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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) will announce its Q1 2022 financial results on May 11, 2022, after market close. A live conference call is scheduled for the same day at 4:30 p.m. ET to discuss these results and other company updates. ADMA specializes in plasma-derived biologics aimed at immunodeficient patients and currently markets three FDA-approved products: ASCENIV™, BIVIGAM®, and NABI-HB®. The company operates from its Boca Raton, Florida facility and maintains FDA approval for its processes and products.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced a poster presentation and Key Opinion Leader symposium on respiratory viral infections (RVIs) and ASCENIV, its FDA-approved IVIG product. The poster, presented by Dr. Kevin Rosenbach, highlights ASCENIV’s real-world outcomes for patients with primary immunodeficiency (PI) suffering from chronic respiratory infections. Additionally, discussions led by Dr. Jolan Walter and Dr. Dareen Siri will focus on the management of RVIs and clinical use of ASCENIV. ASCENIV is designed for treating primary humoral immunodeficiency, leveraging a unique plasma donor screening methodology.
ADMA Biologics has announced FDA approval to extend the shelf life of its ASCENIV and BIVIGAM immune globulin products from 24 to 36 months. This approval applies to all sizes and production scales, enhancing inventory management for healthcare providers. CEO Adam Grossman stated this milestone reflects improvements in ADMA’s manufacturing processes and supports a stronger market position amid fluctuating demand. The updated products are now available to U.S. healthcare providers, potentially increasing market penetration and addressing patient needs more effectively.
ADMA Biologics reported total revenues of approximately $81 million for full year 2021, a 92% increase from 2020. The company's gross profitability was attributed to a higher-margin product mix and increased market penetration. ADMA completed a $175 million debt refinancing with Hayfin Capital Management, extending its interest-only period to March 2027, significantly improving its cash position. For 2022, ADMA expects revenues to exceed $125 million, signifying a projected growth rate of over 50% compared to 2021.
ADMA Biologics has announced it will report its financial results for Q4 2021 and the full year on March 24, 2022, after U.S. markets close. The company, which specializes in plasma-derived biologics for immunodeficient patients, will host a conference call on the same day at 4:30 p.m. ET to discuss these results. ADMA currently markets three FDA-approved products: ASCENIV™, BIVIGAM®, and NABI-HB®. It operates an FDA-licensed facility in Boca Raton, FL, and is dedicated to treating and preventing infectious diseases.
ADMA Biologics has received FDA approval for its fifth plasma collection facility in Conyers, Georgia, enhancing its aim for plasma supply self-sufficiency. This facility, operational since Q3 2021, can now collect human source plasma for manufacturing. With a target of having 10 FDA-approved centers by year-end 2023, ADMA is strengthening its position in the U.S. immunoglobulin market. The new center boasts advanced collection technology and a focus on donor comfort and safety, with a staff of 50 at full capacity.
ADMA Biologics reported preliminary unaudited Q4 2021 revenues of approximately $26 million, marking an 86% increase from Q4 2020. For the full year 2021, revenues reached approximately $81 million, up 92% from 2020. The company emphasizes its robust manufacturing and supply chain, leading to a projected annualized revenue run rate exceeding $100 million. ADMA has also strengthened its cash position through a $53.9 million public offering and is actively pursuing debt refinancing. The ongoing expansion of its plasma collection centers is expected to enhance revenue growth.
ADMA Biologics has received FDA approval for its fourth plasma collection center in Goose Creek, South Carolina. This center can now legally collect human source plasma for further manufacturing. With this approval, ADMA aims to meet its target of having ten FDA-licensed plasma centers by the end of 2023. Currently, it operates four licensed centers with plans for additional facilities. The company anticipates that its strong plasma supply position will facilitate customer acquisition in the U.S. immunoglobulin market despite ongoing industry challenges.
ADMA Biologics has implemented a 6-month stockholder rights plan to shield itself and its shareholders from unwanted takeover bids. Each shareholder will receive one right for every outstanding common stock share, effective from December 30, 2021. The plan will conclude on June 15, 2022. This strategy is part of a broader review of financial and strategic alternatives, without indicating any current takeover threat. The rights plan is designed to ensure that any acquisition attempts are evaluated thoroughly by ADMA's Board of Directors.
ADMA Biologics has secured European Patent No. 3375789 for treating and preventing S. pneumoniae infections using standardized hyperimmune globulins. This patent strengthens ADMA's existing U.S. patents, enhancing its position in developing hyperimmune therapies for vulnerable populations. CEO Adam Grossman highlighted the patent's potential to attract collaboration in addressing unmet medical needs. ADMA aims to leverage its proprietary technology to develop hyperimmune globulins for infectious diseases. The patent is part of ADMA's broader strategy to expand its intellectual property portfolio.
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