ADMA

ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM®

Retrieved on: 
Monday, March 11, 2024

RAMSEY, N.J. and BOCA RATON, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.

Key Points: 
  • Approval of Extended Ambient Storage Conditions for ASCENIV & BIVIGAM is Immediately Effective and Now Commercially Available to U.S. Healthcare Providers
    RAMSEY, N.J. and BOCA RATON, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life.
  • The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.
  • “With the FDA-approved extension of room temperature storage conditions, the Company expects to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, President and Chief Executive Officer of ADMA.
  • “We believe that this added storage flexibility for both ASCENIV and BIVIGAM will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers.”
    The newly approved extension of room temperature storage conditions for both ASCENIV and BIVIGAM is immediately effective, and both products are commercially available to U.S. healthcare providers and patients.

ADMA Biologics Announces CFO Transition

Retrieved on: 
Wednesday, February 28, 2024

RAMSEY, N.J. and BOCA RATON, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced that Brian Lenz, Executive Vice President, Chief Financial Officer & General Manager, ADMA BioCenters will be transitioning from these positions to a consulting role, effective April 1, 2024.

Key Points: 
  • RAMSEY, N.J. and BOCA RATON, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced that Brian Lenz, Executive Vice President, Chief Financial Officer & General Manager, ADMA BioCenters will be transitioning from these positions to a consulting role, effective April 1, 2024.
  • During his tenure, Brian also successfully completed numerous financing transactions and completed the expansion of our ADMA BioCenters business unit.
  • We wish Brian all the best and look forward to continuing to work with him during this transition period,” stated Adam Grossman, President and Chief Executive Officer.
  • Lenz continued, “I wish the ADMA team continued success as the Company embarks on its bright future prospects.”
    Mr. Grossman has been appointed as Interim Chief Financial Officer, effective April 1, 2024.

ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its fourth quarter and full year 2023 financial results and provided a business update.
  • “We are pleased with our 2023 performance, which marked first-time positive adjusted net income on a full year basis.
  • We believe our unwavering focus on the immune deficient patient segment has allowed ADMA to establish itself as a premier provider of specialty biologics.
  • Fourth Quarter 2023 Financial Results:
    Total revenues were $73.9 million for the quarter ended December 31, 2023, as compared to $50.0 million for the quarter ended December 31, 2022, an increase of $23.9 million, or approximately 48%.

ADMA Biologics Successfully Implements Innovative AI Program, Named ADMAlytics

Retrieved on: 
Wednesday, February 21, 2024

RAMSEY, N.J. and BOCA RATON, Fla., Feb. 21, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty biologics, today announced the successful initial use of its Artificial Intelligence (“AI”) program, named ADMAlytics. ADMAlytics combines AI and machine learning to improve and predict outcomes for production and operational processes. Recently, ADMA successfully produced its first batch of ASCENIV™ utilizing this innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during commercial manufacturing. ADMA expects broad implementation of the new ADMAlytics capabilities has the potential to provide for rapid realization of efficiencies across the Company’s supply chain and production operations.

Key Points: 
  • RAMSEY, N.J. and BOCA RATON, Fla., Feb. 21, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty biologics, today announced the successful initial use of its Artificial Intelligence (“AI”) program, named ADMAlytics.
  • ADMAlytics combines AI and machine learning to improve and predict outcomes for production and operational processes.
  • Recently, ADMA successfully produced its first batch of ASCENIV™ utilizing this innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during commercial manufacturing.
  • “We're proud to announce the successful development and implementation of our innovative ADMAlytics AI program,” said Adam Grossman, President and Chief Executive Officer of ADMA.

ADMA Biologics Announces Preliminary Fourth Quarter 2023 Revenue and Provides Business Update

Retrieved on: 
Monday, January 8, 2024

FY 2024 and 2025 Total Revenue Guidance Increased to More than $320 Million and $370 Million, Respectively

Key Points: 
  • FY 2024 and 2025 Total Revenue Guidance Increased to More than $320 Million and $370 Million, Respectively
    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 08, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its preliminary unaudited fourth quarter and full year 2023 revenues and provided a business update.
  • Based on unaudited financial information, ADMA preliminarily estimates that its total revenue for the quarter- and year-ended December 31, 2023 will be between $72 million and $74 million and $256 million and $258 million, respectively.
  • The estimated Adjusted EBITDA amounts included herein are preliminary and reconciliations cannot be produced at this time without unreasonable effort.
  • We estimate that an S. pneumonia hyperimmune globulin, if approved, has the potential to generate peak revenue of $300-500 Million.

ADMA Biologics Announces $135 Million Non-Dilutive Refinancing of Credit Facilities with Ares Management

Retrieved on: 
Monday, December 18, 2023

RAMSEY, N.J. and BOCA RATON, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced the Company has executed a definitive credit agreement with Ares Management credit funds (“Ares”) for $135 million in total senior secured credit facilities, including a $72.5 million asset-backed revolving credit facility and a $62.5 million term loan. The proceeds of the senior secured credit facilities were fully drawn at closing and used, along with existing cash, to repay all obligations under the prior Hayfin Capital Management senior secured credit facility.

Key Points: 
  • New $135 Million Credit Facility Replaces Existing $159 Million Credit Facility, a 15% Decrease in Total Debt
    RAMSEY, N.J. and BOCA RATON, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced the Company has executed a definitive credit agreement with Ares Management credit funds (“Ares”) for $135 million in total senior secured credit facilities, including a $72.5 million asset-backed revolving credit facility and a $62.5 million term loan.
  • The proceeds of the senior secured credit facilities were fully drawn at closing and used, along with existing cash, to repay all obligations under the prior Hayfin Capital Management senior secured credit facility.
  • “This non-dilutive credit facility with Ares materially reduces ADMA’s nominal interest rate and significantly lowers our total debt by 15%, which further supports ADMA’s rapid earnings growth outlook,” said Adam Grossman, President and Chief Executive Officer of ADMA.
  • We look forward to finishing 2023 on a high note and embarking on 2024 from a position of strength."

ADMA Biologics Announces FDA Approval for BIVIGAM® in the Pediatric Patient Setting for Those 2 Years of Age and Older

Retrieved on: 
Tuesday, December 12, 2023

RAMSEY, N.J. and BOCA RATON, Fla., Dec. 12, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients 2 years of age and older.

Key Points: 
  • The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment.
  • Additionally, the approval provides for a revision of BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients 2 years of age and older.
  • "We are pleased to announce that BIVIGAM has received FDA approval for treating PI in patients aged 2 years and older.
  • Previously, the indication for BIVIGAM was restricted to PI patients aged 12 years and older,” said Adam Grossman, President and Chief Executive Officer of ADMA.

ADMA BioCenters Receives FDA Approval for its Tenth Plasma Collection Center, Located in Laurel, MD

Retrieved on: 
Thursday, November 16, 2023

RAMSEY, N.J. and BOCA RATON, Fla. and LAUREL, Md., Nov. 16, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (“FDA”) approval for its tenth ADMA BioCenters plasma collection facility located in Laurel, Maryland.

Key Points: 
  • RAMSEY, N.J. and BOCA RATON, Fla. and LAUREL, Md., Nov. 16, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (“FDA”) approval for its tenth ADMA BioCenters plasma collection facility located in Laurel, Maryland.
  • This plasma collection facility commenced operations and initiated source plasma collection in the first half of 2023.
  • The approval is a testament to the BioCenters team’s tireless commitment, and we thank the FDA for its efforts and expeditious review of the Laurel, MD Biologics License Application (“BLA”),” said Adam Grossman, President and Chief Executive Officer of ADMA.
  • This center is approved to use the state-of-the-art Haemonetics NexSys Persona® plasma collection system.

ADMA Biologics Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, November 8, 2023

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced its third quarter 2023 financial results and provided a business update.
  • Third Quarter 2023 Milestones & Objectives:
    Increased Revenue Guidance for Full Years (FY) 2023, 2024, and 2025.
  • 2023 & Long-Term Financial Guidance:
    Updated 2023 Financial Guidance: ADMA now anticipates FY 2023 total revenues to exceed $250 million, increased from $240 million previously.
  • As a result, ADMA achieved a gross margin of 36.6% in the third quarter of 2023 as compared to 23.5% in the third quarter of 2022.

ADMA Biologics Announces Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, August 9, 2023

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Aug. 09, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced its second quarter 2023 financial results and provided a business update.
  • Driven by 77% year-over-year revenue growth, which reached $60.1 million during the second quarter of 2023, ADMA grew Adjusted EBITDA to $6.4 million.
  • 2023 & Long-Term Financial Guidance:
    Updated 2023 Financial Guidance: ADMA now anticipates full year 2023 total revenues to meet or exceed $240 million, increased from $220 million previously.
  • As a result, ADMA achieved a gross margin of 27.8% in the second quarter of 2023 as compared to 22.9% in the second quarter of 2022.