Immune globulin intravenous, Human-dira

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One trial, SIGMA, will evaluate Grifols’ intravenous immunoglobulin (Ig) GAMUNEX®-C (immune globulin injection [human], 10% caprylate chromatography purified) plus standard medical treatment in patients with secondary immunodeficiency A second trial, XPERT, will determine whether Grifols’ subcutaneous Ig, XEMBIFY® (immune globulin subcutaneous human klhw) is non-inferior to GAMUNEX-C in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Both studies are designed to support U.S. label expansion on these fast-growing Grifols Ig franchise therapies and offer patients more treatment options for their immune system disorders Barcelona, Spain, July 16, 2026 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced that the first patients have been dosed in two separate Phase 3 trials aiming to expand the U.S. labels for its signature immunoglobulin therapeutics, GAMUNEX®-C, an intravenous immunoglobulin (IVIg), and XEMBIFY®, its subcutaneous immunoglobulin (SCIg). The SIGMA trial (NCT07582432) will evaluate the pharmacokinetics (PK), efficacy and safety of GAMUNEX-C in combination with standard of care treatment to prevent infections in patients with secondary immunodeficiency (SID) characterized by low immunoglobulin levels. Unlike primary immunodeficiency (PID), which is genetic, SID occurs when a person’s previously healthy immune system is compromised by factors such as blood cancer and treatments like chemotherapy or B-cell-targeted therapies. This trial will focus specifically on patients with common blood cancers including Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin Lymphoma (NHL), which together account for more than 1 million patients in the U.S.[1] Expanding the label to include hematologic cancer–associated SID would broaden the approved indications for GAMUNEX-C in the U.S. The second clinical trial, XPERT (NCT07540221) will determine if XEMBIFY’s PK profile is non-inferior to that of GAMUNEX-C to treat patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). It will also evaluate XEMBIFY’s safety profile and efficacy based on its ability to keep the patients’ condition under control. GAMUNEX-C is already indicated to treat this autoimmune disease. Favorable results showing non-inferiority between the two Ig therapeutics, which share similar manufacturing processes, may support future regulatory discussions, including a potential application to seek expansion of XEMBIFY’s U.S. label to include CIDP. About 60,000 patients in the U.S.[2] suffer from CIDP, a chronic illness, with symptoms including progressive weakness in the arms and legs and changes in sensation. Ig therapy, including GAMUNEX-C, is a first-line treatment with immunomodulatory properties that can improve neuromuscular disability and prevent relapse. "The GBS I CIDP Foundation International embraces Grifols’ commitment to innovate and to support the patient community with additional choice in treatment and access options," said Lisa Butler, president and CEO of The GBS | CIDP Foundation, which works to ensure the CIDP patient community has access to all necessary treatments at all points of care. These two new trials aim to expand the U.S. indications of Grifols’ Ig portfolio, adding to a third Ig trial already underway. Announced at the end of 2022, Grifols’ EXCELL trial (NCT05645107) is a study to evaluate efficacy, safety, and PK of XEMBIFY+standard medical treatment (SMT) compared to placebo+SMT to prevent infections in participants with hypogammaglobulinemia (HGG) and recurrent or severe infections associated with B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma. “We’re excited about the potential to provide patients with more immunoglobulin treatment options to help manage their conditions with flexibility and convenience,” said Eduardo Herrero, Grifols’ Executive Vice President Biopharma Industrial and Scientific Innovation. “Whether it’s our IVIg or SCIg treatments, Grifols’ Igs are backed by decades of deep expertise on this protein.” Grifols’ suite of Ig products to treat immune-system disorders continues to perform very strongly, driven by increasing patient need across the world. XEMBIFY, in particular, has benefited from robust demand, growing nearly 60% year over year in 2025. About the new Phase 3 trials The primary efficacy objective of the SIGMA trial is to demonstrate that the rate of serious bacterial infections is less than 1 per participant per year when treated with GAMUNEX-C plus standard of care medical treatment. Fifty participants will take part in the open-label, multicenter single-arm prospective study, all diagnosed with B-cell CLL, MM or NHL with hypogammaglobulinemia. The XPERT trial is an open label, multicenter study that will evaluate the PK, efficacy and safety of XEMBIFY compared to GAMUNEX-C as maintenance therapy in approximately 40 CIDP patients across 20 sites in the U.S. and Europe. This trial builds on the company’s longstanding history of investing in CIDP research and treatment options for this patient community. In the mid-2000s, a pivotal trial centered on Gamunex-C –– demonstrated its short-term and long-term efficacy in reducing disability, including improvement in grip strength, in patients with CIDP compared to placebo. About GAMUNEX®-C in the U.S. Indication GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Important Safety Information Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable. GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity. Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C. There have been reports of aseptic meningitis, hemolytic anemia, and noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) in patients administered with IVIG, including GAMUNEX-C. The high-dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern. Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis. If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient’s serum. After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia (in ITP). The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP). Please see full Prescribing Information for GAMUNEX-C or visit www.gamunex-c.com. About XEMBIFY® in the U.S. Indication XEMBIFY® (immune globulin subcutaneous human–klhw) is a 20% immune globulin indicated for treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older. XEMBIFY is for subcutaneous administration only. Important Safety Information WARNING: THROMBOSIS Thrombosis may occur with immune globulin products, including XEMBIFY. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors For patients at risk of thrombosis, administer XEMBIFY at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity Contraindications XEMBIFY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity. Warnings and Precautions Aseptic meningitis syndrome (AMS). AMS may occur with human immune globulin treatment, including XEMBIFY. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuation of treatment has resulted in remission within several days without sequelae. Thrombosis. Thrombosis may occur following treatment with immune globulin products, including XEMBIFY. Thrombosis may occur in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. Hypersensitivity. Severe hypersensitivity reactions may occur with immune globulin products, including XEMBIFY. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. XEMBIFY contains IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Renal dysfunction/failure. Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with use of human immune globulin products, especially those containing sucrose. XEMBIFY does not contain sucrose. Ensure patients are not volume-depleted prior to starting infusion. In patients at risk due to preexisting renal insufficiency or predisposition to acute renal failure, assess renal function prior to the initial infusion of XEMBIFY and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation. Hemolysis. XEMBIFY may contain blood group antibodies that may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis. If signs and symptoms are present after infusion, perform confirmatory lab testing. Transfusion-related acute lung injury (TRALI). Noncardiogenic pulmonary edema may occur in patients following treatment with immune globulin products, including XEMBIFY. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support. Transmissible infectious agents. Because XEMBIFY is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt- Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD, or CJD have ever been associated with the use of XEMBIFY. Interference with lab tests. After infusion of XEMBIFY, passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Adverse Reactions The most common adverse reactions in ≥ 5% of subjects in the clinical trial were local adverse reactions, including infusion-site erythema (redness), infusion-site pain, infusion-site swelling (puffiness), infusion-site bruising, infusion-site nodule, infusion-site pruritus (itching), infusion-site induration (firmness), infusion-site scab, infusion-site edema, and systemic reactions including cough and diarrhea. Drug Interactions Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (eg, measles, mumps, rubella, and varicella). Please see accompanying full Prescribing Information for XEMBIFY or visit www.xembify.com Globally, prescribing information varies; refer to the individual country product label for complete information. [1] National Cancer Institute. SEER Cancer Stat Facts. Surveillance, Epidemiology, and End Results Program. Updated April 15, 2022. Accessed July 14, 2025. [2] Arackal S, Venker C, Wang M, Schwinn J, Mina-Osorio P. Assessing the incidence and prevalence of chronic inflammatory demyelinating polyradiculoneuropathy in the United States: retrospective claims data analysis. Neurology. 2024;102(7 Suppl 1):P9-11.010. Published April 9, 2024. doi:10.1212/WNL.0000000000204780 Our media relations team can be reached at: (+34) 93 571 00 02 media@grifols.com. Restricted to media inquiries only. For general questions and requests, please contact corporatecomms@grifols.com. The information contained on the Grifols worldwide website is not applicable to all countries. For specific information on the products and services available in your country, please select your country from the list included in the corresponding section. The purpose of this website is to provide information about Grifols' products and services, and it is not intended for, nor may it be construed as, promoting any products in countries in which they are not approved.

Q1 2026 performance was aligned with plan and on track to deliver our 2026 objectives Revenue growth is driven by Biopharma (+6.8% at constant currency (cc)) on the back of the continued momentum of IG, which grew 15.3% at cc Strong IG performance in the U.S., supported by successful launch of Biotest’s next-gen IVIG, Yimmugo® supported by sustained traction of Gamunex® in the U.S. and core EU markets Adjusted EBITDA increased to €381 million (€404 million at cc), with margin stable at 22.4% Free cash flow pre-M&A improved by €30 million year-on-year primarily driven by working capital management across the supply chain, lower both CAPEX and financial expenses Leverage ratio stood at 4.3x in Q1 2026, and liquidity position at €1.6billion Grifols successfully refinanced all 2027 debt maturities, further strengthening its balance sheet and financial flexibility Strategic initiatives continued to advance, including the Egypt and Canada self-sufficiency projects Barcelona, Spain, May 7, 2026 - Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, reported a total revenue of €1.7 billion in the first quarter of 2026, a year-over-year increase of 3.3% on a constant currency basis (cc), driven by the continued strength of its Biopharma business, which grew 6.8% cc., led by the strong performance of the immunoglobulin (IG) franchise. On a reported basis, there was a negative impact due to foreign exchange translation effects. Growth was supported by the launch of Biotest’s next-gen IVIG, Yimmugo® in the U.S and the sustained performance in the U.S. and core EU markets of flagship Gamunex® contributed to momentum during the quarter. Overall revenue performance was partially offset by pricing pressure in albumin in China and a tougher comparison base in Alpha-1 and Specialty Proteins, reflecting a prior year that benefited from inventory buy-ins for both Alpha-1 and other proteins at the time. Adjusted EBITDA reached €381 million, up 0.8% cc., with margin stable at 22.4%, reflecting ongoing operational discipline across the Group’s business. EBITDA growth was supported by ongoing efficiency improvements and a 7.7% cc reduction in OPEX, partially offset by the full-year impact of China albumin pricing concessions affecting H1’26, and €23 million of FX headwinds from a softer U.S. dollar. Grifols expects further margin expansion driven by gross margin improvements, supported by the ramp-up of Egypt plasma and associated immunoglobulin sales, ongoing plasma sourcing and footprint optimization, as well as increasing CPL benefits, alongside continued progress in the Biotest turnaround and operating leverage. Group profit increased to €73 million in the first quarter, up 21.9% year-on-year. Free cash flow pre-M&A for the first quarter improved by €30 million year-on-year to minus €8 million, supported by working capital management and lower CAPEX and financial expenses. At the end of Q1 2026, leverage ratio as per the credit agreement stood at 4.3x, while liquidity stood at €1,573 million. Recently, Grifols successfully refinanced all 2027 debt maturities, strengthening its financial flexibility and balance sheet profile. The refinancing included an upsized Term Loan B of approximately €3 billion equivalent and a revolving credit facility commitment increased from $938 million to over $2 billion, with improved pricing and extended maturities, supported by strong institutional demand and broad backing from global financial institutions. Together with the previously announced €500 million partial redemption of its highest-cost 2030 bond, these actions targets 2026 cash interest to be in line with 2025 or better. Grifols has no significant debt maturities until October 2028 and maintains a strong liquidity position. Over the past 18 months, our corporate credit ratings have been upgraded multiple times by S&P, Fitch, and Moody’s. S&P Global Ratings has upgraded the company’s issuer credit rating by two notches to BB- with a stable outlook. Similarly, Moody’s and Fitch Ratings have also improved Grifols’ rating and / or outlook, highlighting the company’s strengthening financial profile, improving leverage trajectory and continued progress in restoring balance sheet strength. All three credit rating agencies acknowledge Grifols’ strong investment grade-like business characteristics. Nacho Abia, Chief Executive Officer of Grifols,said: “We started the year delivering performance in line with our expectations and reassured that we are on track to achieve our guidance for the full-year 2026 as we continue to build momentum over the course of the year. These results were achieved in a complex geopolitical and macroeconomic environment, marked by persistent uncertainties. In this context, these results underscore both the resilience of our business and the strength of our underlying fundamentals.” Rahul Srinivasan, Chief Financial Officer of Grifols, added: “We continue to make tangible progress across the business, supported by the strong momentum in our core immunoglobulin franchise. Notably, we also made decisive progress in strengthening our capital structure following our successful refinancing this quarter – leaving us with strong liquidity, no meaningful maturities until Q4’28 and targeting cash interest in 2026 to be in line with or better than 2025 cash interest.” The upcoming Annual General Meeting is expected to approve the 2025 final cash dividend, reinforcing Grifols’ commitment to delivering sustainable shareholder returns. This step reflects the company’s improved financial flexibility and continuous focus on disciplined capital allocation, underpinned by ongoing progress in deleveraging and improved free cash flow generation. Biopharma remains the growth engine Biopharma revenues increased 6.8% cc. basis in the first quarter, reinforcing Biopharma’s role as a core growth driver for the Group. The IG franchise grew 15.3% cc. with intravenous IG up 16.2% cc., supported by sustained traction of Gamunex® in the U.S. and core EU markets, as well as by the U.S. launch of Yimmugo®, which is further enhancing the momentum of the company’s existing brands. Subcutaneous IG increased 5%, with continued double-digit in-market demand growth of Xembify® partially offset by inventory phasing. Albumin declined 6.1% cc., reflecting ongoing government-driven pricing pressure in China, consistent with market pricing dynamics anticipated at year-end affecting the entire healthcare industry in the market. After several years of strong growth, demand stagnated in 2025, prompting mid-year price adjustments. With pricing more stable in recent quarters, the company maintains a constructive full-year outlook for albumin. Grifols continues to leverage its strategic local partnership with SRAAS, combining disciplined pricing, a broader joint commercial footprint and a sharper contracting and marketing approach to deepen penetration in lower-tier hospitals and expand retail pharmacy reach in. In parallel, the company continues to pursue growth opportunities in ex-China markets, particularly in the U.S., to support overall portfolio balance. Alpha-1 and Specialty proteins declined 7.4% in this first quarter of 2026, reflecting a tougher comparison against 2025, which benefited from inventory buy-in following distribution model change. In Alpha-1, patient base continued to grow, underscoring continued unmet needs. The company remains focused on expanding diagnosis and treatment, while the expected phase 3 SPARTA trial readout in H2 2026 represents a potentially important inflection point for the franchise, supporting greater awareness, improved access and long-term market expansion. Strategic projects supporting long-term margin expansion and supply optimization Grifols continues to advance key strategic initiatives to strengthen its long-term operating model and profitability. The Egypt project remains on schedule and is becoming central to the company’s self-sufficiency strategy and long-term plasma optimization plan. Beyond adding capacity, it is expected to structurally improve margin expansion over time by better aligning plasma sourcing with local markets economics. As Egyptian plasma volumes ramp up, Grifols expects to progressively optimize its global plasma footprint, reducing the share of U.S. plasma allocated to ex-U.S. markets and improving overall plasma economics. The company expects Egypt plasma collection to reach approximately 1 million liters in 2026 and up to 3 million liters by 2029, enabling a gradual rebalancing of the global plasma network. As a result, Grifols expects to reduce reliance on U.S.-sourced plasma for ex-U.S. markets, improve cost efficiency per liter, and enhance supply resilience. Following EMA approval of the Grifols Egypt entire supply chain, Grifols is now positioned to optimize its global plasma network more effectively, progressively reducing the reliance on U.S.-sourced plasma for ex-U.S. markets. Between 2025 and 2029, ex-U.S. plasma supply is expected to more than double, driven largely by Egypt. This rebalancing is expected to enhance plasma economics, support mid- to high-single digit growth in ex-U.S. supply, strengthen supply resilience and contribute to a structurally improved margin profile. This strategy will not just allow Grifols to expand its plasma and industrial footprint, but to also reshape the economics of how the company sources and delivers plasma-derived therapies globally. Additionally, the recent recognition of plasma-derived therapies as strategic assets under Section 232 of the U.S. Trade Expansion Act further reinforces the structural relevance of Grifols’ vertically integrated model. Diagnostic performance in line with expectations Diagnostic performance in the quarter was impacted by the early dissolution of the Quidel Ortho joint business, which had a one-off negative effect on Immunoassay Diagnostic Solutions (IDS) revenues. This impact is partially mitigated by a total USD 65 million compensation to be received across 2026–2028. Excluding this effect, the remaining Diagnostic business performed in line with expectations, with like-for-like revenue growth in the low single digits. Strategically, the dissolution of the joint business provides Grifols with full control over its clinical diagnostics roadmap, supporting the development of its next-generation platforms. The company is advancing the launch of its Barcelona-based Blood Typing Solutions (BTS) platform, featuring modular, trackable gel card technology and a simplified workflow, with presentation expected in Q2 2026. This milestone supports Grifols’s broader innovation roadmap in Diagnosis and its long-term ambition to strengthen its position in blood typing and donor screening. 2026 Guidance Grifols confirms that Q1 2026 performance was aligned with expectations and supports its full-year 2026 guidance. Our media relations team can be reached at: (+34) 93 571 00 02 media@grifols.com. Restricted to media inquiries only. For general questions and requests, please contact corporatecomms@grifols.com.