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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 revenues of $13.9 million for Q4 2020, marking a 16% increase from Q4 2019, and full-year revenues of $42.2 million, a 44% increase compared to 2019. The company anticipates significant value-creating FDA decisions in 2021 that could enhance supply chains and improve margins. ADMA plans to continue revenue growth and aims for revenues exceeding $250 million by 2024, supported by new plasma collection centers and expanded production capabilities.
ADMA Biologics announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new reimbursement C-code, C9072, and transitional pass-through payment status for ASCENIV, effective January 1, 2021. This approval facilitates streamlined reimbursement for ASCENIV in outpatient settings, allowing infusion at list price plus 6%. CEO Adam Grossman stated this is a significant milestone, enhancing insurance coverage and patient access. ADMA aims to achieve over $250 million in revenue from its products by 2024.
ADMA Biologics announced the approval of a stockholder rights plan by its Board of Directors on December 16, 2020, aimed at safeguarding stockholders from potential hostile takeovers. This plan allows for a dividend distribution of one right for each share of common stock, with a record date of December 30, 2020, and an expiration on December 15, 2021. The rights plan is triggered if ownership exceeds 10% without Board approval, enabling rights holders to purchase shares at a market value of twice the exercise price. Further details will be provided in SEC filings.
ADMA Biologics announced an amendment to its senior secured term loan with Perceptive Advisors, increasing the credit facility to $100 million. The amendment includes a two-year extension of the interest-only period, maturing in March 2024, at an unchanged borrowing rate of 11%. The $15 million tranche was used to settle obligations under a subordinated note with Biotest AG. ADMA aims to achieve $250 million in topline revenues by 2024 and aims for profitability before the loan's new maturity date.
ADMA Biologics has announced the opening of a new plasma collection facility in Maryville, Tennessee, which is part of its strategy to enhance plasma supply chain control. The facility is designed to support increased plasma collection throughput as the company aims to establish a self-sufficient supply chain. ADMA has submitted a Biologics License Application (BLA) for this center to the FDA, expecting a decision by Q4 2021. The facility will be equipped with advanced technology to improve donor experience and will employ 50 trained staff members.
ADMA Biologics (Nasdaq: ADMA) announced that its President and CEO, Adam Grossman, will participate in a fireside chat at the Jefferies 2020 Virtual London Healthcare Conference on November 17, 2020, at 7:55 a.m. ET. The event will be accessible via a webcast on the company's website, archived for 90 days post-event.
ADMA is focused on developing specialty plasma-derived biologics for immune-compromised patients and markets three FDA-approved products: BIVIGAM®, ASCENIV™, and NABI-HB®. The company operates a plasma fractionation facility in Boca Raton, Florida.
ADMA Biologics reported total revenues of $28.3 million for the first nine months of 2020, a 63% increase year-over-year. The third quarter generated $10.3 million, marking a 42% growth compared to Q3 2019. Despite revenue growth, net loss for the quarter was $16.9 million, attributed to rising costs and increased operational expenses. The company is ahead of schedule in expanding its plasma collection centers, aiming for five to ten new centers by 2025. ADMA's cash reserves rose to $59.7 million as of September 30, 2020.
ADMA Biologics announced a live conference call on November 5, 2020, at 4:30 p.m. ET, to discuss its Q3 2020 financial results and business highlights. The call will be accessible via phone and an audio webcast, with an archived version available two hours post-event. ADMA specializes in manufacturing and marketing plasma-derived biologics, including ASCENIV™, BIVIGAM®, and NABI-HB®, approved by the FDA for treating immunodeficient patients. More information can be found on their website.
ADMA Biologics, Inc. (Nasdaq: ADMA) is hosting an exclusive educational event at IDWeek 2020 on respiratory viral infections, featuring experts Dr. Michael Ison and Dr. Lisa Forbes Satter. The session on October 22 will focus on managing infections in immunocompromised patients. Additionally, new data on Streptococcus pneumoniae will be presented in an on-demand session. ADMA Biologics develops specialty plasma-derived biologics for immunodeficient patients, with FDA-approved products including ASCENIV™, BIVIGAM®, and NABI-HB® to combat infectious diseases.
ADMA Biologics, a biopharmaceutical company, will have its CEO Adam Grossman participate in a fireside chat at the Morgan Stanley Virtual Healthcare Conference on September 14, 2020, at 4:30 p.m. ET. This event will provide insights into the company's operations and product offerings, focusing on specialty plasma-derived biologics for immunodeficient patients. A webcast of the event will be available on the ADMA website and archived for 90 days. ADMA manufactures three FDA-approved products for treating immune deficiencies and infectious diseases.
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