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Grifols completes sale of a 20% equity stake in SRAAS and forges strategic alliance with Haier Group
Newsfilter· 2024-06-18 11:30
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, ...
Grifols' Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies
Newsfilter· 2024-06-17 08:20
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 ...
Grifols' Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies
GlobeNewswire News Room· 2024-06-17 08:20
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 ...
GigaGen Doses First Patient in Phase 1 Trial of Anti-CTLA-4 Oncology Drug Candidate GIGA-564 in Advanced Solid Tumors
Newsfilter· 2024-05-20 12:00
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 ...
Grifols 2023 Annual Report on Form 20-F filed with the SEC
Prnewswire· 2024-04-19 20:42
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 ...
Grifols(GRFS) - 2023 Q4 - Annual Report
2024-04-19 20:30
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].
Grifols Celebrates 50 Years of Manufacturing Life-Changing Plasma-Derived Medicines for Patients at Flagship Site in Clayton, N.C.
Newsfilter· 2024-04-18 13:30
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 Procleix ArboPlex Assay® Receives CE Mark, the First and Only 4-in-1 NAT for Arbovirus Screening
Newsfilter· 2024-04-04 08:00
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 ...
Grifols(GRFS) - 2023 Q3 - Earnings Call Transcript
2023-11-03 02:33
Grifols, S.A. (NASDAQ:GRFS) Q3 2023 Earnings Conference Call November 2, 2023 8:30 AM ET Nuria Pascual Thomas Glanzmann Let me now walk you through how we are meeting our other commitments. Q3 was another quarter of strong revenue growth, where we also delivered a 25.1% adjusted EBITDA margin, which is a significant improvement of 480 basis points compared to Q4 '22 margin. The revenue growth was primarily driven by biopharma and our flagship franchises, immunoglobulin and albumin, and we expect that moment ...
Grifols(GRFS) - 2023 Q2 - Earnings Call Transcript
2023-07-27 19:45
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 ...