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Financial Exposure and Risks - As of December 31, 2024, the company had $3.2 billion and €6.0 billion of senior interest-bearing debt, with 29.0% of this debt bearing interest at variable rates[130] - In 2024, €4.8 billion, or 66.6%, of the company's net revenue of €7.2 billion was denominated in U.S. dollars, exposing it to foreign currency exchange rate fluctuations[131] - The company has approximately $3.2 billion of U.S. dollar denominated senior debt, increasing its exposure to currency risk[132] - Fluctuations in the exchange rate between the U.S. dollar and the euro may increase volatility and affect the value of ADSs and shares[234] Operational Risks - The company relies on third parties for the sale, distribution, and delivery of its products, which could materially affect its business if these parties fail to perform[140] - The company’s manufacturing capacity could be significantly impacted by accidents or force majeure events affecting its main facilities, which could lead to substantial revenue loss[133] - The company’s reliance on a limited number of suppliers for key components may impair its manufacturing ability if these suppliers fail to deliver on time[136] - The company may face delays in product commercialization due to the need for extensive preclinical tests and clinical trials, which are costly and time-consuming[142] - The company’s product development costs may increase significantly if it experiences delays in testing or approvals, impacting its ability to commercialize products[145] - The company’s insurance may be insufficient to cover losses from accidents or force majeure events, potentially leading to unrecoverable inventory value[135] Regulatory and Compliance Risks - The company is subject to evolving data privacy regulations, such as GDPR and CCPA, which could increase operational costs and require changes to business practices[152] - The California Privacy Rights Act (CPRA) was enacted in November 2020 and became effective on January 1, 2023, expanding consumer control over personal information and increasing compliance obligations for businesses[154] - Noncompliance with the GDPR can result in penalties of up to €20 million or 4% of global company revenues, highlighting the financial risks associated with data protection regulations[156] - The implementation of GDPR, CCPA, and other data protection requirements is expected to impose additional costs on the company, potentially affecting its business operations[157] - The company is subject to extensive government regulation and oversight, which includes compliance with the Federal Food, Drug and Cosmetic Act and the Federal False Claims Act, potentially leading to criminal and civil penalties[200] - Non-compliance with the 340B Program can result in civil monetary penalties of up to $5,000 for each instance of overcharging covered entities, adversely affecting revenues and profitability[202] - The company must report detailed pricing information to CMS, and inaccuracies could lead to fines and sanctions, impacting business operations[205] - Regulatory approvals are required for marketing products outside the U.S., and delays in obtaining these approvals could hinder commercialization efforts[206] - The company is required to report payments to healthcare providers under the Physician Payment Sunshine Act, which imposes additional compliance costs[207] - Heightened scrutiny and government efforts to increase transparency around pharmaceutical pricing could impact the company's ability to negotiate sales contracts[212] - Proposed state legislation regulating drug pricing may impose additional pricing pressures on the company's products[213] Intellectual Property Risks - The company relies on a combination of patents and trade secrets to protect its intellectual property, but there is a risk that these protections may not be sufficient against competitors[163] - Patent litigation and other intellectual property proceedings can incur substantial costs, potentially affecting the company's ability to compete effectively in the marketplace[175] - The company may face claims related to the inadvertent use of proprietary information from former employers of its employees, which could lead to costly litigation[176] - The company has in-licensed certain patent rights, and its ability to compete may depend on the performance of third-party licensors under these agreements[177] - Breaching obligations under in-license agreements could result in termination of licenses, adversely affecting the company's ability to develop and commercialize products[178] Strategic Developments - The company has acquired multiple plasma collection centers, including Canadian Plasma Resources Corporation in 2023 and Haema Plasma Kft. in 2024, as part of its plasma acquisition strategy[179] - A cost savings plan has been implemented to reduce headcount and improve efficiency in plasma procurement, which may lead to unexpected charges and expenses[179] Environmental and Health Risks - Climate change poses risks to the company's operations, including physical risks like water scarcity and flooding, which could increase costs and disrupt the supply chain[182] - New regulatory requirements related to climate change may increase operating costs and necessitate additional investments in technology[183] - The company faces risks associated with environmental, health, and safety regulations, which could lead to substantial liabilities and compliance costs[219] Market and Shareholder Risks - 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[226] - Class B ADSs traded as high as $11.56 on October 1, 2024, and as low as $5.47 on March 13, 2024, closing at $6.52 on April 10, 2025[227] - Negative publicity from short sellers has previously created downward pressure on the market price of shares, potentially impacting revenues and customer confidence[230] - The company may face significant expenses defending against lawsuits resulting from negative publicity, which could adversely affect financial condition and results of operations[232] - Ineffective internal controls could harm the company's ability to provide reliable financial reports, affecting market confidence and trading prices[224] - The company has been subject to scrutiny and investigations by the SEC or CNMV due to negative publicity, which could divert management's attention from operations[230] - Subscription rights may be unavailable to U.S. holders of shares or ADSs, potentially leading to substantial dilution[236] - The market price of shares may be influenced by various factors, including market expectations, actual fluctuations in results, and short selling techniques[229] - The company intends to evaluate costs and potential liabilities associated with registration requirements for any future rights offerings[239] Healthcare Industry Risks - The ongoing changes and uncertainties surrounding the Affordable Care Act (ACA) could materially affect the company's operations in the United States[188] - Government pressures on pricing and reimbursement in the healthcare industry may adversely impact the company's financial performance[190] - The 340B Program requires the company to extend discounts, and changes to this program could negatively affect financial results[191] - The company anticipates increasing pricing and cost containment pressures in the healthcare industry through 2025 and beyond, which may impact reimbursement rates[192] - Off-label uses of drug products may be reimbursed by Medicare, but reductions in reimbursement could adversely affect the company's financial performance[214]

Financial Exposure and Debt - 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]. - 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]. - 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]. - Fluctuations in the exchange rate between the U.S. dollar and the euro may increase the risk of holding ADSs or shares, affecting their market price [231]. 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 approval for product candidates, impacting commercialization timelines [138]. - The company’s product development costs may increase due to delays in testing or approvals, affecting profitability [139]. - The company’s ability to commercialize products may be hindered by difficulties in obtaining regulatory approval or achieving market acceptance [140]. Data Privacy and Cybersecurity - 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]. - Cyber-attacks pose significant risks, potentially leading to the misappropriation of sensitive personal information and operational disruptions, which could materially impact financial condition and results [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]. - Failure to secure information technology systems could lead to reputational damage, litigation, and significant financial penalties, adversely affecting business operations [155]. Intellectual Property and Regulatory Compliance - The company relies on a combination of patents and trade secrets to protect its intellectual property, but faces risks related to the effectiveness of these protections and potential infringement claims [157][166]. - Patent litigation and other intellectual property proceedings could incur substantial costs and distract management, impacting competitive positioning in the marketplace [168]. - The company may need to obtain additional licenses or renew existing agreements, with uncertainty regarding the terms and availability of such licenses [172]. - The company is subject to extensive government regulations, including the Federal Food, Drug and Cosmetic Act, which can result in significant penalties for non-compliance [195]. - The company previously operated under a consent decree due to FDCA violations, which was vacated in March 2012 [196]. Market and Pricing Pressures - Government pressures on pricing and reimbursement in the healthcare sector may adversely affect the company's financial performance, particularly in the U.S. market [184]. - The 340B Program requires the company to extend discounts to eligible entities, and changes to this program could negatively impact financial performance [185]. - The company anticipates increasing pricing and cost containment pressures in 2024 and beyond, which may affect reimbursement rates for its products [186]. - Proposed state legislation may impose additional pricing pressures on pharmaceutical products, adversely affecting the company's business [208]. - Off-label drug use may be reimbursed by Medicare, but changes in reimbursement policies could negatively impact the company's revenue [209]. Environmental and Operational Risks - Climate change poses risks such as increased water scarcity and severe weather events, which could disrupt operations and supply chains, potentially leading to increased costs and business interruptions [176]. - The company faces risks from environmental, health, and safety regulations, which could lead to substantial liabilities in case of accidents [214]. 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 created downward pressure on the price of the company's securities, potentially impacting business operations [226]. - The company may incur significant expenses defending against lawsuits resulting from negative publicity, which could adversely affect financial condition and results of operations [229]. - The company’s Class A and Class B shares are traded on Spanish Stock Exchanges and NASDAQ, with potential volatility due to exchange rate fluctuations [231]. - Subscription rights may be unavailable to U.S. holders of shares or ADSs during future capital increases, potentially leading to dilution [233]. - The depositary may refuse to deliver or register transfers of ADSs under certain conditions, impacting liquidity for ADS holders [238].

Financial Position and Revenue - As of December 31, 2022, the company had $2.3 billion and €1.3 billion of senior interest-bearing debt, with 37% of this debt bearing interest at variable rates [118]. - In 2022, €4,416.9 million, or 73%, of the company's net revenue of €6,064.0 million was denominated in U.S. dollars, exposing it to foreign currency exchange rate fluctuations [119]. - The company had approximately $2,313.9 million of U.S. dollar-denominated senior debt as of December 31, 2022 [120]. Operational Risks - A significant portion of the company's revenue is derived from plasma fractionation, and any disruption to its main facilities could materially affect revenue [121]. - 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 [128]. - The company may face significant delays in obtaining regulatory approval for its product candidates, which could increase product development costs [133]. - The company’s operations are highly dependent on information technology systems, which are vulnerable to cybersecurity incidents that could disrupt business [139]. - The company’s clinical trials may be delayed due to unforeseen events, impacting the ability to obtain marketing approval for product candidates [137]. - The company’s product development costs may increase if there are delays in testing or approvals, potentially shortening the patent protection period [134]. Strategic Developments - The company acquired plasma collection centers from GC Pharma, BPL, and Kedrion, and entered into a plasma supply agreement with Haema AG in Hungary, as well as acquiring Biotest AG in 2022 [164]. - The company has implemented a cost savings plan for 2023 aimed at reducing headcount and improving efficiency in plasma procurement [164]. Regulatory and Compliance Challenges - The company faces potential penalties of up to €20 million or 4% of global revenues for noncompliance with GDPR regulations [145]. - The company is subject to evolving data privacy and security regulations, which could impose increased operational costs and require changes to business practices [141]. - The implementation of the Affordable Care Act (ACA) has led to significant changes in the U.S. healthcare industry, including a shift towards managed or value-based care, which could adversely impact financial performance [172]. - The 340B Program, which extends discounts to eligible entities, has been expanded under the ACA, increasing the number of qualified entities and potentially affecting financial performance due to pricing pressures [173]. - Regulatory pressures and government constraints on pricing and reimbursement are expected to continue, potentially leading to negative impacts on business operations [175]. - Non-compliance with laws governing sales and marketing could result in significant penalties, including fines and exclusion from federal programs, adversely affecting business operations [183]. - The company faces challenges in obtaining timely regulatory approvals for product commercialization outside the United States, which may hinder market expansion [189]. - The company is subject to various cost-containment measures that could adversely affect pricing and reimbursement for its products, impacting financial results [193]. Intellectual Property and Litigation Risks - The company’s success is heavily reliant on obtaining and maintaining intellectual property protection, particularly for its purification processes [147]. - The company may face substantial costs and operational disruptions due to potential patent litigation and other intellectual property disputes [159]. - The company’s patents may not provide sufficient protection against competitors, as many patents relate to processes rather than products [148]. - The company may need to seek licenses from third parties to avoid patent infringement claims, which could impose additional costs [158]. - The company has taken steps to protect proprietary information through confidentiality agreements, but risks of unauthorized use remain [154]. Market and Shareholder Considerations - The Grifols Family and Scranton Enterprises B.V. control approximately 36% of Class A shares, allowing them significant influence over corporate decisions [209]. - The market price of Class B ADSs has experienced volatility, trading between $5.95 and $19.78 since December 31, 2020, influenced by various market factors [212]. - Fluctuations in the exchange rate between the U.S. dollar and the euro may increase the risk and volatility of the company's ADSs and shares [215]. - Existing shareholders generally entitled to subscription rights under Spanish law for future capital increases, unless waived [216]. - Holders of Class B shares typically do not have voting rights on capital increase resolutions [216]. - U.S. holders of ADSs may face dilution if preemptive rights are not exercised due to registration issues [217]. - The company will evaluate costs and liabilities associated with registration requirements during any rights offering [218]. - No assurance that the company will comply with registration requirements for subscription rights [219]. - If rights are not exercised or sold, they may lapse without value for ADS holders [219]. - ADS holders may face limitations on the transfer of their ADSs due to depositary policies [221].

Plasma Collection and Expansion - Grifols expanded its global plasma collection network to 312 centers, an increase of 18% from 264 centers in 2020[19]. - By the end of 2022, the company expects to have over 400 plasma centers, including 31 in Germany, 57 in North America, and additional centers in Canada and Egypt[42]. - Plasma collections increased by 24% in weeks 21-24 of 2022 compared to the same weeks in 2021, indicating a strong recovery from COVID-19 impacts[44]. - The company reported a 20% year-to-date increase in plasma collections compared to the previous year, driven by new donor compensation schemes and enhanced digital marketing efforts[45]. - Average liters of plasma collected per center increased by 26% in Q2 2022 compared to Q2 2021, reflecting improved donor experience and marketing campaigns[62]. - The integration of new plasma centers has led to greater efficiency gains, with 35 integrations completed since 2018[50]. - Grifols aims to establish sustainable plasma-collection models and donor-center networks internationally, emphasizing the importance of self-sufficiency in plasma supply[86]. Operational Efficiency and Innovation - The company has implemented a new organizational model to enhance operational efficiency and reduce complexity[25]. - The digital transformation initiatives, including the migration to new BECS systems, are expected to streamline operations and improve efficiency by reducing manual verification steps[52]. - Grifols is focusing on innovation with 7 therapeutic areas to drive revenue growth and margin expansion[22]. - The company is focusing on expanding its digital presence and utilizing data-driven marketing to attract new donors and enhance engagement[71]. - The reorganization efforts are aimed at fully capturing the benefits of scale and integration to support sustainable growth in plasma donations[82]. Social Responsibility and Sustainability - Grifols aims to achieve 100% of its electricity consumption from renewable energies, up from 70%[31]. - The company has committed to donating 240 million international units of clotting factor medicines to support hemophilia patients in developing countries[27]. - Grifols created 141,500 jobs, with 60% stemming from plasma centers, contributing to an economic impact of €7,700 million[29]. - The company plans to increase the number of social outreach initiatives by 50%[27]. - Grifols has set a goal to achieve 50% of women in senior management positions by 2030[27]. - Grifols is recognized among the world's most sustainable companies, with its new office building awarded LEED Gold certification[34]. Market Growth and Product Development - The global plasma-derived proteins market is projected to grow at a CAGR of 7.2% from FY20 sales of EUR 25 billion, driven by high unmet medical needs[122]. - Bioscience revenues showed a positive trend in Q1'22, with core growth products achieving a CAGR of 8.1% compared to Q1'21[124]. - Grifols' immunology product, Gamunex®-C, is recognized as the 1 prescribed immunoglobulin for chronic inflammatory demyelinating polyneuropathy (CIDP)[131]. - The company is launching Xembify® in several European countries, capitalizing on the growing preference for subcutaneous immunoglobulin (SCIG) therapy[135]. - Grifols maintains a leading position in the Alpha-1 market, with Prolastin® showing steady growth and over 70% of Alpha-1 patients globally receiving this treatment[138]. - Prolastin® showed steady growth in 2021 and Q1 2022, with significant improvements in therapy compliance and health outcomes in the EU[140]. - HyperRAB® achieved record sales in 2021, treating over 1 million patients since its launch, with a market share exceeding 80%[144]. - Albutein FlexBag™ launched successfully, with high customer satisfaction reflected in revenues, and fast adoption in the U.S. market[146]. - Tavlesse® sales volume exceeded targets in Germany, Spain, and Italy, with plans for launches in 12 more countries by 2023[147]. - Vistaseal® experienced double-digit growth worldwide in FY21 compared to FY20, with ongoing globalization and scale-up efforts[150]. Diagnostic and Testing Innovations - Grifols aims to truncate the time to diagnosis for primary immunodeficiency (PI) patients, with 500,000 undiagnosed cases estimated globally[155]. - The diagnostic division reported solid growth in 2021, driven by COVID-19 innovations, with a CAGR of +2.8% from 2017 to 2021[178]. - Grifols is expanding its blood collection capabilities with a new red blood cell manufacturing facility in San Diego, contributing to a worldwide market CAGR of +8.5%[185]. - The company’s testing program for Alpha-1 continues to accelerate diagnostics globally, with over 950,000 tests performed since 2006[187]. - Grifols is actively partnering with insurers and patient groups to enhance the diagnosis rate for AAT deficiency, with a significant increase in testing efforts[162]. - Grifols has successfully launched the A1AT Genotyping Test with over 350 saliva samples collected and a genetic result report provided for 500 individuals, achieving a >90% understanding score[189]. - The company has submitted an Over The Counter 510(k) filing to the FDA for the AlphaID™ at Home program, which is ready to launch upon clearance, aimed at expanding the U.S. screening program[190]. - Grifols is on track with the initial IVDR certification timeline, having received its first certifications in December 2021, ensuring timely delivery for all relevant products[193]. - Grifols is enhancing its digital transformation with advanced software solutions, including a new customer portal and Bloodstream software for NAT testing laboratories, aimed at improving operational efficiency[196]. - The company is expanding its diagnostic capabilities to support biopharma growth and is embracing future initiatives, including Biotest projects[191]. - Grifols has successfully launched its A1AT Genotyping Test in Spain and Germany, receiving extremely positive feedback from users[188]. - The company is committed to a digital safety environment, providing up-to-date documentation and quick access to information across its laboratory network[197]. - Grifols is focused on evolving its business model to strengthen competitiveness and drive efficiencies across its broad portfolio of platforms[198]. - The company is actively working on innovative testing strategies for various patient groups, including Alpha-1 patients, to enhance its product offerings[192].

Financial Position and Debt - As of December 31, 2021, the company had $2.4 billion and €1.3 billion of senior interest-bearing debt, with 40% of this debt bearing interest at variable rates [120]. - The company had approximately $3 billion of U.S. dollar-denominated senior debt as of December 31, 2021 [122]. - The company’s financial performance may be adversely impacted by government pressures and constraints on reimbursement, particularly in the U.S. healthcare market [169]. Revenue and Currency Exposure - In 2021, €3.6 billion, or 73%, of the company's net revenue of €4.9 billion was denominated in U.S. dollars, exposing it to foreign currency exchange rate fluctuations [121]. Operational Risks - A significant portion of the company's revenue is derived from plasma fractionation at its facilities, and any major accidents or force majeure events could materially affect revenue [123]. - The company relies on third-party suppliers for key components and equipment, and any disruptions could impair manufacturing ability and product sales [125]. - The company is highly dependent on distribution agreements with third parties, and any breaches or failures could materially impact product distribution [129]. - The company faces risks related to cybersecurity incidents that could disrupt operations and lead to data breaches, impacting sensitive information [141]. Regulatory Compliance and Legal Risks - The company is subject to complex and evolving data privacy regulations, which could increase operational costs and require changes to business practices [143]. - The California Consumer Protection Act (CCPA) and the California Privacy Rights Act (CPRA) impose new compliance obligations that could affect the company's operations [144]. - The company faces potential penalties of up to €20 million or 4% of global revenues for noncompliance with GDPR and other data protection regulations [145]. - The company is subject to increasing pricing and cost containment pressures, which may adversely affect reimbursement rates for its products [170]. - The company is required to comply with the Physician Payment Sunshine Act, which mandates reporting of financial relationships with healthcare providers [187]. - The company is subject to heightened scrutiny regarding compliance with fraud and abuse laws, which could result in significant penalties and reputational harm [180]. - The company is subject to extensive government regulatory compliance, which may require updates to operations and incur unforeseen costs [198]. Intellectual Property and Patent Risks - The company’s success is heavily reliant on maintaining intellectual property protection, particularly for its purification processes, which are subject to complex legal challenges [148]. - The company may incur substantial costs from patent litigation and other proceedings, which could adversely affect its competitive position in the marketplace [159]. - The company’s ability to commercialize products may be hindered if it is found to infringe on third-party patent rights, potentially leading to significant licensing fees or operational restrictions [158]. - The company’s patent applications may not be published for 18 months, creating uncertainty regarding the protection of its intellectual property [149]. - The company’s reliance on trade secrets and nondisclosure agreements poses risks of unauthorized use of proprietary information, which could disadvantage its competitive position [156]. - The company may face challenges in enforcing its intellectual property rights in jurisdictions with weak legal protections, potentially limiting its ability to exclude competitors [151]. Pricing and Market Pressures - The 340B Program requires the company to extend discounts to eligible entities, potentially impacting financial performance due to evolving regulatory requirements [170]. - The company has entered into a pharmaceutical pricing agreement with the government to comply with the 340B Program, limiting drug prices to the ceiling price [170]. - The ACA introduced a new abbreviated regulatory approval pathway for biosimilars, which may lead to increased competition and patent challenges for the company [176]. - The company faces potential penalties under the 340B Program for overcharging covered entities, with fines up to $5,000 for each instance [182]. - Regulatory approval processes for products are lengthy and costly, with no assurance of obtaining approvals in various jurisdictions [174]. - The company may be adversely affected by government or private payors limiting reimbursement amounts or eligibility for its products [190]. - The company faces pricing pressures due to government regulations and price controls in key markets, which may adversely affect gross margins [191]. - In the U.S., proposed legislation aims to increase transparency around pharmaceutical pricing, potentially impacting the company's ability to negotiate sales contracts [192]. - Several U.S. states have enacted or proposed laws regulating drug pricing, which could lead to additional pricing pressures on the company's products [193]. - Proposed federal and state legislation may lead to direct negotiations with manufacturers over drug pricing, posing risks to the company's pricing strategies [195]. Corporate Governance and Shareholder Influence - The Grifols Family and Scranton Enterprises B.V. own approximately 36% of Class A shares, exerting significant influence over corporate decisions [206]. - The market price of Class B ADSs has shown volatility, trading between $10.21 and $19.78 since December 31, 2020 [208]. - Fluctuations in the exchange rate between the U.S. dollar and the euro may affect the value of the company's shares and ADSs [210]. - ADS holders may face limitations on the transfer of their ADSs due to regulatory requirements or company directives [217].

Investment - GIC, the sovereign wealth fund of Singapore, will invest approximately US$1 billion in Grifols' wholly-owned US subsidiary Biomat USA, Inc. in exchange for a minority stake[7] - Proceeds from GIC's investment will be used to repay debt[9] Operations - Biomat operates 296 plasma collection centers across the United States, maintaining control over day-to-day management by Grifols[8]

Financial Risks - As of December 31, 2020, the company had $2.5 billion and €1.3 billion of senior interest-bearing debt, with 53.9% of this debt bearing interest at variable rates [110]. - In 2020, €4.1 billion, or 76%, of the company's net revenue of €5.3 billion was denominated in U.S. dollars, exposing the company to foreign currency exchange rate fluctuations [111]. - The company has approximately $2.5 billion of U.S. dollar denominated senior debt as of December 31, 2020 [112]. - The market price of Class B ADSs may be volatile due to various factors, including market expectations and actual or anticipated fluctuations in financial performance [191][197]. - Fluctuations in the exchange rate between the U.S. dollar and the euro may impact the value of ADSs and shares, increasing volatility [192][194]. Regulatory and Compliance Challenges - The company is subject to complex and evolving data privacy regulations, which could impose increased operational costs and require changes to business practices [131]. - Noncompliance with data privacy laws such as GDPR could result in penalties of up to €20 million or 4% of global revenues [133]. - The company may experience significant delays in obtaining regulatory approvals for its product candidates, impacting its ability to commercialize products [123]. - The company is subject to government regulations that mandate pricing controls and reimbursement pressures, which could negatively impact financial performance [154]. - The implementation of the ACA has led to significant changes in the healthcare industry, including a shift towards managed care, which may adversely affect the company’s operations [155]. - The company must comply with the 340B Program, which requires extending discounts and could impact reimbursement rates for its products [156]. - The regulatory approval process for biosimilars in the U.S. remains lengthy and costly, with a new abbreviated pathway introduced under the ACA to expedite approvals [161]. - The FDA mandates that no biosimilar application can be accepted for review until four years after the reference product's first licensing, and approval cannot be effective until 12 years post-licensing [162]. - The ACA's Patient-Centered Outcomes Research Institute could influence reimbursement levels for therapies deemed less cost-effective, potentially impacting financial results [163]. - Companies face significant penalties for non-compliance with the 340B Program, with fines up to $5,000 for each instance of overcharging covered entities [168]. - The ACA's Physician Payment Sunshine Act requires detailed reporting of financial relationships with healthcare providers, imposing additional compliance costs [173]. - The company has implemented extensive compliance programs to adhere to healthcare laws, but there is no guarantee against investigations or penalties by regulatory agencies [180]. Operational Risks - A significant portion of the company's revenue is derived from plasma fractionation or products manufactured at key facilities, which could be adversely affected by accidents or force majeure events [113]. - The company relies on third parties for the sale, distribution, and delivery of its products, which could impair its business if these parties fail to perform [118]. - The company may face significant delays and increased costs in product development due to the need for extensive preclinical tests and clinical trials [121]. - The company is highly dependent on third-party suppliers for key components and materials, which could disrupt production if these suppliers fail to deliver [115]. - The company may incur substantial costs from patent litigation or proceedings, which could adversely affect its competitive position in the marketplace [147]. - The company is exposed to risks from potential conflicts of interest between principal shareholders and other shareholders [189]. - The company maintains workers' compensation insurance, but it may not provide adequate coverage against potential liabilities from hazardous materials [184]. - Future changes in federal, state, local, or foreign laws may require operational updates and incur unforeseen costs [185]. - The company may face additional costs and liabilities due to changing regulatory requirements, which could materially affect operations [181]. Intellectual Property Risks - The company relies heavily on intellectual property protection for its technology and products, particularly in purification processes, which may be challenged or invalidated, impacting competitive advantage [135]. - The company’s patents may not provide sufficient protection against competitors, and the uncertainty in biotechnology patenting could limit its ability to enforce rights [137]. Governance and Control Risks - The Grifols Family and Scranton Enterprises B.V. own approximately 36% of Class A shares, which exercise 100% voting control, potentially influencing corporate decisions [189]. - There is a risk of material weaknesses in internal control over financial reporting, which could adversely affect the reliability of financial information and market confidence [186][188]. - The company may not comply with registration requirements for subscription rights, potentially leading to dilution for ADS holders [196][199].

Financial Performance - In 2019, €3.9 billion, or 76%, of the company's net revenue of €5.1 billion was denominated in U.S. dollars, exposing the company to foreign currency exchange rate fluctuations [133]. - Total net revenue for the year ended December 31, 2019, was €5.1 billion, an increase from €4.5 billion in 2018 [231]. - The United States and Canada accounted for 66.5% of total net revenue in 2019, while Europe accounted for 16.8% [227]. - The Bioscience division accounted for €4.0 billion, or 78.3%, of the total net revenue in 2019 [221]. - The Diagnostic division generated €733.6 million, or 14.4%, of total net revenue in 2019 [222]. - The Hospital division contributed €134.4 million, or 2.6%, of total net revenue in 2019 [223]. - The Bio Supplies division reported €266.5 million, or 5.2%, of total net revenue in 2019 [224]. Debt and Financial Risks - As of December 31, 2019, the company had $2.50 billion and €1.36 billion of senior interest-bearing debt, with 55.2% of this debt bearing interest at variable rates [132]. - The company has approximately $2.5 billion of U.S. dollar-denominated senior debt, exposing it to currency risk [135]. - The company may face increased operational costs and disruptions due to evolving data privacy regulations, including GDPR and CCPA, which could impose penalties of up to €20 million or 4% of global revenues for noncompliance [151]. - The company is subject to significant pressures on pricing and reimbursement rates due to the implementation of the Healthcare Reform Law, which could adversely affect financial performance [171]. - The company faces potential penalties under the 340B/PHS program for overcharging covered entities, with civil monetary penalties up to $5,000 for each instance [180]. Operational Risks - The company relies on a limited number of suppliers for key equipment and disposable goods, which could impair manufacturing ability if there are delivery failures [137]. - A significant portion of the company's revenue is derived from plasma fractionation at specific facilities, and any force majeure events could materially affect revenue [135]. - The company is highly dependent on third parties for the sale and distribution of its products, and any breach of contracts by these parties could adversely affect business [139]. - The company faces risks related to cybersecurity incidents that could disrupt operations and lead to data breaches, impacting sensitive information [148]. - The company must conduct extensive preclinical and clinical trials for product candidates, which are costly and time-consuming, with uncertain outcomes [142]. Regulatory Compliance - The company is subject to extensive government regulatory compliance and ethics oversight, including anti-corruption and healthcare compliance policies [193]. - The company must comply with various laws and regulations governing sales and marketing, with violations potentially leading to severe penalties [177]. - The company must report detailed pricing information to CMS, and inaccuracies could lead to fines and sanctions [182]. - The company has established systems for collecting and reporting pricing data accurately to avoid FCA liability [182]. - The company is required to comply with various environmental, health, and safety laws, which may incur substantial costs for compliance and potential liabilities [194]. Market Position and Competition - The company ranks among the top three largest producers of plasma derivatives globally [200]. - The company anticipates facing increased competition from biosimilars, which could impact its market position and financial results [175]. - The outcomes of Comparative Effectiveness Research could influence reimbursement levels for the company's products, potentially affecting financial results [176]. - Grifols has a 67% global market share for A1PI as of December 2019, with Prolastin/Prolastin-C being the leading product in North America and Europe [267]. - HyperRAB holds an estimated 90% market share of anti-rabies immunoglobulins in the U.S. as of December 2019 [265]. Research and Development - Research and development spending increased from €240.6 million in 2018 to €276.0 million in 2019, reflecting a growth of 14.7% [322]. - The Bioscience division has a total of 84 research and development projects as of December 31, 2019, up from 77 in 2018 [325]. - The company has 1,029 scientists and support staff dedicated to research and development as of December 31, 2019 [322]. - The number of clinical development phase projects in the Bioscience division decreased from 28 in 2018 to 21 in 2019 [325]. - The AMBAR study showed a 61% reduction in disease progression for Alzheimer's patients treated with albumin and IVIG over a 14-month period [327]. Acquisitions and Expansion - The Novartis Acquisition was completed for a purchase price of $1.7 billion (€1.2 billion) [212]. - The Talecris Acquisition was completed for a total of $3.7 billion, including net debt of approximately $3.3 billion [214]. - The company has been expanding both organically and through acquisitions over the last 25 years, transitioning from a predominantly domestic Spanish company to a global entity [198]. - The company plans to increase its fractionation capacity to approximately 19 million liters by 2023 and aims to have 370 approved plasma collection centers globally by 2024 [200]. - The company has expanded its plasma collection network through both organic growth and acquisitions, including rights to plasma from an additional 59 centers in the U.S. and Germany [237].

Financial Risk and Debt Exposure - As of December 31, 2018, the company had $5.3 billion and €607 million of senior interest-bearing debt, with 81.2% of this debt bearing interest at variable rates [128]. - The company has approximately $5.3 billion of U.S. dollar-denominated senior debt, which increases its exposure to currency risk [130]. - In 2018, €3.4 billion, or 75%, of the company's net revenue of €4.5 billion was denominated in U.S. dollars, exposing the company to foreign currency exchange rate fluctuations [129]. Operational Risks - A significant portion of the company's revenue is derived from plasma fractionation products manufactured at key facilities, which could be adversely affected by accidents or force majeure events [130]. - The company relies on third-party suppliers for essential equipment and disposable goods, and any disruptions could impair manufacturing capabilities and product sales [133]. - The company is highly dependent on distribution agreements with group purchasing organizations and other entities for the sale and delivery of its products, which could impact business if these agreements are not upheld [135]. Regulatory and Compliance Challenges - The commercialization of product candidates is contingent upon successful completion of extensive preclinical and clinical trials, which are costly and time-consuming [136]. - The company faces potential delays in obtaining regulatory approvals for its product candidates, which could affect market entry and patent protection [140]. - The company is subject to extensive government regulatory compliance and ethics oversight, including anticorruption, privacy, healthcare, and corporate compliance policies [186]. - The company is subject to anti-bribery laws and may face risks from third-party compliance failures in foreign markets [185]. Intellectual Property and Legal Risks - The company’s success is heavily reliant on obtaining and maintaining intellectual property protection, particularly for its purification processes, which may be challenged or invalidated [146]. - The company faces risks related to the expiration and enforcement of its patents, which may not provide sufficient competitive advantages or protection against competitors [149]. - The company may incur substantial expenses from patent litigation or other proceedings, which could divert management's attention and resources [158]. - The company relies on trade secrets and nondisclosure agreements to protect its intellectual property, but there is a risk of unauthorized use that could harm its competitive position [154]. Market and Pricing Pressures - The implementation of the Healthcare Reform Law has introduced significant cost-saving measures that could adversely impact the company's financial performance, particularly regarding Medicaid and Medicare programs [164]. - The company may face increased competition from biosimilar products due to the new regulatory approval pathway established by the Healthcare Reform Law, potentially affecting its financial performance [167]. - Price controls in key markets, such as Spain and the EU, may negatively impact the company's ability to maintain gross margins [171]. - The Medicare reimbursement methodology has changed, with significant cuts under the 340B/PHS program potentially decreasing demand for the company's products [173]. - Proposed regulations aimed at lowering drug prices could disrupt current market practices and adversely affect the company's business [174]. - Increasing state-level regulations on drug pricing may lead to additional pricing pressures on the company's products [175]. Environmental and Safety Liabilities - The company faces potential liabilities from environmental, health, and safety laws and regulations, including costs for investigation and remediation of hazardous substances [187]. - The company maintains workers' compensation insurance, but it may not provide adequate coverage against potential liabilities related to hazardous materials [188]. - Future adoption of more stringent federal, state, local, or foreign laws may result in substantial capital costs and operating expenses for compliance [189]. - The company may incur costs to install new pollution control equipment or modify operations to comply with environmental regulations [189]. - Fines and penalties may be imposed for noncompliance with environmental and health and safety laws [189]. Financial Reporting and Compliance - The Physician Payment Sunshine Act requires detailed reporting of financial relationships between manufacturers and healthcare providers, with potential compliance costs for the company [169]. - The company must report accurate pricing information to CMS, with potential fines for inaccuracies that could impact business operations [182]. - Off-label use of products may be reimbursed, but changes in reimbursement policies could adversely affect the company's financial performance [176]. - The company faces risks from government and private payors limiting reimbursement amounts, which could adversely affect financial results and reputation [170].