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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 secured FDA approval for its eighth plasma collection facility located in Hammond, Louisiana, supporting its goal of plasma supply self-sufficiency and ongoing revenue growth. This facility, operational since Q2 2022, can now legally collect human source plasma for plasma-derived biologics. The company aims to have all ten centers FDA-licensed by year-end 2023, further enhancing productivity and profitability. The state-of-the-art center features advanced technology and aims to employ 50 healthcare workers at full capacity.
ADMA Biologics has reported preliminary unaudited total revenues for Q4 2022 of approximately $49-$50 million, marking an 89% year-over-year increase. Full-year revenues for 2022 are estimated at $153-$154 million, a growth of 90% compared to 2021. For 2023, the company expects revenues to exceed $210 million, reflecting a projected growth rate of about 40%. Notably, ADMA anticipates achieving positive EBITDA for the first time in the second half of 2023, supported by an expanding product line and operational efficiencies.
ADMA Biologics received FDA approval for room temperature storage of its products ASCENIV and BIVIGAM for up to 4 weeks during the first 24 months of their 36-month shelf life. This approval enhances product accessibility for healthcare providers by alleviating supply chain constraints related to refrigeration. The room temperature storage capability is effective immediately, making these products commercially available to U.S. healthcare providers, thus improving inventory management and ease of administration.
ADMA Biologics, Inc. (Nasdaq:ADMA) has successfully closed its underwritten public offering, selling 20,979,020 shares at $2.86 per share, raising $69 million in total gross proceeds, including $9 million from an overallotment option. The funds will be allocated towards accelerating commercialization, completing plasma center buildouts, and FDA approvals, alongside general corporate purposes. Raymond James, Cantor Fitzgerald, and Mizuho acted as joint book-running managers. The offering was made under a previously filed 'shelf' registration statement.
ADMA Biologics, Inc. (Nasdaq:ADMA) has announced a public offering of 20,979,020 shares of its common stock at $2.86 per share, aiming for gross proceeds of approximately $60 million. The offering is expected to close on December 9, 2022, with a 30-day option for underwriters to purchase an additional 3,146,853 shares. Proceeds will support commercialization, production activities, plasma center buildout, and FDA approvals. Raymond James, Cantor Fitzgerald, and Mizuho Securities are managing the offering.
ADMA Biologics announced plans for an underwritten public offering of common stock, with underwriters receiving a 30-day option to purchase up to 15% more shares. The offering is contingent on market conditions and the exact size is yet to be determined. Proceeds will be allocated towards commercialization, plasma center expansion, FDA approvals, R&D, and working capital. This follows the company's strategic focus on developing specialty plasma-derived biologics. The offering will be filed under a previously effective registration statement with the SEC.
ADMA Biologics has announced preliminary estimates for its total revenue for Q4 and the full year of 2022. The company expects revenues for Q4 to be between $48 million and $50 million, representing over 85% year-over-year growth from $26.4 million in Q4 2021. For the entire year, projected revenues range from $152 million to $154 million. ADMA specializes in manufacturing and marketing plasma-derived biologics treating immunodeficient patients, further solidifying its position in the biopharmaceutical sector.
ADMA Biologics reported a 99% year-over-year revenue increase for Q3 2022, totaling $41.1 million, with gross profit rising to $9.7 million. The company has raised its FY 2022 revenue guidance to $145 million from $130 million. Gross margins are expected to improve as legacy lower-margin BIVIGAM inventory is exhausted. Operational losses narrowed to $14.9 million, down from $17.7 million in 2021. ADMA anticipates achieving profitability by early 2024, with long-term revenue targets set at approximately $250 million in 2024 and $300 million thereafter.
ADMA Biologics (Nasdaq: ADMA) announced it will release its financial results for Q3 2022 on November 9, 2022, after market close. Management will host a conference call at 4:30 p.m. ET the same day to discuss the results and company updates. ADMA specializes in manufacturing and marketing plasma-derived biologics for immunocompromised patients. It currently offers three FDA-approved products including ASCENIV™ and BIVIGAM® for primary immunodeficiency. The company operates a licensed facility in Boca Raton, Florida, and is committed to supporting niche patient populations.
ADMA Biologics announced FDA approval for its seventh plasma collection facility in Greensboro, North Carolina, enhancing its plasma supply self-sufficiency and revenue growth. This new facility, operational since Q1 2022, now complies with FDA standards for human source plasma collection. ADMA aims to achieve ten FDA-licensed plasma centers by the end of 2023, with this being the fourth approval this year. The facility features advanced technology to improve donor experience and is expected to employ 50 trained healthcare professionals.
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