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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 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.
ADMA Biologics has announced the election of Cyndi Tolman, Senior Vice President of Plasma Services, to the PPTA Source Board for the 2022-2024 term. This appointment is seen as a recognition of her leadership in expanding the ADMA BioCenters collection network. President and CEO Adam Grossman expressed confidence in Tolman's experience to advocate for access to plasma-derived therapies. The PPTA works to ensure affordable therapies and support regulatory dialogue. ADMA operates FDA-licensed facilities for plasma collection and has three FDA-approved plasma-derived biologics in its portfolio.
ADMA Biologics has expanded its operational footprint with the opening of a new plasma collection center in Myrtle Beach, SC. This addition brings the total to six operational centers, with three more under construction, highlighting the company's strategy to enhance its plasma supply chain. By the end of 2023, ADMA aims to have ten licensed plasma centers, bolstering its revenue growth potential for its commercial Immune Globulin portfolio. The new center is equipped with advanced technology to improve donation efficiency and is expected to support the company's goal of self-sufficiency in plasma supply.
ADMA Biologics reported a strong third quarter of 2021, with revenues of $20.7 million, reflecting a 101% increase from the previous year. For the first time, the company achieved a positive gross profit of approximately $0.4 million, narrowing its net loss to $17.7 million. The company's balance sheet was strengthened by a public offering, raising $57.5 million in gross proceeds. Looking ahead, ADMA aims to reach profitability by the first quarter of 2024 and is expanding its plasma collection network.
ADMA Biologics will announce its Q3 2021 financial results on November 10, 2021, after U.S. markets close. A conference call will follow at 4:30 p.m. ET to discuss these results and provide company updates. ADMA, focused on specialty plasma-derived biologics, has three FDA-approved products: ASCENIV™, BIVIGAM®, and NABI-HB®, aimed at treating immunodeficient patients. The company manufactures these products at its FDA-licensed facility in Florida.
ADMA Biologics announced the closing of its underwritten public offering of 50 million shares at $1.00 per share, with an additional 7.5 million shares sold through the underwriters’ option, totaling $57.5 million in gross proceeds. The funds will support the commercial sales of FDA-approved products, expand plasma collection facilities, increase manufacturing capacity, and explore business development opportunities. The offering was conducted under a previously filed shelf registration statement.
ADMA Biologics (ADMA) presented a poster at the ISIRV-WHO Conference detailing ASCENIV™'s use in treating a COVID-19 patient with severe respiratory distress. The study involved a 70-year-old male with bronchiectasis whose condition improved after receiving ASCENIV™ alongside other treatments. Ultimately, the patient's respiratory function recovered, indicating potential benefits of ASCENIV™ for vulnerable populations battling severe respiratory diseases. Further research is required to validate these findings.
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