduce our Genio neurostimulation solution to treat Obstructive Sleep Apnea in England. Congratulations to Mr. Cheong and his team on this remarkable achievement. We look forward to expanding our collaboration with UCLH and other leading hospitals in England as we continue our mission to make sleep simple for OSA patients.”

About Nyxoah

Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

FORWARD-LOOKING STATEMENTS

Certain statements, beliefs and opinions in this press release are forward-looking, reflecting Nyxoah’s current expectations and beliefs regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and potential receipt of FDA approval and entrance into the U.S. market. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of Nyxoah’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that Nyxoah files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, Nyxoah expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither Nyxoah nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
IR@nyxoah.com

For Media
In UK
Kinfolk Communications
rebecca@wearekinfolk.co.uk
gemma@wearekinfolk.co.uk

In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu

Newron and EA Pharma (a subsidiary of Eisai Co., Ltd.) announce license agreement for evenamide in Japan and other Asian territories

• Newron will receive up to a maximum of €117 million from an upfront payment, development milestones and commercialization milestones, and up to double-digit tiered royalties on net sales
• Evenamide is a unique modulator of the excessive release of glutamate in treatment resistant schizophrenia (TRS) and poorly responding patients with schizophrenia
• Newron expects to begin a pivotal Phase III trial in H1 2025 for evenamide as an add-on therapy to any current anti-psychotic in TRS patients
• Newron continues to pursue further development opportunities for evenamide in other territories

Milan, Italy, Morristown, NJ, USA, and Tokyo, Japan, December 13, 2024, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, and EA Pharma Co., Ltd. (Head Office, Chuo-ku, Tokyo, Japan; President, Hidenori Yabune; “EA Pharma”), a subsidiary of Eisai Co., Ltd., today announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated Asian territories.¹

Under the terms of the license agreement, in exchange for full rights in the licensed territories, Newron will receive up to a maximum total of €117 million from EA Pharma, including an upfront payment of €44 million, financial contributions to its upcoming Phase III one-year study to be performed outside of the licensed territories, regulatory and commercialization milestones, and tiered royalties up to a double-digit percentage of net sales for evenamide.

The execution of this agreement, especially the upfront payment of €44 million, is expected to materially impact Newron’s 2024 financial statements.

Stefan Weber, CEO of Newron, commented: “This partnering agreement for evenamide is a key milestone in our goal to offer a truly innovative, evidence-based alternative to patients suffering from schizophrenia, those who are responding poorly to their treatments, or who have become treatment resistant to currently available medications. We are thrilled to work with the EA Pharma team and to have the opportunity to advance evenamide through a Phase III study and towards regulatory submission in Japan and other Asian territories by one of Japan’s leading pharmaceutical companies. Newron will now focus on the initiation of our Phase III one-year study in TRS and expect to start that study outside of the licensed territories in H1 2025. We are also pursuing further development opportunities for evenamide in other territories.”

“EA is thrilled to acquire the license for evenamide in Japan and other Asian territories. Evenamide has a new mechanism of action involving glutamate regulation and is the first in the world with this mechanism of action to demonstrate therapeutic efficacy in clinical trials. It is the result of many years of outstanding research by the Newron team. We believe evenamide has the potential to be transformational for patients suffering from schizophrenia.” said Hidenori Yabune, President of EA Pharma.

Jefferies International Limited (“Jefferies”) acted as the exclusive financial advisor to Newron. Orrick Herrington & Sutcliffe LLP advised as legal counsel to Newron.

About schizophrenia

Approximately 25 million people worldwide are affected by schizophrenia. Despite more than 60 different types of atypical and typical antipsychotics used for schizophrenia globally, a considerable number of patients remain severely ill or resistant to treatment. Overall, 30-50% of patients do not respond to the available medications and are defined treatment resistant. In addition to the patients with treatment-resistant schizophrenia (TRS), another 20-30% are described as “poor responders to anti-psychotic medication,” even if not meeting the criteria for TRS. New findings indicate that patients with TRS have abnormalities in the glutamatergic system, but not in dopaminergic transmission, so there is a huge unmet medical need for a glutamatergic mechanism of action, efficacious both in TRS patients and in those who are poor responders to the current treatments.

About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial, as an add-on treatment to second generation anti-psychotics including clozapine, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS)², and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit” on the outcome variables. Evenamide was extremely well tolerated, without any of the usual side effects of available anti-psychotics.

Evenamide development milestones

During Q1 2024, Newron reported final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in treatment-resistant patients. The data demonstrated that evenamide as an add-on treatment for patients with TRS was associated with sustained, clinically significant benefits that increased throughout the one-year course of treatment, with more than 70% of patients experiencing a clinically important reduction in disease severity.

Overall, data from study 014 has demonstrated that evenamide was safe and well-tolerated at all doses, with 97% of patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).

In Q2 2024, the Company announced two sets of data from study 008A, a potentially pivotal four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic. Topline data announced in April confirmed evenamide’s favorable safety and tolerability profile, followed by compelling data from additional analyses reported in May.

The study met the primary endpoint (improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score), and there was no increase in EPS, weight gain, blood glucose, metabolic syndrome, sexual dysfunction or gastro-intestinal side effects, CNS or cardiac effects, or laboratory abnormalities. The study also met the secondary endpoint (improvement of the Clinical Global Impression of Severity (CGI-S)), with a high rate of study completion (96%). No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%).

The totality of these results validated evenamide as the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study.

Newron is expected to initiate a Phase III randomized, double-blind, one-year trial in H1 2025 that will compare evenamide to placebo as add-on treatment in at least 600 patients with treatment-resistant schizophrenia (TRS). The primary efficacy endpoint will be change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Following this initial period, subjects will continue on their assigned treatment until week 52, for demonstration of long-term efficacy and safety and tolerability of evenamide. Newron continues to pursue further development opportunities for evenamide in other territories.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago^®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

About EA Pharma

EA Pharma Co., Ltd. is a subsidiary of Eisai Co., Ltd. It was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/

References:

[1] Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic, Malaysia, the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand, the Socialist Republic of Vietnam

[2] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

For more information, please contact:

Newron

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

UK/Europe

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

Switzerland

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

Germany/Europe

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

USA

Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

EA Pharma

EA Pharma Co., Ltd. Corporate Communication Dept., contact_ea@eapharma.co.jp

Important Notices

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

Adhoc release

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

Specification of the full-year forecast

Berlin, December 12, 2024 – Medios AG (“Medios”) specifies its full-year forecast as follows: The Company expects revenues of c. €1.85 billion (previous year: €1.8 billion which corresponds to an increase of 2.8%) and EBITDA pre¹ of c. €80 million (previous year: €60.5 million which corresponds to an increase of 32.2%). The EBITDA pre¹ margin is therefore expected to be around 4.3% (previous year: 3.4 %).

Previously, revenues of €1.9 billion to €2.1 billion and EBITDA pre¹ of €82 million to €91 million were expected. Accordingly, an EBITDA pre¹ margin of around 4.3% was previously expected.

¹ EBITDA is defined as consolidated earnings before interest, taxes, depreciation and amortization. EBITDA pre is adjusted for special charges for stock options and expenses for M&A activities and expenses for ERP-System implementation as well as for one-time performance-based payments for the acquisition of compounding volumes.

Disclosing person: Matthias Gärtner, CEO

End of Inside Information

Contact

Medios AG, Heidestraße 9, 10557 Berlin

Telefon: +49 30 232 5668 00; Fax: +49 30 232 5668 01

E-Mail: ir@medios.group; www.medios.group

——————-

About Medios AG

Medios is a leading provider of Specialty Pharma in Europe. With locations in Germany, the Netherlands, Belgium and Spain, the company supports key partners in the supply chain with innovative solutions and intelligent services. Medios has focused on pioneering individualized medicine to make the most innovative therapies available to everyone together with pharmacies, specialist practices and pharmaceutical companies.

Medios AG is Germany’s first listed specialty pharmaceutical company. The shares are listed on the regulated market of the Frankfurt Stock Exchange (Prime Standard) and are included in the SDAX selection index.

www.medios.group

Contact

Claudia Nickolaus

Head of Investor & Public Relations, ESG Communications

Medios AG

Heidestraße 9 | 10557 Berlin

T +49 30 232 566 800

ir@medios.group

www.medios.group

Disclaimer

This communication contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those currently anticipated as a result of various risk factors and uncertainties, including, but not limited to, changes in business, economic and competitive conditions, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. Medios AG assumes no responsibility to update any forward-looking statements contained in this release.

Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 12 December 2024

AEVIS VICTORIA SA (AEVS.SW) – AEVIS VICTORIA announces the acquisition of Spital Zofingen by Swiss Medical Network and a strategic partnership with Kantonsspital Aarau

AEVIS VICTORIA SA (AEVIS) announces the acquisition of Spital Zofingen, a subsidiary of Kantonsspital Aarau AG (KSA), by Swiss Medical Network Holding SA (SMN), marking an important milestone in its strategy for growth and the development of integrated healthcare in Switzerland. This acquisition, with payment made in SMN shares, paves the way for a strategic partnership between SMN and KSA.

KSA becomes a strategic shareholder in SMN, holding 3.57% of the capital, thereby establishing a sustainable collaboration between the two institutions. This transaction confirms the valuation of SMN, consistent with the valuation applied during the capital increase with Visana Beteiligungen. 

As a result of this operation, AEVIS’s consolidated equity will increase by CHF 50 million. Additionally, the integration of Spital Zofingen is expected to boost the group’s consolidated revenues by approximately CHF 100 million in 2025, underscoring the significant financial impact of this acquisition. The acquisition of Spital Zofingen will generate substantial synergies, particularly in procurement, training, and resource allocation. These efficiencies are expected to positively impact the group’s consolidated results from the 2025 fiscal year onward, enhancing operational performance and the quality of care. 

This acquisition aligns also with the development of integrated healthcare, a strategic pillar for SMN and KSA. Together, the two partners aim to establish a new collaborative model to benefit patients and enhance the efficiency of the Swiss healthcare system.

Antoine Hubert, Delegate of the Board of AEVIS, said: “This acquisition fits perfectly into our strategy of broadening Swiss Medical Network’s shareholder base by bringing in top-tier strategic partners. By partnering with Kantonsspital Aarau, we strengthen our commitment to integrated healthcare and consolidate our position in the Swiss healthcare market.”

Conference call today at 3 p.m.
AEVIS VICTORIA SA will comment on the transaction in a conference call at 3 p.m. today. The call will be headed by Antoine Hubert, Delegate of the Board. Registration is not required. Dial-in number for participants: +41 43 550 14 52

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network Holding SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.

BRAIN Biotech AG Sharpens Focus on Profitable Growth

• Combination of BioProducts segment and BioScience Zwingenberg to form the growth segment BRAINBiocatalysts
• Five-year targets in the BRAINBiocatalysts segment: revenues of EUR 100 million, 15 % adjusted EBITDA margin and high R&D ratio
• Significant improvement in the liquidity and earnings situation due to the two completed transactions with Royalty Pharma and Akribion Therapeutics
• Significant future potential through licensing of further BioIncubator and research projects

ZWINGENBERG, Germany, December 12, 2024 – BRAIN Biotech AG is creating the new growth segment BRAINBiocatalysts in the new financial year 2024/2025. The company announces this at today’s Fifth Capital Markets Day in Zwingenberg. By combining the two previous segments BioProducts and BioScience Zwingenberg, BRAIN Biotech is further sharpening its focus on the enzyme business and ensuring a more efficient integration of its research activities. The successful commercialization of the BioIncubator programs will be continued, thereby further strengthening the company’s liquidity position and profitability.

“We already have a unique product portfolio of enzymes and related activities in highly attractive niches that cannot be served efficiently by larger providers. Bundling our production and research activities on a joint technology platform will take us another major step forward,” says Adriaan Moelker, CEO of BRAIN Biotech AG, at the Capital Markets Day. “We are now focusing even more strongly on the successful implementation of our operational growth strategy and on consistently seizing opportunities,” said Moelker. “Our vision is to become a top 10 innovative enzyme player with reliable profitable sales growth and positive cash flows, our strong science foundation will help us reach this vision.”

The company is updating its medium-term forecast and now expects revenue of EUR 100 million in five years for the BRAINBiocatalysts segment alone. This corresponds to forecast growth of over 80 % in total compared to the 2022/23 financial year (comparable figure for the Group: EUR 55.3 million). The adjusted EBITDA margin in the segment is expected to grow to 15 %. The planning is based on a continued high Group R&D ratio of 7 – 10 %. Growth is expected to be predominantly organic. Strategically bolt-on acquisitions can add product expertise and accelerate the growth trajectory.

The BRAINBioIncubator represents the second segment of BRAIN Biotech AG. Due to the recently signed transactions with Royalty Pharma and Akribion Therapeutics GmbH, the commercial harvesting phase in the more volatile project business has now begun. The company expects the ongoing commercialization of the pipeline to have significant additional positive effects on BRAIN-Group sales and adjusted EBITDA over the next five years.

Michael Schneiders, CFO of BRAIN Biotech AG, explains: “The bundling of our continuous growth business in the new segment BRAINBiocatalysts emphasizes our company’s focus on sustainable, profitable growth. In my opinion, we are also establishing now a valuation cornerstone for the company that is ideally complemented by the existing and future opportunities with high value potential from the BRAINBioIncubator segment.” 

+++

About BRAIN Biotech

BRAIN Biotech AG is a leading provider of integrated solutions and products in the field of industrial biotechnology. The company specializes in enzymes and proteins, microbial production strains and bioprocesses for biotechnological production methods. BRAIN Biotech focuses on the growth markets of nutrition and life sciences as well as on innovative solutions for environment issues. BRAIN Biotech AG is the parent company of the international BRAIN Biotech Group. Its business activities are divided into three segments: 1. BioProducts: Production and sale of specialty enzymes and proteins; 2. BioScience: Customized solutions based on enzyme engineering, production strain and bioprocess development, and screening for bioactive compounds; 3. BioIncubator: Pipeline of research-intensive development projects. For production, the Group operates fermentation plants in the UK and other production facilities in continental Europe and the USA. BRAIN Biotech has been listed on the Frankfurt Stock Exchange since February 9, 2016 (ticker: BNN; ISIN DE0005203947 / WKN 520394). The company employs around 310 people and generated revenues of EUR 55.3 million in the fiscal year 2022/23. For more information, please visit www.brain-biotech-group.com .

Contact Media

Dr Stephanie Konle
PR & Corporate Communications
Phone: +49 6251 9331-70
E-mail: stk@brain-biotech.com

Contact Investor Relations

Martina Schuster
Investor Relations
Phone: +49 6251 9331-69
E-mail: ms@brain-biotech.com

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations and assumptions of the management of BRAIN Biotech AG and are based on information currently available to management.

Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors.

BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.

SCHOTT Pharma with strong growth and record margin after solid year-end finish

• All 2024 targets met including raised revenue guidance: 12% revenue growth and EBITDA margin of 27.8%, both at constant currencies
• Q4 2024 revenues reached EUR 237m; EBITDA margin of 27.9% well above prior year
• FY 2024 revenues reached EUR 957m; EBITDA margin of 26.9% above prior year
• Share of strong-margin high-value solutions (HVS) at 55% in FY 2024
• Guidance for FY 2025 reflects further strong revenue and earnings growth at constant currencies

SCHOTT Pharma, a pioneer in pharma drug containment solutions and delivery systems, showed a solid year-end finish and achieved all financial targets for the fiscal year 2024¹. Revenues in Q4 2024 amounted to EUR 237m (+4% yoy). At constant currencies, revenue grew by 9% yoy in Q4, driving revenue growth for the fiscal year 2024 to 12%, the top half of the previously raised guidance. EBITDA increased even stronger to EUR 66m (+28% yoy). This was driven by the successful expansion of capacities and more than offset the continuous ramp-up efforts and underutilization. The EBITDA margin increased by more than five percentage points to 27.9%, both as reported and at constant currencies, which led to a higher margin of 26.9% for the fiscal year 2024 (FY 2023: 26.6%). At constant currencies, margin was even stronger at 27.8%. “The strong results demonstrate our deep understanding of market needs, even in volatile times. Our team has been able to adapt quickly and flexibly, capitalizing on long-term trends with the most innovative solutions to lead the industry,” said Andreas Reisse, CEO of SCHOTT Pharma.

“Thanks to a strong year-end finish, we are concluding a very successful year with strong results that have enabled us to meet all our 2024 targets. These results serve as a strong foundation on the way to deliver towards our mid-term targets as we enter what we expect to be a year of versatility, in which we will balance short-term market volatility with our growth projects. With our profitable growth strategy, we remain very confident about our 2025 guidance as well as our mid-term targets,“ said Dr. Almuth Steinkühler, CFO of SCHOTT Pharma.

All 2024 targets achieved

For FY 2024, SCHOTT Pharma achieved a strong revenue growth of 7% (at constant currencies: 12%). With that, revenue growth at constant currencies came in in the upper half of the increased FY 2024 guidance. This growth was primarily fueled by the high demand for HVS products and SCHOTT Pharma’s continuous expansion of the corresponding capacities. 55% of revenue in FY 2024 came from strong-margin HVS, bringing the company closer to its mid-term target of above 60%.

SCHOTT Pharma’s profit growth in FY 2024 outperformed the already strong revenue increase. EBITDA increased by 8% yoy to EUR 258m, resulting in a margin of 26.9%. At constant currencies, EBITDA growth was even higher at 17% yoy. Consequently, the EBITDA margin expanded notably to a record level of 27.8%.

Strong innovation pipeline and capacity expansion as growth accelerators

In FY 2024, SCHOTT Pharma remained dedicated to its strategic pillars of innovation and expansion, aiming to further accelerate growth supported by intact market dynamics. With regards to innovation, the company recently launched an optimized nest for its ready-to-use (RTU) cartridges, marking yet another significant step towards more sustainability and efficiency in the pharmaceutical value chain. Following the optimized SCHOTT TOPPAC^® Nest 160 for prefillable polymer syringes, this innovation underscores the benefits of SCHOTT Pharma’s deep and longstanding customer relationships and good understanding of the pharmaceutical value chain. 

To boost its innovation power further, SCHOTT Pharma announced a strategic industry alliance “Alliance for RTU” together with Stevanato and Gerresheimer to promote the market acceptance and penetration of RTU vials and cartridges. With this, SCHOTT Pharma demonstrates its strong market position and its role as a trusted partner to the pharma industry.

These innovations mark a strong finish to the fiscal year and perfectly complement the new and improved solutions by SCHOTT Pharma launched throughout 2024. The development of large-volume 10 ml cartridges for on-body injectors, as well as large-volume polymer and glass syringes for subcutaneous infusions of high drug dosages and the introduction of a blister-free syringe concept to reduce packaging waste and CO2 footprint are just a few examples of how the company advanced its broad product portfolio. With all product innovations, SCHOTT Pharma addresses increased market demand and key pharma megatrends: From GLP-1 to advancing the subcutaneous administration of medication and the sustainable transformation and optimization of manufacturing to name a few.

In FY 2024, SCHOTT Pharma continued to drive its various expansion projects. The projects underscore the company’s commitment to meeting the high demand, especially in the Drug Delivery Systems (DDS) segment as well as the RTU cartridges from the Drug Containment Solutions (DCS) segment. In Germany, capacities for prefillable polymer syringes have been increased, which is expected to support the company’s short- to mid-term growth trajectory. In Hungary, the production of prefillable glass syringes has started following the inauguration of a new state-of-the-art facility and final customer qualifications. At the new best-cost production site in Serbia, which is expected to go into commercial supply in early 2025, machines are being installed, and product qualifications are underway. At the same time, production capacities for RTU cartridges were expanded in Switzerland and for RTU vials in the U.S. with an additional increase being currently implemented.

Good momentum in glass syringe business as main driver of revenue growth in Q4

The main driver of SCHOTT Pharma’s revenue growth in Q4 2024 was the strong year-end finish of the DDS segment. Revenues in the DDS segment reached EUR 118m, an increase by 12% yoy (at constant currencies: 11%). Q4 represented the highest quarterly revenue in this segment. This development was driven by the ongoing strong demand for prefillable syringes, and in particular by a good momentum in glass syringes. On a twelve-months basis, revenue in the DDS segment amounted to EUR 439m, an increase by 28%yoy (at constant currencies: 26%). Based on the good development in the DDS segment, which consists only of HVS products, the HVS revenue share increased by 7 percentage points to 55%.

The DCS segment achieved revenues of EUR 119m in the fourth quarter compared to EUR 126m a year ago. However, adjusted for the FX headwinds, growth at constant currencies was up by 5% yoy supported by a continued improvement in orders. For the fiscal year, the DCS segment achieved revenues of EUR 519m compared to EUR 558m a year ago. However, at constant currencies, DCS achieved solid revenue growth of 3% yoy as a result of the gradual improvement in demand in core vials and continued growth in other product categories.

Record profitability while simultaneously investing in expansion and innovation

In Q4 2024, EBITDA reached EUR 66m and grew stronger than revenue by 28% yoy (at constant currencies: 35%). Consequently, SCHOTT Pharma achieved strong profitability improvement in Q4 2024 with an EBITDA margin of 27.9%, both as reported and at constant currencies (Q4 2024: 22.6%).

In the DDS segment, the company increased EBITDA to EUR 45m which was up 21% yoy (at constant currencies: 19%). This resulted in the high quarterly margin of 35.5% (at constant currencies: 38.0%). On a twelve-month basis, EBITDA in DDS increased to EUR 166m, representing 29% yoy growth (at constant currencies: 26%).

EBITDA in the DCS segment increased to EUR 17m, showing strong growth of 21% yoy (at constant currencies: 48%). This was due to the positive product mix effects and cost efficiency initiatives. On a twelve-month basis, EBITDA reached EUR 101m compared to EUR 109m a year ago. However, adjusted for FX headwinds, EBITDA grew by 6%.

In FY 2024, SCHOTT Pharma’s high operational cash flow was driven by its profitability and improved working capital performance and led to a strong free cash flow of EUR 79m. The strong cash generation (cash flows from operating activities of EUR 225m) enabled the company to self-fund its investments, mainly its growth investments related to the ongoing expansion of HVS capacities. Total CAPEX amounted to EUR 145m (FY 2023: EUR 176m). The company’s net profit after minorities came in at EUR 150m, a slight decline of 1% yoy. SCHOTT Pharma recorded earnings per share of EUR 0.99 (FY 2023: EUR 1.01).

Outlook

In fiscal year 2025, the company expects to grow thanks to its strong market position, particularly for HVS products. Accordingly, significant revenue growth at constant currencies in the high single digits is expected for the coming fiscal year. As a result, SCHOTT Pharma also expects an increase in EBITDA and forecasts an EBITDA margin approximately at the strong level of FY 2024.

Going forward, SCHOTT Pharma will continue to pursue its strategic priorities along the pillars expansion and innovation while taking advantage of fully intact long-term industry trends such as GLP-1, antibody-drug conjugates (ADCs), homecare, subcutaneous injections and mRNA. The company confirms its mid-term outlook with a revenue CAGR above 10% and an EBITDA margin in the lower 30s% range.

 For additional news about SCHOTT Pharma please visit our media center.

Key figures Q4 2024

Key figures FY 2024

¹The fiscal year runs from October to September. Q4 2024 therefore relates to the period from July 2024 to September 2024.
²CC = at constant currencies

Webcast

Andreas Reisse (CEO) and Dr. Almuth Steinkühler (CFO) will speak at an analyst and investor conference call at 11:00 a.m. CET on 12 December 2024 to discuss the Q4 and FY 2024 results. The audio webcast can be followed via a conference call. The accompanying presentation can also be downloaded on the IR website: www.schott-pharma.com/investor-relations  

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 around 4,700 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 957 million in the fiscal year 2024. Further information at www.schott-pharma.com

Press contact

Joana Kornblum

Media Relations

Tel.: +49 151 2922 3552

E-Mail: joana.kornblum@schott.com

Tobias Erfurth

Head of Investor Relations

E-Mail: ir.pharma@schott.com

Jasko Terzic, CFA

Senior Manager Investor Relations

E-Mail: ir.pharma@schott.com

Viromed Medical AG seeks extensive cooperation with a major global Group

Pinneberg, 11 December 2024 – Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; ‘Viromed’; the ‘Company’) is seeking an extensive cooperation with a major global Group that is also active in the pharmaceutical sector. Based on today’s discussions, the subject of the cooperation will be in particular the granting of a worldwide licence in favour of Viromed Medical AG for the application of cold atmospheric pressure plasma in medicine. Subject to a contractual agreement, which is expected within the next three months, Viromed expects to generate initial revenues from the use of cold atmospheric pressure plasma in the low double-digit million range as early as the second half of the 2025 financial year.

Another subject of the negotiations for the establishment of an extensive cooperation is a possible participation of the global Group in Viromed or, conversely, a participation of Viromed in portfolio companies of the global Group. However, decisive negotiations on the essential terms of the respective participations are still pending.

Viromed will inform the capital market about the further progress of the negotiations on the intended cooperation in accordance with its legal obligation.

Contact Viromed Medical AG

Uwe Perbandt
CEO
Flensburger Straße 18
25421 Pinneberg
E-Mail: kontakt@viromed-medical.de
www.viromed-medical-ag.de

Classification of First Berlin Equity Research GmbH to Formycon AG

First Berlin Equity Research has published a research update on Formycon AG (ISIN: DE000A1EWVY8). Analyst Simon Scholes reiterated his BUY rating and maintained his EUR 82.00 price target.

Abstract:
Nine months results were in line with our expectations showing a 31.7% decline in revenue to €41.1m (9M/23: €60.2m) due to lower income from milestones, and reduced revenue from development of FYB201 (Lucentis biosimilar) and FYB203 (Eylea biosimilar) as planned work on these programs wound down. FYB201 was launched in 2022, and following FDA approval in June 2024 and expected EMA approval in January 2025, the launch of FYB203 is scheduled for next year subject to the outcome of ongoing litigation with Regeneron. Meanwhile, adjusted EBITDA (includes the at-equity accounted result of bioeq AG) fell only slightly to €2.9m (9M/23: €3.5m). Formycon’s most important near-term launch will be the Stelara biosimilar, FYB202, which was approved by both the FDA and the EMA in September 2024. Stelara generated worldwide sales of USD10.9bn in 2023. This compares with USD3.6bn of sales for Lucentis in 2021, the last year before the launch of biosimilars of the drug. Furthermore, Formycon will earn a royalty of 30-40% on FYB202 sales. The current royalty on FYB201 sales is 7-8%. There will be more competition on the Stelara biosimilar market than on the Lucentis biosimilar market. But critically, unlike Roche, whose 2022 launch of the Lucentis successor product, Vabysmo, coincided with the introduction of Lucentis biosimilars, Johnson & Johnson do not have a near-term successor product to Stelara. We expect Formycon to generate triple digit €m royalties from FYB202 as early as 2026. This compares with our total 2026 royalty forecast for FYB201 (including both top-line and at-equity revenues) of ca. €15m. We think the current share price level represents a good opportunity to pick up Formycon stock ahead of the lucrative FYB202 launch. We maintain our Buy recommendation with an unchanged price target of €82.

First Berlin Equity Research hat ein Research Update zu Formycon AG (ISIN: DE000A1EWVY8) veröffentlicht. Analyst Simon Scholes bestätigt seine BUY-Empfehlung und bestätigt sein Kursziel von EUR 82,00.

Zusammenfassung:
Die Neunmonatsergebnisse entsprachen unseren Erwartungen und zeigten einen Umsatzrückgang von 31,7 % auf €41,1 Mio. (9M/23: €60,2 Mio.), der auf geringere Einnahmen aus Meilensteinen und aus der Entwicklung von FYB201 (Lucentis-Biosimilar) und FYB203 (Eylea-Biosimilar) zurückzuführen ist, da die geplanten Arbeiten an diesen Programmen auslaufen. FYB201 wurde 2022 auf den Markt gebracht, und nach der FDA-Zulassung im Juni 2024 und der erwarteten EMA-Zulassung im Januar 2025 ist die Markteinführung von FYB203 für das nächste Jahr geplant, vorbehaltlich des Ausgangs des laufenden Rechtsstreits mit Regeneron. Unterdessen sank das bereinigte EBITDA (einschließlich des at-equity bilanzierten Ergebnisses der bioeq AG) nur leicht auf €2,9 Mio. (9M/23: €3,5 Mio.). Formycons wichtigste kurzfristige Markteinführung wird das Stelara-Biosimilar FYB202 sein, das im September 2024 sowohl von der FDA als auch von der EMA zugelassen wurde. Stelara erzielte 2023 einen weltweiten Umsatz von USD10,9 Mrd. Zum Vergleich: Im Jahr 2021, dem letzten Jahr vor der Einführung von Biosimilars für Lucentis, lag der Umsatz bei USD3,6 Mrd. Darüber hinaus wird Formycon eine Lizenzgebühr von 30-40 % auf den Umsatz von FYB202 erhalten. Die derzeitige Lizenzgebühr für den Umsatz von FYB201 beträgt 7-8 %. Auf dem Markt für Stelara-Biosimilars wird es mehr Wettbewerb geben als auf dem Markt für Lucentis-Biosimilars. Im Gegensatz zu Roche, dessen Lucentis-Nachfolgeprodukt Vabysmo 2022 zeitgleich mit der Einführung von Lucentis-Biosimilars auf den Markt kam, verfügt Johnson & Johnson jedoch nicht über ein kurzfristiges Nachfolgeprodukt für Stelara. Wir gehen davon aus, dass Formycon bereits im Jahr 2026 Lizenzgebühren im dreistelligen €Mio.-Bereich aus FYB202 erzielen wird. Dies steht im Vergleich zu unserer Gesamtprognose für 2026 für die Lizenzgebühren von FYB201 (einschließlich Umsatzerlöse und At-Equity-Erlöse) von ca. €15 Mio. Wir sind der Meinung, dass das aktuelle Kursniveau eine gute Gelegenheit darstellt, Formycon-Aktien im Vorfeld der lukrativen Markteinführung von FYB202 zu erwerben. Wir behalten unsere Kaufempfehlung mit einem unveränderten Kursziel von €82 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/31527.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