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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, Inc. (NASDAQ: ADMA) announced the opening of its new plasma collection facility in Goose Creek, South Carolina, marking a significant expansion in its operations. Governor Henry McMaster participated in the ribbon-cutting ceremony, highlighting South Carolina's favorable environment for plasma collection. ADMA aims to have 10 or more facilities operational by 2024 to meet growing plasma demand. The new facility will enhance ADMA's self-sufficient plasma supply chain and support revenue growth. A Biologics License Application (BLA) is expected to be filed in three months.
ADMA Biologics presented a poster at the 2021 Academy of Managed Care Pharmacy Annual Meeting, emphasizing the substantial healthcare costs associated with Hepatitis B Virus (HBV) and its higher transmission risk compared to HIV. The analysis advocates for aligning CDC treatment guidelines for sexual assault victims exposed to HBV with those for HIV. The proposed intervention involves using Nabi-HB, a hyperimmune globulin, to provide cost-effective prophylaxis. CEO Adam Grossman urges policymakers to address this unmet patient need to mitigate clinical and financial consequences for the healthcare system.
ADMA Biologics reported a full year 2020 revenue of $42.2 million, marking a 44% increase from 2019. The company anticipates revenues of $250 million or more by 2024, driven by expanded plasma collection centers and improved product offerings. Despite revenue growth, ADMA faced a consolidated net loss of $75.7 million, an increase attributed to higher operational costs and investments in commercialization. The firm successfully expanded its plasma collection network and expects significant operational efficiencies with FDA approvals mid-year.
ADMA Biologics will report its financial results for Q4 and full year 2020 on March 25, 2021, after market close. The executive team will host a conference call at 4:30 p.m. ET to discuss these results, along with updates on the company's operations and products. ADMA produces FDA-approved plasma-derived biologics aimed at treating immunodeficient patients. The conference call can be accessed by dialing the provided numbers or via a live audio webcast on the company's investor website.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced that CEO Adam Grossman will participate in a fireside chat at the Jefferies Virtual Plasma Summit on March 11, 2021, at 11:20 a.m. ET. Interested parties can view the event via a webcast on the company’s website, which will be archived for 90 days post-event. The company specializes in manufacturing and marketing FDA-approved plasma-derived biologics aimed at treating immunodeficient patients and preventing infectious diseases. ADMA's key products include BIVIGAM®, ASCENIV™, and NABI-HB®.
ADMA Biologics, Inc. (NASDAQ: ADMA) has received approval from the Korean Ministry of Food and Drug Safety for its Kennesaw, Georgia plasma collection center to sell source plasma in South Korea. This approval, alongside FDA approval for a Hepatitis B immunization program at the center, marks a significant regulatory milestone for ADMA. These advancements align with ADMA's strategy to enhance its global presence and secure its supply chain for plasma-derived biologics, aimed at treating immune deficiencies and infectious diseases.
ADMA Biologics highlights a poster presentation at the AAAAI 2021 Conference, showcasing a potential polyclonal hyperimmune globulin targeting S. pneumoniae. This therapy aims to improve clinical outcomes for immune-compromised patients, bridging the gap between vaccination and seroconversion. CEO Adam Grossman emphasized the importance of addressing infection risks despite existing vaccines. The company holds patents related to this hyperimmune globulin, aiming to expand its product pipeline for underserved patient populations.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced that CEO Adam Grossman will participate in a fireside chat at the Raymond James Institutional Investor Conference on March 1, 2021, at 10:50 a.m. ET. The event will be available via webcast on the company’s website and will be archived for 90 days. ADMA focuses on manufacturing and developing specialty plasma-derived biologics, with three FDA-approved products aimed at treating immunodeficient patients and preventing infectious diseases.
ADMA Biologics, Inc. (NASDAQ: ADMA) has received FDA approval for its ADMA BioCenters plasma collection facility in Knoxville, Tennessee, which began operations in Q3 2020. This approval enhances the company's raw material supply chain and manufacturing control. ADMA aims to open up to ten plasma collection centers by 2024. The facility uses state-of-the-art equipment and employs 50 trained healthcare workers. This milestone is expected to improve product yields and margins, positioning ADMA for future growth and profitability.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced that CMS has issued a permanent J-code (J1554) for ASCENIV™, effective April 1, 2021, enhancing reimbursement processes. This J-code is expected to facilitate patient access and simplify claims processing in outpatient settings. CEO Adam Grossman highlighted that this milestone supports the company's goal of achieving over $250 million in revenue by 2024. ASCENIV is a plasma-derived immune globulin approved for treating primary immunodeficiency in patients aged 12 and older.
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