View Future GrowthBiotest 過去の業績過去 基準チェック /06Biotestは47.4%の年平均成長率で業績を伸ばしているが、Biotechs業界はgrowingで30.2%毎年増加している。売上は成長しており、年平均10.6%の割合である。主要情報47.40%収益成長率48.62%EPS成長率Biotechs 業界の成長17.04%収益成長率10.55%株主資本利益率-4.81%ネット・マージン-3.86%次回の業績アップデート04 Aug 2025最近の業績更新お知らせ • Mar 18+ 1 more updateBiotest Aktiengesellschaft to Report Q3, 2025 Results on Nov 10, 2025Biotest Aktiengesellschaft announced that they will report Q3, 2025 results on Nov 10, 2025お知らせ • Nov 15Biotest Aktiengesellschaft to Report Fiscal Year 2024 Results on Mar 28, 2025Biotest Aktiengesellschaft announced that they will report fiscal year 2024 results on Mar 28, 2025お知らせ • Jul 29Biotest Aktiengesellschaft to Report Q2, 2024 Results on Aug 06, 2024Biotest Aktiengesellschaft announced that they will report Q2, 2024 results on Aug 06, 2024お知らせ • Jan 23+ 2 more updatesBiotest Aktiengesellschaft to Report First Half, 2024 Results on Jul 30, 2024Biotest Aktiengesellschaft announced that they will report first half, 2024 results on Jul 30, 2024お知らせ • Nov 03Biotest Aktiengesellschaft to Report Fiscal Year 2023 Results on Mar 28, 2024Biotest Aktiengesellschaft announced that they will report fiscal year 2023 results on Mar 28, 2024すべての更新を表示Recent updatesお知らせ • May 23Biotest Aktiengesellschaft announces Annual dividend, payable on July 07, 2025Biotest 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.お知らせ • May 22Biotest Aktiengesellschaft, Annual General Meeting, Jul 02, 2025Biotest Aktiengesellschaft, Annual General Meeting, Jul 02, 2025, at 10:30 W. Europe Standard Time.お知らせ • Apr 02Grifols 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.お知らせ • Mar 18+ 1 more updateBiotest Aktiengesellschaft to Report Q3, 2025 Results on Nov 10, 2025Biotest Aktiengesellschaft announced that they will report Q3, 2025 results on Nov 10, 2025お知らせ • Mar 07Martin Möller to Leave as Chief Financial Officer of Biotest AG on 15 March 2025The 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.お知らせ • Jan 09Important 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.お知らせ • Nov 15Biotest Aktiengesellschaft to Report Fiscal Year 2024 Results on Mar 28, 2025Biotest Aktiengesellschaft announced that they will report fiscal year 2024 results on Mar 28, 2025お知らせ • Jul 29Biotest Aktiengesellschaft to Report Q2, 2024 Results on Aug 06, 2024Biotest Aktiengesellschaft announced that they will report Q2, 2024 results on Aug 06, 2024お知らせ • Jun 18Biotest Receives FDA Approval for Innovative Yimmugo Immunoglobulin to Treat Primary ImmunodeficienciesGrifols 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.お知らせ • Mar 29Biotest Aktiengesellschaft, Annual General Meeting, May 07, 2024Biotest 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.お知らせ • Jan 23+ 2 more updatesBiotest Aktiengesellschaft to Report First Half, 2024 Results on Jul 30, 2024Biotest Aktiengesellschaft announced that they will report first half, 2024 results on Jul 30, 2024お知らせ • Nov 03Biotest Aktiengesellschaft to Report Fiscal Year 2023 Results on Mar 28, 2024Biotest Aktiengesellschaft announced that they will report fiscal year 2023 results on Mar 28, 2024お知らせ • Oct 07Biotest Aktiengesellschaft Raises Earnings Guidance for the Year 2023Biotest 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.お知らせ • Oct 06Biotest AG Appoints Peter Janssen as Chairman of the Management Board, Effective from January 1, 2024Biotest 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.お知らせ • Sep 13Biotest Treats First Patient with Severe Community- Acquired Pneumonia in Phase III Trial with TrimodulinBiotest 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.お知らせ • Sep 08Biotest AG Announces US Food and Drug Administration Accepts Marketing Authorization Application for Immunoglobulin YimmugoBiotest 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.収支内訳Biotest の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史OTCPK:BIES.F 収益、費用、利益 ( )EUR Millions日付収益収益G+A経費研究開発費31 Mar 25635-24815731 Dec 2472626835730 Sep 2470769856830 Jun 24781164876531 Mar 24783177867131 Dec 23685127846730 Sep 2365691845630 Jun 23538-10855731 Mar 23517-47845031 Dec 22516-32825130 Sep 22505-69845130 Jun 22511-65835031 Mar 22512-54825131 Dec 21516-63825230 Sep 21514-28775530 Jun 21507-33785531 Mar 21507-35805631 Dec 20484-31805630 Sep 20466-34825630 Jun 20459-24845431 Mar 20439-15835231 Dec 19419-5835330 Sep 19406-9825230 Jun 19395-3825331 Mar 19390-6825131 Dec 18400-13854930 Sep 1840518915030 Jun 184096915231 Mar 184001995431 Dec 17378-161005530 Sep 17257-48955630 Jun 17301-47935231 Mar 17340-29894931 Dec 164086884830 Sep 16531128783630 Jun 1652552886231 Mar 1652636887231 Dec 1553527937930 Sep 15590-881079330 Jun 1560631097331 Mar 15602161106931 Dec 14582191086730 Sep 14543271057230 Jun 14522319869質の高い収益: BIES.Fは現在利益が出ていません。利益率の向上: BIES.Fは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: BIES.Fは利益を出していないが、過去 5 年間で年間47.4%の割合で損失を削減してきた。成長の加速: BIES.Fの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: BIES.Fは利益が出ていないため、過去 1 年間の収益成長をBiotechs業界 ( 31.5% ) と比較することは困難です。株主資本利益率高いROE: BIES.Fは現在利益が出ていないため、自己資本利益率 ( -4.81% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2025/06/07 12:34終値2025/03/10 00:00収益2025/03/31年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Biotest Aktiengesellschaft 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。3 アナリスト機関Torben TeichlerHauck Aufhäuser Investment BankingJan KeppelerHSBCKlaus SchloteSolventis Wertpapierhandelsbank GmbH
お知らせ • Mar 18+ 1 more updateBiotest Aktiengesellschaft to Report Q3, 2025 Results on Nov 10, 2025Biotest Aktiengesellschaft announced that they will report Q3, 2025 results on Nov 10, 2025
お知らせ • Nov 15Biotest Aktiengesellschaft to Report Fiscal Year 2024 Results on Mar 28, 2025Biotest Aktiengesellschaft announced that they will report fiscal year 2024 results on Mar 28, 2025
お知らせ • Jul 29Biotest Aktiengesellschaft to Report Q2, 2024 Results on Aug 06, 2024Biotest Aktiengesellschaft announced that they will report Q2, 2024 results on Aug 06, 2024
お知らせ • Jan 23+ 2 more updatesBiotest Aktiengesellschaft to Report First Half, 2024 Results on Jul 30, 2024Biotest Aktiengesellschaft announced that they will report first half, 2024 results on Jul 30, 2024
お知らせ • Nov 03Biotest Aktiengesellschaft to Report Fiscal Year 2023 Results on Mar 28, 2024Biotest Aktiengesellschaft announced that they will report fiscal year 2023 results on Mar 28, 2024
お知らせ • May 23Biotest Aktiengesellschaft announces Annual dividend, payable on July 07, 2025Biotest 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.
お知らせ • May 22Biotest Aktiengesellschaft, Annual General Meeting, Jul 02, 2025Biotest Aktiengesellschaft, Annual General Meeting, Jul 02, 2025, at 10:30 W. Europe Standard Time.
お知らせ • Apr 02Grifols 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.
お知らせ • Mar 18+ 1 more updateBiotest Aktiengesellschaft to Report Q3, 2025 Results on Nov 10, 2025Biotest Aktiengesellschaft announced that they will report Q3, 2025 results on Nov 10, 2025
お知らせ • Mar 07Martin Möller to Leave as Chief Financial Officer of Biotest AG on 15 March 2025The 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.
お知らせ • Jan 09Important 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.
お知らせ • Nov 15Biotest Aktiengesellschaft to Report Fiscal Year 2024 Results on Mar 28, 2025Biotest Aktiengesellschaft announced that they will report fiscal year 2024 results on Mar 28, 2025
お知らせ • Jul 29Biotest Aktiengesellschaft to Report Q2, 2024 Results on Aug 06, 2024Biotest Aktiengesellschaft announced that they will report Q2, 2024 results on Aug 06, 2024
お知らせ • Jun 18Biotest Receives FDA Approval for Innovative Yimmugo Immunoglobulin to Treat Primary ImmunodeficienciesGrifols 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.
お知らせ • Mar 29Biotest Aktiengesellschaft, Annual General Meeting, May 07, 2024Biotest 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.
お知らせ • Jan 23+ 2 more updatesBiotest Aktiengesellschaft to Report First Half, 2024 Results on Jul 30, 2024Biotest Aktiengesellschaft announced that they will report first half, 2024 results on Jul 30, 2024
お知らせ • Nov 03Biotest Aktiengesellschaft to Report Fiscal Year 2023 Results on Mar 28, 2024Biotest Aktiengesellschaft announced that they will report fiscal year 2023 results on Mar 28, 2024
お知らせ • Oct 07Biotest Aktiengesellschaft Raises Earnings Guidance for the Year 2023Biotest 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.
お知らせ • Oct 06Biotest AG Appoints Peter Janssen as Chairman of the Management Board, Effective from January 1, 2024Biotest 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.
お知らせ • Sep 13Biotest Treats First Patient with Severe Community- Acquired Pneumonia in Phase III Trial with TrimodulinBiotest 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.
お知らせ • Sep 08Biotest AG Announces US Food and Drug Administration Accepts Marketing Authorization Application for Immunoglobulin YimmugoBiotest 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.