Congenital fibrinogen deficiency

PRESS RELEASE Biotest AG increases sales by 6% in financial year 2024 EBIT guidance of € 94.5 million at the upper end of the forecast range achieved Marketing authorization application for fibrinogen submitted in key European markets and to the US Food and Drug Administration (FDA) Approval of Yimmugo in June 2024 by the US Food and Drug Administration (FDA), which simultaneously certified the corresponding production facility Dreieich, March 31, 2025. The Biotest Group generated sales of € 726.2 million in the reporting year after € 684.6 million in the previous year. This corresponds to an increase in sales of 6.1 % (€ 41.6 million). The sales growth is mainly attributable to increased sales of Intratect® and Yimmugo®. The new intravenous immunoglobulin Yimmugo®, sales of which rose by € 34.9 million to € 62.1 million, is the first commercial preparation to be produced in an innovative manufacturing process at the Biotest Next Level production facility. Sales from technology disclosure and development services for Grifols, S.A. declined from € 190.1 million in the same period of the previous year to € 123.1 million in the financial year. For the financial year 2024, EBIT amounted to € 94.5 million after € 143.5 million in the same period of the previous year and has therefore decreased. The year-on-year decline in EBIT is primarily due to the lower earnings effect from technology disclosure and development services for Grifols, S.A. amounting to € 89.3 million (same period of the previous year: € 158.2 million). Adjusted EBIT improved from € 9.8 million in the previous year to € 64.5 million. This improvement was due to higher special effects in the previous year, which weighed on the adjusted result. These effects relate to the capital gain on the sale of five Biotest subsidiaries in the amount of € 23.1 million and a higher earnings effect from technology disclosure and development services for Grifols, S.A. in the previous year. The Biotest Group’s core business (adjusted EBIT) amounted to € 64.5 million in the past financial year. The forecast was € 65 to 85 million. Earnings before taxes (EBT) for the Biotest Group amounted to € 46.5 million, compared to € 106.3 million in the same period of the previous year. The Biotest Group's profit (EAT) for the 2024 financial year amounted to € 26.4 million after € 127.0 million in the same period of the previous year. Furthermore, the Management Board expected a slightly improved return on capital employed (ROCE) for the 2024 financial year compared to the 2023 financial year. ROCE amounted to 7.9 % for the 2024 financial year after 12.3 % in 2023. This development is mainly based on the forecast decline in EBIT, while capital employed is at a similar level to the previous year. Cash flow from operating activities was forecast to be positive at the beginning of the financial year and well above the previous year's level. With a positive cash flow from operating activities of € 60.9 million (previous year: € - 2.7 million), the forecast was confirmed in full. The main reason for this was the significantly improved cash flow from the change in working capital. Overall, Biotest 2024 has taken another major step forward on its growth path. Following the successful market launch of Yimmugo® in European countries, Yimmugo® was the first product from Dreieich to be approved in the USA, the world's largest single market for plasma derivatives. In June 2024, Biotest received approval from the US Food and Drug Administration (FDA), which also certified the corresponding production facility. We then immediately began producing the quantities required for the market launch in the USA, thereby raising the capacity utilization of Biotest Next Level to a new level. For the market launch in the USA in 2025, we have concluded a long-term agreement with Kedrion Biopharma for the complete marketing and distribution of Yimmugo® in the USA. This will generate sales of more than one billion US dollars over the next seven years and thus make a significant contribution to increasing the profitability of our company. In 2024, Biotest successfully completed the AdFirst Phase III trial. The approval applications based on this for the new preparation Fibrinogen, which is manufactured in Dreieich, in important European markets and the USA lay the foundation for further growth. Fibrinogen will meet the high medical demand for additional fibrinogen for the treatment of acquired and congenital fibrinogen deficiency. We expect a decision on the approval applications by the end of 2025. Outlook: The Management Board expects a mid-single-digit percentage decline in sales for the 2025 financial year compared to 2024. Revenue in the 2024 financial year was positively influenced by technology disclosure and development services for Grifols, S.A. in the amount of € 123.1 million, which will be significantly lower due to the technology disclosure that has already fully taken place. The Executive Board expects an operating result (EBIT) in the range of € - 55 million to € - 75 million for 2025. This results from the aforementioned sales forecast and the corresponding development of cost of sales. The return on capital employed (ROCE) for the 2025 financial year is expected to be in the range of – 3 % to – 7 %. This development is mainly due to the expected negative operating result (EBIT). Cash flow from operating activities is expected to be in the low negative triple-digit million range. This essentially follows the operating performance and the development of net working capital. The 2024 Annual Report is available on the company's website. The presentation for the 2024 conference call for analysts and journalists is also available for download. About Biotest Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology 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 haematopoietic 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, based in Barcelona, Spain (www.grifols.com). Biotest AG will now also be publishing official press releases via X. You can find us at: https://twitter.com/BiotestAG 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.

PRESS RELEASE Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA) Biotest's fibrinogen aims to fulfill a high unmet medical need for additional fibrinogen to treat acquired fibrinogen deficiency US submission follows EU application for marketing authorization submitted in October 2024 Subject to FDA approval, new treatment would bring significant improvement in sales, EBIT and cash flow Dreieich, Germany, January 9, 2025. 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. “Clinical data demonstrates efficacy and safety of Biotest's Fibrinogen in various bleeding conditions,” said Dr. Christina Erb, Head of Scientific Operations and Innovation. “Fibrinogen deficiency can lead to uncontrolled blood loss potentially resulting in patient’s death. Biotest’s Fibrinogen can be stored at room temperature and is designed to be more convenient and faster to prepare than alternatives for the treatment of fibrinogen deficiency associated with severe blood loss. As such, it will provide an effective and safe option for the management of bleeding in patients with serious and potentially life-threatening conditions”. 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. As a member of the Grifols Group, Biotest is committed to playing a leading role in expanding access to this therapy to a broader patient population. About Biotest’s Fibrinogen The newly developed manufacturing process for fibrinogen results in high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility. About AdFIrst trial no. 995 The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of Fibrinogen (BT524) in patients with acquired fibrinogen deficiency. Patients experiencing high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen (BT524) or fresh frozen plasma (FFP)/cryoprecipitate. To evaluate the efficacy of BT524, blood loss was compared between the two treatment options. For more information on the trial design and outcomes, please visit www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20). Full trial results are expected to be published in a medical journal later in 2025. About fibrinogen and fibrinogen deficiency Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood's ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. The Fibrinogen alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to administration. The defined amount of fibrinogen in the fibrinogen developed by Biotest will allow a tailor-made, patient specific and highly effective treatment. 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.

PARAMUS, N.J, Aug. 1, 2024 /PRNewswire/ -- Octapharma USA, Inc. has announced the expanded approval of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the U.S. Food and Drug Administration (FDA). As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate). Fibrinogen plays an important role in coagulation and blood clotting in emergency and surgical settings. Fibrinogen is the first coagulation factor to drop to critically low levels during severe bleeding episodes. Rapid replenishment of fibrinogen is essential for achieving hemostasis in bleeding patients. Acquired fibrinogen deficiency (AFD) often results from severe bleeding and can impair blood clot formation, increasing the risk of ongoing hemorrhage in patients. Cryoprecipitate, which was introduced in 1964, comes with significant drawbacks, including long thawing and preparation processes, variable levels of fibrinogen, inclusion of additional coagulation-dependent components, and a higher risk of viral transmission. The approval of fibryga for AFD is a major advancement from the current standard of care. As a lyophilized powder, it can be stored at room temperature or refrigerated and can be quickly reconstituted at the point of patient care. It's precise and delivers a highly purified and consistent amount of fibrinogen for accurate treatment. "In the surgical theater, time matters. And confidence matters. This expanded FDA approval of fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently," said Flemming Nielsen, President, Octapharma USA, Inc. "We are proud to be the first to offer this therapeutic advancement—and a new standard of care—to hospitals, anesthesiologists, surgeons, OB/GYNs, and patients across the United States." The expanded FDA approval of fibryga was based on the FIBRES [FIBrinogen REplenishment in Surgery] study published in JAMA, which was a head-to-head, multicenter, randomized clinical trial in 735 patients, demonstrating that fibrinogen concentrate was non-inferior to cryoprecipitate and may be used instead of cryoprecipitate for the treatment of bleeding related to AFD. Fibryga has already received regulatory approval for the treatment of AFD in both the European Union in 2019 and Canada in 2020. Today's approval marks the third FDA approval received to date for fibryga. In 2017, the FDA granted an approval for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. A second was received in 2020 for pediatric patients under 12 years for treatment of acute bleeding episodes in congenital fibrinogen deficiency. "The recent FDA approval is the result of years of dedicated research and development in fibrinogen replacement," commented Huub Kreuwel, Ph.D., VP of Medical Affairs at Octapharma USA, Inc. "Fibryga's expanded indication will allow practitioners and health systems to support a broader range of patients with serious bleeding complications who require fibrinogen replacement therapy." The medical community has welcomed this approval as a significant advancement in patient care for those with AFD. "This first-in-class FDA approval for fibryga, a fibrinogen concentrate with an expanded indication to treat bleeding patients urgently in need of fibrinogen replacement, is an important step toward improving patient safety and outcomes. Compared to cryoprecipitate, fibrinogen concentrate allows for targeted dosing and faster treatment of low fibrinogen in maternal hemorrhage," states John Kowalczyk, MD, and Michaela Farber, MD, MS, Division of Obstetric Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Octapharma is committed to working closely with healthcare providers and patient organizations to ensure broad access to fibryga for those who can benefit from it. For more information about the FIBRES study, please review our journal publication: Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery The FIBRES Randomized Clinical Trial Indications and Important Safety Information for fibryga Indications and Usage Fibryga is a human fibrinogen concentrate indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency and in treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Fibryga is not indicated for dysfibrinogenemia. Contraindications Fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride). Warnings and Precautions Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving fibryga. Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis. Fibryga is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Reactions The most serious adverse reactions observed with fibryga are thromboembolic episodes and anaphylactic-type reactions. The most common adverse reactions observed in clinical studies with fibryga in acquired fibrinogen deficiency (>5% of patients) were abnormal hepatic function, acute kidney injury, anemia, atrial fibrillation, delirium and renal failure. The most common adverse reactions observed in clinical studies with fibryga in congenital fibrinogen deficiency (>5% of patients) were nausea, vomiting, pyrexia (fever) and thrombocytosis. Please see fibryga full Prescribing Information. For more information about fibryga, please visit fibrygausa.com. About Octapharma and Octapharma USA Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs nearly 12,000 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology, and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. Octapharma has 40 years of experience in patient care. The company's American subsidiary, Octapharma USA, Inc., is located in Paramus, N.J. For more information, please visit octapharmausa.com. SOURCE Octapharma