ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process
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.
ADMA Biologics (Nasdaq: ADMA) ha ottenuto l'approvazione FDA per il suo innovativo processo di produzione che migliora la resa, segnando un traguardo importante per l'azienda biofarmaceutica. Il nuovo processo dimostra la capacità di aumentare la produzione di circa il 20% a parità di volume di plasma iniziale, a vantaggio sia dei prodotti ASCENIV che BIVIGAM.
Essendo il primo produttore statunitense di prodotti derivati dal plasma a ottenere questa approvazione normativa, ADMA prevede un'accelerazione significativa dei ricavi e degli utili a partire dalla fine del 2025, con un'accelerazione ulteriore nel 2026. La piattaforma interna di R&S dell'azienda continua a progredire, con lo sviluppo in corso di nuovi programmi pipeline, incluso SG-001, un immunoglobulina iperimmune preclinica mirata contro S. pneumoniae.
ADMA Biologics (Nasdaq: ADMA) ha recibido la aprobación de la FDA para su innovador proceso de producción que mejora el rendimiento, marcando un hito importante para la compañía biofarmacéutica. El nuevo proceso demuestra la capacidad de aumentar la producción en aproximadamente un 20% con el mismo volumen inicial de plasma, beneficiando tanto a los productos ASCENIV como BIVIGAM.
Como el primer productor estadounidense de productos derivados del plasma en obtener esta aprobación regulatoria, ADMA espera una aceleración significativa en los ingresos y ganancias a partir de finales de 2025, con un impulso mayor en 2026. La plataforma interna de I+D de la empresa continúa avanzando, con el desarrollo en curso de nuevos programas en la cartera, incluyendo SG-001, una globulina hiperinmune preclínica dirigida contra S. pneumoniae.
ADMA Biologics (나스닥: ADMA)는 혁신적인 수율 향상 생산 공정에 대해 FDA 승인을 받으며 바이오제약 회사로서 중요한 이정표를 세웠습니다. 이 새로운 공정은 동일한 시작 혈장량으로부터 생산 수율을 약 20% 증가시킬 수 있음을 입증했으며, ASCENIV 및 BIVIGAM 제품 모두에 혜택을 제공합니다.
미국 내 혈장 유래 제품 생산업체 중 최초로 이 규제 승인을 획득한 ADMA는 2025년 말부터 매출 및 수익 성장세가 가속화되기 시작해 2026년에는 더욱 가속화될 것으로 기대하고 있습니다. 회사의 내부 연구개발 플랫폼은 계속 발전 중이며, S. pneumoniae를 표적으로 하는 전임상 하이퍼면역글로불린 SG-001을 포함한 새로운 파이프라인 프로그램 개발도 진행 중입니다.
ADMA Biologics (Nasdaq : ADMA) a obtenu l'approbation de la FDA pour son processus de production innovant améliorant le rendement, marquant une étape importante pour cette entreprise biopharmaceutique. Ce nouveau procédé démontre une capacité à augmenter les rendements de production d'environ 20% à partir du même volume initial de plasma, bénéficiant aux produits ASCENIV et BIVIGAM.
En tant que premier producteur américain de produits dérivés du plasma à obtenir cette approbation réglementaire, ADMA prévoit une accélération significative de ses revenus et bénéfices à partir de la fin 2025, avec une accélération supplémentaire en 2026. La plateforme interne de R&D de l'entreprise continue de progresser, avec le développement en cours de nouveaux programmes en pipeline, notamment SG-001, un immunoglobuline hyperimmune préclinique ciblant S. pneumoniae.
ADMA Biologics (Nasdaq: ADMA) hat die FDA-Zulassung für seinen innovativen Produktionsprozess zur Steigerung der Ausbeute erhalten, was einen bedeutenden Meilenstein für das biopharmazeutische Unternehmen darstellt. Der neue Prozess zeigt die Fähigkeit, die Produktion um etwa 20% bei gleichem Ausgangsvolumen an Plasma zu erhöhen, was sowohl den Produkten ASCENIV als auch BIVIGAM zugutekommt.
Als erster US-amerikanischer Hersteller von plasma-abgeleiteten Produkten, der diese behördliche Zulassung erhält, erwartet ADMA ab Ende 2025 eine deutliche Beschleunigung bei Umsatz und Gewinn, die sich 2026 weiter verstärken wird. Die interne F&E-Plattform des Unternehmens entwickelt sich weiterhin weiter, mit laufender Entwicklung neuer Pipeline-Programme, darunter SG-001, ein präklinisches hyperimmunes Globulin, das auf S. pneumoniae abzielt.
- 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
- Benefits of yield enhancement won't materialize until late 2025
Insights
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.
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
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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
“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
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.
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FAQ
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