Epinephrine Bitartrate

GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company Approval provides a long-awaited first-ever option to reduce the burden of care associated with GSDIa Ultragenyx received a Priority Review Voucher upon approval Ultragenyx to host conference call on 8/19/26 at 6:00 p.m. Eastern Time NOVATO, Calif., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for GENGLYCOS™ (pariglasgene brecaparvovec-opnr), also known as DTX401, in adult and pediatric patients eight years and older with glycogen storage disease type Ia (GSDIa). “The approval of GENGLYCOS fulfills our commitment to provide the first therapy that directly targets the root cause of GSDIa. The reduced reliance on cornstarch, experienced by patients in our clinical studies, demonstrates this gene therapy’s ability to establish the normal breakdown of glycogen to produce glucose during fasting or episodes of metabolic stress. This ability to regulate glucose has alleviated the disease burden and has the potential to mitigate the risk of severe or life-threatening hypoglycemia for these patients,” said Eric Crombez, M.D., chief medical officer at Ultragenyx. “As our first gene therapy approval, GENGLYCOS represents an important achievement for our company and the realization of the promise of a powerful new tool to deliver transformative medicines for people living with rare diseases.” GSDIa is an ultra-rare genetic metabolic disorder caused by a deficiency of the enzyme needed to release glucose from the liver to the bloodstream. The deficiency reduces the liver’s ability to control glucose levels and is associated with potentially life-threatening hypoglycemia episodes and other serious complications, requiring rigorous nutritional management that involves a burdensome, around-the-clock regimen of raw cornstarch intake as an oral glucose replacement therapy. Glucose control with cornstarch is crude with large swings in glucose, and patients instead end up spending a large fraction of their day significantly hyperglycemic to avoid hypoglycemic episodes. GSDIa affects 1,500-2,500 patients in the U.S. and 6,000-8,000 worldwide within commercially accessible geographies. “Day-to-day management of GSDIa requires a relentless regimen of raw cornstarch and strict dietary management that can be extraordinarily demanding for patients and families. Even with meticulous adherence to this regimen, patients must be perfect. Any missed cornstarch puts patients at risk of severe hypoglycemia, seizures, and even death,” said David Weinstein, M.D., MMSc, one of the world's leading GSDIa experts. “The approval of GENGLYCOS represents a major step forward for the GSDIa community and reflects almost 30 years of work and scientific progress aimed at improving safety and the quality of life of people living with this disease.” “For families affected by GSDIa, every day revolves around strict schedules, overnight vigilance, and the constant worry that a missed meal or dose of cornstarch could trigger life-threatening hypoglycemia,” said David and Wendy Feldman, co-founders and current Board members at The Children’s Fund for Glycogen Storage Disease Research. “This approval is an incredibly meaningful milestone for a community that has spent decades hoping, advocating, and helping advance the research for new treatment options that could ease the burdens of this disease.” Clinical Program and Post-Marketing Study Requirements Supporting Accelerated Approval of GENGLYCOS The approval of GENGLYCOS is based on positive data from the 48-week randomized, double-blind, placebo-controlled Phase 3 GlucoGene study which treated 46 participants aged eight years and older with DTX401 (1.0 x 10^13 GC/kg dose) or placebo, showing a reduction in the cornstarch requirements in the treated group (p<0.001). There were 44 participants in the modified intention-to-treat (mITT) population providing efficacy data within the Week 48 analysis period following treatment with DTX401 (n=20) or placebo (n=24). At Week 48, eligible participants crossed over and received the alternate treatment. After crossover, participants continued to be followed, with analyses conducted at Week 96 and Week 144. As part of accelerated approval, Ultragenyx has agreed to provide two years of safety and efficacy clinical data from open-label commercial treatment of 50 patients and 20 control patients through enhancement of its existing GSDIa Disease Monitoring Program (DMP). The control group will consist of patients who sought commercial treatment but cannot be treated with GENGLYCOS due to the presence of anti-AAV8 antibodies. The study will provide more data to support the reduction in cornstarch clinical burden, fasting tolerance, and other measures in a post-marketing setting where patients can know their immediate glucose levels, and their cornstarch and diet can be managed more promptly by their physician. The DMP will also evaluate previously treated clinical trial participants as well as these new commercial patients for a total of 10 years. Enabling Access for Eligible Patients Ultragenyx will provide support to help enrolled patients and caregivers navigate access to treatment through its UltraCare ® program, which now includes specially trained UltraCare ® Gene Therapy Guides to help understand insurance coverage, assist in obtaining treatment support, and answer questions about the treatment process. Dedicated in-house UltraCare Gene Therapy Guides are available Monday through Friday from 9 a.m. to 8 p.m. Eastern Time at 888-756-8657. More information is available at . GENGLYCOS will be available through a national network of Qualified Treatment Centers (QTCs) with specialized expertise and training to safely administer gene therapy. GENGLYCOS is manufactured entirely at Ultragenyx’s Gene Therapy Manufacturing Facility (GTMF) in Bedford, Mass., strengthening the Company’s ability to scale production of high-quality gene therapy products and deliver them to patients as efficiently as possible. More information will be available at This approval reflects the work of a remarkable team spanning many years and organizations. Ultragenyx is deeply grateful to the patients, families, and clinical investigators who made our clinical studies possible; Dr. David Weinstein, whose scientific and clinical leadership laid critical groundwork across early research and clinical trials; Dr. Janice Chou for her early work at NIH, and the team from Dimension Therapeutics. Their collective commitment and perseverance have transformed a scientific vision into a new therapeutic option for patients. Investor Conference Call and Webcast Information Ultragenyx will host a conference call today at 6:00 p.m. Eastern Time / 3:00 p.m. Pacific Time to discuss the approval of GENGLYCOS. The live and replayed webcast of the call will be available through the company's website at . INDICATION GENGLYCOS (pariglasgene brecaparvovec-opnr) is indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa). This indication is approved under accelerated approval based on reduction in daily cornstarch intake . Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GENGLYCOS is contraindicated in patients with known severe hepatic fibrosis or cirrhosis. WARNINGS AND PRECAUTIONS Hypersensitivity and Infusion Reactions (IRs) Hypersensitivity reactions including anaphylaxis and IRs have occurred with GENGLYCOS treatment. Severe reactions have been reported. Monitor for signs and symptoms of hypersensitivity and IRs, including urticaria, flushing, hypotension, bronchospasm, dyspnea, chest tightness, nausea, vomiting, headache, abdominal pain, lightheadedness, flu-like symptoms, shivering, rash, and hypertension. Premedicate with acetaminophen and non-sedating antihistamines and administer GENGLYCOS according to recommended infusion rates. Monitor patients during and after completion of GENGLYCOS infusion as clinically indicated. If anaphylaxis or severe IR occurs, pause GENGLYCOS infusion immediately and initiate medical treatment as clinically indicated, monitoring as needed. For mild to moderate IRs, consider slowing or temporarily interrupting the infusion, and administer symptomatic treatment as clinically indicated. The infusion may be restarted at half the prior rate upon resolution of symptoms. Medical support measures, including cardiopulmonary resuscitation equipment and medications for the treatment of anaphylaxis (e.g., epinephrine, antihistamines, corticosteroids), should be available during GENGLYCOS administration. Hepatotoxicity Immune-mediated hepatotoxicity, with elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels, has occurred with GENGLYCOS. Avoid use in patients with preexisting hepatic impairment or acute hepatic viral infection. Prior to GENGLYCOS infusion, evaluate liver-related medical history and assess liver function by clinical examination and laboratory testing. Advise patients to immediately report signs and symptoms of hepatotoxicity, including fatigue, jaundice, dark urine, nausea, vomiting, and right upper quadrant pain. Administer corticosteroids to all patients after GENGLYCOS infusion in order to mitigate hepatic reactions. Elevated transaminases may require adjustment of the corticosteroid treatment regimen, including increased dose or prolongation of the corticosteroid taper. Monitor transaminase levels for the first 6 months after GENGLYCOS administration. Continue to monitor transaminases in all patients who develop transaminase elevations, until transaminases return to baseline or as clinically indicated. Adrenal Insufficiency Adrenal insufficiency, including serious events, has been reported in patients receiving GENGLYCOS during corticosteroid use and tapering. Signs and symptoms of adrenal insufficiency include fatigue, weakness, anorexia, nausea, vomiting, hypotension, hyponatremia, and hypoglycemia. Adrenal crisis may present as severe hypotension, acute abdominal pain, or loss of consciousness. Monitor patients for signs and symptoms of adrenal insufficiency and adrenal crisis after GENGLYCOS administration during and after corticosteroid therapy and tapering. Taper corticosteroid therapy gradually. Do not abruptly discontinue corticosteroid therapy. AAV Vector Integration and Risk of Tumorigenicity There is a theoretical risk of tumorigenicity due to integration of AAV vector DNA into the genome. GENGLYCOS is composed of a recombinant, non-replicating AAV8 vector whose DNA persists largely in episomal form. Random integration of recombinant AAV-vector DNA into human DNA has been reported with AAV gene therapies. The clinical relevance of individual integration events is unknown, but it is acknowledged that individual integration events could potentially contribute to a risk of tumorigenicity. If a tumor develops in a patient receiving GENGLYCOS, health care providers should contact and report the tumor to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657. Adverse Reactions Seven serious adverse events were observed in the Primary Efficacy Analysis Period (PEAP) of Study 1 (Weeks 1-48), including anaphylaxis/infusion reaction (2), adrenal insufficiency (2), high lactate level (2) and hypoglycemia (1). The most common adverse reactions during the PEAP of Study 1 (occurring in ≥10% of patients) with higher frequency in GENGLYCOS compared to placebo were ALT/AST Enzyme elevated (71%), Nausea (38%), Headache (24%), Hypertriglyceridemia (29%), Adrenal Insufficiency (24%), Constipation (19%), Hyperglycemia (14%), Acne/Dermatitis Acneiform (19%), Cushingoid Features (14%), and Anaphylaxis (10%). DRUG INTERACTIONS Vaccinations Vaccine schedules may need to be adjusted for immunosuppressive therapy, and vaccines should be avoided 1 month prior to GENGLYCOS administration. USE IN SPECIFIC POPULATIONS Pregnancy GENGLYCOS should not be used during pregnancy. There are no data on the use of GENGLYCOS in pregnant women. It is unknown whether GENGLYCOS can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Contraception Women of childbearing potential should use effective contraception for at least 12 months after administration of GENGLYCOS. For 6 months after administration of GENGLYCOS, men must not donate semen, and men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception. ADDITIONAL PATIENT COUNSELING INFORMATION Vector Shedding Inform patients/caregivers that vector distribution in blood and vector shedding in urine, stool, and saliva can occur after GENGLYCOS infusion. Advise patients/caregivers on proper hygiene when handling patient body waste. These precautions should be followed for 3 months after GENGLYCOS infusion. Report negative side effects of prescription drugs to the FDA. Visit  or call 1-800-FDA-1088. You may also report side effects to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657. Please see the full Prescribing Information for GENGLYCOS. About Glycogen Storage Disease Type Ia (GSDIa) GSDIa is an ultra-rare, serious, and life-threatening disease due to an inborn error of carbohydrate metabolism caused by pathogenic variants of the G6PC gene, which encodes G6Pase, an enzyme that is critical for the release of glucose from glycogen and other metabolic sources. Deficiency of G6Pase activity results in severe hypoglycemia during periods of fasting between meals and during the night along with excess hepatic glycogen storage, metabolic derangements, and other disease-related complications. Cornstarch is critical in the management of GSDIa throughout the day and night in providing an exogenous source of glucose to help avoid sudden and severe drops in plasma glucose levels; however, current management strategies carry a significant burden to patients and families. GSDIa affects 1,500-2,500 patients in the U.S. and 6,000-8,000 worldwide within commercially accessible geographies. About Ultragenyx Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved medicines and treatment candidates aimed at addressing diseases with high unmet medical need and clear biology, for which there are typically no approved therapies treating the underlying disease. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency. For more information on Ultragenyx, please visit the company's website at: . Forward-Looking Statements and Use of Digital Media Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the commercial launch, availability and market acceptance of GENGLYCOS; Ultragenyx's ability to manufacture GENGLYCOS at its gene therapy manufacturing facility, scale production and supply GENGLYCOS to Qualified Treatment Centers; patient access to GENGLYCOS, including insurance coverage and reimbursement; the safety, efficacy, durability and potential benefits of GENGLYCOS; estimates of the number of patients with GSDIa and the potential commercial opportunity for GENGLYCOS; the design, enrollment, timing, conduct and results of the post-marketing Disease Monitoring Program and other post-marketing requirements; and Ultragenyx's ability to satisfy FDA requirements and maintain accelerated approval for GENGLYCOS, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks and uncertainties related to the commercial launch and market acceptance of GENGLYCOS; the ability to identify eligible patients and establish and support a network of Qualified Treatment Centers; uncertainty related to insurance coverage and reimbursement; risks related to serious or undesirable side effects, including risks associated with AAV gene therapy; manufacturing risks, including Ultragenyx's limited experience operating its own manufacturing facility and the ability to manufacture and supply GENGLYCOS in sufficient quantities and in compliance with regulatory requirements; Ultragenyx's ability to complete the post-marketing Disease Monitoring Program and other post-marketing requirements within required timeframes and to confirm clinical benefit; the risk that the FDA may modify the approved indication or impose additional requirements, or may withdraw accelerated approval if clinical benefit is not confirmed or post-marketing requirements are not satisfied; smaller than anticipated market opportunities; competition from other therapies or products; product liability; regulatory scrutiny; and other matters that could affect the availability or commercial potential of Ultragenyx's products and product candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2026, and its subsequent periodic reports filed with the SEC. In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx's Investor Relations website ( ) and LinkedIn website ( ). Ultragenyx Contacts Investors Joshua Higa ir@ultragenyx.com Media Jess Rowlands media@ultragenyx.com

2Q 2026 Total Revenue of $124.4 Million, Increasing 2% Year-over-Year 2Q 2026 ASCENIV Revenue of $102.9 Million, Increasing 24% Year-over-Year BIVIGAM Utilization Stabilized with Sequential Improvement in Demand and Revenue 2Q 2026 GAAP Net Income of $37.8 Million, Increasing 11% Year-over-Year ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); 2Q 2026 Adjusted Net Income ( 1) of $39.0 Million, Increasing 8% Year-over-Year 2Q 2026 GAAP Basic EPS of $0.17, Increasing 17% Year-over-Year 2Q 2026 Adjusted EBITDA ( 2) of $61.8 Million, Increasing 22% Year-over-Year Strong Balance Sheet and Financial Flexibility Support Continued Execution ACAAI Abstract Submitted Highlighting Significant Real-World Health Outcomes and Healthcare Resource Utilization Improvements in PI Patients Treated with ASCENIV Accelerating ASCENIV Demand and Expanding Real-World Evidence Reinforce ADMA’s Robust Growth Opportunity Reiterates FY2026 Financial Guidance RAMSEY, N.J. and BOCA RATON, Fla., Aug. 05, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S.-based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its second quarter 2026 financial results and provided a business update. “Our second quarter results reflect strong execution across the business and demonstrate the power of ASCENIV’s growth trajectory,” said Adam Grossman, President and Chief Executive Officer of ADMA. “ASCENIV continued to outperform, supported by increasing physician adoption, broader prescriber engagement, new patient starts and higher patient utilization. Growth in ASCENIV utilization accelerated in the quarter, with June delivering the strongest sequential month-over-month utilization growth since the first half of 2024. BIVIGAM demand continued to stabilize during the quarter, resulting in sequential improvement in utilization and revenue. Together, these trends reinforce our confidence in sustained growth throughout the balance of 2026." Mr. Grossman continued, “During the first half of 2026, ADMA further enhanced its robust real-world health outcomes and healthcare resource utilization data, which we believe further differentiates ASCENIV in later-line, refractory and medically complex primary immunodeficiency patients. We generated data comprising 127 real-world ASCENIV-treated patients, the majority of whom had previously received other immune globulin therapies and switched to ASCENIV. The study’s findings demonstrated that patients experienced statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use following ASCENIV administration, and the findings have been submitted as an abstract to the November 2026 American College of Allergy, Asthma & Immunology (“ACAAI”) Annual Scientific Meeting. Supported by this expanding real-world evidence base, we believe these datasets will further strengthen ASCENIV’s already robust patient access and commercial payer coverage. We believe ASCENIV remains early in its penetration of this underserved market, supporting our confidence in meeting or exceeding guidance ranges for 2026 and unwavering optimism in the product’s peak revenue potential.” Reiterated FY2026 Financial Guidance FY2026 total revenue expected to be $530 million to $560 million FY2026 Adjusted Net Income expected to be $170 million to $200 million FY2026 Adjusted EBITDA expected to be $265 million to $300 million The FY2026 outlook continues to reflect sustained competitive dynamics and pricing pressure within the U.S. immune globulin market through the balance of the year. ASCENIV is expected to remain ADMA’s principal growth driver, supported by accelerating demand, expanding physician adoption and an increasing body of differentiated clinical and real-world evidence. Commercial Execution Reinforces ASCENIV’s Growth Trajectory ASCENIV Demand Continued to Accelerate. ASCENIV demand accelerated throughout the second quarter, culminating in June with the strongest sequential month-over-month utilization growth since the first half of 2024. The acceleration in distributor reported end-user utilization in the second quarter of 2026 reinforces management’s view that ASCENIV remains early in its penetration of the later-line, refractory primary immunodeficiency (“PI”) market. ASCENIV Continued to Outperform in its Insulated Total Addressable Market (TAM) and BIVIGAM Utilization is Stabilizing Despite an Evolving, Competitive U.S. IG Market Backdrop. ASCENIV continued to outperform, supported by increasing physician adoption, broader provider engagement, new patient starts and higher patient utilization. BIVIGAM demand stabilized during the second quarter, resulting in sequential improvement in utilization and revenue. New Real-World Health Outcomes Data Further Differentiated ASCENIV. ADMA submitted an abstract for publication at the 2026 ACAAI Annual Scientific Meeting highlighting results from a large real-world health outcomes and healthcare resource utilization analysis of 127 medically complex PI patients, the majority of whom had previously received other immune globulin therapies. Following initiation of ASCENIV treatment, patients experienced statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use. The proportion of patients experiencing infection-related emergency-room visits also declined. The Company believes these findings further validate ASCENIV's differentiated value proposition, reinforce its positioning in later-line, refractory PI patients and support continued physician adoption, payer access and utilization. These findings complement ASCENIV's broad commercial payer coverage and support its continued commercial expansion. The study population consisted of complex patients who, in addition to PI, had one of: (1) respiratory comorbidities (i.e., Asthma, COPD, bronchiectasis, etc.), (2) significant corticosteroid, antibiotic or respiratory antiviral use, or (3) recurrent infection-related healthcare resource utilization (i.e., hospitalizations, ER visits) in a calendar year. The analysis compared patient outcomes and healthcare resource utilization during the 12 months before ASCENIV initiation with the 12 months following administration. Commercial Momentum Supports Reiterated FY2026 Financial Guidance. Accelerating ASCENIV demand, stabilization in BIVIGAM, and continued strong cash generation reinforce management’s confidence in meeting or exceeding the Company’s FY2026 financial guidance. Disciplined Capital Allocation Continues to Enhance Stockholder Value. During the second quarter, ADMA repurchased approximately 7.1 million shares of common stock under its previously authorized share repurchase program. Year-to-date total stock repurchases through June 30, 2026 were approximately 13.8 million shares, amounting to 5.3% of the Company’s common stock outstanding. In addition to the Company’s accelerated share repurchase (ASR) program completed in the second quarter, ADMA’s stock repurchases were funded through organically generated operating cash flow, while the Company maintained substantial financial flexibility to support commercial expansion, manufacturing initiatives and pipeline development. The Company remains active with share repurchases and is on track to complete its previously stated $200 million or more 2026 share repurchase target. SG-001 Development Remains on Track. ADMA continues to advance plasma collection optimization, potency assay development and preclinical activities supporting planned conformance lot production during the second half of 2026, ahead of the anticipated submission of its pre-Investigational New Drug (IND) meeting package to the U.S. Food and Drug Administration by year-end. Leveraging ADMA’s existing platform and commercial infrastructure, the Company believes it is positioned for a potentially rapid commercial ramp-up toward an approximately $300 to $500 million market opportunity. Immunocompromised patients remain at a disproportionately high risk for severe pneumococcal disease. Underlying impairments in functional immunity limit vaccine-mediated protection, leaving a persistent need for alternative targeted preventive strategies in the patients at greatest risk. ADMA believes SG-001 has the potential to mitigate the burden of the disease and is encouraged by the pre-clinical studies conducted to date. Second Quarter 2026 Financial Results: Total revenue for the quarter ended June 30, 2026 was $124.4 million, compared to $122.0 million for the quarter ended June 30, 2025. ASCENIV revenue of $102.9 million in the quarter demonstrated 24% growth year-over-year, while BIVIGAM revenue was $19.4 million, a 49% decline year-over-year, however, growing sequentially from the first quarter 2026 trough levels. Gross profit for the quarter ended June 30, 2026 was $86.3 million, compared to $67.2 million in the prior-year period, resulting in gross margin of 69% in 2026 compared to 55% in the prior-year period. The gross margin expansion year-over-year reflects the product mix shift towards the higher margin ASCENIV product as well as the continued impact of the Company’s yield enhanced manufacturing process approved in 2025. Research and development expenses for the quarter ended June 30, 2026 were $6.0 million, compared to $1.0 million in the prior-year period, primarily driven by investment in the SG-001 development project. Selling, general and administrative expenses for the quarter ended June 30, 2026 were $26.7 million, compared to $22.2 million in the prior-year period, primarily driven by higher employee-related costs, increased software maintenance costs, higher professional and consulting fees associated with ongoing legal and related matters, and strategic initiatives supporting corporate growth. GAAP net income for the quarter ended June 30, 2026 was $37.8 million, compared to $34.2 million for the quarter ended June 30, 2025. The 11% growth in GAAP net income year-over-year was driven primarily by a favorable product mix, reflecting continued ASCENIV growth and higher gross margins, partially offset by an increase in the effective tax rate to 24.7% in the current period as compared to 14.7% in the second quarter of 2025. GAAP Basic EPS was $0.17 for the quarter ended June 30, 2026, compared to $0.14 in the prior-year period, representing 17% year-over-year growth. Adjusted Net Income for the quarter ended June 30, 2026 was $39.0 million, representing 8% year-over-year growth. Adjusted EBITDA for the quarter ended June 30, 2026 was $61.8 million, representing 22% year-over-year growth. First Half 2026 Financial Results: Total revenue for the six months ended June 30, 2026 was $238.9 million, compared to $236.8 million for the six months ended June 30, 2025. ASCENIV revenue of $200.4 million in the first half of 2026 demonstrated 26% growth year-over-year, while BIVIGAM revenue was $34.8 million, representing a year-over-year decline of 51%. Gross profit for the six months ended June 30, 2026 was $167.0 million, compared to $128.3 million in the prior-year period, resulting in gross margin of 70%, compared to 54% in the prior-year period. The year-over-year gross margin expansion reflects a favorable product mix driven by continued ASCENIV growth, as well as the ongoing benefits of the Company's yield-enhanced manufacturing process approved in 2025. Research and development expenses for the six months ended June 30, 2026 were $8.6 million, compared to $1.9 million in the prior-year period, primarily reflecting continued investment in the advancement of the Company's SG-001 pipeline program. Selling, general and administrative expenses for the six months ended June 30, 2026 were $53.5 million, compared to $46.3 million in the prior-year period, primarily driven by an increase in personnel costs, including stock-based compensation, and an increase in professional and consulting fees associated with ongoing legal and related matters and strategic initiatives supporting corporate growth. GAAP net income for the six months ended June 30, 2026 was $83.1 million, compared to $61.1 million in the prior-year period. The 36% year-over-year increase in GAAP net income was primarily driven by favorable product mix resulting from continued ASCENIV growth and higher gross margins, and also benefited from the divestiture of three plasma collection centers during the first quarter of 2026. GAAP Basic EPS for the six months ended June 30, 2026 was $0.36, compared to $0.26 in the prior-year period, representing 38% year-over-year growth. Adjusted Net Income for the six months ended June 30, 2026 was $79.6 million, representing 15% year-over-year growth. Adjusted EBITDA for the six months ended June 30, 2026 was $121.5 million, representing 23% year-over-year growth. Conference Call Information To access the conference call seamlessly, participants are required to register for the call here to receive the dial-in numbers and unique PIN. It is recommended that you join approximately 10 minutes prior to the event start (although you may dial in at any time during the call). Attendees who will not be asking a question during the call are encouraged to listen in to the live webcast here . An archived replay of the event will be available, located under “Events & Webcasts” in the investor section of the Company’s website at . About ASCENIV™ ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and children (2 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes such as bacteria and viruses that safeguard against infection and disease. ASCENIV is protected by numerous issued patents in the United States and internationally and a wide range of patent applications worldwide. Certain data and other information about ASCENIV can be found by visiting Information about ADMA and its products can be found on the Company’s website at Additional Important Safety Information About ASCENIV™ WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. 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. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or lead to fatal outcome. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV 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. ASCENIV™ Contraindications: History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. ASCENIV™ Warnings and Precautions: IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1] Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4] In patients at risk of developing acute renal failure, monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9] Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5] Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6] Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7] Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ASCENIV™ Adverse Reactions: The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or . About ADMA Biologics, Inc. (ADMA) ADMA Biologics is a U.S.-based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM ® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB ® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. Additionally, ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia . ADMA manufactures its immune globulin products and product candidates at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products and product candidates. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit . Use of Non-GAAP Financial Measures This press release includes certain non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The Company believes Adjusted EBITDA and Adjusted Net Income are useful to investors in evaluating the Company’s financial performance. The Company uses Adjusted EBITDA and Adjusted Net Income as key performance measures because it believes that they facilitate operating performance comparisons from period to period that exclude potential differences driven by the impact of variations of non-cash items such as depreciation and amortization, as well as, in the case of Adjusted EBITDA, stock-based compensation or certain non-recurring items, and in the case of Adjusted Net Income, certain non-recurring items. The Company believes that investors should have access to the same set of tools used by its management and Board of Directors to assess its operating performance. Adjusted EBITDA and Adjusted Net Income should not be considered as measures of financial performance under GAAP, and the items excluded from Adjusted EBITDA and Adjusted Net Income are significant components in understanding and assessing the Company’s financial performance. Accordingly, these key business metrics have limitations as an analytical tool. They should not be considered as an alternative to net income, cash flows from operations, or any other performance measures derived in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. Please refer to the tables below for the reconciliation of GAAP measures to these non-GAAP measures for applicable periods. The Company has not provided a reconciliation of its forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measure because certain items that are excluded from such non-GAAP financial measures cannot be reasonably predicted or estimated without unreasonable effort. These items may include, but are not limited to, costs associated with potential business development, licensing, collaboration, acquisition, divestiture or other strategic transactions; unusual legal, litigation, regulatory, settlement and related professional fees, expenses and other organizational optimization costs; and other unusual, non-recurring, infrequent or non-cash items that may arise during the applicable period. The timing, occurrence, and magnitude of these items are inherently uncertain and depend on a variety of factors that are outside of the Company's control or cannot be reasonably predicted at this time. Accordingly, management is unable to estimate these amounts with reasonable certainty or determine the probable significance of such items to the corresponding GAAP financial measure without unreasonable effort. These items could have a material impact on the Company's GAAP results for the applicable reporting period. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “confident,” “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “position us,” “positioned,” “support,” “should,” “could,” “would,” “may,” “potential,” “view,” “opportunity” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about the Company’s total revenue, Adjusted Net Income, Adjusted EBITDA, earnings and earnings potential, financial guidance in future periods and related assumptions; the current U.S. immune globulin market, including competitive pressures; sustained competitive dynamics, pricing pressure, customer ordering patterns and inventory levels; our commercial execution initiatives and intended financial benefits; ASCENIV revenue growth and potential, value proposition, growth trajectory, penetration curve, appropriate market, patient access, commercial payer coverage, adoption, demand and utilization; our share repurchase target; and SG-001, its data, development, regulatory filings, revenue potential and clinical trial timeline. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto. (1) Adjusted Net Income is a non-GAAP financial measure. For a reconciliation of Adjusted Net Income to the most comparable GAAP measure, see the reconciliation included in the financial tables. All non-GAAP adjustments are presented pre-tax. (2) Adjusted EBITDA is a non-GAAP financial measure. For a reconciliation of Adjusted EBITDA to the most comparable GAAP measure, see the reconciliation included in the financial tables. INVESTOR RELATIONS CONTACT: Argot Partners | 212-600-1902 | ADMA@argotpartners.com MEDIA CONTACT: Longacre Square Partners | ADMABiologics@longacresquare.com ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS June 30, December 31, 2026 2025 (in thousands, except share and per share data) Unaudited ASSETS Current assets: Cash and cash equivalents $ 136,020 $ 87,630 Accounts receivable, net 138,231 158,429 Inventories, net 239,313 206,465 Prepaid expenses and other current assets 14,639 7,458 Assets held for sale - 6,530 Total current assets 528,203 466,512 Property and equipment, net 66,664 65,057 Intangible assets, net 575 632 Goodwill 3,530 3,530 Deferred tax assets, net 69,965 73,261 Right-of-use assets 6,146 6,650 Deposits and other assets 9,127 8,600 TOTAL ASSETS $ 684,210 $ 624,242 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 31,724 $ 22,519 Accrued expenses and other current liabilities 39,105 40,466 Current portion of long-term debt 3,750 2,813 Current portion of lease obligations 1,178 1,096 Liabilities held for sale - 2,647 Total current liabilities 75,757 69,541 Long-term debt 192,839 69,330 Deferred revenue, net of current portion 1,334 1,405 Lease obligations, net of current portion 6,072 6,646 TOTAL LIABILITIES $ 276,002 $ 146,922 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding - - Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, June 30, 2026: 241,089,992 issued and 225,355,228 outstanding; December 31, 2025: 239,793,566 issued and 237,874,496 outstanding 24 24 Treasury stock, at cost, 15,734,764 and 1,919,070 shares as of June 30, 2026 and December 31, 2025, respectively (188,452 ) (32,090 ) Additional paid-in capital 675,139 671,039 Accumulated deficit (78,503 ) (161,653 ) TOTAL STOCKHOLDERS' EQUITY 408,208 477,320 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 684,210 $ 624,242 ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS NON-GAAP RECONCILIATION Three Months ended June 30, Six Months ended June 30, 2026 2025 2026 2025 (in thousands, except share and per share data) Unaudited REVENUES $ 124,395 $ 121,984 $ 238,888 $ 236,786 Cost of product revenue 38,118 54,757 71,861 108,463 Gross profit 86,277 67,227 167,027 128,323 OPERATING EXPENSES: Research and development 6,014 1,031 8,611 1,858 Plasma center operating expenses 1,026 1,152 2,088 2,438 Amortization of intangible assets 55 32 110 57 Gain on sale of plasma centers - - (7,980 ) - Selling, general and administrative 26,737 22,214 53,479 46,292 Total operating expenses 33,832 24,429 56,308 50,645 INCOME FROM OPERATIONS 52,445 42,798 110,719 77,678 OTHER INCOME (EXPENSE): Interest and other income 1,238 400 2,331 1,008 Interest expense (3,424 ) (1,834 ) (5,524 ) (3,809 ) Loss on extinguishment of debt - (1,159 ) - (1,159 ) Other expense (22 ) (108 ) (161 ) (172 ) Other income (expense), net (2,208 ) (2,701 ) (3,354 ) (4,132 ) INCOME BEFORE INCOME TAXES 50,237 40,097 107,365 73,546 Provision for income taxes 12,415 5,878 24,215 12,424 NET INCOME $ 37,822 $ 34,219 $ 83,150 $ 61,122 BASIC EARNINGS PER COMMON SHARE $ 0.17 $ 0.14 $ 0.36 $ 0.26 DILUTED EARNINGS PER COMMON SHARE $ 0.16 $ 0.14 $ 0.35 $ 0.25 WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic 228,232,503 241,490,715 232,136,480 238,309,156 Diluted 230,337,048 248,608,460 235,240,375 245,750,155 RECONCILIATION OF GAAP NET INCOME TO ADJUSTED EBITDA ( 2 ) Three Months ended June 30, Six Months ended June 30, 2026 2025 2026 2025 (in thousands) Unaudited Net income $ 37,822 $ 34,219 $ 83,150 $ 61,122 Depreciation 1,726 2,027 3,510 3,970 Amortization 55 32 110 57 Income taxes 12,415 5,878 24,215 12,424 Interest expense, net 2,186 1,834 3,169 3,809 EBITDA 54,204 43,990 114,154 81,382 Stock-based compensation 6,135 4,963 12,464 9,587 Voluntary Withdrawal and product replacements - 164 - 4,001 Yield enhancement 429 493 841 1,395 Gain on sale of plasma centers - - (7,980 ) - Loss on extinguishment of debt - 1,159 - 1,159 Non-recurring professional fees 1,078 - 2,020 1,182 Adjusted EBITDA $ 61,846 $ 50,769 $ 121,499 $ 98,706 NON-GAAP RECONCILIATION RECONCILIATION OF GAAP NET INCOME TO ADJUSTED NET INCOME ( 1 ) Three Months ended June 30, Six Months ended June 30, 2026 2025 2026 2025 (in thousands) Unaudited Net income $ 37,822 $ 34,219 $ 83,150 $ 61,122 Stock-based compensation modifications - - 609 474 Customer credits related to the Voluntary Withdrawal - 164 - 4,001 Loss on extinguishment of debt - 1,159 - 1,159 Yield Enhancement 323 493 650 1,395 Gain on sale of plasma centers - - (6,332 ) - Non-recurring professional fees 812 - 1,559 1,182 Adjusted net income (a) $ 38,957 $ 36,035 $ 79,636 $ 69,333 (a) Add-backs reflected during the three and six months ended June 30, 2025 exclude estimated tax effect of $0.3 million and $1.4 million, respectively. Add-backs reflected during the three months and six months ended June 30, 2026 were tax affected using the respective effective tax rates. PRODUCT-LEVEL TOTAL REVENUE Three Months ended June 30, Six Months ended June 30, 2026 2025 Increase/ (Decrease) Increase/ (Decrease) % 2026 2025 Increase/ (Decrease) Increase/ (Decrease) % (in thousands) Unaudited ASCENIV $ 102,921 $ 83,321 $ 19,600 23.5 % $ 200,407 $ 159,653 $ 40,754 25.5 % BIVIGAM 19,419 37,710 (18,291 ) -48.5 % 34,841 71,222 (36,381 ) -51.1 % Intermediates and other products (1) 1,297 917 380 41.4 % 2,130 4,790 (2,660 ) -55.5 % ADMA BioManufacturing 123,637 121,948 1,689 1.4 % 237,378 235,665 1,713 0.7 % Plasma Collection Centers 723 - 723 100 % 1,439 1,050 388 37.0 % License revenue 35 36 (1 ) -2.7 % 71 71 - 0.0 % Total Revenues $ 124,395 $ 121,984 $ 2,411 2.0 % $ 238,888 $ 236,786 $ 2,101 0.9 % (1) Due to Nabi-HB historically representing less than 10% of the Company's revenue within the ADMA BioManufacturing segment, it has been included under intermediates and other products. ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENT OF CASH FLOWS Six Months Ended June 30, 2026 2025 (In thousands) Unaudited CASH FLOWS FROM OPERATING ACTIVITIES: Net income $ 83,150 61,122 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 3,620 4,027 Gain on sale of plasma centers (7,980 ) - Loss on disposal of fixed assets 42 - Deferred income tax provision 3,295 5,045 Stock-based compensation 12,464 9,587 Amortization of debt discount 383 350 Loss on extinguishment of debt - 1,159 Amortization of license revenue (71 ) (71 ) Changes in operating assets and liabilities: Accounts receivable 20,198 (59,726 ) Inventories (32,848 ) (21,229 ) Prepaid expenses and other current assets (1,181 ) (2,095 ) Deposits and other assets (22 ) (306 ) Accounts payable 8,846 9,409 Accrued expenses (1,478 ) (5,206 ) Other current and non-current liabilities (630 ) (602 ) Net cash provided by operating activities 87,788 1,464 CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment (4,799 ) (7,123 ) Acquisition of intangible assets (53 ) (124 ) Proceeds on the sales of assets held for sale 5,000 - Net cash provided by (used in) investing activities 148 (7,247 ) CASH FLOWS FROM FINANCING ACTIVITIES: Ares term loan payments - (30,000 ) Ares revolving facility proceeds - 30,000 JPM term loan payments (938 ) - JPM revolving facility proceeds 125,000 - Prepayment penalties on repayment of debt - (450 ) Taxes paid on vested restricted stock units (8,986 ) (8,419 ) Net proceeds from the exercise of stock options 623 2,165 Payment of end of term fee - (375 ) Acquisition of treasury stock (155,245 ) - Net cash used in financing activities (39,546 ) (7,079 ) Net increase (decrease) in cash and cash equivalents 48,390 (12,862 ) Cash and cash equivalents - beginning of period 87,630 103,147 Cash and cash equivalents - end of period $ 136,020 $ 90,285