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ADMA Biologics, Inc. (Nasdaq: ADMA) is an end-to-end commercial biopharmaceutical company dedicated to the development, manufacturing, and commercialization of specialty plasma-derived biologics. The company's core focus is on treating immunocompromised patients at risk of infection, particularly those with primary immune deficiency diseases (PIDD) and other infectious diseases. ADMA's mission is to deliver critical therapeutics to niche patient populations through its robust product portfolio.
The company's lead product, RI-002, has successfully completed a Phase III clinical trial for treating PIDD, meeting its primary endpoint. The Biologics License Application (BLA) for RI-002 was accepted by the U.S. Food and Drug Administration (FDA) on September 18, 2015, marking a significant milestone for ADMA. Additionally, the company has received numerous U.S. patents, including U.S. Patent 9,107,906, further solidifying its innovative approach to plasma-derived therapies.
ADMA's commercial product lineup includes three FDA-approved plasma-derived biologics:
- BIVIGAM® – Immune globulin intravenous for the treatment of primary humoral immunodeficiency (PI).
- ASCENIV™ – Immune globulin intravenous (human – slra 10% liquid), indicated for PI treatment.
- NABI-HB® – Hepatitis B immune globulin for enhanced immunity against the hepatitis B virus.
The company operates through two primary segments: ADMA BioManufacturing, which generates the majority of its revenue, and Plasma Collection Centers. ADMA BioCenters is responsible for collecting human plasma, a vital component for producing its therapeutic products. This network now includes multiple FDA-licensed collection centers across the United States.
ADMA has recently reported impressive financial milestones, including total revenues of $81.9 million for Q1 2024, a 44% year-over-year increase, and a Q1 2024 GAAP net income of $17.8 million, marking a significant turnaround. The company also reported first-time positive GAAP net income of $2.6 million in 3Q 2023, highlighting its profitable trajectory.
The company continues to innovate, leveraging technologies such as ADMAlytics™, an AI-driven platform aimed at optimizing production processes and improving operational efficiency. This platform is expected to provide substantial benefits across the company's supply chain and production operations.
ADMA's strategic growth initiatives include expanding its commercial product offerings, enhancing manufacturing yields, and advancing preclinical pipeline programs targeting S. pneumonia. The company has also secured a new $135 million credit facility to support its growth objectives further.
For more information about ADMA Biologics and its products, please visit the company's website at www.admabiologics.com.
ADMA Biologics reported a record total revenue of $17.8 million for Q2 2021, marking a 129% increase year-over-year, driven primarily by its intravenous immune globulin (IVIG) product portfolio. The company anticipates reaching an annualized revenue run rate of approximately $100 million by the end of 2021. Despite a net loss of $18.9 million for the quarter, improvements in revenue and gross margins were noted. Strategic initiatives, including an expanded production capacity and supply chain enhancements, position ADMA for continued growth and operational efficiencies in the future.
ADMA Biologics (NASDAQ: ADMA) has launched operations at its new plasma collection facility in Conyers, Georgia, marking a significant expansion in its BioCenters network. This center, now the eighth under ADMA, aims to enhance plasma collection efficiency with the introduction of Haemonetics’ Persona® Plasma Collection Solution, expected to increase yield by 9% to 12% per donation. ADMA plans to file a Biologics License Application for this facility in approximately three months, with full FDA review anticipated to take around 12 months. This development is poised to support ongoing revenue growth and profitability.
ADMA Biologics has expanded its commercial offering of Immune Globulin (IG) products by introducing additional vial sizes of BIVIGAM and NABI-HB, now available to U.S. healthcare providers.
These new sizes aim to enhance treatment flexibility, reduce drug wastage, and align with competitor offerings. The FDA has approved the 100 mL BIVIGAM vial, complementing the existing 50 mL option. ADMA anticipates that this broader range of vial configurations will facilitate targeted dosing and improve patient care.
ADMA Biologics, a biopharmaceutical company specializing in plasma-derived biologics, will announce its second-quarter financial results on August 11, 2021, after market close. A conference call will follow at 4:30 p.m. ET for discussion of the results and company updates. ADMA's products include ASCENIV™, BIVIGAM®, and NABI-HB®, all FDA-approved for treating immunodeficient patients. The company’s manufacturing is based in Boca Raton, Florida, and it operates FDA-approved plasma collection centers to support its production.
ADMA Biologics announced successful completion of a Pre-Approval Inspection by the FDA for its VanRx fill-finish machine at its Boca Raton facility, with zero observations noted. The company anticipates regulatory approval in the second half of 2021. This approval is expected to enhance internal production capabilities, improve gross margins, and create new revenue opportunities through third-party contracts. ADMA emphasizes its commitment to compliance with Good Manufacturing Practices amidst pandemic-related challenges.
ADMA Biologics, a biopharmaceutical company focused on specialty plasma-derived biologics, announced that CEO Adam Grossman will participate in a fireside chat at the Raymond James Human Health Innovation Virtual Conference on June 21, 2021, at 9:20 a.m. ET. The event will be available via webcast on the company's website and will be archived for 90 days. ADMA manufactures several FDA-approved products aimed at treating immunodeficient patients and operates an FDA-licensed plasma fractionation facility in Boca Raton, Florida.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced that CEO Adam Grossman will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 4:00 p.m. ET. The event will be accessible via a webcast on ADMA's website and will be archived for 90 days. ADMA is committed to developing specialty plasma-derived biologics for immunodeficient patients and currently offers three FDA-approved products: BIVIGAM®, ASCENIV™, and NABI-HB®. The company operates an FDA-licensed facility in Boca Raton, Florida, focusing on plasma fractionation and purification.
ADMA Biologics reported first-quarter 2021 revenues of $16.0 million, up 57% from $10.2 million in Q1 2020. The company increased total asset value to $235.7 million, including $94.1 million in inventories, aimed at supporting production growth in a supply-constrained IVIG market. ADMA narrowed net losses to $18.4 million or $(0.16) per share, an improvement from $(19.2 million) or $(0.26) per share last year. The FDA's approval for IVIG production scale expansion is expected to boost capacity by 50%.
ADMA Biologics will announce its financial results for Q1 2021 on May 12, 2021, after market close. The event will include a conference call at 4:30 p.m. ET to discuss financial performance and company updates. ADMA specializes in plasma-derived biologics for immunodeficient patients, holding FDA approvals for three products: ASCENIV™, BIVIGAM®, and NABI-HB®. The call can be accessed via phone or audio webcast, with availability for an archived recording soon after.
ADMA Biologics announces a significant expansion in manufacturing capacity, increasing from 400,000 liters to 600,000 liters, enhancing its potential peak revenues to exceed $300 million. The FDA has approved the company’s expanded manufacturing process for intravenous immune globulin (IVIG), which is expected to enhance gross margins and operational efficiencies starting late 2021 and throughout 2022. This expansion allows ADMA to produce IVIG using a 4,400-liter plasma pool, confirming its position in the market and paving the way for consistent revenue growth.
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