The Management Board of aap Implantate AG (“Company“) informs today about the increase of the guidance of the EBITDA target. The Company increases its EBITDA in the first nine months from EUR – 1.6 million to EUR 0.  Despite the ongoing investments in silver technology, which amounts to around EUR 0.6 million net after deduction of the funding support, the Company expects a positive EBITDA in the same amount in the operating trauma business and is thus raising the overall guidance for the Company’s EBITDA from EUR -1.5 million to EUR -2.5 million to between EUR -0.5 million and EUR 0.5 million. This means that the company will be able to close a financial year profitably at EBITDA level for the first time in the trauma business. In terms of sales, the company confirms its sales guidance of between EUR 11.5 million and EUR 13.0 million.

 

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

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

 

About aap Implantate AG

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

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

Forward-Looking Statements

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

 

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

Phone: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de

 

*****

Press Release // November 18, 2024
 

Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®

• Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of FYB203 for the treatment of Neovascular Age-Related Macular Degeneration (nAMD), along with several other serious retinal diseases
• Approval decision by the European Commission expected in the second half of January 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to Eylea^®1 (aflibercept).

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea^®. As our second ophthalmic biosimilar therapy following the success of our Lucentis^®2 biosimilar, FYB203 represents a further advancement in treatment options for serios retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”

Under the tradenames AHZANTIVE^®3/ Baiama^®4 FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB203/ AHZANTIVE^®/ Baiama^® in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway, which is expected in the second half of January 2025.

Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® reached global sales of around US$ 9 billion⁵, confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.

FYB203 was approved by the U.S. Food and Drug Administration (FDA) in June 2024.
 

1) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) Lucentis^® is a registered trademark of Genentech Inc.
3) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
4) Baiama^® is a registered trademark of Klinge Biopharma GmbH
5) Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/

 

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 at the Prime Standard of Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

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

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

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

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

 

 

 

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

Aflibercept-Biosimilar FYB203 / AHZANTIVE^®/ Baiama^® receives positive CHMP Opinion from EMA
 

Planegg-Martinsried, Germany, November 15, 2024 – Formycon (FSE: FYB, “Formycon“) announces that the European Medicines Agency (EMA) published today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for market approval for FYB203/ AHZANTIVE^®1/ Baiama^®2, a biosimilar candidate to Eylea^®3 (Aflibercept).

FYB203 has thus been recommended for approval in the European Union (EU) for the treatment of adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Oedema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Oedema following Retinal Vein Occlusion (RVO). The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization, which is expected in the second half of January 2025.

The CHMP recommendation for FYB203 / AHZANTIVE^®/ Baiama^® is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203 / AHZANTIVE^®/ Baiama^® demonstrated comparable quality, efficacy, safety and immunogenicity to the reference drug Eylea^® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).

1) AHZANTIVE^® is a registered Trademark of Klinge Biopharma GmbH
2) Baiama^® is a registered Trademark of Klinge Biopharma GmbH
3) Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.
 

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

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

 

Disclaimer
Certain statements contained in this release may constitute “forward-looking statements” that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” or “aim,” or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change. Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.

 

 

PRESS RELEASE

 

Minister of Economic Affairs Mansoori and Lord Mayor Benz visit Biotest’s plasma center in Darmstadt and call for plasma donations

 

• Plasma donation centers in Europe to secure the long-term supply of plasma

Dreieich, Germany, November 15, 2024. Darmstadt’s most modern blood plasma donation center in the TOWN HOUSE in the former Roemer department store at the White Tower (Weisser Turm) had prominent visitors. On November 14, numerous guests from politics and business took the opportunity to visit the state-of-the-art plasma donation center at Ernst-Ludwig-Strasse 12. Among the guests were Kaweh Mansoori, Hessian Minister of Economics and Deputy Prime Minister, Hanno Benz, Lord Mayor of Darmstadt, and Peter Franz and Bijan Kaffenberger, Members of the State Parliament. The center is operated by Plasma Service Europe GmbH, a wholly-owned subsidiary of Biotest AG, which was founded more than 20 years ago to strengthen plasma donation in Germany.

Hesse’s Minister of Economics, Kaweh Mansoori, emphasizes: “The Darmstadt Plasma Center opposite the White Tower, is not only an important step in providing patients with life-saving medications. It also creates qualified jobs and revitalizes the city center in a prominent location. Both the people from the region who respond to the call to donate plasma and the employees make an important contribution to the care of seriously ill patients”.

Lord Mayor Hanno Benz sees the new plasma center as an opportunity to raise public awareness of blood plasma donation. “Blood donation is well known, plasma donation less so. However, plasma is also a vital component of medical treatment, especially in the care of people with serious illnesses. It is important to emphasize the importance of plasma donation in our society and to encourage more people to donate regularly. Every donation can save a life, and together we can significantly improve patient care”.

In addition to Peter Janssen, CEO of Biotest AG, and the management of Plasma Service Europe GmbH, a number of interesting guests were also present. Among them was Dr Gerd Klock, patient representative of dsai e.V., a patient organization for congenital immunodeficiencies. He shared his moving life story and spoke to the interested guests about the vital importance of plasma donation for him.

Plasma Service Europe GmbH has an important supply mission: plasma serves as the basis for various, often vital medications. Many rare diseases are treated with medicines made from blood plasma. Since blood plasma cannot be produced artificially, plasma donations are vital for many people.

Peter Janssen, CEO of Biotest AG, welcomed the attendees and highlighted the advantages of the centrally located site: “The state-of-the-art equipment of the Plasma Service center ensures a pleasant atmosphere in which donors feel comfortable. The motivated and highly qualified team enables convenient and smooth donations under professional medical supervision, five days a week, from Monday to Friday. We also hope to welcome many employees of Biotest AG here in Darmstadt.”

The collected plasma is processed exclusively in Germany at Biotest AG in Dreieich. Regular audits in Germany ensure that the high legal and internal quality and safety requirements are met.

 

About human blood plasma

Human blood plasma is the source material for the production of plasma protein preparations used in the treatment of various diseases of the immune system and the blood system as well as in emergency medicine. Biotest is one of the six largest manufacturers of plasma protein products in the world.

 

About Plasma Service Europe

Plasma Service Europe GmbH is a wholly owned-subsidiary of Biotest AG, which was founded in 2001 and today operates 14 of the most modern plasmapheresis centers in Germany. Its core competence lies in the collection of blood plasma. To date, more than 170,000 donors have been welcomed. The goal for the future is to be able to supply even more patients with vital medicines.

 

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

 

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

 

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

 

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

 

Ad hoc: Comment on media report

Hamburg, Germany – Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE 000 566480 9, WKN 566480; NASDAQ: EVO)

With respect to a media report, Evotec SE (“Company”) declares that it has received, without prior contact, a non-binding expression of interest from the listed US biotechnology company Halozyme Therapeutics Inc. regarding a takeover offer addressed to the shareholders of the Company with an offer price of EUR 11.00 per share. The Company will carefully analyze this expression of interest, decide on next steps, and inform the capital market in accordance with the legal requirements.

– End of the ad hoc release –

Contact: Volker Braun, EVP Head of Global Investor Relations & ESG, Evotec SE, Manfred Eigen Campus, Essener Bogen 7, 22419 Hamburg, Germany, Phone: +49 (0) 151 1940 5058 (m), volker.braun@evotec.com

Korneuburg, Austria, November 14, 2024 – Marinomed Biotech AG (VSE:MARI) announces that the creditors’ assembly unanimously approved the restructuring plan presented at the final court hearing at the Korneuburg Regional Court on November 14, 2024. The established quota is 30%, payable in several tranches within two years. 5% is to be deposited as a cash quota. The liquidity required for the repayment of the quotas is to be partially funded through the sale of the Carragelose business unit of Marinomed Biotech AG. A super quota of up to a further 7% will be distributed if milestone payments from the sale of the Carragelose business within two years exceed the planned amount. Confirmation of the restructuring plan and termination of the proceedings are subject, among other things, to the payment of the 5% cash deposit and a standstill declaration from the European Investment Bank (EIB). The Company will provide information on further developments.

+++ End of ad-hoc announcement +++ 

The acquisition of WEECO Pharma by the European hemp and cannabis group SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) is proving to be a valuable deal in the truest sense of the word. WEECO Pharma is well above the previously planned revenue target for 2024, at EUR 6.75 million as of the end of October 2024. Revenues of over EUR 8 million are expected for the full year 2024. For this reason, WEECO Pharma’s sales plans for 2025 and 2026 will be realistically, but still conservatively, adjusted upwards in the coming weeks.

“We firmly believed that our partnership would create positive synergies for both sides. Despite our great confidence, we would never have dreamt that we would be able to present such figures so soon. The whole is indeed more than the sum of its parts,” explain Börge Diessel, Managing Director of WEECO Pharma, and Daniel Kruse, CEO of SYNBIOTIC.

As a German importer and wholesaler, WEECO Pharma brings together an international network of medical cannabis producers, including some of the world’s leading EU GMP manufacturers. The company specialises in the national and international trade in medicinal cannabis, including proprietary genetics. With WEECO Pharma, SYNBIOTIC has a full range of high-quality cannabis flowers within the group of companies. WEECO Pharma benefits from proven structures, experienced managers and contacts with suppliers from other SYNBIOTIC subsidiaries, specifically MH medical hemp and SynBiotic Distribution. This enables the group to fully exploit its potential. At the same time, SYNBIOTIC is planning further acquisitions in the areas of cultivation and the supply chain for medical cannabis.

“WEECO has developed into a real asset for our investors and shareholders in a very short space of time,” confirms Daniel Kruse. “Over the next 18 months, we will increasingly focus on the extremely growing market for medical cannabis.”

And this is also fuelling current discussions with potential investors. SYNBIOTIC’s Investor Relations team is using the good news for an extended November roadshow.

SYNBIOTIC On the Road Again

mwb research from Hamburg, one of the largest analysis firms in Europe, organised an exclusive online presentation for investors at the launch. Daniel Kruse presented SYNBIOTIC’s strategy together with Lukas Kendel and Emilio Ropero from SYNBIOTIC’s management team and answered questions from selected investors.

As part of the Talman event “Shape the Future of Cannabis Investment” in Munich, Daniel Kruse discussed investment opportunities in the emerging legal cannabis industry as a panellist with other experts from the cannabis industry. The Talman House is a members-only service that connects investors with successful cannabis companies in Europe and around the world. SYNBIOTIC also supported the event on the second weekend of November as a Gold Sponsor.

From 25 to 27 November, SYNBIOTIC’s IR team, headed by Daniel Kruse, will be a guest at the German Equity Forum. The event, organised by Deutsche Börse AG, is one of the most important capital market events about corporate financing in Europe. At the Steigenberger Airport Hotel Frankfurt, institutional investors and financial analysts enter dialogue with around 250 listed companies. In addition to SYNBIOTIC, there are also several DAX-listed companies on the list of registered companies.

Diversity advantage

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

Publisher
SYNBIOTIC SE
Daniel Kruse
CEO
Münsterstraße 336
40470 Düsseldorf
Germany

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

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

PRESS RELEASE

Biotest increases revenues in the first 9 months by 4.5% to Euro 523 million

 

• Product sales and toll manufacturing increased by 13,7% to € 414 million, in part thanks to the growth of Yimmugo^®
• Adjusted EBIT was maintained at previous year’s level as growing core business gradually replaces earnings  from technology transfer and development services
• Biotest submitted initial marketing authorization application for its Fibrinogen Concentrate (BT524) following the decentralized procedure for approval in Germany, Austria and Spain
• Guidance for revenue, cash flow and ROCE corrected
• EBIT guidance remains unchanged

 

Dreieich, Germany, November 14, 2024. The Biotest Group generated sales of € 522.7 million in the first nine months of the financial year 2024. This corresponds to an increase of 4.5% compared to the same period of the previous year (€ 500.3 million). Revenue from products and toll manufacturing increased by € 49.9 million or 13.7%, to € 414.4 million. In addition, revenue from technology disclosure and development services for Grifols, S.A. as part of the technology transfer and license agreement amounted to € 108.3 million, compared to € 135.4 million in the same period of the previous year.

The new intravenous immunoglobulin Yimmugo^® had a particularly positive impact, with sales increasing by € 25.5 million to € 41.6 million.

Group EBIT decreased to € 71.1 million in the first nine months of 2024 from € 125.4 million in the same period of 2023. This development is largely due to the contribution from technology disclosure and development services as part of the technology and license agreement with Grifols, S.A. which reduced to € 87.3 million, compared to € 112.3 million.

At € 37.0 million, adjusted EBIT, which reflects operating performance excluding exceptional items, was above the previous year’s level (€ 34.8 million).

The financial result for the first nine months of the current financial year improved to € -26.6 million (previous year: € -29.3 million). This development is mainly due to the € 4.9 million decrease in interest expenses. Tax expenses increased by € 7.0 million to € 14.6 million compared to the previous year.

As a result of the factors described above, earnings after tax (EAT) for the Biotest Group fell to € 29.9 million in the first three quarters of the 2024 financial year, compared to € 88.4 million in the same period of the previous year. This corresponds to earnings per ordinary share of € 0.75, compared with € 2.22 in the same period of the previous year.

Biotest submitted the initial marketing authorization application for its fibrinogen concentrate (BT524) to the Paul-Ehrlich-Institute, following the decentralized procedure for approval in Germany, Austria and Spain. A first marketing authorization is expected for mid-2025.

 

Outlook:

The Board of Management currently expects a revenue increase in the low single-digit percentage range for the 2024 financial year compared to 2023. This includes revenues from technology disclosure and from development services for Grifols, S.A. Previously, an increase in the high single-digit percentage range had been expected. The ongoing conflict in the Middle East poses significant risks to revenue and earnings. Economic instability in the region could lead to decreasing sales figures and may impact our financial performance. Additionally, supply chain disruptions may result in delays and increased costs.

The return on capital employed (ROCE) for the 2024 financial year is to be corrected to the range of 5-8% and the cash flow from operating activities to a negative mid-double-digit million range. Previously, a slightly improved ROCE compared to the 2023 financial year (12.3% as of December 31, 2023) and a positive cash flow from operating activities significantly above the previous year’s level have been expected (€ -2.7 million as of December 31, 2023). Measures to improve the cash flow have already been initiated.

The Board of Management expects an operating result (EBIT) in a range between € 80 million and € 100 million for 2024.

The nine-month report is available on the company’s website under Quarterly Reports (biotest.com).

 

 

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

 

 

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

 

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Ad hoc NOTICE

Notification pursuant to Art. 17 EU Market Abuse Regulation (MAR)

 

Biotest corrects forecast for revenue, cash flow and ROCE – EBIT guidance unchanged

 

Dreieich, Germany, November 14, 2024. The Board of Management currently expects a revenue increase in the low single-digit percentage range for the 2024 financial year compared to 2023. This includes revenues from technology disclosure and from development services for Grifols, S.A. Previously, an increase in the high single-digit percentage range had been expected.

The return on capital employed (ROCE) for the 2024 financial year is to be corrected to the range of 5-8% and the cash flow from operating activities to a negative mid-double-digit million range. Previously, a slightly improved ROCE compared to the 2023 financial year (12.3% as of December 31, 2023) and a positive cash flow from operating activities significantly above the previous year’s level have been expected
(€ -2.7 million as of December 31, 2023).

The Board of Management continues to expect an operating result (EBIT) in a range between € 80 million and € 100 million for the 2024 financial year.

 

Biotest Aktiengesellschaft
The Board of Management
 

Biotest AG
Landsteinerstr. 5
D-63303 Dreieich

www.biotest.com

 

Disclaimer

This document contains forward-looking statements on the overall economic development and the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on the company’s current plans, estimates, forecasts and expectations and are therefore subject to risks and uncertainties that could cause actual developments to differ materially from those anticipated. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and does not assume any obligation to do so.

 

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

 

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

 

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

 

 

Contact:

Martin Möller
Chief Financial Officer
Biotest AG
Landsteinerstr. 5
63303 Dreieich
Tel. +40 6103 801 2999
Fax: +49 6103 801 767
martin.moeller@biotest.com

Dermapharm Holding SE posts strong results for Q3 2024,
Arkopharma (France) back above prior-year EBITDA levels for first time

 

• Consolidated revenue up 2.7% to EUR 890.1 million. Growth in high-margin “Branded pharmaceuticals” more than offsets declining revenue in “Other healthcare products” segment.
• Above-average increase in (unadjusted) consolidated EBITDA by 12.3% to EUR 234.1 million, unadjusted EBITDA margin improves by 2.3 percentage points to 26.3%. Adjusted EBITDA of EUR 240.3 million results in adjusted EBITDA margin of 27.0%.
• Taken in isolation, Q3 2024 revenue up 9.5% on prior-year quarter; unadjusted consolidated EBITDA up 22.0% and adjusted consolidated EBITDA up 15.2%. Trend fuelled by branded pharmaceuticals segment in general and improvement at Arkopharma.
• Board of Management confirms outlook for 2024 overall, continues to expect consolidated revenue of EUR 1,170–1,210 million and adjusted EBITDA of EUR 305–315 million.

 

Grünwald, 14 November 2024 – Dermapharm Holding SE (“Dermapharm”), a rapidly growing manufacturer of branded pharmaceuticals and other healthcare products, today publishes its results for the first nine months of 2024.

Dermapharm Holding SE performed in line with expectations in the first nine months of 2024. Consolidated revenue increased by 2.7% to EUR 890.1 million as compared to the prior-year period (prior-year period: EUR 866.6 million). This was due to the strong organic growth in the existing portfolio, which more than offset the decline in revenue at Arkopharma and the projected decrease in revenue from the vaccine business. In addition, the rise in revenue was also bolstered by the revenue from Montavit, which was consolidated from July 2023.

Adjusted for non-recurring effects, EBITDA amounted to EUR 240.3 million, on par with the figure for the prior-year period (EUR 243.8 million); the adjusted EBITDA margin fell by 1.1 percentage point to 27.0%. Wage increases and the inflation-related rise in other operating expenses were thus partially offset by an increase in the gross margin. Adjusted to account for the loss of revenue from vaccines, sustainable EBITDA for the first 9 months of 2024 rose by a considerable 12.4%, with the corresponding EBITDA margin up year on year by 1.4 percentage points. Unadjusted EBITDA increased substantially by 12.3% to EUR 234.1 million (prior-year period: EUR 208.4 million). There were markedly fewer items to adjust for in the first nine months of 2024 than in the same period of the previous year (EUR 6.2 million compared to EUR 35.5 million).

“We are immensely satisfied with the Company’s performance in the first nine months of 2024. We were able to offer further evidence of our M&A expertise by successfully acquiring and integrating Montavit in the wake of its insolvency. I am particularly pleased to report that our internationalisation efforts are gaining pace. We are therefore highly optimistic for the final quarter and confident that we will meet our forecasted targets for 2024”, said Dr Hans-Georg Feldmeier, Chairman of the Board of Management of Dermapharm Holding SE.

 

Branded pharmaceuticals

In the “Branded pharmaceuticals” segment, organic growth in the Group’s core business in Germany and at its international subsidiaries translated to a 9.1% rise in revenue from EUR 395.7 million in the previous year to EUR 431.6 million. Additionally, after having been consolidated for three months in the previous year, starting from July 2023, Montavit made a positive contribution to revenue growth. The projected decline in revenue from the vaccine business, which had last peaked in Q1 2023, was therefore more than offset by the Group’s strong existing business.

Adjusted EBITDA amounted to EUR 197.3 million, representing 45.7% of revenue (prior-year period: EUR 183.8 million, or 46.4%). Unadjusted EBITDA rose by 18.7% to EUR 192.3 million (prior-year period: EUR 162.0 million), resulting in an EBITDA margin of 44.6% (prior-year period: 40.9%).

Other healthcare products

In the “Other healthcare products” segment, Dermapharm generated EUR 271.7 million in revenue in the first nine months of 2024 (prior-year period: EUR 287.9 million). This decline in revenue was attributable primarily to the French company, Arkopharma. The first half of 2023 had seen unusually high sales in the French pharmacies market in the wake of a price hike at the beginning of the year as well as major product launches. Although sales to end customers via pharmacies remained at a high level, pharmacies had been reducing their sizeable inventories since the end of 2023, resulting in lower demand in the first few months of 2024. This trend was amplified by increasingly fierce competition and the associated pressure on prices and volumes. In the third quarter of 2024, Arkopharma increased its revenue to the previous year’s level for the first time, with EBITDA even exceeding the previous year’s figure.

Adjusted EBITDA for the segment amounted to EUR 45.8 million (prior-year period: EUR 63.3 million). This translates to an adjusted EBITDA margin of 16.9% (prior-year period: 22.0%). The decline is due to the effects described above, which resulted in a lower gross margin. However, cost-cutting measures at the beginning of the year made it possible to partially offset this development. Unadjusted EBITDA amounted to EUR 44.6 million (prior-year period: 49.6 million), and the EBITDA margin amounted to 16.4% (prior-year period: 17.2%).

Parallel import business

Revenue in the “Parallel import business” segment rose by 2.2% to EUR 186.9 million (prior-year period: EUR 182.9 million). This increase was attributable primarily to the high availability of products, attractive procurement prices and growing market volume. From an operational standpoint, the decision to increase stockpiles helped to improve product availability to an appropriate level. In addition, efficiency enhancements in production and successful product launches were realised. However, the increase in sales allowances resulting from higher health insurance discounts related to the portfolio eroded these positive effects, with EBITDA remaining at the same level as in the previous year (EUR 1.1 million in the current and prior-year period). Just as in the previous year, the EBITDA margin for the segment was also 0.6% for the first nine months.

Board of Management confirms outlook for 2024 overall

In light of the Company’s projected performance in the first nine months of financial year 2024 and the recently reinforced positive trend at Arkopharma, the Board of Management confirms that both consolidated revenue and adjusted EBITDA will be in line with the published forecast range of between EUR 1,170–1,210 million and EUR 305–315 million, respectively.

The full interim statement for Q3 2024 is available from today at https://ir.dermapharm.de/en.
 

IFRS figures for 9M 2024 and the prior-year period 

(excluding segment reconciliation/Group holding company)¹

EUR million	9M 2024	9M 2023	Change
Consolidated revenue	890.1	866.6	+2.7%
Branded pharmaceuticals	431.6	395.7	+9.1%
Other healthcare products	271.7	287.9	-5.6%
Parallel import business	186.9	182.9	+2.2%
Adjusted consolidated EBITDA*	240.3	243.8	-1.4%
Branded pharmaceuticals	197.3	183.8	+7.3%
Other healthcare products	45.8	63.3	-27.6%
Parallel import business	1.1	1.1	0.0%
Adjusted EBITDA margin* (%)	27.0	28.1	-1.1 pp
Branded pharmaceuticals	45.7	46.4	-0.7 pp
Other healthcare products	16.9	22.0	-5.1 pp
Parallel import business	0.6	0.6	0.0 pp
Consolidated EBITDA	234.1	208.4	+12.3%
Branded pharmaceuticals	192.3	162.0	+18.7%
Other healthcare products	44.6	49.6	-10.1%
Parallel import business	1.1	1.1	0.0%
EBITDA margin (%)	26.3	24.0	+2.3 pp
Branded pharmaceuticals	44.6	40.9	+3.7 pp
Other healthcare products	16.4	17.2	-0.8 pp
Parallel import business	0.6	0.6	0.0 pp

*9M 2024 EBITDA was adjusted for non-recurring items amounting to EUR 6.2 million.
  9M 2023 EBITDA was adjusted for non-recurring items amounting to EUR 35.5 million.

 

Company profile

Dermapharm – Pharmaceutical Excellence “Made in Europe”

Dermapharm is an innovative and rapidly growing manufacturer of branded pharmaceuticals and other healthcare products. Founded in 1991, the Company is based in Grünwald near Munich. In addition to its main location in Brehna near Leipzig, Dermapharm also operates other production, development and distribution locations in Germany, the rest of Europe and the United States.

In the “Branded pharmaceuticals” segment, Dermapharm has more than 1,300 marketing authorisations with more than 390 active pharmaceutical ingredients. Dermapharm’s portfolio of pharmaceuticals is tailored to selected therapeutic areas in which the Company is a market leader, especially in Germany. The Company’s integrated business model extends from in-house product development and production through quality management and logistics to the distribution of branded pharmaceuticals by a trained pharmaceutical sales force.

Dermapharm bundles food supplements, herbal pharmaceuticals, cosmetics, medical devices, herbal extracts and medicinal cannabis in its “Other healthcare products” segment. In this segment, Dermapharm can tap the expertise of Arkopharma, the market leader for herbal food supplements in France, and the Spanish company Euromed S.A., a leading global manufacturer of herbal extracts and plant-based active ingredients for the pharmaceuticals, nutraceuticals, foodstuffs and cosmetics industries.

Dermapharm also operates the “Parallel import business” segment under the axicorp brand. axicorp imports originator pharmaceuticals from other EU Member States and resells them to pharmaceuticals wholesalers and pharmacies in Germany. This enables axicorp to benefit from the different pricing structures in the individual EU member states. Based on revenue, axicorp is currently the sixth largest parallel importer in Germany.

With a consistent R&D strategy and numerous successful product and company acquisitions and by stepping up its internationalisation efforts, the Group is continuously optimising its business activities and seeks external growth opportunities in addition to organic growth.

 

Contact

Investor Relations & Corporate Communications
Britta Hamberger
Tel.: +49 (0)89 – 64186-233
E-mail: ir@dermapharm.com

 

 

[1] Due to rounding differences, the figures presented for the segments may not entirely match the reported totals.