ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process

Rhea-AI Summary

ADMA Biologics (Nasdaq: ADMA) has received FDA approval for its innovative yield enhancement production process, marking a significant milestone for the biopharmaceutical company. The new process demonstrates an ability to increase production yields by approximately 20% from the same starting plasma volume, benefiting both ASCENIV and BIVIGAM products.

As the first U.S. producer of plasma-derived products to achieve this regulatory approval, ADMA expects meaningful acceleration in revenue and earnings trajectory beginning in late 2025 and accelerating into 2026. The company's internal R&D platform continues to advance, with ongoing development of novel pipeline programs including SG-001, a pre-clinical hyperimmune globulin targeting S. pneumonia.

Positive

• FDA approval received for innovative yield enhancement production process
• 20% increase in production output from same plasma volume
• Expected revenue and earnings acceleration starting late 2025
• First U.S. producer to achieve regulatory approval for this process
• Production enhancement applies to both ASCENIV and BIVIGAM products

Negative

• Benefits of yield enhancement won't materialize until late 2025

Insights

Pharmaceutical Manufacturing Expert

FDA approval of ADMA's yield process provides 20% more product from same plasma input, dramatically improving economics of -supply biologics.

The FDA approval of ADMA's innovative yield enhancement process represents a significant manufacturing breakthrough in the plasma therapeutics industry. The 20% production increase from the same plasma volume is particularly valuable because plasma is a biological resource that requires extensive collection and processing infrastructure.

In plasma fractionation, maximizing output from collected plasma is a fundamental driver of business economics. This approval creates a substantial competitive advantage by effectively increasing ADMA's production capacity without additional plasma collection - addressing one of the industry's primary constraints.

The technology benefits both ASCENIV and BIVIGAM, ADMA's immunoglobulin therapies for immunocompromised patients. This advancement demonstrates ADMA's manufacturing innovation capabilities, positioning them as the first U.S. plasma producer to receive approval for such a yield enhancement process.

This achievement directly addresses ongoing supply challenges in the immune globulin market while potentially expanding product availability for patients. The approval validates ADMA's internal R&D capabilities in process development - a specialized expertise that can be difficult for competitors to replicate quickly.

Financial Analyst

ADMA's FDA-approved yield enhancement creates dual financial catalysts: expanded revenue potential and improved margins from 20% more product per plasma unit.

The approval of ADMA's yield enhancement process delivers a compelling financial catalyst through dual economic benefits. The 20% production increase from the same plasma input effectively reduces per-unit manufacturing costs while expanding revenue potential.

This improvement is particularly significant because plasma acquisition and processing represents a substantial portion of cost of goods sold in this business. The enhanced efficiency effectively creates immediate margin expansion opportunity while potentially accelerating topline growth.

Management indicates financial impact will begin in late 2025 with acceleration through 2026 and beyond, suggesting this represents a fundamental long-term improvement to the company's financial profile rather than a one-time benefit.

This approval strengthens ADMA's competitive position in the plasma therapeutics market by improving their production economics and enabling them to potentially increase market share. The manufacturing innovation also validates ADMA's R&D capabilities, showing they can successfully develop and commercialize both process and product advancements - creating additional value from their existing development platform.

Approval Supports Revenue Growth and Margin Expansion Opportunity, and Substantially Increases Peak Production Output Capacity

First U.S. Regulatory Approval of Innovative IG Yield Enhancement Process Highlights ADMA’s Uniquely Efficient Internal R&D Engine, Spanning Production and Product Development Capabilities

Anticipate Approximately 20% Production Output Enhancement from Same Starting Plasma Volume

The 20% Yield Enhancement Will Benefit Both ASCENIV and BIVIGAM

RAMSEY, N.J. and BOCA RATON, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced U.S. FDA approval of its innovative yield enhancement production process. This innovative process has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma volume.

“This approval represents a pivotal milestone for ADMA, unlocking the opportunity for meaningful acceleration in our revenue and earnings trajectory beginning in late 2025 and accelerating further into 2026 and beyond,” said Adam Grossman, President and Chief Executive Officer of ADMA. “As the first U.S. producer of plasma-derived products to achieve regulatory approval for its innovative yield enhancement production process, ADMA continues to demonstrate its leadership in modernizing and advancing plasma fractionation through agile, forward-thinking scientific development and execution. We commend our team for driving this novel process from concept to approval with speed and capital efficiency, and we thank the FDA for its thorough and timely review as well as the Agency’s commitment to expanding immune globulin access for immunocompromised patients. Looking ahead, we are excited to continue to advance our internal R&D platform—further optimizing production capabilities and progressing novel pipeline programs, most notably SG-001, our pre-clinical, investigative hyperimmune globulin targeting S. pneumonia, which exemplify our commitment to product and process innovation.”

About ADMA Biologics, Inc. (ADMA)

ADMA Biologics is a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. Additionally, ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia. ADMA manufactures its immune globulin products and product candidates at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “supports,” “confident,” “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “position us,” “should,” “could,” “would,” “may,” “potential,” “opportunity” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about revenue growth, margin expansion and production output capacity as a result of FDA approval of the yield enhancement process, and timing related thereto, and our R&D platform. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

INVESTOR RELATIONS CONTACT:
Argot Partners | 212-600-1902 | ADMA@argotpartners.com

FAQ

What is the expected production yield increase from ADMA's new FDA-approved process?

ADMA's new FDA-approved process is expected to increase production yields by approximately 20% from the same starting plasma volume.

When will ADMA's new yield enhancement process impact revenues?

The revenue impact from the yield enhancement process is expected to begin in late 2025 and accelerate further into 2026 and beyond.

Which ADMA products will benefit from the new yield enhancement process?

Both ASCENIV and BIVIGAM products will benefit from the 20% yield enhancement process.

What makes ADMA's yield enhancement process approval significant for the industry?

ADMA is the first U.S. producer of plasma-derived products to receive FDA approval for this innovative yield enhancement production process.

What new products is ADMA developing in its pipeline?

ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia.