Through a share purchase agreement Grifols has sold a 20% equity stake in SRAAS to Haier Group for RMB 12.5 billion (approximately EUR 1.6 billion) cash consideration. Grifols retains a significant 6.58% economic stake in SRAAS as well as a seat on its Board of Directors. Grifols Press Office media@grifols.com Tel.: +34 93 571 00 02 BARCELONA, Spain, June 18, 2024 (GLOBE NEWSWIRE) -- Grifols ((MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, ...

Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest's portfolio and is manufactured with an innovative process at Biotest's new FDA-certified 'Next Level' facility BARCELONA, Spain, June 17, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world's leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administrati ...

U.S. approval of Yimmugo paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin 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. Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest's portfo ...

Researchers from the National Cancer Institute will conduct the Phase 1 trial, as established in a recently signed Cooperative Research and Development Agreement (CRADA) SAN CARLOS, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the first patient has been dosed in a Phase 1 clinical trial evaluating the safety ...

BARCELONA, Spain, April 19, 2024 /PRNewswire/ -- Grifols, S.A. ("Grifols") (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announces the filing of its Annual Report on Form 20-F for the fiscal year ended December 31, 2023, with the United States Securities and Exchange Commission ("SEC"). Grifols' annual report on Form 20-F provides investors with an overview of the company's governance practices, including information about the B ...

Debt and Financial Exposure - As of December 31, 2023, the company had $2.3 billion and €2.0 billion of senior interest-bearing debt, with 39.0% of this debt bearing interest at variable rates [124]. - The company had approximately $2.8 billion of U.S. dollar-denominated senior debt as of December 31, 2023, increasing its exposure to currency fluctuations [126]. - In 2023, €5.3 billion, or 80.3%, of the company's net revenue of €6.6 billion was denominated in U.S. dollars, exposing it to foreign currency exchange rate risks [125]. Revenue and Operational Risks - A significant portion of the company's revenue is derived from plasma fractionation, and any disruption at its main facilities could materially affect revenue [126]. - The company relies on third parties for the sale, distribution, and delivery of its products, making it vulnerable to breaches or failures in these contracts [133]. - The company may face significant delays in obtaining regulatory approvals for its product candidates, impacting commercialization timelines [140]. - The company’s product development costs may increase due to delays in testing or approvals, affecting its ability to bring products to market [139]. Regulatory and Compliance Challenges - The company is subject to complex and evolving data privacy regulations, which could increase operational costs and require changes to business practices [146]. - The California Privacy Rights Act (CPRA) was enacted in November 2020, effective January 1, 2023, expanding consumer control over personal information and increasing compliance obligations for businesses [148]. - Noncompliance with GDPR can result in penalties of up to €20 million or 4% of global company revenues [149]. - The implementation of GDPR, CCPA, and other data protection requirements is expected to impose additional costs on the company, with potential material adverse effects on business operations [150]. - The company is required to disclose payments to healthcare providers under the Physician Payment Sunshine Act, which imposes additional compliance costs [202]. Cybersecurity and Data Privacy Risks - The company is exposed to risks from cybersecurity incidents that could disrupt operations and lead to data breaches [142]. - Cyber-attacks pose significant risks, including potential loss of sensitive personal information and operational disruptions, which could materially impact the company's financial condition [153]. - The company faces increased exposure to privacy and data breaches as it stores more sensitive personal information, particularly medical records, which are high-value targets for cyber-attacks [154]. Intellectual Property and Patent Risks - The company relies on patents for its technology, but the patent landscape is uncertain, and there is a risk that patents may be challenged or invalidated, limiting competitive advantages [157]. - The company may face substantial costs and management distractions from patent litigation and other intellectual property proceedings, which could adversely affect its market competitiveness [168]. - Employees previously from competitors may inadvertently use proprietary information, leading to potential litigation and associated costs [170]. - The company has in-licensed certain patent rights, and any failure of licensors to enforce their rights could impact the company's competitive position [171]. - Breaching obligations under in-license agreements could lead to termination of licenses, adversely affecting product development and commercialization [172]. Market and Competitive Environment - The company anticipates ongoing pricing and cost containment pressures in 2024 and beyond, which may affect reimbursement rates for products [186]. - The company expects greater competition from biosimilars, which could lead to increased patent challenges and negatively impact financial performance [192]. - The company faces pressures from U.S. healthcare reforms, including the ACA, which could significantly impact operations and financial performance [181]. - Trends in the healthcare industry, such as managed care and cost containment, may adversely affect reimbursement rates and overall financial performance [184]. - The 340B Program requires discounts for eligible entities, and changes to this program could negatively impact financial performance [185]. Legal and Financial Liabilities - The company’s insurance may be insufficient to cover losses from accidents or force majeure events, potentially impacting financial stability [129]. - The 340B Program under the Public Health Service Act imposes penalties of up to $5,000 for each instance of overcharging covered entities, which could adversely affect revenues [197]. - The company must report detailed pricing information to CMS, and inaccuracies could lead to fines and sanctions [200]. - The company may incur significant expenses defending against lawsuits resulting from negative publicity, which could materially affect financial condition and results of operations [229]. Shareholder and Market Dynamics - The Grifols Family and Scranton Enterprises B.V. own approximately 36% of Class A shares, exercising 100% voting control, which may lead to conflicts of interest with other shareholders [221]. - The market price of Class B ADSs has fluctuated between a high of $13.28 on May 24, 2022, and a low of $5.95 on September 29, 2022, closing at $6.78 on April 16, 2024 [224]. - Negative publicity from short sellers has previously impacted the company's market price and may lead to increased scrutiny from regulators [226]. - Ineffective internal controls could result in material weaknesses affecting the reliability of financial reporting, potentially harming the company's reputation and market price [218]. - The market price of shares may be volatile due to various factors, including market expectations and actual fluctuations in financial performance [222]. Environmental and Operational Risks - Climate change poses risks such as extreme weather events and water scarcity, which could disrupt operations and increase costs [176]. - Regulatory changes related to biometric information privacy may require significant resources for compliance, potentially leading to increased costs and legal liabilities [178]. - The company faces risks from changing regulatory requirements that could necessitate operational adjustments and incur unforeseen costs [213]. Future Considerations - The company has acquired plasma collection centers from Canadian Plasma Resources Corporation in 2023, Biotest AG in 2022, and BPL Plasma Inc. in 2021, among others, but there is no assurance of success from this plasma acquisition strategy [173]. - A cost savings plan has been implemented to reduce headcount and improve efficiency in plasma procurement, but unexpected charges and expenses may negatively impact financial results [173]. - The company intends to evaluate costs and liabilities associated with registration requirements for any future rights offerings [235]. - Subscription rights may be unavailable to U.S. holders of shares or ADSs, potentially leading to dilution of their holdings [233]. - ADS holders may face limitations on the transfer of their ADSs due to legal or regulatory requirements [238].

The addition of the Clayton site in 2011 marked a new milestone for Grifols, turning the company into a top-three plasma industry leader and setting the stage for sustained business growth The flagship Grifols campus is a touchstone of Grifols' leadership in plasma therapeutics, producing about 40% of the company's total medicinal output globally and helping enhance the quality of life of patients all over the worldAn engineering masterwork, the Clayton site is a model for new Grifols plants while its envir ...

Grifols' in vitro nucleic acid test detects four types of arboviruses, helping mitigate the risk of transfusion-transmitted infections Arboviruses are a growing emerging threat, with changes in climate and increasing global connectivity making the geographic spread more prevalent CE mark for Grifols' Procleix ArboPlex Assay reinforces the company's leadership in transfusion medicine and commitment to ensuring the safety of the world's blood supply BARCELONA, Spain, April 04, 2024 (GLOBE NEWSWIRE) -- Grifols ...

Financial Data and Key Metrics Changes - In Q3 2023, the company achieved a revenue growth of 11.7% at constant currency, totaling over €4.8 billion for the first nine months of the year [6][34] - Adjusted EBITDA margin improved to 25.1%, a significant increase of 480 basis points compared to Q4 2022 [4][34] - Gross margin reached 41% in Q3, reflecting a 400 basis point improvement year-over-year, driven by Biopharma performance and a 22% decline in cost per liter [10][34] Business Line Data and Key Metrics Changes - The Biopharma segment saw a remarkable performance with immunoglobulin sales growing 17.4% in Q3 and nearly 15% year-to-date at constant currency [11][34] - Albumin revenue increased by close to 18% year-to-date, supported by higher demand in China and solid price increases in key markets [7][34] - Diagnostic revenues declined by 3.1% in Q3, attributed to pricing concessions and lower sales of GelCards in China, although strong instrument sales in Japan and Indonesia partially offset this decline [33][34] Market Data and Key Metrics Changes - Plasma supply growth remained solid at 10% year-to-date, positioning the company to meet growing demand for its products [12][34] - The company is focused on expanding its immunoglobulin franchise in the U.S. and selected countries, particularly in the immune deficiency market [31][34] Company Strategy and Development Direction - The company aims to strengthen its core strengths and competitive advantages while accelerating innovation in select therapeutic areas [12][34] - A collaboration agreement was signed with the National Cancer Institute for the GIGA564 project, marking a strategic move into oncology [8][34] - The company is committed to achieving a leverage ratio of 4x by 2024, with a focus on organic deleveraging and a planned transaction to generate at least €1.5 billion in cash [28][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, particularly regarding the Fibrinogen and Trimodulin products, which are expected to drive growth [5][34] - The company is confident in achieving the high end of its adjusted EBITDA guidance for 2023, with total revenue growth expected to be between 10% to 12% at constant currency [35][34] - Management acknowledged the challenges in the operating environment but emphasized the strong fundamentals and progress made in the first nine months of the year [36][34] Other Important Information - The company has completed nine out of twelve innovation milestones set for 2023, indicating strong progress in its R&D efforts [137] - The operational improvement plan is expected to yield €450 million in savings, contributing to margin expansion and improved profitability [10][34] Q&A Session Summary Question: Can you provide details on the evolution of alpha-1 sales? - Management noted that alpha-1 sales have been relatively flat due to lower demand for plasma-derived factor VIII, but improvements are expected as the commercial model stabilizes [22][34] Question: What is the guidance on cash flow and working capital investments? - Management indicated that high working capital investments are necessary due to increased sales activity, but positive cash flow is anticipated by year-end [23][34] Question: What is the strategy for the new IVIg product Yimmugo? - The company plans to position Yimmugo against existing brands like Gamunex and Xembify, aiming to switch from Flebogamma to Yimmugo as it gains approval in various countries [38][34] Question: Can you confirm the timeline for the Shanghai RAAS transaction? - Management expressed confidence in signing the transaction by year-end 2023, with regulatory approvals expected in the first half of 2024 [133][34] Question: What are the expectations for the Alzheimer's vaccine development? - The company is open to out-licensing the Alzheimer's vaccine for Phase III trials, indicating a strategic approach to funding and development [100][34]

Victor Grifols Deu Okay. Thank you. We have now on the line Tom Jones from Berenberg. Hi, Tom. Alfredo Arroyo Nuria Pascual Nuria Pascual Victor Grifols Deu Thank you. And next question coming from Alvaro Lenze from Alantra Equities. Alvaro? Victor Grifols Deu Okay. We have a question from - coming from JoaquÃn GarcÃa-Quirós from JB Capital. Hi, JoaquÃn. Victor Grifols Deu Great. We have a couple of follow-up questions. First from - he was the first to be again nonetheless Tom, I think you have something el ...