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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 has priced a public offering of 50 million shares at $1.00 each, aiming to raise around $50 million before expenses. The offering is set to close on October 25, 2021, pending standard conditions. The company has extended a 30-day option for underwriters to purchase an additional 7.5 million shares. Proceeds will be used for enhancing commercial sales of FDA-approved products, expanding plasma collection facilities, increasing manufacturing capacity, exploring new business opportunities, and general corporate expenses.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced its intention to conduct an underwritten public offering of common stock. The company aims to grant underwriters a 30-day option to purchase an additional 15% of the shares. Proceeds from the offering will be used to advance commercial sales of FDA-approved products, expand the plasma collection facility network, scale manufacturing capacity, explore business development opportunities, and for general corporate purposes. The offering is subject to market conditions and is filed under a shelf registration statement with the SEC.
ADMA Biologics (ADMA) announced a poster presentation at the virtual 2021 ISIRV-WHO Conference on October 19-22. The poster details the clinical impact of ASCENIV™, a novel intravenous immune globulin, as a concomitant therapy for a patient with severe respiratory viral disease and COVID-19. ASCENIV, approved by the FDA in April 2019, treats primary humoral immunodeficiency (PI). ADMA manufactures and markets three FDA-approved plasma-derived biologics, focusing on immunocompromised patients and infectious diseases.
ADMA Biologics announced the appointment of Young T. Kwon, Ph.D., to its Board of Directors. Dr. Kwon brings over a decade of experience in corporate finance and strategic advising within the life sciences industry. His previous roles include C-suite positions and leading a $6.5 billion acquisition at Momenta Pharmaceuticals. Chairman Steven Elms emphasized Dr. Kwon's strategic insights as crucial for ADMA's revenue growth in its immunoglobulin product line. Dr. Kwon expressed his commitment to enhancing shareholder value by maximizing the potential of ADMA's biologics manufacturing platform.
ADMA Biologics, Inc. (Nasdaq: ADMA) has announced on-demand access to an educational event at IDWeek 2021 focused on respiratory viral infections. Renowned experts Dr. Michael Ison and Dr. Jolan Walter highlighted the benefits of ASCENIV™, an intravenous immunoglobulin product, in treating pediatric patients with primary immunodeficiency and RSV. The presentation included two illustrative cases demonstrating ASCENIV's efficacy. Approved by the FDA in April 2019, ASCENIV is designed for treating primary humoral immunodeficiency and is backed by proprietary manufacturing methods.
ADMA Biologics has announced an exclusive educational event at IDWeek 2021, focusing on respiratory viral infections, including RSV. The event features expert discussions by Dr. Michael Ison and Dr. Jolan Walter addressing key clinical challenges and introducing ASCENIV™, a novel intravenous immunoglobulin. ASCENIV is FDA-approved for treating primary immune deficiency and is manufactured using a unique plasma donor screening methodology. The session will occur on October 1, 2021, from 1:00 PM to 1:45 PM ET at the IDWeek Learning Lounge.
ADMA Biologics (Nasdaq: ADMA) will participate in a virtual fireside chat at the Cantor Healthcare Conference on September 30, 2021, at 9:20 a.m. ET. Adam Grossman, President and CEO, will lead the discussion. A webcast of the event will be available on the company’s website and archived for 90 days. ADMA specializes in the manufacturing and marketing of plasma-derived biologics, currently offering three FDA-approved products for immunodeficient patients and those at risk of infectious diseases. The company operates an FDA-licensed facility in Boca Raton, Florida.
ADMA Biologics has received FDA approval for its in-house aseptic fill-finish machine, the VanRx SA25, marking a pivotal development in its supply chain strategy. This approval allows ADMA to handle internal fill-finish operations, improving gross margins, patient supply consistency, and reducing production cycle times. The VanRx's advanced design enhances operational control and visibility over product releases. Additionally, the approval opens doors for new contract manufacturing opportunities, positioning ADMA to potentially exceed its financial targets and sustain revenue growth.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced that CEO Adam Grossman will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 12:30 p.m. ET. A webcast of this event will be available on ADMA's website and will be archived for 90 days following the event. ADMA specializes in developing plasma-derived biologics aimed at treating immunodeficient patients and is known for FDA-approved products such as BIVIGAM®, ASCENIV™, and NABI-HB®.
ADMA Biologics, Inc. has received FDA approval for its ADMA BioCenters plasma collection facility in Maryville, Tennessee, enhancing its ability to collect human source plasma. This facility started operations in Q4 2020 and is now licensed to introduce plasma into interstate commerce. With a goal of operating 10+ FDA-approved centers by 2024, ADMA aims to secure plasma supply and control manufacturing operations. The center is equipped with advanced technology and aims to employ 50 staff at full capacity, while offering new donors competitive compensation for contributions.
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