Tillkännagivande • May 23
Biotest Aktiengesellschaft announces Annual dividend, payable on July 07, 2025 Biotest Aktiengesellschaft announced Annual dividend of EUR 0.0400 per share payable on July 07, 2025, ex-date on July 03, 2025 and record date on July 04, 2025. Tillkännagivande • May 22
Biotest Aktiengesellschaft, Annual General Meeting, Jul 02, 2025 Biotest Aktiengesellschaft, Annual General Meeting, Jul 02, 2025, at 10:30 W. Europe Standard Time. Tillkännagivande • Apr 02
Grifols Biotest Holdings GmbH, proposed to acquire remaining 28.31% stake in Biotest Aktiengesellschaft (XTRA:BIO3) from shareholders for approximately €340 million. Grifols Biotest Holdings GmbH, proposed to acquire remaining 28.31% stake in Biotest Aktiengesellschaft (XTRA:BIO3) from shareholders for approximately €340 million on March 31, 2025. The Management Board and the Supervisory Board will carefully review the offer document for the public delisting acquisition offer and issue a joint reasoned statement in accordance with Section 27 of the German Securities Acquisition and Takeover Act. The delisting agreement contains provisions that Grifols, S.A. intends to support Biotest AG in an economically reasonable manner. After the revocation of the stock exchange admission becomes effective, the shares of Biotest AG will no longer be admitted to trading on a domestic regulated market or a comparable market abroad. According to the provisions of the delisting agreement, Grifols Biotest Holdings GmbH, a 100% subsidiary of Grifols, S.A., will make an unconditional public delisting acquisition offer to the shareholders of Biotest AG to acquire all ordinary and preference shares of Biotest AG that are not already held by Grifols Biotest Holdings GmbH, in exchange for a cash consideration of €43.00 per Biotest ordinary share and €30.00 per Biotest preference share, subject to adjustments due to legal provisions. The terms and conditions of the delisting offer will be communicated in the offer document ("Offer Document") to be prepared by Grifols and to be examined by the German federal financial supervisory. Banco Santander, S.A. acted as a financial advisor to Biotest Aktiengesellschaft. Tillkännagivande • Mar 07
Martin Möller to Leave as Chief Financial Officer of Biotest AG on 15 March 2025 The Board of Management of Biotest AG announced that Chief Financial Officer Martin Möller will terminate his position as CFO as planned at the end of his contract expires on 15 March 2025. The Supervisory Board has already initiated the search for a suitable successor and aims to fill the position in the near future. Martin Möller will continue to support Biotest AG in an advisory capacity beyond the end of his contract. Tillkännagivande • Jan 09
Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA) Biotest AG announced that the Biologics License Application (BLA) for Biotest’s Fibrinogen has been submitted to the US Food and Drug Administration. Fibrinogen is the second product developed and manufactured by Biotest in Dreieich, Germany, for which a BLA has been submitted to the FDA. The new application covers both supplementation in patients with acquired fibrinogen deficiency and treatment and prophylaxis of acute bleeding episodes in all patients with congenital fibrinogen deficiency. The application is now under evaluation by the FDA, with a decision anticipated by the end of 2025. This submission follows Biotest’s earlier application for marketing authorization in selected European markets filed in October 2024. In many regions of the world, the use of cryoprecipitate or fresh frozen plasma as a fibrinogen substitute is the standard of care for the management of major surgical bleeding. However, these treatments contain not only fibrinogen, but also additional proteins and components that may exhibit undesired effects for the patient. In addition, they are not subject to the same rigorous pathogen safety protocols as Fibrinogen. Fibrinogen also offers the significant advantages of being readily available and allowing for faster administration, ensuring timely and targeted treatment. Tillkännagivande • Nov 15
Biotest Aktiengesellschaft to Report Fiscal Year 2024 Results on Mar 28, 2025 Biotest Aktiengesellschaft announced that they will report fiscal year 2024 results on Mar 28, 2025 Tillkännagivande • Jul 29
Biotest Aktiengesellschaft to Report Q2, 2024 Results on Aug 06, 2024 Biotest Aktiengesellschaft announced that they will report Q2, 2024 results on Aug 06, 2024 Tillkännagivande • Jun 18
Biotest Receives FDA Approval for Innovative Yimmugo Immunoglobulin to Treat Primary Immunodeficiencies Grifols announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration (FDA) for Yimmugo®, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID). Yimmugo, developed by Biotest, adds to Grifols’ strong franchise of industry-leading intravenous and subcutaneous Ig treatments at a time of growing demand for plasma-derived medicines to treat immunodeficiencies, in which a part of the body’s immune system is missing or does not function properly, and other medical conditions. The first U.S.-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified “Next Level” production facility in Dreieich, Germany, which is already approved for production and marketing in Europe. The launch of Yimmugo in the U.S. in the second part of 2024 follows its successful introduction in Europe at the end of 2022 and is poised to add to Grifols' future revenue growth and profitability. Yimmugo is the first of a threesome of Biotest plasma proteins on the horizon destined for markets including the U.S. The other two, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency – it would be the first FC approved for this indication in the U.S. – and trimodulin, a polyvalent Ig to treat community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP). The strategic acquisition of Biotest and the integration of its specialized resources has significantly accelerated Grifols innovation, deepened its product pipeline and furthered its industry leadership. Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources. Important Safety Information: Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Tillkännagivande • Mar 29
Biotest Aktiengesellschaft, Annual General Meeting, May 07, 2024 Biotest Aktiengesellschaft, Annual General Meeting, May 07, 2024, at 10:30 Central European Standard Time. Location: Alte Oper Frankfurt, Mozart Saal, Opernplatz, Franfurt Am Main Germany Agenda: To consider the adopted annual financial statements of Biotest AG and the approved consolidated financial statements as at 31 December 2023; to consider the Resolution on the discharge of the members of the Management Board for the financial year 2023; to consider Resolution on the discharge of the members of the Supervisory Board for the financial year 2023; to consider the Election of the auditor for the financial year 2024; and to consider the other business matters. Tillkännagivande • Nov 03
Biotest Aktiengesellschaft to Report Fiscal Year 2023 Results on Mar 28, 2024 Biotest Aktiengesellschaft announced that they will report fiscal year 2023 results on Mar 28, 2024 Tillkännagivande • Oct 07
Biotest Aktiengesellschaft Raises Earnings Guidance for the Year 2023 Biotest Aktiengesellschaft raised earnings guidance for the year 2023. Biotest AG had forecasted in April 2023 an EBIT that may possibly exceed EUR 100 million. Based on current information, the Executive Board expects EBIT for fiscal 2023 to be in the order of EUR 130 - 170 million. The Executive Board continues to aim for a mid-single-digit percentage increase in revenue for the 2023 financial year compared to 2022, excluding revenue from the technology transfer and licensing agreement. Tillkännagivande • Oct 06
Biotest AG Appoints Peter Janssen as Chairman of the Management Board, Effective from January 1, 2024 Biotest AG at its meeting held on October 5, 2023 appointed Mr. Peter Janssen (57) as Chairman of the Management Board of Biotest AG with effect from 1 January 2024. He will take over the chairmanship of the Board of Management from Dr Michael Ramroth (62), who held this position for three and a half years and is retiring as planned for reasons of age. Peter Janssen has been a member of the Management Board of Biotest AG since 2022 and heads the Commercial and Industrial Operations divisions. Previously, he was Executive VP of Prothya Netherlands and CEO of Prothya Belgium. Mr. Janssen also worked for Pfizer for 14 years and for its animal health spin-off Zoetis for 5 years. Peter Janssen started his career as an assistant professor at the University of Leuven in Belgium, was a reserve officer in the Belgian Air Force and worked in the semiconductor division of the industrial gas company Air Products in Pennsylvania, USA. He holds a Master of Science (Dipl. Ing.) in Electromechanics, a Master in Business Administration and a Management Diploma from INSEAD in France. In addition to Peter Janssen as Chairman of the Management Board, the Management Board of Biotest AG will continue to include Ainhoa Mendizabal Zubiaga as CFO and Dr. Jörg Schüttrumpf as CSO. Tillkännagivande • Sep 13
Biotest Treats First Patient with Severe Community- Acquired Pneumonia in Phase III Trial with Trimodulin Biotest announced that the first patient with sCAP has been treated in the phase III ESsCAPE trial in an intensive care unit. This multinational phase III clinical trial is expected to enrol approximately 590 adult patients with severe Community Acquired Pneumonia (sCAP). The ESsCAPE trial will be conducted in up to 20 countries worldwide and patients will receive either trimodulin or placebo as add-on therapy to standard of care. Severe CAP is a life-threatening condition. Patients must be admitted to an intensive care unit (ICU) and often receive oxygen through invasive mechanical ventilation (IMV). These patients often develop additional critical illnesses such as sepsis, septic shock, and multiple organ dysfunction or failure. Despite existing treatment options, mortality in these patients remains high. The clinical concept of this prospective, double-blind, placebo-controlled phase III trial, was developed based on the promising results of the previous phase II clinical trial (CIGMA) in 160 sCAP patients requiring IMV. In the CIGMA trial a subgroup of patients with evidence of severe inflammation showed an encouraging reduction in the mortality rate when treated with trimodulin. Biotest's development product trimodulin is a globally unique, innovative polyvalent IgM, IgA, IgG antibody composition, purified from human plasma. In addition to clinical development for sCAP, trimodulin is also currently in development for the treatment of COVID-19. Biotest's development products trimodulin is an innovative polyvalent antibody composition, purified from human Plasma. In comparison to standard IgG preparations (IVIG), trimodulin contains relevant amounts of IgM and IgA in addition to IgG. Trimodulin is currently in clinical development for the treatment of patients with severe community-acquired pneumonia (sCAP) and for patients with moderate or severe COVID-19. Research so far has shown that trimodulin could intervene with a number of mechanisms involved in pathological processes that would otherwise lead to respiratory failure, sepsis, multi-organ failure and finally to death of the patient. Due to the large variety of polyvalent antibodies present in trimodulin, the impaired immune system is supported in various ways. The antibodies bind to various types of pathogens including viruses and bacteria as well as their toxins and support their clearance by the immune system. Particularly the IgM component in trimodulin can reduce dysregulated immune responses, preventing the immune system to attack host tissues, in this case, the lung. In this way, trimodulin may prevent progression of disease, including the need for invasive mechanical ventilation and other intensive care procedures, and finally death. Severe community acquired pneumonia (sCAP) is usually defined as pneumonia acquired outside the hospital that requires intensive medical care. mortality of sCAP patients admitted to the intensive care unit is high and has not improved much in recent years. Tillkännagivande • Sep 08
Biotest AG Announces US Food and Drug Administration Accepts Marketing Authorization Application for Immunoglobulin Yimmugo Biotest AG announced that the Biologics License Application (BLA) for the polyspecific immunoglobulin preparation Yimmugo (IgG Next Generation) has been accepted for review by the U.S. Food and Drug Administration (FDA) after the 60-day validation phase. With this filing notification the marketing authorization application will enter the next phase, in which the application dossier will be subjected to an in-depth substantive review. The marketing authorization application covers the indication primary immunodeficiencies (PID). After receiving approval, Biotest plans to expand the indication to include chronic primary immune thrombocytopenia (ITP). The FDA's decision on the marketing authorization application of Yimmugo is expected on June 29, 2024. Biotest's new immunoglobulin is manufactured in an innovative production process and is the main product of the new Biotest Next Level production facility. The new production facility, which uses technologies, represents Biotest's increased commitment to the global immunoglobulin market. Reported Earnings • Mar 29
Full year 2022 earnings released: €0.80 loss per share (vs €1.60 loss in FY 2021) Full year 2022 results: €0.80 loss per share (improved from €1.60 loss in FY 2021). Revenue: €516.1m (flat on FY 2021). Net loss: €31.7m (loss narrowed 50% from FY 2021). Products in clinical trials Phase I: 1 Phase III: 6 Post-clinical trial products Approved (during full year): 2 Launched (during full year): 1 Revenue is forecast to grow 9.5% p.a. on average during the next 2 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 41% per year but the company’s share price has increased by 21% per year, which means it is well ahead of earnings. Tillkännagivande • Feb 11
Biotest AG Appoints Ainhoa Mendizabal as CFO, with Effect from 15 February, 2023 Biotest AG appointed Ms. Ainhoa Mendizabal (50) to the company's Management Board as Chief Financial Officer (CFO) with effect from 15 February 2023. When Dr. Michael Ramroth was appointed Chief Executive Officer (CEO) on 1 May 2019, he initially continued to perform the duties of Chief Financial Officer in addition to his other duties. In view of the constantly growing reporting requirements, the company has now filled the position of Chief Financial Officer with Ms Mendizabal. As 'Chief Financial Officer', Ms. Mendizabal will be responsible within the Biotest Group for the areas of finance, including the treasury and tax departments, controlling, investor relations and insurance. Ms Mendizabal has worked for several years in an international consulting firm in the area of CFO Services and Enterprise Applications. From there she moved to Talecris Biotherapeutics GmbH before Talecris was acquired by Grifols S.A. Since then, Ms Mendizabal has held various executive and managerial roles in the Grifols Group in Germany and in Europe. Ms. Mendizabal holds a dual Master of Business Administration (Business Administration) in Spain and in Germany. 
