1. Achieved Full Year 2020 Total Revenues of $42.2 Million, a 44% Increase Over Full Year 2019

    Accelerated ADMA BioCenters Plasma Collection Network Expansion Guidance; Anticipates Having 10 or More Plasma Collection Centers in Operation by 2024

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., March 25, 2021 (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 reported financial results for its fiscal fourth quarter and year ended December 31, 2020 and provided an overview of recent progress and accomplishments…

    Achieved Full Year 2020 Total Revenues of $42.2 Million, a 44% Increase Over Full Year 2019

    Accelerated ADMA BioCenters Plasma Collection Network Expansion Guidance; Anticipates Having 10 or More Plasma Collection Centers in Operation by 2024

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., March 25, 2021 (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 reported financial results for its fiscal fourth quarter and year ended December 31, 2020 and provided an overview of recent progress and accomplishments.

    "In a year full of unprecedented health and economic challenges due to the pandemic, the ADMA team's unwavering commitment produced remarkable achievements across all our business segments," said Adam Grossman, President and Chief Executive Officer of ADMA Biologics. "Operationally, while enacting all the medically recommended COVID-19 safeguards to protect our patients, employees and customers, we successfully expanded our plasma collection center network ahead of schedule and delivered on all of our manufacturing and regulatory objectives as a part of our supply chain enhancement initiatives. We generated record revenues of $42.2 million despite COVID-19 headwinds, and because of our strong commercial execution, we confidently provided first-time peak annual revenue guidance of $250 million or greater expected to be achieved in 2024 and additionally committed to reaching profitability no later than the first quarter of 2024."

    "On the financial front, we substantially strengthened our balance sheet with year-end 2020 assets totaling $207.7 million, significantly growing inventories to a year-end balance of $81.5 million as well as increasing accounts receivable and investments in property, plant and equipment. We look forward to continuing to deliver quarter-over-quarter revenue growth and execute on our strategy during 2021, building on the momentum created by 2020's achievements across all of our business segments," concluded Mr. Grossman.

    Select 2020 Achievements & Recent Corporate Developments:

    • Executed Commercially with Significant Year-Over-Year Revenue Growth. Achieved full year 2020 total revenues of $42.2 million, compared to $29.3 million for the full year 2019, reflecting a substantial 44% increase. Achieved fourth quarter 2020 total revenues of $14.0 million, compared to $12.0 million for the fourth quarter of 2019, representing an approximately 16% increase. 



    • Substantially Increased Inventory Levels. Grew inventories to a year-end 2020 balance of $81.5 million compared to $53.1 million at year-end 2019, which we regard as a solid basis to support our anticipated quarter-over-quarter revenue growth in 2021 and beyond. This inventory consists of raw materials, including source plasma, work-in-process and finished goods.



    • Refinanced Senior Secured Term Loan. Refinanced senior secured term loan with Perceptive Advisors, which among other things, lowered the effective cost of capital, consolidated ADMA's long-term debt and provided for a two-year extension of the interest-only period through March 2024, which we believe will allow ADMA to reach profitability prior to maturity.



    • Expanded Plasma Collection Center Network. With the approval of another plasma collection facility in early February, ADMA now has seven plasma collection facilities under its corporate umbrella at various stages of development and approval, including one facility pending Biologics License Application ("BLA") approval in the second half of this year, and two additional plasma collection centers which we intend to open and file BLAs during 2021. Accordingly, we have revised our previous guidance from building 5-10 plasma collection facilities by 2024 to our current expectation of having 10 or more plasma collection facilities in operation by 2024.



    • Advanced Supply Chain Enhancement Initiatives. We remain on track to receive potential United States Food and Drug Administration ("FDA") approval decisions mid-year for our Intravenous Immune Globulin ("IVIG") increased production capacity scale, as well as our in-house Vanrx aseptic fill-finish machine. Upon FDA approval, ADMA expects to realize significant operating efficiencies and improved gross margins beginning potentially as early as mid-2021, which will ultimately support durable profitability and a fully vertically integrated value chain.



    • Strengthened ASCENIV's Coverage and Patient Access. Secured a permanent J-code, to be effective April 1, 2021, which will provide for a streamlined and permanent reimbursement process in outpatient treatment settings.



    • Continued Medical Community Engagement. At the recent American Academy of Allergy, Asthma & Immunology Conference ("AAAAI"), ADMA presented a late-breaking abstract detailing data that underscore the exciting prospect of bridging vaccination and protective seroconversion with a targeted, plasma-derived hyperimmune anti S. pneumonia globulin to ensure protection against infection for at-risk patients in the hospital and outpatient settings. Our existing intellectual property portfolio includes issued patents on the composition of matter and methods of use for producing a standardized hyperimmune globulin targeted to the most common 23 serotypes of S. pneumoniae bacteria. We will continue to evaluate opportunities to expand our pipeline and future product offerings to maximize value for our shareholders.



    • Received Several Industry Awards.   Our organization's 2020 achievements were recognized in the form of several third-party accolades, including receiving the BioNJ Innovator of the Year Award, being included on the Deloitte Fast 500 List as well as in 2021 our CEO being voted a Top 10 Biotech Executive by Healthcare Technology Report.

    Fourth Quarter 2020 Financial Results

    Total revenues for the quarter ended December 31, 2020 were $14.0 million, compared to $12.0 million for the quarter ended December 31, 2019, representing an increase of approximately $2.0 million, or approximately 16%. The revenue growth for the fourth quarter of 2020, compared to the fourth quarter of 2019, was favorably impacted by the continued commercial ramp up of our IVIG product portfolio.

    Consolidated net loss for the quarter ended December 31, 2020 was $19.4 million, or $(0.20) per basic and diluted share, compared to a consolidated net loss of $10.6 million, or $(0.18) per basic and diluted share, for the quarter ended December 31, 2019. The $8.8 million increase in net loss compared to the prior year period was primarily attributable to increased cost of product revenue of $7.4 million; increases in selling, general and administrative expenses of $2.3 million related to employee compensation, new hires along with other costs to support the commercialization efforts for BIVIGAM® and ASCENIV™ and a $0.5 million increase in research and development expenses mainly related to increased costs associated with clinical studies. The increased net loss additionally includes $1.1 million in higher plasma center operating expenses due to the opening of additional plasma centers during 2020. Included in the net loss for the fourth quarter of 2020 were non-cash expenses of approximately $2.4 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    Full Year 2020 Financial Results

    Total revenues for the year ended December 31, 2020 were $42.2 million, compared to $29.3 million for the year ended December 31, 2019, representing an increase of $12.9 million, or 44%. The increase in revenues was primarily attributable to increased sales of our IVIG products portfolio offset by lower plasma collection revenues.

    Consolidated net loss for the year ended December 31, 2020 was approximately $75.7 million, or $(0.88) per basic and diluted share, compared to a consolidated net loss of $48.3 million, or $(0.89) per basic and diluted share, for the year ended December 31, 2019. The increase in net loss of approximately $27.4 million was primarily attributable to a $21.8 million increase in cost of product revenue, which reflects the increase in sales volume as well as $7.5 million of non-recurring production charges incurred for the manufacturing of BIVIGAM conformance lots at an increased plasma pool production scale in connection with our planned capacity expansion. The increase in net loss in 2020 was also attributable to increased selling, general administrative expenses of approximately $9.1 million related to the overall growth in the size and scope of the Company's operations, including the commercialization efforts of BIVIGAM® and ASCENIV™; a $3.6 million increase in research and development expenses associated with the validation for a capacity expansion of a new filling line and increases in various clinical research activities, some of which are required by the FDA. Included in the net loss for the year ended 2020 were non-cash expenses of $8.6 million for stock-based compensation, depreciation and amortization and non-cash interest expense.

    At December 31, 2020, ADMA had cash and cash equivalents of $55.9 million and accounts receivable of $13.2 million, compared to cash and cash equivalents of $26.8 million and accounts receivable of $3.5 million at December 31, 2019. ADMA's net working capital as of December 31, 2020 was $133.8 million, compared to $71.8 million as of December 31, 2019.  

    Conference Call Information

    ADMA will host a conference call today, March 25, 2021, at 4:30 p.m. Eastern Time, to discuss the fiscal fourth quarter and full year 2020 financial results and recent corporate updates. To access the conference call, please dial (855) 884-8773 or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 5109699. A live audio webcast of the call will be available under "Events & Webcasts" in the Investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.   An archived webcast will be available on the Company's website approximately two hours after the event.

    About BIVIGAM®

    BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies.   Certain data and other information about BIVIGAM® or ADMA Biologics and its products can be found on the Company's website at www.admabiologics.com.

    About ASCENIV™

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company's proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.   Certain data and other information about ASCENIV™ or ADMA Biologics and its products can be found on the Company's website at www.admabiologics.com.

    About Nabi-HB®

    Nabi-HB® is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB® is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB® is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (HBsAg), prenatal exposure to infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB® has a well-documented record of long-term safety and effectiveness since its initial market introduction. Certain data and other information about Nabi-HB® or ADMA Biologics and its products can be found on the Company's website at www.admabiologics.com.

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations, including our anticipated timing for reaching profitability; the goal of building and opening new plasma collection centers by 2024; the outcome and timing of our BLA application for our new plasma centers; and our continued evaluation of opportunities to expand our pipeline and future product offerings. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 | 

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |







    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONSOLIDATED STATEMENTS OF OPERATIONS

      Three Months Ended

    December 31,
     Year Ended

    December 31,
       2020   2019   2020   2019 
             
    REVENUES:        
    Product revenue $13,920,378  $12,001,340  $42,076,949  $29,206,249 
    License revenue  35,709   35,709   142,834   142,834 
    Total Revenues  13,956,087   12,037,049   42,219,783   29,349,083 
             
    OPERATING EXPENSES:        
    Cost of product revenue  19,111,107   11,691,603   61,291,426   39,504,238 
    Research and development  1,013,464   464,823   5,907,013   2,343,848 
    Plasma center operating expenses  1,572,607   464,131   4,170,051   2,169,629 
    Amortization of intangible assets  178,839   211,234   715,353   844,938 
    Selling, general and administrative  9,300,359   7,032,067   35,050,817   25,910,757 
    Total operating expenses  31,176,376   19,863,858   107,134,660   70,773,410 
             
    LOSS FROM OPERATIONS  (17,220,289)  (7,826,809)  (64,914,877)  (41,424,327)
             
    OTHER INCOME (EXPENSE):        
    Interest and other income  19,483   181,682   288,126   800,785 
    Interest expense  (3,109,469)  (2,730,890)  (11,985,066)  (8,993,379)
    Gain (loss) on extinguishment of debt  991,797   -   991,797   (9,962,495)
    Gain on transfer of plasma center assets  -   -   -   11,527,421 
    Other expense  (89,296)  (185,014)  (128,528)  (227,322)
    Other expense, net  (2,187,485)  (2,734,222)  (10,833,671)  (6,854,990)
             
    NET LOSS $(19,407,774) $(10,561,031) $(75,748,548) $(48,279,317)
             
    BASIC AND DILUTED LOSS PER COMMON SHARE $(0.20) $(0.18) $(0.88) $(0.89)
             
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:        
    Basic and Diluted  96,620,486   59,318,355   86,145,052   54,348,136 







    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

     December 31, December 31,
      2020   2019 
    ASSETS   
    Current assets:   
    Cash and cash equivalents$55,921,152  $26,752,135 
    Accounts receivable, net 13,237,290   3,469,919 
    Inventories 81,535,599   53,064,734 
    Prepaid expenses and other current assets 3,046,466   2,533,593 
    Total current assets 153,740,507   85,820,381 
    Property and equipment, net 41,593,090   31,741,317 
    Intangible assets, net 2,444,121   3,159,474 
    Goodwill 3,529,509   3,529,509 
    Right-to-use assets 4,259,191   1,245,029 
    Deposits and other assets 2,106,976   1,595,015 
    TOTAL ASSETS$207,673,394  $127,090,725 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    Current liabilities:   
    Accounts payable$11,073,708  $9,174,591 
    Accrued expenses and other current liabilities 8,365,143   4,481,395 
    Current portion of deferred revenue 142,834   142,834 
    Current portion of lease obligations 365,682   229,073 
    Total current liabilities 19,947,367   14,027,893 
    Senior notes payable, net of discount 92,968,866   68,291,163 
    Deferred revenue, net of current portion 2,118,698   2,261,532 
    Subordinated note payable, net of discount -   14,908,053 
    Lease obligations, net of current portion 4,334,151   1,302,361 
    Other non-current liabilities 54,886   106,574 
    TOTAL LIABILITIES 119,423,968   100,897,576 
        
    COMMITMENTS AND CONTINGENCIES   
        
    STOCKHOLDERS' EQUITY    
    Preferred Stock, $0.0001 par value, 10,000,000 shares authorized,   
    no shares issued and outstanding -   - 
    Common Stock - voting, $0.0001 par value, 150,000,000 shares authorized,   
    104,902,888 and 59,318,355 shares issued and outstanding 10,490   5,932 
    Additional paid-in capital 428,704,039   290,903,772 
    Accumulated deficit (340,465,103)  (264,716,555)
    TOTAL STOCKHOLDERS' EQUITY  88,249,426   26,193,149 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $207,673,394  $127,090,725 



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  2. RAMSEY, N.J. and BOCA RATON, Fla., March 18, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it will report financial results for the fourth quarter and full year ending December 31, 2020 on Thursday, March 25, 2021 after the U.S. financial markets close. ADMA's management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to discuss its financial results and other company updates.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time…

    RAMSEY, N.J. and BOCA RATON, Fla., March 18, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it will report financial results for the fourth quarter and full year ending December 31, 2020 on Thursday, March 25, 2021 after the U.S. financial markets close. ADMA's management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to discuss its financial results and other company updates.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 5109699. A live audio webcast of the call will be available under "Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 | 

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  3. RAMSEY, N.J. and BOCA RATON, Fla., March 04, 2021 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the upcoming Jefferies Virtual Plasma Summit being held on Thursday, March 11, 2021, at 11:20 a.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end American commercial…

    RAMSEY, N.J. and BOCA RATON, Fla., March 04, 2021 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the upcoming Jefferies Virtual Plasma Summit being held on Thursday, March 11, 2021, at 11:20 a.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552|

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  4. RAMSEY, N.J. and BOCA RATON, Fla. and KENNESAW, Ga., March 03, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that its plasma collection center located in Kennesaw, Georgia received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the sale of source plasma into South Korea. In conjunction with the South Korean approval, ADMA additionally announced the Kennesaw plasma collection center received FDA approval to implement a Hepatitis B immunization program, enabling ADMA to collect source plasma from donors immunized with an FDA-licensed Hepatitis…

    RAMSEY, N.J. and BOCA RATON, Fla. and KENNESAW, Ga., March 03, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that its plasma collection center located in Kennesaw, Georgia received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the sale of source plasma into South Korea. In conjunction with the South Korean approval, ADMA additionally announced the Kennesaw plasma collection center received FDA approval to implement a Hepatitis B immunization program, enabling ADMA to collect source plasma from donors immunized with an FDA-licensed Hepatitis B vaccine.

    "These approvals demonstrate ADMA's strict adherence to the regulatory requirements of the global plasma community and build upon the significant regulatory milestones already achieved by our Company in 2021," said Adam Grossman, President and Chief Executive Officer of ADMA Biologics. "The approvals announced today further enhance our existing global presence as a source plasma provider, which includes the United States and now South Korea. Our BioCenters expansion strategy remains comfortably on track, and these approvals represent another important step towards our objective of further securing our raw material supply chain and enhancing our end-to-end control of manufacturing operations."

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "intend," "target," "plan," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's objective of further securing its raw material supply chain and enhancing its end-to-end control of manufacturing operations. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 | 

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

     



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  5. Poster Presentation Highlights the Need for a Polyclonal Hyperimmune Globulin Targeting S. Pneumoniae to Bridge Vaccination and Seroconversion Across Multiple Serotypes

    By Using as an Add-On with a Vaccine or Antibiotics, This Therapeutic Strategy has the Potential to Improve S. Pneumoniae-Related Hospital Clinical Outcomes

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 26, 2021 (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 presentation of a late-breaking poster at the 2021 American Academy of Allergy, Asthma & Immunology Conference ("AAAAI") Virtual…

    Poster Presentation Highlights the Need for a Polyclonal Hyperimmune Globulin Targeting S. Pneumoniae to Bridge Vaccination and Seroconversion Across Multiple Serotypes

    By Using as an Add-On with a Vaccine or Antibiotics, This Therapeutic Strategy has the Potential to Improve S. Pneumoniae-Related Hospital Clinical Outcomes

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 26, 2021 (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 presentation of a late-breaking poster at the 2021 American Academy of Allergy, Asthma & Immunology Conference ("AAAAI") Virtual Annual Meeting taking place February 26 – March 1, 2021. The abstract has been published online in a supplement to The Journal of Allergy and Clinical Immunology.

    "Vulnerable patient populations, including the immune compromised, remain at risk of S. pneumoniae infection despite the availability of FDA-approved vaccines," said Adam Grossman, President and Chief Executive Officer of ADMA. "These data underscore the exciting prospect of bridging the time between vaccination and seroconversion to achieve protective levels of antibody with a targeted, plasma derived hyperimmune globulin to ensure protection against infection for at-risk patients in hospital and outpatient settings. Our existing intellectual property portfolio includes issued patents on the composition of matter and methods of use for producing a standardized hyperimmune globulin targeted to the most common 23 serotypes of S. pneumoniae bacteria. We will continue to evaluate opportunities to expand our pipeline and future product offerings to maximize value for our shareholders and to address the unmet needs of our targeted patient populations."

    Details for the AAAAI 2021 presentation are as follows:

    Abstract Title: Results of Cross-Stakeholder Qualitative Study on the Potential Utility of a Hyperimmune Globulin for the Prophylaxis/Treatment for S. Pneumoniae Infection in Vulnerable Populations

    Author: Gruenglas, et al.

    Session Title: Poster Abstract Sessions

    Session Dates: Friday, February 26 – Monday, March 1, 2021

    Session Location: Virtual Poster Hall

    Poster No: L30

    A PDF copy of the abstract can be accessed here.

    About ADMA Biologics, Inc.

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, but not limited to, statements regarding the expansion of our product pipeline and future product offerings. Such statements are identified by use of the words "anticipates," "believes," "estimates," "expects," "intends," "plans," "predicts," "projects," "should," and similar expressions. Any forward-looking statements contained herein are based on current expectations, but are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including, but not limited to, the effectiveness of the rights plan in providing the Board of Directors with time to make informed decisions that are in the best long-term interests of ADMA and its stockholders, and other risk factors discussed from time to time in our filings with the SEC, including those factors discussed under the caption "Risk Factors" in our most recent annual report on Form 10-K, filed with the SEC on March 13, 2020, and in subsequent reports filed with or furnished to the SEC. ADMA assumes no obligation and does not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today's date.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  6. RAMSEY, N.J. and BOCA RATON, Fla., Feb. 22, 2021 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Raymond James Institutional Investor Conference on Monday, March 1, 2021, at 10:50 a.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical…

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 22, 2021 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Raymond James Institutional Investor Conference on Monday, March 1, 2021, at 10:50 a.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 | 

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  7. RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), 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 ADMA BioCenters plasma collection facility located in Knoxville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2020, and with today's approval, it is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.

    "The approval of this…

    RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), 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 ADMA BioCenters plasma collection facility located in Knoxville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2020, and with today's approval, it is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.

    "The approval of this plasma collection facility was received well-ahead of the scheduled FDA goal date. This milestone represents yet another example of the Company's continued progression towards achieving its objective of further securing its raw material supply chain and enhancing our end-to-end control of manufacturing operations," said Adam Grossman, President and Chief Executive Officer of ADMA. "With the Knoxville approval, we remain comfortably on track to achieve our goal of building out up to 10 plasma collection centers by 2024, including the potential approval of our plasma collection facility located in Maryville, Tennessee in the second half of this year, as well as the filing of Biologics License Applications ("BLAs") for an additional two plasma collection centers. 2021 is off to an excellent start for our Company and today's approval is the first in what we expect to be a series of value-creating FDA decisions during the year across all business segments. These achievements are expected to enhance the supply chain, increase product yields and improve margins for our revenue generating products as we continue towards profitability."

    This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat-screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first. At full capacity, the plasma center expects to maintain a staff of 50 highly trained healthcare workers. This center is approved to use the state-of-the-art Haemonetics NexSys plasma collection system.

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "intend," "target," "plan," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; expansion plans and the goal of opening up to ten new plasma collection centers by 2024; our expectation to receive an FDA approval for our Maryville, Tennessee plasma collection center and the timing thereof; our expectation to file additional BLAs; and the receipt of additional FDA approvals during 2021 and the effects on our business of such approvals. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |  

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |  



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  8. RAMSEY, N.J. and BOCA RATON, Fla., Jan. 26, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent, product-specific J-code for ASCENIV™. Under the Healthcare Common Procedure Coding System (HCPCS), the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes. The Company will retain transitional pass-through status granted for ASCENIV from CMS.

    "The issuance of this…

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 26, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent, product-specific J-code for ASCENIV™. Under the Healthcare Common Procedure Coding System (HCPCS), the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes. The Company will retain transitional pass-through status granted for ASCENIV from CMS.

    "The issuance of this product-specific J-code by CMS for ASCENIV is a significant milestone in the product's commercial launch. This J-code will provide for a streamlined and permanent reimbursement process in all outpatient treatment settings," said Adam Grossman, President and Chief Executive Officer of ADMA. "The J-code implementation will accelerate and expand patient access to ASCENIV, and as a result, increases our confidence in the ongoing commercial roll-out, in addition to the product's potential contribution to our overall 2024 revenue target of $250 million or more."

    Permanent J-codes are used by commercial insurers and government payers to standardize claims submissions and reimbursements for medications, such as ASCENIV, that are administered by a healthcare professional in an outpatient setting. While not a guarantee of payment, these codes enable timely claims adjudication and processing, and consequently facilitate a simplified pathway to prescription, administration and ultimately patient utilization. 

    About ASCENIV™

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company's proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    About ADMA Biologics, Inc.

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the anticipated benefits and expected consequences of the rights plan that ADMA has adopted. Such statements are identified by use of the words "anticipates," "believes," "estimates," "expects," "intends," "plans," "predicts," "projects," "should," and similar expressions. Any forward-looking statements contained herein are based on current expectations, but are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including, but not limited to, the effectiveness of the rights plan in providing the Board of Directors with time to make informed decisions that are in the best long-term interests of ADMA and its stockholders, and other risk factors discussed from time to time in our filings with the SEC, including those factors discussed under the caption "Risk Factors" in our most recent annual report on Form 10-K, filed with the SEC on March 13, 2020, and in subsequent reports filed with or furnished to the SEC. ADMA assumes no obligation and does not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today's date.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  9. Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception

    Full Year 2020 Preliminary Unaudited Total Revenues of $42.2 Million, a 44% Increase Over Full Year 2019

    Multiple Value-Creating FDA Decisions Across All Business Segments Anticipated in 2021 Are Expected to Enhance the Supply Chain, Increase Product Yields and Improve Margins for Revenue Generating Products

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 19, 2021 (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 preliminary…

    Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception

    Full Year 2020 Preliminary Unaudited Total Revenues of $42.2 Million, a 44% Increase Over Full Year 2019

    Multiple Value-Creating FDA Decisions Across All Business Segments Anticipated in 2021 Are Expected to Enhance the Supply Chain, Increase Product Yields and Improve Margins for Revenue Generating Products

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 19, 2021 (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 preliminary unaudited fourth quarter and full year 2020 revenues. The Company also provided commercial updates for its immune globulin product portfolio, as well as introduced its 2021 strategic and operational outlook.

    Fourth Quarter and Full Year 2020 Highlights

    • Achieved record fourth quarter 2020 preliminary unaudited revenues of $13.9 million, compared to $12.0 million during the fourth quarter of 2019, reflecting a 16% increase. The preliminary results for the fourth quarter of 2020 represent the Company's highest revenue generating quarter since its inception.
    • Full year 2020 preliminary unaudited total revenues of $42.2 million, compared to $29.3 million for the full year 2019, reflecting a substantial 44% increase over full year 2019.

    "We are extremely pleased with our preliminary record fourth quarter and full year 2020 revenue results. ADMA's continued execution through COVID-19 headwinds is a testament to our organization's unwavering commitment to provide patients with products to ensure the continuity of care. Our 2020 full year operating results, we believe, will ultimately unlock significant value for ADMA shareholders," said Adam Grossman, ADMA's President and Chief Executive Officer. "2021 is poised to be a transformative year for ADMA as we continue to execute on our mission of providing specialty immune globulin products to patients and building a highly profitable, end-to-end biologics manufacturing company."

    Mr. Grossman continued, "Throughout 2021 and beyond, we anticipate delivering ongoing quarter-over-quarter revenue growth. We also anticipate realizing robust operating efficiencies as early as mid-2021, pending United States Food and Drug Administration (FDA) decisions regarding ADMA's submissions for its supply chain enhancement initiatives, most notably consisting of our Intravenous Immune Globulin (IVIG) production scale increase and for our in-house aseptic fill-finish production line. Additionally, we expect to potentially obtain FDA approvals in 2021 for two new plasma collection centers located in Knoxville and Maryville, TN as well as file Biologics License Applications (BLAs) for an additional two plasma collection centers. COVID-19 notwithstanding, ADMA remained on track in 2020 and achieved all its stated 2020 strategic and operating objectives. We anticipate 2021 will be another year of achieving value-creating milestones, including executing on the ongoing production ramp up and inventory build to support annual revenue generation in excess of $250 million by 2024 which will provide for substantial profitability."

    ADMA executed on all of its 2020 strategic objectives, including:

    • Navigated COVID-19 operating headwinds evidenced by preliminary total revenues of approximately $42.2 million generated for the first full calendar year of commercialization, in addition to significantly building inventory balances throughout the year, establishing a solid basis for continued quarter-over-quarter revenue growth.
    • Expanded ADMA BioCenters' plasma collection center network on schedule with the construction of two new collection centers which are currently operational and collecting plasma, as well as initiated the establishment of three additional collection centers. The Company currently has six plasma collection centers under its corporate umbrella at various stages of approval and development.
    • Refinanced ADMA's senior secured term loan with Perceptive Advisors, which among other things, consolidated ADMA's long term debt and provided for a two year extension of the interest-only period through March 2024, which we believe will allow ADMA to reach profitability prior to maturity. As part of the refinancing transaction, the Company negotiated a $1 million principal reduction to the payoff of ADMA's subordinated debt facility prior to maturity without any prepayment penalty.
    • Advanced supply chain enhancements and capacity expansion initiatives in-line with Company provided timelines and maintained anticipated regulatory decisions and FDA interactions.
    • Expanded the Company's IP portfolio with new patents and developed the ImmunoRank™ Neutralization MICRO-ELISA to detect the presence and levels of COVID-19 neutralizing antibodies.
    • Entered into a manufacturing and supply agreement to produce and sell plasma-derived intermediate fractions which is expected to contribute $10-20 million in revenues at full scale.
    • Hosted an exclusive educational event at IDWeek 2020 on respiratory viral infections and novel treatment modalities, as well as presented new data on the preparation of a hyperimmune globulin for the prevention and treatment of Streptococcus pneumonia in an on-demand poster session.

    ADMA is focused on the following key strategic priorities in 2021:

    • Generate ongoing quarter-over-quarter and year-over-year revenue growth throughout 2021 and beyond as the Company progresses towards achieving profitability with peak revenues of $250 million or greater by 2024.
    • Continue building ADMA's inventory balance to support anticipated ongoing revenue growth and solidify ADMA's position as a reliable supplier for the growing U.S. immune globulin marketplace ultimately ensuring the continuity of immune globulin supply for our patients and customers.
    • Complete certain supply chain enhancements and capacity expansion programs as early as mid-2021. Once FDA approved, the Company's newly installed fill-finish machine as well as the IVIG manufacturing scale increase should allow ADMA to realize significant operating efficiencies and improved gross margins beginning potentially as early as mid-2021. These projects will ultimately position the Company to be fully vertically integrated with in-house control over the Company's most critical manufacturing functions.
    • Expand ADMA's plasma collection center network to achieve the goal of building up to 10 plasma collection centers in the U.S. by 2024. During 2021, ADMA expects two regulatory approval decisions for the Company's Knoxville and Maryville, TN plasma collection centers. ADMA also anticipates filing BLAs for two additional plasma collection centers during 2021.

    Fourth Quarter and Full Year 2020 Financial Results Conference Call

    ADMA plans to host a conference call and webcast to discuss its fourth quarter and full year 2020 financial results during the first quarter of 2021 in conjunction with filing its Annual Report on Form 10-K, which is expected to be filed with the U.S. Securities and Exchange Commission in the first quarter of 2021.

    The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the Company's fourth quarter and full year financial results for 2020.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and Nabi-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; timing of revenue and profitability; execution of corporate objectives and achievement of goals, including but not limited to, the Company's key strategic priorities for 2021; receipt of future regulatory approvals; realization of shareholder value; and future appreciation of the asset value of manufactured plasma and plasma collection centers. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |  



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  10. RAMSEY, N.J. and BOCA RATON, Fla., Jan. 04, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through payment status and established a new reimbursement C-code, C9072, for ASCENIV which is effective January 1, 2021.

    "Assignment of this new C-code by CMS for ASCENIV, along with pass-through payment status, will provide a more streamlined reimbursement process in the increasingly important hospital outpatient setting," said Adam Grossman, President and Chief Executive Officer of ADMA. "This…

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 04, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through payment status and established a new reimbursement C-code, C9072, for ASCENIV which is effective January 1, 2021.

    "Assignment of this new C-code by CMS for ASCENIV, along with pass-through payment status, will provide a more streamlined reimbursement process in the increasingly important hospital outpatient setting," said Adam Grossman, President and Chief Executive Officer of ADMA. "This is another significant milestone in our ongoing commercial rollout of ASCENIV and is a testament to our market access and commercial teams' continued execution. We believe our improving insurance coverage and expanding patient access for our commercial immunoglobulin portfolio is another indication that we remain well on track to achieve all of our previously provided operating targets by 2024, including generating revenues from all of our products of $250 million or greater."

    A C-code is a unique temporary product code established by CMS to help support Fee-for-Service pass-through payments in the Hospital Outpatient Prospective Payment System (OPPS). The formal implementation of the C-code will enable hospital outpatient departments to infuse ASCENIV in the outpatient setting and be reimbursed at the list price, also known as the Average Sales Price (ASP), for ASCENIV at +6%. Other payers, such as commercial insurers, may also use the C-code for billing purposes while awaiting a permanent J-Code, which ADMA expects will be assigned during 2021. Permanent J-codes can be used across all settings of care for government insurers and commercial payers to support timely claims submissions and receive standardized reimbursement rates.

    About ASCENIV™

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company's proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    About ADMA Biologics, Inc.

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the anticipated benefits and expected consequences of the rights plan that ADMA has adopted. Such statements are identified by use of the words "anticipates," "believes," "estimates," "expects," "intends," "plans," "predicts," "projects," "should," and similar expressions. Any forward-looking statements contained herein are based on current expectations, but are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including, but not limited to, the effectiveness of the rights plan in providing the Board of Directors with time to make informed decisions that are in the best long-term interests of ADMA and its stockholders, and other risk factors discussed from time to time in our filings with the SEC, including those factors discussed under the caption "Risk Factors" in our most recent annual report on Form 10-K, filed with the SEC on March 13, 2020, and in subsequent reports filed with or furnished to the SEC. ADMA assumes no obligation and does not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today's date.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  11. RAMSEY, N.J. and BOCA RATON, Fla., Dec. 16, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that its Board of Directors has approved the adoption of a limited duration stockholder rights plan and declared a dividend distribution of one right for each outstanding share of common stock. The record date for such dividend distribution is December 30, 2020. The rights plan expires, without any further action being required to be taken by ADMA's Board of Directors, on December 15, 2021.

    The adoption of the rights plan is intended to protect ADMA and its stockholders from the actions…

    RAMSEY, N.J. and BOCA RATON, Fla., Dec. 16, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that its Board of Directors has approved the adoption of a limited duration stockholder rights plan and declared a dividend distribution of one right for each outstanding share of common stock. The record date for such dividend distribution is December 30, 2020. The rights plan expires, without any further action being required to be taken by ADMA's Board of Directors, on December 15, 2021.

    The adoption of the rights plan is intended to protect ADMA and its stockholders from the actions of third parties that ADMA's Board of Directors determines are not in the best interests of ADMA and its stockholders, and to enable all stockholders to realize the full potential value of their investment in ADMA. The rights plan was not adopted in response to any specific takeover proposal, any current accumulation of shares, or any currently threatened or pending effort to acquire control of ADMA of which the Board of Directors is aware. The rights plan was adopted to provide the Board of Directors with time to make informed decisions that are in the best long-term interests of ADMA and its stockholders and does not prevent ADMA's Board of Directors from considering any offer to acquire ADMA that it considers to be in the best interest of ADMA's stockholders.

    The rights plan is similar to stockholder rights plans adopted by other publicly-traded companies. Under the rights plan, the rights generally would become exercisable only if a person or group acquires beneficial ownership of 10% or more of ADMA's common stock in a transaction or series of transactions not approved by ADMA's Board of Directors. In that situation, each holder of a right (other than the acquiring person or group, whose rights will become void and will not be exercisable) will have the right to purchase, upon payment of the exercise price and in accordance with the terms of the rights plan, a number of shares of ADMA's common stock having a market value of twice such price. In addition, if ADMA is acquired in a merger or other business combination after an acquiring person acquires 10% or more of ADMA's common stock, each holder of the right would thereafter have the right to purchase, upon payment of the exercise price and in accordance with the terms of the rights plan, a number of shares of common stock of the acquiring person having a market value of twice such price. The acquiring person or group would not be entitled to exercise these rights. In the rights plan, the definition of "beneficial ownership" includes derivative securities.

    Stockholders who beneficially owned 10% or more of ADMA's outstanding common stock prior to the first public announcement by ADMA of the adoption of the rights plan will not trigger the rights plan so long as they do not acquire beneficial ownership of any additional shares of common stock at a time when they still beneficially own 10% or more of such common stock, subject to certain exceptions as set forth in the rights plan.

    Further details of the rights plan will be contained in a Current Report on Form 8-K and in a Registration Statement on Form 8-A that ADMA will be filing with the Securities and Exchange Commission (SEC). These filings will be available on the SEC's web site at www.sec.gov. Copies will also be available at no charge on the Investors section of ADMA's corporate website at www.admabiologics.com.

    Jefferies LLC acted as financial advisor to ADMA in connection with the adoption of the rights plan. Morgan, Lewis & Bockius LLP is serving as legal advisor to ADMA.

    About ADMA Biologics, Inc.

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the anticipated benefits and expected consequences of the rights plan that ADMA has adopted. Such statements are identified by use of the words "anticipates," "believes," "estimates," "expects," "intends," "plans," "predicts," "projects," "should," and similar expressions. Any forward-looking statements contained herein are based on current expectations, but are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including, but not limited to, the effectiveness of the rights plan in providing the Board of Directors with time to make informed decisions that are in the best long-term interests of ADMA and its stockholders, and other risk factors discussed from time to time in our filings with the SEC, including those factors discussed under the caption "Risk Factors" in our most recent annual report on Form 10-K, filed with the SEC on March 13, 2020, and in subsequent reports filed with or furnished to the SEC. ADMA assumes no obligation and does not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today's date.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  12. Increases Size of Facility and Extends Interest-Only Period Enabling ADMA to Reach Profitability Prior to Maturity

    Demonstrates Perceptive's Commitment and Long-Term Positive Outlook for ADMA's Commercial IG Drug Product Portfolio, IP Estate, and Asset Value Supported by Plasma Centers and a Vertically Integrated Plasma Fractionation and Fill/Finish Manufacturing Plant

    RAMSEY, N.J. and BOCA RATON, Fla., Dec. 09, 2020 (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 an amendment to its existing senior secured term loan with Perceptive Advisors ("Perceptive…

    Increases Size of Facility and Extends Interest-Only Period Enabling ADMA to Reach Profitability Prior to Maturity

    Demonstrates Perceptive's Commitment and Long-Term Positive Outlook for ADMA's Commercial IG Drug Product Portfolio, IP Estate, and Asset Value Supported by Plasma Centers and a Vertically Integrated Plasma Fractionation and Fill/Finish Manufacturing Plant

    RAMSEY, N.J. and BOCA RATON, Fla., Dec. 09, 2020 (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 an amendment to its existing senior secured term loan with Perceptive Advisors ("Perceptive"), which provides for an additional loan tranche of $15 million, increasing the total size of the credit facility to $100 million.   The amended terms for the existing $85 million credit facility additionally provide for, among other things, a two-year extension of the interest only period through the duration of the credit facility now maturing in March 2024, at an unchanged borrowing rate of 11%.   The newly issued loan tranche of $15 million from Perceptive was fully drawn and used to pay the remaining obligations under the Biotest AG subordinated note entered into in June of 2017, at a 7% mutually agreed discount with no associated prepayment penalties. This additional loan tranche carries the same terms as the amended senior secured loans. There were no modifications made to the existing revenue covenants of the credit facility with Perceptive.

    "This upsized loan amendment demonstrates Perceptive's long-term view for the plasma industry and ADMA's important role as a reliable producer of plasma-derived biologics," said Joseph Edelman, Chief Executive Officer and Founder of Perceptive Advisors. "We remain committed to supporting ADMA's business and unlocking shareholder value that we believe has yet to be realized. We are optimistic that the asset value of manufactured plasma and plasma collection centers will continue to appreciate into the future."

    "This amendment to our senior secured term loan, with its increased size and extended maturities, strengthens our long-term capital position and allows us to continue to execute on our strategic priorities, including supply chain enhancement initiatives and plasma center expansion, in addition to generating considerable near-term and ongoing revenue growth," stated Adam Grossman, President and Chief Executive Officer of ADMA. "Despite ongoing COVID-19 headwinds, we remain on track to achieve our previously provided guidance for topline revenues of $250 million or greater by 2024, and we are confident that we are well-positioned to achieve profitability prior to the new 2024 maturity date of the loan. The continued support from Perceptive, who remains our largest equity holder, is a testament to the shareholder value that we believe will be created as we execute on these corporate objectives and establish ADMA as the only fully integrated American plasma fractionator."

    "Perceptive is pleased to provide additional capital to support ADMA's near-term revenue and profitability growth strategy," stated Sam Chawla, Portfolio Manager at Perceptive. "The Company has made significant progress and has met all of our goals and objectives to date. We look forward to seeing ADMA's continued progress and supporting the Company's mission and value creating business objectives, focused on improving healthcare options for patients at risk of infectious diseases."

    The Perceptive credit amendment has an interest-only term with a maturity date of March 1, 2024. Borrowings under the Perceptive credit agreement bear interest at a rate per annum equal to 7.5% plus the greater of one-month LIBOR and 3.5%. ADMA will also issue a warrant to Perceptive to purchase 2,390,000 shares of the Company's common stock at the lower of ADMA's closing share price on the date of the amendment and the 10-day VWAP ahead of closing.

    The debt financing disclosed in this press release is not all inclusive and, as such, the statements in this press release are qualified in their entirety by reference to the description of the debt financing transaction and corresponding exhibits, which are included in a Current Report on Form 8-K filed concurrently with this press release by ADMA with the Securities and Exchange Commission.

    About Perceptive Advisors (Perceptive)

    Founded in 1999, Perceptive Advisors is a leading healthcare focused investment firm with over $8.5 billion of regulatory assets under management as of October 29, 2020. Since inception, Perceptive Advisors has focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare.  For more information about Perceptive, visit www.perceptivelife.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; timing of revenue and profitability; execution of corporate objectives and achievement of goals; realization of shareholder value; and future appreciation of the asset value of manufactured plasma and plasma collection centers. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |  

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  13. RAMSEY, N.J. and BOCA RATON, Fla. and MARYVILLE, Tenn., Dec. 01, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Maryville, Tennessee. ADMA also announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for this third plasma collection center.

    "We believe the rapid expansion of our ADMA BioCenters plasma collections facilities demonstrates the Company's focus on ensuring…

    RAMSEY, N.J. and BOCA RATON, Fla. and MARYVILLE, Tenn., Dec. 01, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Maryville, Tennessee. ADMA also announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for this third plasma collection center.

    "We believe the rapid expansion of our ADMA BioCenters plasma collections facilities demonstrates the Company's focus on ensuring essential raw material supply chain continuity and control into the future," said Adam Grossman, President and Chief Executive Officer of ADMA. "The opening of the Maryville, TN facility will allow us to continue to increase plasma collection throughput into 2021 and beyond, thereby ensuring the Company's ability to self-supply a portion of its needs in order to continue to execute on top-line revenue growth. In the face of COVID-19 headwinds, we currently remain on track to achieve the Company's stated goal of opening five to ten new plasma collection centers over the next three to five years, and ultimately progressing towards our goal of solidifying a fully vertically integrated and essentially self-sufficient supply chain."

    This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat-screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first. At full capacity, the plasma center expects to maintain a staff of 50 highly trained healthcare workers.

    The FDA regulatory process for obtaining approval for this plasma collection center includes a site inspection and an approximately 12-month BLA review period. As such, ADMA expects to receive an approval decision for this third plasma facility in the fourth quarter of 2021. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can use the plasma collected for production of its FDA approved immunoglobulin products.

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "intend," "target," "plan," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; expansion plans and the goal of opening five to ten new plasma collection centers over the next three to five years; our expectation to receive an FDA approval decision to our filed BLA and the timing thereof; and the use of plasma collected at the Maryville facility for production of immunoglobulin products. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |  

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



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  14. RAMSEY, N.J. and BOCA RATON, Fla., Nov. 10, 2020 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Jefferies 2020 Virtual London Healthcare Conference on Tuesday, November 17, 2020, at 7:55 a.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical…

    RAMSEY, N.J. and BOCA RATON, Fla., Nov. 10, 2020 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Jefferies 2020 Virtual London Healthcare Conference on Tuesday, November 17, 2020, at 7:55 a.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |  

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  15. Generated Total Revenues of $28.3 Million for the First Nine Months of 2020, Reflecting a 63% Increase Over the Same Prior Year Period

    Successfully Opened Newest ADMA BioCenters Plasma Collection Facility; On Track to Achieve Stated Goal of Opening Five to 10 New Collection Centers Over the Next Three to Five Years

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., Nov. 05, 2020 (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 reported financial results for its fiscal third quarter and nine months ended…

    Generated Total Revenues of $28.3 Million for the First Nine Months of 2020, Reflecting a 63% Increase Over the Same Prior Year Period

    Successfully Opened Newest ADMA BioCenters Plasma Collection Facility; On Track to Achieve Stated Goal of Opening Five to 10 New Collection Centers Over the Next Three to Five Years

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., Nov. 05, 2020 (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 reported financial results for its fiscal third quarter and nine months ended September 30, 2020, and provided an overview of recent progress and accomplishments.

    "On the commercial front, demand for immune globulins and our marketed products remained robust with our product portfolio generating sales of $28.3 million year-to-date (‘YTD') in 2020, an increase of 63% compared to the same period in 2019. The third quarter was our strongest quarter of the year, even in the face of continued COVID-19 operating headwinds, as we generated $10.3 million in revenue, representing quarterly year-over-year growth of 42%," said Adam Grossman, President and Chief Executive Officer of ADMA. "We continue to build our inventory balance in support of anticipated revenue growth in the fourth quarter and into 2021. Our supply chain robustness initiatives continue as planned and the expansion of our Company-owned plasma collection center network is ahead of schedule. We now have six centers under our corporate umbrella at various stages of approval and development, including two that are fully operational and collecting plasma. We are confident in our continued ability to successfully navigate the Company against the backdrop of COVID-19, and anticipate a strong fourth quarter and ultimately achieving considerable growth in the second half of 2020 versus the first half."

    Third Quarter 2020 and Recent Highlights

    • Expansion of ADMA BioCenters Plasma Collection Center Network Ahead of Schedule – ADMA BioCenters, a wholly-owned subsidiary of ADMA Biologics, successfully opened, began donor collections and submitted a Biologics License Application to the U.S. Food and Drug Administration ("FDA") seeking FDA approval for this second plasma collection center, which we anticipate receiving in mid-2021. The Company currently has six plasma collection centers at various stages of approval and development, including two that are fully operational and collecting plasma, three that are under construction with favorable long-term leases, and one in the planning stage. ADMA remains on track to achieve its stated goal of opening five to 10 new, FDA-approved plasma collection centers over the next three to five years.
    • Manufacturing Capacity Expansion Initiatives – ADMA continues to invest in and make progress with supply chain robustness enhancements, including the successful onboarding of aseptic fill-finish capabilities with our newly installed Vanrx SA25 Workcell, in addition to advancing regulatory efforts for the planned capacity expansion to the 4,400 liter BIVIGAM® plasma pool.  These important initiatives are designed to reduce operating costs, improve margins, increase scale and provide for faster production cycle turnaround time, ultimately providing increased control and independence from third-party vendors and contractors.  ADMA remains on track to submit the appropriate applications to the FDA during the second half of 2020 and into 2021, and expects to begin benefitting from these initiatives as early as mid-2021.
    • Developed COVID-19 ImmunoRank Neutralization MICRO-ELISA – The COVID-19 ImmunoRank Neutralization MICRO-ELISA is a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank, which was developed in collaboration with Leinco Technologies, Inc., is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is important because it offers a potentially faster, simpler, more cost effective way to identify high titer convalescent plasma for use in both treating COVID-19 patients and for creating COVID-19 hyperimmune globulins.

    Financial Results for the Three Months Ended September 30, 2020

    Total revenues for the quarter ended September 30, 2020 were $10.3 million, compared to $7.2 million for the quarter ended September 30, 2019, representing an increase of approximately $3.1 million, or 42%. The revenue growth for the third quarter of 2020, compared to the third quarter of 2019, was favorably impacted by the continued commercial ramp up of BIVIGAM and ASCENIV, and by the manufacturing and supply agreement ADMA entered into in January 2020 to produce and sell intermediate fractions.

    Consolidated net loss for the quarter ended September 30, 2020 was $16.9 million, or $(0.19) per basic and diluted share, compared to a consolidated net loss of $11.4 million, or $(0.19) per basic and diluted share, for the quarter ended September 30, 2019. The $5.5 million increase in net loss compared to the prior year period was primarily attributable to a $3.9 million increase in cost of product revenue resulting from the higher product revenues generated from our immunoglobulin products portfolio, and to increases in selling, general and administrative expenses of $1.9 million related to employee compensation, new hires and other costs to support the commercialization efforts of BIVIGAM and ASCENIV, as well as a $1.2 million increase in research and development expenses related to the validation of a new filling line at one of our contracted third party fill-finishers. Research and development expenses were also impacted by costs associated with developing our neutralization MICRO-ELISA proprietary assay to detect SARS-CoV-2 neutralizing antibodies in plasma in collaboration with a third-party. The increase in net loss also includes a $0.8 million increase in plasma center operating expenses due to the opening of additional plasma centers during 2020. Included in the net loss for the third quarter of 2020 were non-cash expenses of approximately $2.3 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    Financial Results for the Nine Months Ended September 30, 2020

    Total revenues for the nine months ended September 30, 2020 were $28.3 million, compared to $17.3 million for the nine months ended September 30, 2019, representing an increase of $11.0 million, or approximately 63%. The increase in revenues was primarily attributable to increased sales of our immunoglobulin products portfolio: BIVIGAM®, ASCENIV™, Nabi-HB® and intermediate fractions.

    Consolidated net loss for the nine months ended September 30, 2020 was $56.3 million, or $(0.68) per basic and diluted share, compared to a consolidated net loss of $37.7 million, or $(0.72) per basic and diluted share, for the nine months ended September 30, 2019. The increase in net loss of $18.6 million was primarily attributable to a $14.4 million increase in cost of product revenue related to production costs incurred for the manufacture of BIVIGAM conformance lots at an increased plasma pool production scale that pertains to our planned capacity expansion at our Boca Raton, FL plasma fractionation facility, as well as higher product revenues generated from our immunoglobulin products portfolio. The increase in net loss during the first nine months of 2020 was also attributable to increased selling, general administrative expenses of $6.9 million in connection with the overall growth in the size and scope of the Company's operations, including the commercialization efforts of BIVIGAM® and ASCENIV™, and a $3.0 million increase in research and development expenses associated with the validation of a new filling line at one of our third party fill-finishers, and increases in various clinical research activities, some of which are required by the FDA. Included in the net loss for the first nine months of 2020 were non-cash expenses of approximately $6.2 million for stock-based compensation, depreciation and amortization and non-cash interest expense.

    At September 30, 2020, ADMA had cash and cash equivalents of $59.7 million and accounts receivable of $6.3 million, compared to cash and cash equivalents of $26.8 million and accounts receivable of $3.5 million at December 31, 2019. ADMA's net working capital as of September 30, 2020 was $123.1 million, compared to $71.8 million as of December 31, 2019.

    Conference Call Information

    ADMA will host a conference call today, Thursday, November 5, 2020, at 4:30 p.m. Eastern Time, to discuss the third quarter 2020 financial results and recent corporate updates. To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8185674. A live audio webcast of the call will be available under "Events & Webcasts" in the Investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.   An archived webcast will be available on the Company's website approximately two hours after the event.

    About BIVIGAM®

    BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin (IgG) antibodies.

    About ASCENIV™

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    About Nabi-HB®

    Nabi-HB® is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB® is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB® is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen ("HBsAg"), prenatal exposure to infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB® has a well-documented record of long-term safety and effectiveness since its initial market introduction. Certain data and other information about Nabi-HB® or ADMA Biologics and its products can be found on the Company's website at www.admabiologics.com.

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.atlantaplasma.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; the goal of opening new collection centers over the next three to five years; our supply chain robustness initiatives and their intended outcome, expected benefits, and timing thereof; the outcome and timing of our BLA application for our new plasma center; the expected benefits from the new aseptic fill-finish machine installed at our Boca Raton facility; the intended outcome and expected benefits from our several manufacturing and supply chain enhancement initiatives, and the expected timing for realizing those benefits, and our plan to submit appropriate applications to the FDA related thereto; and the expected benefits relating to the development of the COVID-19 ImmunoRank Neutralization MICRO-ELISA. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

     Three Months Ended September 30, Nine Months Ended September 30,
      2020   2019   2020   2019 
            
    REVENUES:       
    Product revenue$10,240,650  $7,186,795  $28,156,571  $17,204,909 
    License revenue 35,708   35,708   107,125   107,125 
         Total Revenues 10,276,358   7,222,503   28,263,696   17,312,034 
            
    OPERATING EXPENSES:       
    Cost of product revenue (exclusive of amortization expense shown below) 11,855,464   7,916,220   42,180,319   27,812,635 
    Research and development 1,708,391   491,404   4,893,549   1,879,025 
    Plasma center operating expenses 1,218,898   456,899   2,597,444   1,705,498 
    Amortization of intangible assets 178,838   211,235   536,514   633,704 
    Selling, general and administrative 9,115,744   7,197,173   25,750,458   18,878,690 
         Total operating expenses 24,077,335   16,272,931   75,958,284   50,909,552 
            
    LOSS FROM OPERATIONS (13,800,977)  (9,050,428)  (47,694,588)  (33,597,518)
            
    OTHER INCOME (EXPENSE):       
    Interest and other income 1,164   281,896   268,643   619,103 
    Interest expense (3,091,200)  (2,649,404)  (8,875,597)  (6,262,489)
    Loss on extinguishment of debt -   -   -   (9,962,495)
    Gain on transfer of plasma center assets -   -   -   11,527,421 
    Other expense, net (26,440)  (20,523)  (39,232)  (42,308)
         Other expense, net (3,116,476)  (2,388,031)  (8,646,186)  (4,120,768)
            
    NET LOSS$(16,917,453) $(11,438,459) $(56,340,774) $(37,718,286)
            
    BASIC AND DILUTED LOSS PER COMMON SHARE$(0.19) $(0.19) $(0.68) $(0.72)
            
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:       
    Basic and Diluted 87,698,258   59,317,830   82,627,753   52,673,190 
     
     

    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

      September 30, December 31,
       2020   2019 
    ASSETS (Unaudited)  
    Current assets:    
    Cash and cash equivalents $59,675,045  $26,752,135 
    Accounts receivable, net  6,334,536   3,469,919 
    Inventories  69,752,528   53,064,734 
    Prepaid expenses and other current assets  3,786,421   2,533,593 
              Total current assets  139,548,530   85,820,381 
    Property and equipment, net  39,622,510   31,741,317 
    Intangible assets, net  2,622,959   3,159,474 
    Right to use assets  2,782,987   1,245,029 
    Goodwill  3,529,509   3,529,509 
    Deposits and other assets  1,869,548   1,595,015 
    TOTAL ASSETS $189,976,043  $127,090,725 
         
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    Current liabilities:    
    Accounts payable $7,979,772  $9,174,591 
    Accrued expenses and other current liabilities  8,074,989   4,481,395 
    Current portion of deferred revenue  142,834   142,834 
    Current portion of lease obligations  275,988   229,073 
         Total current liabilities  16,473,583   14,027,893 
    Senior notes payable, net of discount  82,108,633   68,291,163 
    Deferred revenue, net of current portion  2,154,407   2,261,532 
    Subordinated note payable, net of discount  14,934,926   14,908,053 
    Lease obligations, net of current portion  2,860,732   1,302,361 
    Other non-current liabilities  67,808   106,574 
    TOTAL LIABILITIES  118,600,089   100,897,576 
         
    COMMITMENTS AND CONTINGENCIES    
         
    STOCKHOLDERS' EQUITY     
    Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding  -   - 
    Common Stock, $0.0001 par value, 150,000,000 shares authorized, 89,616,176 and 59,318,355 shares issued and outstanding  8,960   5,932 
    Additional paid-in capital  392,424,323   290,903,772 
    Accumulated deficit  (321,057,329)  (264,716,555)
    TOTAL STOCKHOLDERS' EQUITY   71,375,954   26,193,149 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $189,976,043  $127,090,725 

     

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  16. RAMSEY, N.J. and BOCA RATON, Fla., Oct. 29, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the Company will host a live conference call and audio webcast on Thursday, November 5, 2020 at 4:30 p.m. ET, to discuss its financial results and business highlights for the third quarter ended September 30, 2020.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8185674. A live audio webcast of the call will be available under "Events & Webcasts" in the…

    RAMSEY, N.J. and BOCA RATON, Fla., Oct. 29, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the Company will host a live conference call and audio webcast on Thursday, November 5, 2020 at 4:30 p.m. ET, to discuss its financial results and business highlights for the third quarter ended September 30, 2020.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8185674. A live audio webcast of the call will be available under "Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

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  17. RAMSEY, N.J. and BOCA RATON, Fla., Oct. 21, 2020 (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 an exclusive educational event at IDWeek 2020 on respiratory viral infections, presented by nationally recognized clinical experts Dr. Michael Ison from Northwestern University and Dr. Lisa Forbes Satter from Baylor College of Medicine and Texas Children's Hospital, as well as new data on Streptococcus pneumonia in an on-demand poster session.

    Educational Event Presentation Title: Challenges in the Management of Respiratory Viral Infections in 2020: An

    RAMSEY, N.J. and BOCA RATON, Fla., Oct. 21, 2020 (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 an exclusive educational event at IDWeek 2020 on respiratory viral infections, presented by nationally recognized clinical experts Dr. Michael Ison from Northwestern University and Dr. Lisa Forbes Satter from Baylor College of Medicine and Texas Children's Hospital, as well as new data on Streptococcus pneumonia in an on-demand poster session.

    Educational Event Presentation Title: Challenges in the Management of Respiratory Viral Infections in 2020: An Expert Discussion

    Session Date: Thursday, October 22, 2020

    Session Time:  3:00 PM – 3:45 PM ET

    Session Location: IDWeek Learning Lounge

    • Michael G. Ison, MD, MS, Professor of Medicine (Infectious Diseases) and Surgery (Organ Transplantation) at the Feinberg School of Medicine at Northwestern University, will present on the management of respiratory viral infections in immunocompromised patients and the unique challenges faced today.
    • Lisa Forbes Satter, MD, Assistant Professor of Pediatrics in the Section of Immunology, Allergy, and Rheumatology at Baylor College of Medicine and Texas Children's Hospital, will discuss current therapeutic modality approaches, and an IVIG product that is manufactured using patented methodologies for donor screening and plasma pooling.

    Poster Presentation TitleKinetics of Post-Vaccination Seroprotection to S. Pneumoniae for the Immune-Compromised and Vaccine-Naïve Populations (Mond et al.)

    Session Title: Adult Vaccines

    Session Date: Wednesday, October 21, 2020

    Session Time:  On Demand

    Session Location: IDWeek Virtual Meeting, Poster Session

    Poster Presentation and Abstract Number: 911378



    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

    Director, Investor Relations and Corporate Strategy | 201-478-5552 |

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 | 

    Primary Logo

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  18. RAMSEY, N.J. and BOCA RATON, Fla., Sept. 09, 2020 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley Virtual Healthcare Conference on Monday, September 14, 2020, at 4:30 p.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical…

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 09, 2020 (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 Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley Virtual Healthcare Conference on Monday, September 14, 2020, at 4:30 p.m. ET.

    A webcast of the event will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

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  19. ImmunoRank Offers a Faster, Simpler, More Cost Effective Way to Identify High Titer Convalescent Plasma for Use in Both Treating COVID-19 Patients and for Creating COVID-19 Hyperimmune Globulins

    Proprietary Assay Developed in Collaboration with Leinco Technologies

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 03, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank™ was developed in collaboration…

    ImmunoRank Offers a Faster, Simpler, More Cost Effective Way to Identify High Titer Convalescent Plasma for Use in Both Treating COVID-19 Patients and for Creating COVID-19 Hyperimmune Globulins

    Proprietary Assay Developed in Collaboration with Leinco Technologies

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 03, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank™ was developed in collaboration with Leinco Technologies, Inc. ("Leinco"). ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes.

    ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the U.S. Food and Drug Administration. We will report on material regulatory and commercial developments as we progress.  ADMA has submitted patents for ImmunoRank in the U.S. and certain foreign markets. Both ADMA and Leinco are named as co-inventors on the patents.

    "We are confident the ImmunoRank assay will be an efficient and effective tool for selecting high titer convalescent plasma units containing neutralizing antibodies to SARS-CoV-2 both for the treatment of COVID-19 patients as well as identifying plasma that can be used for development and production of hyperimmune globulins to treat COVID-19," said Adam Grossman, President and Chief Executive Officer of ADMA.  "Current screening methods to identify circulating SARS-CoV-2 neutralizing antibodies are labor and cost intensive and take multiple days to complete. This assay can be run in approximately 80 minutes, resulting in numerous tests per day, and can be performed at a fraction of the cost of other, more laborious assays.  We believe this proprietary assay will result in important potential product and business development opportunities as we continue to seek out meaningful ways to help patients battling COVID-19." 

    Under the terms of the collaboration agreement between ADMA and Leinco, ADMA has the right to use, market and commercialize ImmunoRank for the screening and selection of human plasma units or plasma pools containing SARS-CoV-2 neutralizing antibodies, for manufacturing products such as plasma proteins for therapeutic use, including but not limited to producing intravenous immunoglobulins ("IVIG") or hyperimmune globulin products, for the screening of convalescent plasma or vaccinated plasma donors, as well as combining these products with SARS-CoV-2 neutralizing monoclonal antibodies.  ADMA also has the rights for commercializing ImmunoRank test kits for use by plasma donation centers to screen donors for neutralizing antibodies to SARS-CoV-2. Leinco will be responsible for manufacturing ImmunoRank and has the right to market and sell the assay for all other potential markets, other than those reserved exclusively to ADMA.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    About Leinco Technologies Inc. (Leinco)

    Leinco Technologies, Inc. is a biotechnology company founded in 1992 as a specialty manufacturer of early discovery research products including antibodies, recombinant proteins, ELISA kits, second step reagents and other life sciences products. Shortly thereafter, we also established ourselves as a premier provider of custom R&D and manufacturing services focusing on monoclonal antibodies and recombinant proteins. Our innovative products and services are used to augment the early discovery process in life science research, diagnostics and ground breaking development of protein therapeutics. To order the ImmunoRank Neutralization MICRO-ELISA Assay to Detect SARS-CoV-2 Neutralizing Antibodies in Plasma for academic use or for more information visit www.leincotechnologies.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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about opportunities relating to the use, sale, and marketing of ImmunoRank™, the potential approval of Emergency Use Authorization for the use of ImmunoRank™, and the opportunities presented by the collaboration between ADMA and Leinco. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |  

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  20. RAMSEY, N.J. and BOCA RATON, Fla., Sept. 02, 2020 (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 Adam Grossman, President and Chief Executive Officer, is scheduled to participate in the following upcoming investor conferences in September:

    • H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 2:30 p.m. ET.
       
    • 2020 Cantor Virtual Global Healthcare Conference on Thursday, September 17, 2020 at 11:20 a.m. ET.

    • Oppenheimer Fall Healthcare Life Sciences & Medtech Summit on Tuesday, September 22, 2020 at 9:10 a.m. ET.

    Webcasts…

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 02, 2020 (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 Adam Grossman, President and Chief Executive Officer, is scheduled to participate in the following upcoming investor conferences in September:

    • H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 2:30 p.m. ET.

       
    • 2020 Cantor Virtual Global Healthcare Conference on Thursday, September 17, 2020 at 11:20 a.m. ET.



    • Oppenheimer Fall Healthcare Life Sciences & Medtech Summit on Tuesday, September 22, 2020 at 9:10 a.m. ET.

    Webcasts of the live presentations will be available on the Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  21. Generated Total Revenues of $18.0 Million for the First Half of 2020, Reflecting a 78% Increase Over First Half of 2019

    Joined CoVIg-19 Plasma Alliance and Successfully Opened New ADMA BioCenters Plasma Collection Center

    Company Anticipates Generating $250 Million or More in Annual Revenues Within Next Three to Five Calendar Years

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., Aug. 05, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today reported business highlights…

    Generated Total Revenues of $18.0 Million for the First Half of 2020, Reflecting a 78% Increase Over First Half of 2019

    Joined CoVIg-19 Plasma Alliance and Successfully Opened New ADMA BioCenters Plasma Collection Center

    Company Anticipates Generating $250 Million or More in Annual Revenues Within Next Three to Five Calendar Years

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., Aug. 05, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today reported business highlights and financial results for its fiscal second quarter and six months ended June 30, 2020, and provided an overview of recent progress and accomplishments.

    "The first half of 2020 was marked by several achievements and challenges as we navigate through these unprecedented macro-market conditions," said Adam Grossman, President and Chief Executive Officer of ADMA. "Total revenues for the first half of 2020 increased approximately 78% compared to the same prior year period. While the second quarter 2020 revenues were approximately 19% higher than second quarter 2019 revenues, ADMA, and certain of its third-party vendors, experienced impacts from the global COVID-19 pandemic which resulted in unforeseen supply chain disruptions. These COVID-19 disruptions were primarily related to delays with final product Current Good Manufacturing Practice ("cGMP") release testing by third-party vendors. This means that a few of our production batches were finished on schedule but we were unable to submit for U.S. Food and Drug Administration ("FDA") lot release authorization due to delayed test results.

    "These delays were mainly experienced during the latter part of the second quarter and have since been resolved during July. In response to these delays, and in partnership with the FDA, we added additional release testing laboratories to our approved consortium and believe we have completely resolved  the issue and do not anticipate additional testing or batch release delays going forward.

    "Market demand for our immunoglobulin product portfolio remains strong and we anticipate considerable revenue growth for the second half of the year and are excited for the anticipated production volume increases from our capacity expansion efforts in 2021 and beyond. We also believe we remain on track to achieve our stated goal of generating $250 million or more in annual revenues within the next three to five calendar years.

    "In accordance with our stated corporate objectives, during the quarter we completed construction of a new plasma collection center, initiated donor collections and submitted a Biologics License Application ("BLA") to the FDA, with an approval decision expected in mid-2021. We also installed and qualified a new aseptic fill-finish machine at our Boca Raton facility, and manufactured conformance batches of BIVIGAM® at an increased scale that will ultimately allow us to manufacture at twice the volume as the process that is in place today. And finally, we joined the CoVIg-19 Plasma Alliance and began collection of plasma from COVID-19 convalesced patients. We are proud of these important achievements and milestones and believe we have set the stage to now be in a position to ensure the U.S. market has a continuous supply of BIVIGAM®, ASCENIV™ and NABI-HB®. We are on target for positioning our operations to capitalize on the continued forecasted growth of the plasma products industry.  Our production throughput and finished product supply remains on track to begin realizing the benefits from these initiatives as early as mid-2021," concluded Mr. Grossman.

    Second Quarter 2020 Highlights and Recent Events

    • Plasma Collection Centers – ADMA BioCenters, a wholly-owned subsidiary of ADMA Biologics, successfully opened, began donor collections and filed a BLA to receive FDA approval for its second plasma collection center.  ADMA expects to open a third U.S. collection center and commence construction on a fourth center by the end of 2020 and remains on track to deliver on its stated milestone of opening five to ten new plasma collection centers over the next three to five years.



    • Plasma Industry Alliance – ADMA recently joined the CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19.  As an Alliance member company, ADMA, through its ADMA BioCenters subsidiary, has initiated collecting and providing COVID-19 plasma from convalesced patients.  This plasma will be used by the CoVIg-19 Plasma Alliance to produce a COVID-19 targeted hyperimmune globulin, as well as for internal research and development purposes.



    • Manufacturing Capacity Expansion Initiatives – ADMA successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new Vanrx SA25 Workcell aseptic filling machine and manufacturing of four conformance batches of BIVIGAM® at an increased scale.  These important initiatives are designed to reduce operating costs, improve margins and provide for faster production cycle turnaround time, ultimately providing increased control and independence from third-party vendors and contractors.  ADMA plans to submit the appropriate applications to the FDA during the second half of 2020, and expects to begin benefitting from these initiatives as early as mid-2021.

    COVID-19 Impacts

    • Final Product Release Testing – ADMA experienced delays with final product release testing for its commercial products due to COVID-19's impact on third-party laboratories that perform the FDA-required cGMP release testing.  These testing delays prevented ADMA from receiving FDA authorization to sell additional completed production batches during the second quarter.  ADMA believes this delay was completely resolved in July 2020.  In response to these delays, and in collaboration with the FDA, ADMA secured additional third-party laboratories, which has completely resolved this specific testing backlog.  ADMA received FDA authorized product releases with data from its new third-party testing laboratories during July. Going forward, ADMA believes access to these additional laboratories will provide more rapid final product release testing as well as more consistent receipt of testing results to submit to the FDA for final product releases.



    • Supply Chain Impacts Due to COVID-19 – As a result of previous state and local "shelter-in-place" orders, ADMA experienced lower than normal donor collections at its FDA-licensed plasma collection center during the second quarter of 2020.  ADMA also experienced delayed timing of shipments of source plasma from its contracted third-party suppliers, as well as delays in deliveries of personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture of its products.



    • Commercial Engagement Opportunities – ADMA observed impacts to its customer engagement initiatives as its sales and medical affairs field forces experienced difficulty communicating directly with physicians and other healthcare professionals.  In addition, a number of key scientific and medical meetings were either canceled or postponed, further limiting ADMA's ability to communicate with potential customers.  ADMA has implemented a comprehensive suite of virtual engagement initiatives; however, clinician engagement has been reduced due to rapidly evolving COVID-19 priorities at U.S. medical centers.

    Financial Results for the Three Months Ended June 30, 2020

    Total revenues for the quarter ended June 30, 2020 were $7.8 million, compared to $6.6 million for the quarter ended June 30, 2019, representing an increase of approximately $1.2 million, or approximately 19%.  The increase is primarily due to sales of BIVIGAM, ASCENIV and intermediates, compared to no sales from these products during the same prior year period.  ADMA's revenues for the second quarter of 2020, compared to the second quarter of 2019, were favorably impacted by the FDA approvals of BIVIGAM and ASCENIV on May 9, 2019 and April 1, 2019, respectively, and by the manufacturing and supply agreement ADMA entered into in January 2020 to produce and sell intermediate fractions to a certain customer.

    Consolidated net loss for the quarter ended June 30, 2020 was $20.2 million, or $(0.23) per basic and diluted share, compared to a consolidated net loss of $13.2 million, or $(0.25) per basic and diluted share, for the quarter ended June 30, 2019.  The increase in net loss of $7.0 million was primarily due to increased cost of product revenue of $3.0 million related to sales of FDA-approved immunoglobulin products not present in the same prior year period, along with the remaining costs associated with the manufacturing of BIVIGAM's increased plasma pool conformance lots as part of our planned capacity expansion, partially offset by a decrease in unabsorbed manufacturing expense at the Boca Raton, FL production facility.  The increase in net loss during the second quarter of 2020 is also attributable to higher research and development expenses of $1.1 million, largely due to costs associated with the testing and development of a new filling line at one of our third-party fill finishers, and to increased selling, general and administrative expenses of $2.6 million, mainly due to increases in employee compensation expenses and other costs in support of our commercialization efforts for BIVIGAM and ASCENIV. In addition, interest expense for the quarter increased by $1.0 million due to our accessing additional debt during the second quarter of 2019 and first quarter of 2020.  Included in the net loss for the second quarter of 2020 were non-cash expenses of approximately $2.0 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    Financial Results for the Six Months Ended June 30, 2020

    Total revenues for the six months ended June 30, 2020 were $18.0 million, compared to $10.1 million for the six months ended June 30, 2019, representing an increase of $7.9 million, or approximately 78%.  The increase in revenues was primarily attributable to sales of BIVIGAM, ASCENIV and intermediates, compared to no sales from these products during the same prior year period.

    Consolidated net loss for the six months ended June 30, 2020 was $39.4 million, or $(0.49) per basic and diluted share, compared to a consolidated net loss of $26.3 million, or $(0.53) per basic and diluted share, for the six months ended June 30, 2019.  The increase in net loss of $13.1 million was primarily attributable to increased cost of product revenue of $10.4 million related to sales of BIVIGAM, ASCENIV and intermediates not present during the first half of 2019, along with the costs associated with the manufacturing of BIVIGAM's increased plasma pool conformance lots as part of our planned capacity expansion, along with other production initiatives and investments at the Boca Raton facility.  Other factors contributing to the increase in net loss include: higher research and development expenses attributed to costs associated with testing and development of a new fill line at our third-party fill finisher and costs incurred for a study we commenced to potentially extend ASCENIV's approved and labeled expiration dating, higher selling, general administrative expenses in support of our commercialization efforts of BIVIGAM's relaunch and ASCENIV's launch and the overall growth in the size and scope of the Company's operations along with higher interest expense due to accessing additional debt during the second quarter of 2019 and first quarter of 2020.  Included in the net loss for the first half of 2020 were non-cash expenses of approximately $3.9 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    At June 30, 2020, ADMA had cash and cash equivalents of $75.8 million and accounts receivable of $6.5 million, compared to cash and cash equivalents of $26.8 million and accounts receivable of $3.5 million at December 31, 2019.  ADMA's net working capital as of June 30, 2020 was $130.1 million, compared to $71.8 million as of December 31, 2019.

    Conference Call Information

    ADMA will host a conference call today, Wednesday, August 5, 2020, at 4:30 p.m. Eastern Time, to discuss the second quarter 2020 financial results and recent corporate updates.  To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8992308.  A live audio webcast of the call will be available under "Events & Webcasts" in the Investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.  An archived webcast will be available on the Company's website approximately two hours after the event.

    About BIVIGAM®

    BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).  BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.  BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma.  These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections.  BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin (IgG) antibodies.

    About ASCENIV™

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).   ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).  ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's proprietary microneutralization assay.  ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease.  ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    About Nabi-HB®

    Nabi-HB® is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB® is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB® is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen ("HBsAg"), prenatal exposure to infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB® has a well-documented record of long-term safety and effectiveness since its initial market introduction. Certain data and other information about Nabi-HB® or ADMA Biologics and its products can be found on the Company's website at www.admabiologics.com.

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.atlantaplasma.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations, including the goal of generating $250 million or more in annual revenues within the next three to five calendar years; our belief that we have corrected third-party release testing delay issues through the addition of release testing laboratories to our FDA-approved consortium; the outcome and timing of our BLA application for our new plasma center; the expected benefits from the new aseptic fill-finish machine installed at our Boca Raton facility; the continued forecasted growth of the plasma products industry and our expectation to capitalize thereon; the construction and opening of plasma collection centers and the timing thereof; the expected and intended use by the CoVIg-19 Plasma Alliance of plasma that we collect; the benefits expected from our several manufacturing and supply chain enhancement, the expected timing for realizing those benefits, and our plan to submit appropriate applications to the FDA related thereto; and the expected benefits from securing additional third-party laboratories to perform cGMP release testing. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 |www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |



    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONSOLIDATED STATEMENTS OF OPERATIONS

     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
            
    REVENUES:       
    Product revenue$7,751,885  $6,525,233  $17,915,921  $10,018,114 
    License revenue 35,709   35,709   71,417   71,417 
    Total Revenues 7,787,594   6,560,942   17,987,338   10,089,531 
            
    OPERATING EXPENSES:       
    Cost of product revenue (exclusive of amortization expense shown below) 13,495,629   10,491,236   30,324,855   19,896,415 
    Research and development 1,656,420   516,986   3,185,158   1,387,621 
    Plasma center operating expenses 877,902   594,113   1,378,546   1,248,599 
    Amortization of intangible assets 178,838   211,234   357,676   422,469 
    Selling, general and administrative 8,702,630   6,086,047   16,634,714   11,681,517 
    Total operating expenses 24,911,419   17,899,616   51,880,949   34,636,621 
            
    LOSS FROM OPERATIONS (17,123,825)  (11,338,674)  (33,893,611)  (24,547,090)
            
    OTHER INCOME (EXPENSE):       
    Interest and other income 19,411   209,808   267,479   337,207 
    Interest expense (3,067,306)  (2,072,578)  (5,784,397)  (3,613,085)
    Loss on extinguishment of debt -   -   -   (9,962,495)
    Gain on transfer of plasma center assets -   -   -   11,527,421 
    Other expense, net (6,371)  (10,428)  (12,792)  (21,785)
    Other expense, net (3,054,266)  (1,873,198)  (5,529,710)  (1,732,737)
            
    NET LOSS$(20,178,091) $(13,211,872) $(39,423,321) $(26,279,827)
            
    BASIC AND DILUTED LOSS PER COMMON SHARE$(0.23) $(0.25) $(0.49) $(0.53)
            
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:       
    Basic and Diluted 86,347,467   52,206,204   80,064,641   49,295,805 
     

    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

        
     June 30, December 31,
     2020 2019
    ASSETS(Unaudited)  
    Current assets:   
    Cash and cash equivalents$75,781,122  $26,752,135 
    Accounts receivable, net 6,514,165   3,469,919 
    Inventories 56,001,348   53,064,734 
    Prepaid expenses and other current assets 4,693,427   2,533,593 
    Total current assets 142,990,062   85,820,381 
    Property and equipment, net 37,373,366   31,741,317 
    Intangible assets, net 2,801,797   3,159,474 
    Goodwill 3,529,509   3,529,509 
    Deposits and other assets 4,846,834   2,840,044 
    TOTAL ASSETS$191,541,568  $127,090,725 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    Current liabilities:   
    Accounts payable$6,909,659  $9,174,591 
    Accrued expenses and other current liabilities 5,616,666   4,481,395 
    Current portion of deferred revenue 142,834   142,834 
    Current portion of lease obligations 210,870   229,073 
    Total current liabilities 12,880,029   14,027,893 
    Senior notes payable, net of discount 81,648,187   68,291,163 
    Deferred revenue, net of current portion 2,190,115   2,261,532 
    Subordinated note payable, net of discount 14,925,760   14,908,053 
    Lease obligations, net of current portion 2,937,292   1,302,361 
    Other non-current liabilities 80,730   106,574 
    TOTAL LIABILITIES 114,662,113   100,897,576 
        
    COMMITMENTS AND CONTINGENCIES   
        
    STOCKHOLDERS' EQUITY    
    Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding -   - 
    Common Stock, $0.0001 par value, 150,000,000 shares authorized, 86,349,981 and 59,318,355 shares issued and outstanding 8,635   5,932 
    Additional paid-in capital 381,010,696   290,903,772 
    Accumulated deficit (304,139,876)  (264,716,555)
    TOTAL STOCKHOLDERS' EQUITY  76,879,455   26,193,149 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $191,541,568  $127,090,725 

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  22. RAMSEY, N.J. and BOCA RATON, Fla., July 29, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the Company will host a live conference call and audio webcast on Wednesday, August 5, 2020 at 4:30 p.m. ET, to discuss its business highlights and financial results for the second quarter ended June 30, 2020.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8992308. A live audio webcast of the call will be available under "Events & Webcasts" in the investor…

    RAMSEY, N.J. and BOCA RATON, Fla., July 29, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the Company will host a live conference call and audio webcast on Wednesday, August 5, 2020 at 4:30 p.m. ET, to discuss its business highlights and financial results for the second quarter ended June 30, 2020.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8992308. A live audio webcast of the call will be available under "Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com 

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  23. RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., July 06, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Knoxville, TN.  ADMA also announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for this second plasma collection center.

    "We are extremely pleased to announce the opening and commencement of operations at our second and newest ADMA BioCenters…

    RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., July 06, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Knoxville, TN.  ADMA also announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for this second plasma collection center.

    "We are extremely pleased to announce the opening and commencement of operations at our second and newest ADMA BioCenters plasma collection facility," said Adam Grossman, President and Chief Executive Officer of ADMA. "The opening of the Knoxville center is an important step in our expansion plans and puts us on track to achieve our goal of opening five to 10 new plasma collection centers by the end of 2022."

    This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first.

    The FDA regulatory process for obtaining approval for this plasma collection center includes a site inspection and an approximately 12-month BLA review period. As such, ADMA expects to receive an approval decision for this second plasma facility in mid-2021. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can use the plasma collected for production of its FDA approved immunoglobulin products.

    About ADMA BioCenters

    ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.atlantaplasma.com.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "intend," "target," "plan," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; expansion plans and the goal of opening five to 10 new plasma collection centers by the end of 2022; our expectation to receive an FDA approval decision to our filed BLA and the timing thereof; and the use of plasma collected at the Knoxville facility for production of immunoglobulin products. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  24. RAMSEY, N.J. and BOCA RATON, Fla., June 23, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the proposed resolution to elect Martha J. Demski to its Board of Directors was approved at the Company's recent Annual Shareholder Meeting, held June 18, 2020. 

    Ms. Demski brings over 35 years of experience in leading business growth and financial strategies for life sciences companies.  She currently serves as the Chairman of the Board of Chimerix, Inc., as well as a Board member for several life science companies including Adamas Pharmaceuticals and Equillium, Inc.

    RAMSEY, N.J. and BOCA RATON, Fla., June 23, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that the proposed resolution to elect Martha J. Demski to its Board of Directors was approved at the Company's recent Annual Shareholder Meeting, held June 18, 2020. 

    Ms. Demski brings over 35 years of experience in leading business growth and financial strategies for life sciences companies.  She currently serves as the Chairman of the Board of Chimerix, Inc., as well as a Board member for several life science companies including Adamas Pharmaceuticals and Equillium, Inc.

    "Martha has a long track record of success serving in executive leadership roles in both finance and manufacturing, as well as on the Boards of several leading biotechnology companies," said Steven A. Elms, Chairman of the Board of ADMA Biologics. "She brings to ADMA over 35 years of experience in the biotechnology sector making her an invaluable addition to our Board.  On behalf of the Board and the entire management team, we welcome her and look forward to working with her in the years ahead."

    "With the commercializations of BIVIGAM and ASCENIV, as well as the expansion of its plasma collection facilities, ADMA is an exciting story in biotechnology and is well-positioned for substantial growth," said Ms. Demski. "I look forward to bringing my extensive experience in financial strategy and business operations to the ADMA Board and I look forward to working with the entire team as we continue to tirelessly work towards our goal of manufacturing and commercializing novel immunoglobulin products for patients at risk for infection."

    Ms. Demski was Senior Vice President and Chief Financial Officer of Ajinomoto Althea, Inc. (now known as Ajinomoto Bio-Pharma Services), a fully-integrated contract development and manufacturing organization, before retiring in May 2017. Prior to joining Althea in 2011, Ms. Demski was Interim Chief Operating Officer and Chief Financial Officer of the Sidney Kimmel Cancer Center (SKCC). Previously, she served as Vice President and Chief Financial Officer of Vical. Additionally, Ms. Demski has more than 13 years of banking experience with Bank of America. In 2017, Ms. Demski was recognized as Director of the Year in Corporate Governance by the Corporate Directors Forum. Ms. Demski earned her M.B.A. from the University of Chicago Booth School of Business with concentrations in Accounting and Finance and her B.A. from Michigan State University.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA being well-positioned for substantial growth. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |  

    Primary Logo

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  25. RAMSEY, N.J. and BOCA RATON, Fla., May 21, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), today announced it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia Inc. ("ADMA BioCenters"), from individuals who have recovered from COVID-19. ADMA is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. 

    ADMA is seeking US citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to…

    RAMSEY, N.J. and BOCA RATON, Fla., May 21, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), today announced it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia Inc. ("ADMA BioCenters"), from individuals who have recovered from COVID-19. ADMA is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. 

    ADMA is seeking US citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. People who have recovered from COVID-19 can have antibodies in their plasma that may be helpful in treating the virus. Immune globulin is a plasma-derived medicine that is comprised of polyclonal antibodies and is routinely used for the prevention and treatment of certain infectious diseases. Currently, six producers of immune globulin, including ADMA Biologics, supply products to the US market.

    "During this unprecedented time, ADMA has risen to the challenge of helping confront the growing coronavirus pandemic, while fulfilling our mission to help patients battle infectious diseases," stated Adam Grossman, President and Chief Executive Officer. "Immune globulin and hyperimmune globulin therapy have the potential to be one of the earliest and best treatment options for patients with COVID-19 infections. The key to developing an immune globulin with high antibody levels to COVID-19 is the collection of plasma from patients that have recovered from COVID-19 infection. We encourage anyone who has recovered from COVID-19 without symptoms for 14 days to come forward and donate plasma to this worthy cause."

    ADMA is a member of the CoVIg-19 Plasma Alliance, a plasma industry alliance established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19. You can learn more about the CoVIg-19 Plasma Alliance here www.covig-19plasmaalliance.org.

    To find out more about donating plasma, including eligibility requirements and location, please visit www.admabiocenters.com or www.donatingplasma.org.

    About ADMA BioCenters

    ADMA BioCenters is a wholly-owned subsidiary of ADMA Biologics, which operates as a source plasma collection business. ADMA BioCenters is an FDA-licensed facility specializing in the collection of human plasma to make special medications for the treatment and prevention of diseases. A typical plasma collection center can collect between 30,000 to 50,000 liters of source plasma annually. Plasma collected from ADMA BioCenters' facility that is not used to manufacture ADMA's products or development-stage candidates is sold to customers under an existing supply agreement or in the open market, generating revenues for the Company.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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. and its subsidiaries (collectively, "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 "estimate," "intend," "anticipate," "plan," "expect," "believe," "will," "can," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about manufacturing of a potential hyperimmune globulin; the use of donated plasma to produce an immune globulin to potentially help infected patients with COVID-19; the potential for antibodies from those who have recovered from COVID-19 can be helpful in treating COVID-19; the potential for immune globulin and hyperimmune globulin therapy to be one of the earliest and best treatment options for patients with COVID-19 infections; and the importance of collecting plasma from patients that have recovered from COVID-19 infection for developing an immune globulin with high antibody levels to COVID-19. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:
    Brian Lenz
    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:
    Sam Martin
    Managing Director, Argot Partners | 212-600-1902 |

    MEDIA RELATIONS CONTACT:
    David Rosen
    Managing Director, Media, Argot Partners | 212-600-1902 |

    Primary Logo

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  26. OSAKA, Japan, and KING OF PRUSSIA, Pa., May 7, 2020 /PRNewswire/ -- The CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration recently established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, is rapidly building momentum. Its membership has expanded globally to include 10 plasma companies, and now also includes global organizations from outside the plasma industry who are providing vital support to encourage more people to donate plasma.

    In addition to those announced at its inception - Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda - the Alliance welcomes new industry members ADMA Biologics, BioPharma Plasma, GC Pharma, and Sanquin. Together, these organizations will contribute specialist advisory expertise, technical guidance and/or in-kind support to contribute to the Alliance goal of accelerating development and distribution of a potential treatment option for COVID-19.

    In parallel, the Alliance has confirmed it will work with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. This global study is currently anticipated to start in the summer
    and will form the foundation for the potential regulatory approval of the hyperimmune therapy.

    "Hyperimmune globulin therapy has the potential to be one of the earliest treatment options for COVID-19, and we look forward to working with NIAID and health authorities to bring this therapy to patients as early as possible," said Bill Mezzanotte, Executive Vice President, Head of R&D, CSL Behring and Co-leader of the CoVIg-19 Plasma Alliance. "One of the stated goals of the alliance is to be an effective partner for important institutions such as NIAID and also to help develop coherent regulatory strategies that can give global health authorities the confidence to streamline the approval process of hyperimmune globulin therapy for COVID-19." 

    Key to developing this potential hyperimmune globulin treatment is the collection of convalescent plasma. To amplify awareness, the Alliance has gained support from large organizations outside of the plasma industry. Examples of those offering resources to the Alliance include Microsoft and Uber Health. Microsoft is providing technology support, including the Alliance website and the Plasmabot for donor recruitment. The Plasmabot streamlines the process for a potential donor to quickly gain information about their nearest collection center from across the member network. In parallel, Uber Health has agreed to donate 25,000 round-trip rides to transport potentially eligible donors to and from plasma collection centers. These rides will be coordinated by the plasma collection center directly for individuals with confirmed appointments.

    "Partnership and collaboration are critical to the success of the CoVIg-19 program," said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda, and co-leader of the CoVIg-19 Plasma Alliance. "We now have enough plasma to initiate clinical manufacturing, but more is needed to ensure both speed and scale. The growing and active involvement of leading companies from outside the plasma industry, who support this Alliance as well as convalescent plasma for transfusion initiatives – demonstrates the potential of convalescent plasma to fight this public health crisis. Together, we all share the same goal – to save lives by using the power of convalescent plasma in different ways."

    The success of the CoVig-19 program depends heavily right now on the support of people across the world to donate convalescent plasma. We encourage those who have recovered from COVID-19 and who are interested in contributing to our development program – or to any other – by donating their plasma to visit the website for more information.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics (NASDAQ:ADMA) ("ADMA"), is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    About BioPharma

    Biopharma is a Ukrainian biopharmaceutical company, focused on the development and production of plasma-derived medicines. It is the only plant in Ukraine and neighboring countries that has the latest technology for manufacturing. The company was founded in 1896 and have been producing plasma-derived drugs for almost 50 years. Since 2019 Biopharma operates in a new R&D complex. The company focuses on the supply of albumins, immunoglobulins, coagulation factors to Ukraine and to over 30 countries worldwide. Also Biopharma develops national network of plasma centers.  www.biopharma.ua

    About Biotest AG
    Biotest is a provider of plasma proteins and biological drugs. The corporate offices are located in Dreieich (near Frankfurt), Germany. With a value-added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. Biotest owns and operates 22 plasma donation centers across Europe in Germany, Hungary and Czech Republic. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. For more information visit http://www.biotest.com.

    About Bio Products Laboratory (BPL)
    Recognising the power of plasma and with over 60 years heritage in the industry, BPL supplies high-quality plasma derived medicines to meet the needs of clinicians, patients and customers globally.  Headquartered in the United Kingdom and with plasma collection centres across the United States, we are dedicated to producing medicines for the treatment of immune deficiencies, bleeding disorders and infectious diseases as well for critical care.  BPL invests in the latest R&D, technology and manufacturing methods, and continuously adapts to ensure that we continue to serve all our stakeholders effectively.  For more information visit http://www.bplgroup.com.

    About CSL Behring
    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited ((ASX:CSL, OTC:CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 70 countries. For more information, visit www.cslbehring.com and for inspiring stories about the promise of biotechnology, visit Vita www.cslbehring.com/Vita.

    About GC Pharma
    GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Pharma is one of the leading plasma protein product manufacturers in the world and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company's registered, legal name.

    About LFB

    LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB was founded in 1994 in France and is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals, with blood-derived therapeutics with the vision to provide treatment options to patients in three major areas: immunology, haemostasis, and intensive care. LFB currently markets 15 products in more than 30 countries. www.groupe-lfb.com

    About Octapharma

    Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology; Immunotherapy and Critical care. Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 mil litres of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US. For more information visit: www.octapharma.com

    About Sanquin

    Sanquin is responsible for the Dutch collection of both blood and plasma and consists of the Sanquin Blood Bank and its pharmaceutical entity, Sanquin Plasma Products. Through Sanquins efforts in combating SARS-COV-2, we have collected plasma donations from convalescent patients for both research purposes and the manufacturing of an anti-COVID-19 immunoglobulin. Adding to this, our research initiatives complete a spectrum of corona-related projects: from publishing the first large scale investigation on the prevalence of COVID-19 antibodies in Dutch donors up to supporting conclusive research on the effects of transfusion of hyper-immune plasma to patients. We are proud and eager to take part in the international endeavor to make anti-COVID-19 immunoglobulin available to a broad range of people in risk groups.

    About Takeda Pharmaceutical Company Limited
    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit www.takeda.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/covig-19-plasma-alliance-builds-strong-momentum-through-expanded-membership-and-clinical-trial-collaboration-301054894.html

    SOURCE CSL Behring

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  27. RAMSEY, N.J. and BOCA RATON, Fla., May 07, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immuno-deficient patients at risk for infection and others at risk for certain infectious diseases, today announced several recent corporate achievements pertaining to its supply chain robustness objectives as established at the beginning of 2020.

    "We have been very active during these challenging times in executing upon what we believe to be high value-added improvements to our supply chain to enhance robustness, increase capacity and heighten control over the production…

    RAMSEY, N.J. and BOCA RATON, Fla., May 07, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immuno-deficient patients at risk for infection and others at risk for certain infectious diseases, today announced several recent corporate achievements pertaining to its supply chain robustness objectives as established at the beginning of 2020.

    "We have been very active during these challenging times in executing upon what we believe to be high value-added improvements to our supply chain to enhance robustness, increase capacity and heighten control over the production of our products.  These achievements include the successful manufacturing of three BIVIGAM® conformance batches at an increased scale of plasma volume, purchase of a new aseptic filling machine and installation, along with our plasma collection center expansion initiatives, all of which are on schedule with our budgeted expectations.  These important accomplishments are in-line with our 2020 corporate goals and are designed to enhance shareholder valued by reducing operating costs, improve margins and provide for faster turnaround time in the production cycle of our commercial immunoglobulin products," stated Adam Grossman, President and Chief Executive Officer. "We believe these additional capabilities will also allow us to provide a broader range of high-quality services, both to our existing customers, as well as potential new clients and ultimately provide increased control and independence from vendors and contractors as we grow our Company."

    The conformance batch production for BIVIGAM is at double the plasma volume of the currently U.S. Food and Drug Administration ("FDA") approved process for the manufacture of immune globulin ("IG").  There have been no significant changes to the manufacturing process, in-process controls or final release testing other than validating the effectiveness of the ADMA manufacturing process at the larger scale.  At the newly increased scale, we observed the same potency and purity of the IG production process as our FDA-approved production process.  Upon approval of this manufacturing change, ADMA anticipates it will be in a position to produce double the peak forecasted quantity of BIVIGAM using the same equipment, single-use disposables and same labor force.  

    Mr. Grossman continued, "Additionally, we completed the installation and site acceptance testing of our new in-house aseptic filling machine, a Vanrx SA25 Workcell, which utilizes a state-of-the-art closed isolator design allowing for the removal of human interventions and provides safe drug products for patients.  The combination of increased production capacity for BIVIGAM and the enhanced vertical integration of in-house filling and packaging will allow ADMA to bring our products to market faster, and substantially increase ADMA's end-to-end control over our complete manufacturing process." 

    The Vanrx SA25 Workcell has been installed by many leading biologics and vaccine producers in the U.S. and has been FDA approved numerous times.  Once installed, the SA25 Workcell will have the capability of rapidly switching between different container and closure formats enabling aseptic filling in a variety of different fill volumes and presentation sizes.

    Before the BIVIGAM production scale increase and filling machine can be fully implemented for commercial manufacturing, ADMA must submit an amendment(s) to its Biologics License Application to the FDA.  ADMA anticipates submitting applications to the FDA for the increased production scale conformance batches of BIVIGAM and the Vanrx filling machine during the second half of 2020.  Both the increased production scale and filling machine initiatives and investments are anticipated to be fully operational and contribute to product supply during 2021.

    "Lastly, we have executed on our plasma collection center buildout expansion initiatives, which are on schedule.  We have secured additional locations and have commenced construction of two facilities in Tennessee. All of these important plasma collection site expansion activities will continue for the duration of 2020 and into 2021 and we believe we should be able to submit for FDA approvals toward the end of the second half of this year.  We look forward to keeping our investors apprised of meaningful developments as we continue to execute on our 2020 stated goals and objectives." concluded Mr. Grossman. 

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; being well-positioned to weather current macroeconomic challenges while continuing to execute on future growth plans; continuing progress regarding the commercial launches for BIVIGAM and ASCENIV; ramping production throughput for commercial products and building inventory; continued sales growth and market penetration; potential plasma product supply constraints and the timing thereof; increasing ADMA's production throughput; expansion of manufacturing capacity; reducing our operating costs, improving margins and providing for faster turnaround time in the production cycle of our commercial products; and expected annual revenues from ADMA's manufacturing and supply agreement to produce and sell plasma-derived intermediate fractions. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

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  28. Achieved First Quarter 2020 Total Revenues of $10.2 Million, a 189% Increase Over First Quarter 2019

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public Offering

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., May 06, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today reported financial results for the quarter ended March 31, 2020, ADMA's first fiscal quarter, and provided an…

    Achieved First Quarter 2020 Total Revenues of $10.2 Million, a 189% Increase Over First Quarter 2019

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public Offering

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., May 06, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today reported financial results for the quarter ended March 31, 2020, ADMA's first fiscal quarter, and provided an overview of recent progress and accomplishments.

    "During the first quarter of 2020, we invested in our supply-chain robustness strategy and continued to make progress with reinforcing and expanding our commercial infrastructure by building out our salesforce and medical affairs teams, while generating encouraging year-over-year quarterly revenue growth," said Adam Grossman, ADMA's President and Chief Executive Officer.  "I am extremely proud of the ADMA Biologics team as they have risen to the challenge of navigating the Company through the COVID-19 pandemic while continuing to provide critical immune globulin (IG) and hyperimmune globulin products that U.S. patients and physicians need.  Due to our strong foundation, we believe we are well-positioned to not only weather the current macroeconomic challenges, but to continue to execute on our future growth plans.  Most importantly, everyone at ADMA offers our immense gratitude to all of the healthcare personnel, first responders and others working on the front lines during this pandemic."

    2020 Outlook and Objectives Update

    • Commercial launches for BIVIGAM and ASCENIV continue to progress.  With in-person field opportunities reduced at medical meetings and customer sites due to "shelter-in-place" orders across the U.S., ADMA has successfully implemented virtual engagement initiatives with key opinion leaders, prescribers and other healthcare professionals to facilitate the ongoing commercial rollouts.
    • ADMA continues to ramp its production throughput for its commercial products and build inventory to support continued sales growth, market penetration and increase available market supply.  While ADMA has not experienced any significant decreases in its plasma collection operations to date, there have been reports that other plasma collection organizations are experiencing more meaningful declines as a result of the COVID-19 pandemic which could lead to potential plasma product supply constraints.  ADMA is working diligently to increase its production throughput to potentially offset a portion of any potential supply shortfall the overall IG market may experience due to the COVID-19 pandemic. 
    • Investments in support of our stated supply chain robustness initiatives remain on schedule and within budget and, most notably, the expansion of IG manufacturing capacity continues to be on track:
      º Aseptic filling machinery installed, Site Acceptance Testing completed and validation testing underway.
      º Successfully manufactured three BIVIGAM conformance batches at an increased plasma pool scale, which has the potential to increase overall plant production capacity by approximately 50% or more.
      º Expansion of plasma collection center network continues on track with the commencement of collection center build-outs and the securing of additional locations.

    Mr. Grossman continued, "These three substantial objectives and investments, including increased raw material plasma collection, expanded production capacity and aseptic filling capability, are anticipated to change the forward-looking outlook for ADMA in many positive ways, including potentially lowering costs, improving gross margins, providing more flexibility with a reduction to batch production cycle time and ultimately giving ADMA additional end-to-end control previously reserved for only the largest plasma fractionators."

    First Quarter 2020 and Recent Highlights

    • Achieved first quarter 2020 total revenues of $10.2 million, compared to $3.5 million for the first quarter of 2019, representing a 189% increase.
    • Strengthened the balance sheet through the successful completion of an underwritten public offering of ADMA's common stock resulting in net proceeds of $88.7 million to the Company, after deducting underwriting discounts and commissions and other offering expenses.
    • Strengthened the intellectual property estate protecting ASCENIV.  The Company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent extension application related to its intellectual property portfolio encompassing immunoglobulin plasma pool compositions used in the manufacturing of ASCENIV.  The patent extension is expected to publish during the first half of 2020.
    • Entered into a 5-year manufacturing and supply agreement with a third-party customer to produce and sell plasma-derived intermediate fractions from ADMA's U.S. Food and Drug Administration (FDA) approved IG manufacturing process.  This agreement is expected to add $5-10 million per year in annual revenues for 2020 and 2021, and $10-20 million per year for 2022 through 2024.
    • Received BioNJ 2020 Innovator Award in recognition of the development and approval of ASCENIV, ADMA's novel, proprietary immune globulin product.

    First Quarter 2020 Financial Results

    Total revenues for the quarter ended March 31, 2020 were $10.2 million, compared to $3.5 million for the first quarter ended March 31, 2019, representing an increase of approximately $6.7 million, or 189%.  The increase is mainly due to increased sales and production throughput of our immunoglobulin products generated by our Boca Facility manufacturing operations in 2020 totaling $6.4 million, and to a $0.3 million increase in plasma revenues generated by our plasma collection facility in 2020 as compared to the same period of a year ago. Our revenues for the first quarter of 2020 as compared to the first quarter of 2019 were favorably impacted by the FDA approvals of BIVIGAM and ASCENIV on May 9, 2019 and April 1, 2019, respectively, and by the manufacturing and supply agreement we entered into in January 2020 to produce and sell intermediate fractions to a certain customer.

    Consolidated net loss for the first quarter of 2020 was $19.2 million, or $(0.26) per basic and diluted share, compared to a consolidated net loss of $13.1 million, or $(0.28) per basic and diluted share, for the first quarter of 2019.  The increase in net loss of $6.2 million was primarily due to the increase in cost of product revenue of approximately $7.4 million, which increase is mainly a result of the investment made for the production of BIVIGAM's conformance lots at an increased plasma pool production scale, which pertains specifically to our planned capacity expansion, as well as other production enhancement initiatives and supply chain investments at the Boca Facility.  The increase in net loss during the first quarter of 2020 is also attributable to higher selling, general and administrative expenses of $2.3 million, mainly due to increases in employee compensation expenses in support of our commercialization efforts, increased interest expense of $1.2 million due to our accessing additional debt during the second quarter 2019, along with higher research and development expenses of $0.7 million, primarily related to a study we commenced for ASCENIV to potentially extend its approved and labeled expiration dating, partially offset by the increase in revenues.  Included in the net loss for the first quarter of 2020 were non-cash expenses of approximately $1.9 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    At March 31, 2020, ADMA had cash and cash equivalents of $101.2 million and accounts receivable of $7.1 million, compared to cash and cash equivalents and accounts receivable of $26.8 million and $3.5 million, respectively, at December 31, 2019.  ADMA's net working capital as of March 31, 2020 was $151.6 million, compared to $71.8 million as of December 31, 2019.

    In February 2020, ADMA completed an underwritten public offering of 27,025,000 shares of its common stock at a public offering price of $3.50 per share, resulting in net proceeds of $88.7 million.

    Conference Call Information

    ADMA will host a conference call today, Wednesday, May 6, 2020, at 4:30 p.m. Eastern Time, to discuss the first quarter 2020 financial results and recent corporate updates.  To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 5339498.  A live audio webcast of the call will be available under "Events & Webcasts" in the Investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.  An archived webcast will be available on the Company's website approximately two hours after the event.

    About Primary Humoral Immunodeficiency

    Primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.  According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI.  Some disorders are present at birth or in early childhood and the disorders can affect anyone regardless of age or gender.  Some affect a single part of the immune system, others may affect one or more components of the system.  PI patients are vulnerable to infections and are more likely to suffer complications from these infections compared to individuals with a normal functioning immune system.  Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products.  Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections.  Initially thought to be very rare, it is now estimated that the prevalence of PI in the U.S. is 1 in 1,200, which translates to approximately 250,000 people.

    About BIVIGAM®

    BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).  BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.  BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma.  These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections.  BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin (IgG) antibodies.

    About ASCENIV™

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).   ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).  ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's proprietary microneutralization assay.  ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease.  ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; being well-positioned to weather current macromarket challenges while continuing to execute on future growth plans; continuing progress regarding the commercial launches for BIVIGAM and ASCENIV; ramping production throughput for commercial products and building inventory; continued sales growth and market penetration; potential plasma product supply constraints; increasing ADMA's production throughput; expansion of manufacturing capacity, investments related thereto, and the timing of such investments; and expected annual revenues from ADMA's manufacturing and supply agreement to produce and sell plasma-derived intermediate fractions. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    ADMA BIOLOGICS, INC. AND SUBSIDIARIES
    CONSOLIDATED STATEMENTS OF OPERATIONS

      Three Months Ended March 31, 
      2020
      2019
                 
    REVENUES:            
    Product revenue $   10,164,036     $   3,492,881  
    License revenue     35,708         35,708  
    Total Revenues     10,199,744         3,528,589  
           
    OPERATING EXPENSES:      
    Cost of product revenue (exclusive of amortization expense shown below)     16,829,226         9,405,179  
    Research and development     1,528,738         870,635  
    Plasma center operating expenses     500,644         654,486  
    Amortization of intangible assets     178,838         211,235  
    Selling, general and administrative     7,932,084         5,595,470  
    Total operating expenses     26,969,530         16,737,005  
           
    LOSS FROM OPERATIONS     (16,769,786 )       (13,208,416 )
           
    OTHER INCOME (EXPENSE):      
    Interest and other income     248,068         127,399  
    Interest expense     (2,717,091 )       (1,540,507 )
    Loss on extinguishment of debt     -         (9,962,495 )
    Gain on transfer of plasma center assets     -         11,527,421  
    Other expense, net     (6,421 )       (11,357 )
    Other (expense) income, net     (2,475,444 )       140,461  
           
    NET LOSS $   (19,245,230 )   $   (13,067,955 )
           
    BASIC AND DILUTED LOSS PER COMMON SHARE $   (0.26 )   $   (0.28 )
               
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:          
    Basic and Diluted   73,781,507     46,353,068  
               

    ADMA BIOLOGICS, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS

      March 31,   December 31,
        2020       2019  
    ASSETS (Unaudited)    
    Current assets:      
    Cash and cash equivalents $   101,235,699     $   26,752,135  
    Accounts receivable, net     7,107,834         3,469,919  
    Inventories     52,288,803         53,064,734  
    Prepaid expenses and other current assets     4,855,344         2,533,593  
    Total current assets     165,487,680         85,820,381  
    Property and equipment, net     35,060,795         31,741,317  
    Intangible assets, net     2,980,636         3,159,474  
    Goodwill     3,529,509         3,529,509  
    Deposits and other assets     3,465,207         2,840,044  
    TOTAL ASSETS $   210,523,827     $   127,090,725  
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable $   9,152,239     $   9,174,591  
    Accrued expenses and other current liabilities     4,419,043         4,481,395  
    Current portion of deferred revenue     142,834         142,834  
    Current portion of lease obligations     193,987         229,073  
    Total current liabilities     13,908,103         14,027,893  
    Senior notes payable, net of discount     81,212,090         68,291,163  
    Deferred revenue, net of current portion     2,225,823         2,261,532  
    Subordinated note payable, net of discount     14,916,837         14,908,053  
    Lease obligations, net of current portion     1,831,639         1,302,361  
    Other non-current liabilities     93,652         106,574  
    TOTAL LIABILITIES     114,188,144         100,897,576  
           
    COMMITMENTS AND CONTINGENCIES      
           
    STOCKHOLDERS' EQUITY      
    Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding     -         -  
    Common Stock - voting, $0.0001 par value, 150,000,000 shares authorized, 86,345,313 and 59,318,355 shares issued and outstanding     8,635         5,932  
    Additional paid-in capital     380,288,833         290,903,772  
    Accumulated deficit     (283,961,785 )       (264,716,555 )
    TOTAL STOCKHOLDERS' EQUITY     96,335,683         26,193,149  
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $   210,523,827     $   127,090,725  

     

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  29. RAMSEY, N.J. and BOCA RATON, Fla., April 29, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced that it will report financial results for the first quarter ended March 31, 2020 on Wednesday, May 6, 2020 after the U.S. financial markets close.  ADMA's management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to discuss its financial results and other Company updates.

    To access the conference call, please dial (855…

    RAMSEY, N.J. and BOCA RATON, Fla., April 29, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced that it will report financial results for the first quarter ended March 31, 2020 on Wednesday, May 6, 2020 after the U.S. financial markets close.  ADMA's management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to discuss its financial results and other Company updates.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 5339498. A live audio webcast of the call will be available under "Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. ADMA manufactures its immune globulin products 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 a portion of 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about the Company's financial results and other Company updates. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  30.  Achieved Fourth Quarter 2019 Total Revenues of $12.0 Million, a 197% Increase Over Fourth Quarter 2018

    Achieved Full Year 2019 Total Revenues of $29.3 Million, a 73% Increase Over Full Year 2018

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public Offering Resulting in Gross Proceeds of $94.6 Million

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., March 12, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain…

     Achieved Fourth Quarter 2019 Total Revenues of $12.0 Million, a 197% Increase Over Fourth Quarter 2018

    Achieved Full Year 2019 Total Revenues of $29.3 Million, a 73% Increase Over Full Year 2018

    Strengthened Balance Sheet Through Successful Completion of Underwritten Public Offering Resulting in Gross Proceeds of $94.6 Million

    Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

    RAMSEY, N.J. and BOCA RATON, Fla., March 12, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of recent progress and accomplishments.

    "In 2019, ADMA embarked on the commercial rollout of BIVIGAM® and ASCENIV™, our two lead intravenous immune globulin (IVIG) products for the treatment of patients with primary humoral immunodeficiency," said Adam Grossman, ADMA's President and Chief Executive Officer.  "We are pleased with the commercial launch thus far and we look forward to continuing an upward production ramp throughout 2020.  On the financial front, we recently strengthened our balance sheet and enhanced our working capital position by securing gross proceeds of $94.6 million in an underwritten public offering of our common stock.  Collectively, we believe all of these achievements leave us well positioned for continued growth in 2020 and beyond."

    2019 and Recent Highlights

    • Achieved fourth quarter 2019 total revenues of $12.0 million, compared to $4.1 million for the fourth quarter of 2018, representing a 197% increase.  Achieved full year 2019 total revenues of $29.3 million, compared to $17.0 million for the full year 2018, representing a 73% increase.

    • Commercial launches for BIVIGAM and ASCENIV are progressing in line with management's expectations.  ADMA continues to ramp commercial production of these two products and build inventory to support continued growth and market supply.
       
    • Strengthened the balance sheet through the successful completion of an underwritten public offering of ADMA's common stock resulting in gross proceeds of $94.6 million to the Company, before deducting underwriting discounts and commissions and other offering expenses.

    • Added to the NASDAQ Biotechnology Index in December 2019.

    • Entered into a 5-year manufacturing and supply agreement with a third-party customer to produce and sell plasma-derived intermediate fractions from ADMA's U.S. Food and Drug Administration (FDA) approved immune globulin (IG) manufacturing process.  This agreement is expected to add $5-10 million per year in annual revenues for 2020 and 2021, and $10-20 million per year for 2022 through 2024.

    Fourth Quarter 2019 Financial Results

    Total revenues for the quarter ended December 31, 2019 were $12.0 million, compared to $4.1 million for the quarter ended December 31, 2018, representing an increase of approximately $7.9 million, or 197%.  The increase in revenues was primarily due to the first commercial sales of ASCENIV in October 2019, the commercial relaunch of BIVIGAM in August 2019, intermediate fraction sales as well as contract manufacturing revenue, all generated by our Boca Raton, FL manufacturing operations, partially offset by a decrease in plasma center revenues due to the transfer of two of our plasma centers on January 1, 2019 as part of the purchase price for the Florida operations.

    Consolidated net loss for the fourth quarter 2019 was $10.6 million, or $(0.18) per basic and diluted share, compared to a consolidated net loss of $18.0 million, or $(0.39) per basic and diluted share, for the fourth quarter 2018.  The decrease in net loss of $7.4 million was primarily due to the increase in higher revenues of approximately $7.9 million and a reduction in total operating expenses of $0.7 million during the fourth quarter 2019 compared to the fourth quarter 2018, partially offset by increased interest expense.  Included in the net loss for the fourth quarter 2019 were non-cash expenses of approximately $1.9 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    Full Year 2019 Financial Results

    Total revenues for the full year 2019 were $29.3 million, compared to $17.0 million for the full year 2018, representing an increase of approximately $12.3 million, or 73%.  The increase in revenues was primarily due to the first commercial sales of ASCENIV and commercial relaunch of BIVIGAM, as well as intermediate fraction sales and contract manufacturing revenue, none of which were present in 2018, partially offset by a decrease in plasma center revenues.

    Consolidated net loss for the full year 2019 was $48.3 million, or $(0.89) per basic and diluted share, compared to a consolidated net loss of $65.7 million, or $(1.45) per basic and diluted share, for the full year 2018.  The decrease in net loss of $17.4 million was primarily due to the increased revenues of $12.3 million as well as lower total operating expenses of $6.5 million for the year ended 2019 compared to 2018, partially offset by increased interest expense.  Included in the net loss for the full year 2019 were non-cash expenses of approximately $7.1 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

    At December 31, 2019, ADMA had cash and cash equivalents of $26.8 million and accounts receivable of $3.5 million, compared to cash and cash equivalents and accounts receivable of $22.8 million and $1.4 million, respectively, at December 31, 2018.  ADMA's net working capital as of December 31, 2019 was $71.8 million, compared to $34.9 million as of December 31, 2018.

    In February 2020, ADMA completed an underwritten public offering of 27,025,000 shares of its common stock at a public offering price of $3.50 per share, resulting in gross proceeds of $94.6 million.  Net proceeds to ADMA, after deducting underwriting discounts and commissions and other offering expenses, were approximately $88.5 million.

    Conference Call Information

    ADMA will host a conference call today, Thursday, March 12, 2020, at 4:30 p.m. Eastern Time, to discuss the fourth quarter and full year 2019 financial results and recent corporate updates. To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 9365775. A live audio webcast of the call will be available under "Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.  An archived webcast will be available on the Company's website approximately two hours after the event.

    About Primary Humoral Immunodeficiency

    Primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.  According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI.  Some disorders are present at birth or in early childhood and the disorders can affect anyone regardless of age or gender.  Some affect a single part of the immune system, others may affect one or more components of the system.  PI patients are vulnerable to infections and are more likely to suffer complications from these infections compared to individuals with a normal functioning immune system.  Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products.  Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections.  Initially thought to be very rare, it is now estimated that the prevalence of PI in the U.S. is 1 in 1,200, which translates to approximately 250,000 people.

    About BIVIGAM®

    BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).  BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.  BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma.  These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections.  BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin (IgG) antibodies.

    About ASCENIV™ (Formerly RI-002)

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).   ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).  ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's proprietary microneutralization assay.  ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease.  ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to statements about expected revenues in the future and ADMA's future results of operations; statements about increasing demand for our therapeutic products; statements about ADMA's fractionation plant turnaround; expansion of ADMA's plasma collection center network; statements about ADMA's research and development activities and management's belief regarding implementation of manufacturing strategies and improvements with the ultimate goal of efficiently bringing plasma-derived products to market. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 |www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

     
    ADMA BIOLOGICS, INC. AND SUBSIDIARIES
    CONSOLIDATED STATEMENTS OF OPERATIONS
     
      Three Months Ended December 31,   Year ended December 31,
        2019       2018       2019       2018  
                   
    REVENUES:              
    Product revenue $ 12,001,340     $ 4,020,715     $ 29,206,249     $ 16,842,456  
    License revenue   35,709       35,709       142,834       142,834  
    Total Revenues   12,037,049       4,056,424       29,349,083       16,985,290  
                   
    OPERATING EXPENSES:              
    Cost of product revenue   11,691,603       11,142,116       39,504,238       42,194,635  
    Research and development   464,823       917,304       2,343,848       3,926,120  
    Plasma center operating expenses   464,131       2,260,379       2,169,629       7,805,619  
    Amortization of intangible assets   211,234       211,234       844,938       844,938  
    Selling, general and administrative   7,032,067       6,073,051       25,910,757       22,502,922  
    Total operating expenses   19,863,858       20,604,084       70,773,410       77,274,234  
                   
    LOSS FROM OPERATIONS   (7,826,809 )     (16,547,660 )     (41,424,327 )     (60,288,944 )
                   
    OTHER INCOME (EXPENSE):              
    Interest and other income   181,682       60,206       800,785       195,403  
    Interest expense   (2,730,890 )     (1,437,968 )     (8,993,379 )     (5,522,783 )
    Loss on extinguishment of debt   -       -       (9,962,495 )     -  
    Gain on transfer of plasma center assets   -       -       11,527,421       -  
    Other (expense) income   (185,014 )     (112,565 )     (227,322 )     (127,121 )
    Other expense, net   (2,734,222 )     (1,490,327 )     (6,854,990 )     (5,454,501 )
                   
    NET LOSS $ (10,561,031 )   $ (18,037,987 )   $ (48,279,317 )   $ (65,743,445 )
                   
    BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.18 )   $ (0.39 )   $ (0.89 )   $ (1.45 )
                   
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:              
    Basic and Diluted   59,318,355       46,351,860       54,348,136       45,188,899  
                                   



     
    ADMA BIOLOGICS, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
     
      December 31,   December 31,
        2019       2018  
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 26,752,135     $ 22,754,852  
    Accounts receivable, net   3,469,919       1,392,441  
    Inventories   53,064,734       18,616,169  
    Prepaid expenses and other current assets   2,533,593       1,766,163  
    Total current assets   85,820,381       44,529,625  
    Property and equipment, net   31,741,317       30,115,730  
    Intangible assets, net   3,159,474       4,004,412  
    Goodwill   3,529,509       3,529,509  
    Assets to be transferred under purchase agreement   -       1,153,508  
    Restricted cash   -       4,000,000  
    Deposits and other assets   2,840,044       1,543,737  
    TOTAL ASSETS $ 127,090,725     $ 88,876,521  
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable $ 9,174,591     $ 5,900,394  
    Accrued expenses and other current liabilities   4,481,395       3,551,835  
    Current portion of deferred revenue   142,834       142,834  
    Current portion of lease obligations   229,073       29,983  
    Total current liabilities   14,027,893       9,625,046  
    Senior notes payable, net of discount   68,291,163       26,440,830  
    End of term liability, notes payable   -       2,760,000  
    Deferred revenue, net of current portion   2,261,532       2,404,365  
    Subordinated note payable, net of discount   14,908,053       14,874,184  
    Obligation to transfer assets under purchase agreement   -       12,621,844  
    Lease obligations, net of current portion   1,302,361       119,080  
    Other non-current liabilities   106,574       260,734  
    TOTAL LIABILITIES   100,897,576       69,106,083  
           
    COMMITMENTS AND CONTINGENCIES      
           
    STOCKHOLDERS' EQUITY      
    Preferred Stock, $0.0001 par value, 10,000,000 shares authorized,      
    no shares issued and outstanding   -       -  
    Common Stock - voting, $0.0001 par value, 150,000,000 and 75,000,000 shares authorized,      
    59,318,355 and 46,353,068 shares issued and outstanding   5,932       4,635  
    Additional paid-in capital   290,903,772       236,203,041  
    Accumulated deficit   (264,716,555 )     (216,437,238 )
    TOTAL STOCKHOLDERS' EQUITY   26,193,149       19,770,438  
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 127,090,725     $ 88,876,521  
                   

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  31. RAMSEY, N.J. and BOCA RATON, Fla., March 05, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced that it will report financial results for the fourth quarter and full year ending December 31, 2019 on Thursday, March 12, 2020 after the U.S. financial markets close.  ADMA's management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to discuss its financial results and other company updates.

    To access the conference…

    RAMSEY, N.J. and BOCA RATON, Fla., March 05, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced that it will report financial results for the fourth quarter and full year ending December 31, 2019 on Thursday, March 12, 2020 after the U.S. financial markets close.  ADMA's management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to discuss its financial results and other company updates.

    To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 9365775. A live audio webcast of the call will be available under "Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts. An archived webcast will be available on the Company's website approximately two hours after the event.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about the launch and commercialization of ASCENIV and its ability to help appropriate patients in the U.S. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:
    Brian Lenz
    Executive Vice President and Chief Financial Officer | 201-478-5552 |www.admabiologics.com

    INVESTOR RELATIONS CONTACT:
    Sam Martin
    Managing Director, Argot Partners | 212-600-1902 |  

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  32. Company Offers Assistance with Coronavirus Global Health Initiatives

    Company Receives Notification from USPTO Regarding Extension to Its Issued Patents Related and Applied to Composition and Therapeutic Use of Immune Globulin; Extension Expected to Publish in 1H2020

    RAMSEY, N.J. and BOCA RATON, Fla., March 03, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced that it has received another Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent…

    Company Offers Assistance with Coronavirus Global Health Initiatives

    Company Receives Notification from USPTO Regarding Extension to Its Issued Patents Related and Applied to Composition and Therapeutic Use of Immune Globulin; Extension Expected to Publish in 1H2020

    RAMSEY, N.J. and BOCA RATON, Fla., March 03, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced that it has received another Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application related to its intellectual property portfolio encompassing immunoglobulin plasma pool compositions used in the manufacturing of ASCENIV™.  ADMA is the exclusive owner of intellectual property encompassing certain immunotherapeutic, immunoglobulin (IG & IVIG) compositions for the prevention and treatment of a wide variety of respiratory infections, including certain strains of coronavirus.

    "We are pleased to announce the continued enhancement and strengthening of our patent estate focused on plasma derived immune globulins for the treatment and prevention of respiratory viral infections," said Adam Grossman, President and Chief Executive Officer of ADMA.  "This most recent notice of patent allowance by the USPTO is very timely in the midst of the reported global coronavirus epidemic.  We are pleased to be one of the leading plasma products companies focused on developing novel and patentable approaches for the use of immune globulins to treat and prevent respiratory infections and illness caused by viral pathogens."

    ADMA's commercially available immune globulin products, intellectual property, and the Company's deep understanding of specialty antibody-rich immune globulins focused on respiratory pathogens provide ADMA a unique position to collaborate with government agencies, vaccine manufacturers and other parties in the fight to combat emerging infectious disease including the global coronavirus epidemic.

    ADMA's issued patents include proprietary immunotherapeutic compositions comprised of plasma derived immune globulin which has higher than normal titers for respiratory pathogens including respiratory syncytial virus (RSV), multiple strains of coronavirus (OC43 and V229E), parainfluenza virus 1, parainfluenza virus 2, influenza A virus, influenza B virus, and metapneumovirus.  These patents also include methods of using an immune globulin composition to treat or prevent any type of respiratory viral infection including upper respiratory tract infections and lower respiratory tract infections.

    There is relevant, published scientific literature that describes meaningful antibody family cross-reactivity among many respiratory viruses, including various strains of coronaviruses, and that immunological memory of human humoral antibodies can be stimulated between different strains of coronaviruses.  

    Reports in the media are emerging from China regarding the positive clinical results yielded by the use of plasma components as a therapy used for treating COVID-19 infected patients.  The therapy in these reports describe that plasma is obtained from patients who have recently recovered from the COVID-19 infection.  This information strongly supports ADMA's patented technology platform for the use of immunoglobulins derived from appropriate hyperimmune plasma, whether naturally occurring antibodies or vaccine-induced, for treating respiratory viral infections for immune compromised patients and other vulnerable patient populations.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about the launch and commercialization of ASCENIV and its ability to help appropriate patients in the U.S. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  33. RAMSEY, N.J. and BOCA RATON, Fla., Feb. 24, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced the closing of the issuance of an additional 3,525,000 shares of its common stock at a public offering price of $3.50 per share. The shares were issued pursuant to the full exercise of the underwriters' overallotment option in connection with ADMA's previously announced underwritten public offering of 23,500,000 shares of its common stock. The gross proceeds…

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 24, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced the closing of the issuance of an additional 3,525,000 shares of its common stock at a public offering price of $3.50 per share. The shares were issued pursuant to the full exercise of the underwriters' overallotment option in connection with ADMA's previously announced underwritten public offering of 23,500,000 shares of its common stock. The gross proceeds from the exercise of the overallotment option were approximately $12.3 million, bringing the total gross proceeds to ADMA from the offering to approximately $94.6 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

    ADMA intends to use the net proceeds from this offering (i) for the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV; (ii) to support the ongoing commercial sales of BIVIGAM and ASCENIV; (iii) to expand the manufacturing capacity of its Boca Facility, including supply chain functions, and enhance the robustness of its supply chain oversight; (iv) to expand its plasma collection facility network; (v) for research and development and business development opportunities; and (vi) for general corporate purposes and other capital expenditures.

    Morgan Stanley and Jefferies LLC acted as joint book-running managers for the offering. Oppenheimer & Co. Inc. acted as co-manager for the offering.

    The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of a "shelf" registration statement on Form S-3 (File No. 333-234107) previously filed with the Securities and Exchange Commission ("SEC") on October 4, 2019, and declared effective by the SEC on October 15, 2019. The final prospectus supplement and the accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at: .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates.

    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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include statements about the offering and ADMA's intended use of proceeds generated from the offering. Actual events or results may differ materially from those described in this document 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, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the public offering and the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

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  34. RAMSEY, N.J. and BOCA RATON, Fla., Feb. 11, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced that it was awarded the BioNJ 2020 Innovator Award in recognition of the development and approval of ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) by the U.S. Food and Drug Administration (FDA) in 2019.

    "We are honored to be recognized by BioNJ with this prestigious award," said Adam Grossman, President and Chief Executive Officer of ADMA.  "The…

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 11, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced that it was awarded the BioNJ 2020 Innovator Award in recognition of the development and approval of ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) by the U.S. Food and Drug Administration (FDA) in 2019.

    "We are honored to be recognized by BioNJ with this prestigious award," said Adam Grossman, President and Chief Executive Officer of ADMA.  "The robust life sciences community in New Jersey provides ADMA with talented and dedicated healthcare professionals that are contributing to the launch and commercialization of ASCENIV, our novel, proprietary immune globulin product, which we believe can help appropriate patients in the U.S."

    "The purpose of the BioNJ Innovator Award is to celebrate the dominant role New Jersey plays in the healthcare landscape and to highlight the vision and innovation contributed by these recipients," said Debbie Hart, President and Chief Executive Officer of BioNJ. "We are delighted to present ADMA with the 2020 Innovator Award for its success in bringing ASCENIV to market to help immune deficient patients."

    About Primary Humoral Immunodeficiency

    Primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.  According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI.  Some disorders are present at birth or in early childhood and the disorders can affect anyone regardless of age or gender.  Some affect a single part of the immune system, others may affect one or more components of the system.  PI patients are vulnerable to infections and are more likely to suffer complications from these infections compared to individuals with a normal functioning immune system.  Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products.  Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections.  Initially thought to be very rare, it is now estimated that the prevalence of PI in the U.S. is 1 in 1,200, which translates to approximately 250,000 people.

    About ASCENIV™ (Formerly RI-002)

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).   ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).  ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's proprietary microneutralization assay.  ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease.  ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    Indication

    ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

    WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

    Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV.  Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors.  Thrombosis may occur in the absence of known risk factors.

    Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.

    Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.  ASCENIV does not contain sucrose.

    For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable.  Ensure adequate hydration in patients before administration.  Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

    For additional safety information about ASCENIV, please see full Prescribing Information.

    Contraindications

    ASCENIV is contraindicated in:

    • Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
    • IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity.

    Warnings and Precautions

    Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

    Thrombosis may occur following treatment with immunoglobulin products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity and ensure adequate hydration before administration. For patients at risk of thrombosis, administer ASCENIV at the minimum dose and infusion rate practicable.  Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

    Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at risk patients, administer ASCENIV at the minimum infusion rate practicable.

    Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia.  Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.  

    Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including ASCENIV.  AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.

    IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing.

    Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

    Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.  All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at (1-800-458-4244).

    After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs') test.

    Adverse Reactions

    The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

    You are encouraged to report side effects of prescription drugs to ADMA Biologics @ 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about the launch and commercialization of ASCENIV and its ability to help appropriate patients in the U.S. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

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  35. RAMSEY, N.J. and BOCA RATON, Fla., Feb. 06, 2020 (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 for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced the pricing of its previously announced underwritten public offering of 23,500,000 shares of its common stock at a public offering price of $3.50 per share, resulting in gross proceeds of approximately $82.3 million before deducting underwriting discounts and commissions and other estimated offering expenses.

    The offering is expected to close…

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 06, 2020 (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 for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced the pricing of its previously announced underwritten public offering of 23,500,000 shares of its common stock at a public offering price of $3.50 per share, resulting in gross proceeds of approximately $82.3 million before deducting underwriting discounts and commissions and other estimated offering expenses.

    The offering is expected to close on February 11, 2020, subject to the satisfaction of customary closing conditions. The Company has also granted the underwriters a 30-day option to purchase up to 3,525,000 additional shares of common stock at the public offering price less the underwriting discount.

    ADMA intends to use the net proceeds from this offering (i) for the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV; (ii) to support the ongoing commercial sales of BIVIGAM and ASCENIV; (iii) to expand the manufacturing capacity of its Boca Facility, including supply chain functions, and enhance the robustness of its supply chain oversight; (iv) to expand its plasma collection facility network; (v) for research and development and business development opportunities; and (vi) for general corporate purposes and other capital expenditures.

    Morgan Stanley and Jefferies LLC are acting as joint book-running managers for the offering.  Oppenheimer & Co. Inc. is acting as co-manager for the offering.

    The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-234107) previously filed with the Securities and Exchange Commission ("SEC") on October 4, 2019, and declared effective by the SEC on October 15, 2019. The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and an accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at .

    Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and its accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and its accompanying prospectus, which provide more information about the Company and the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ADMA Biologics, Inc. (ADMA)
    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates.

    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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include statements about the offering, including the expected timing of its closing, and ADMA's intended use of proceeds generated from the offering. Actual events or results may differ materially from those described in this document 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, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the public offering and the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:
    Brian Lenz
    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:
    Sam Martin
    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

    View Full Article Hide Full Article
  36. RAMSEY, N.J. and BOCA RATON, Fla., Feb. 06, 2020 (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 for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced that it has commenced an $75 million underwritten public offering of its common stock. The Company intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering. The proposed offering is subject to market and other conditions…

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 06, 2020 (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 for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases, today announced that it has commenced an $75 million underwritten public offering of its common stock. The Company intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

      
    ADMA intends to use the net proceeds from this offering (i) for the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV; (ii) to support the ongoing commercial sales of BIVIGAM and ASCENIV; (iii) to expand the manufacturing capacity of its Boca Facility, including supply chain functions, and enhance the robustness of its supply chain oversight; (iv) to expand its plasma collection facility network; (v) for research and development and business development opportunities; and (vi) for general corporate purposes and other capital expenditures.

    Morgan Stanley and Jefferies LLC are acting as joint book-running managers of the proposed offering.

    The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-234107) previously filed with the Securities and Exchange Commission ("SEC") on October 4, 2019, and declared effective by the SEC on October 15, 2019. The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at .

    Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and its accompanying prospectus to be filed with the SEC, and the other documents that the Company has filed with the SEC that will be incorporated by reference in the prospectus supplement and its accompanying prospectus, which will provide more information about the Company and the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About ADMA Biologics, Inc. (ADMA)
    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates.

    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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include statements about the offering, ADMA's intention to grant the underwriters a 30-day option to purchase additional shares in the offering, and ADMA's intended use of proceeds generated from the offering. Actual events or results may differ materially from those described in this document 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, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the public offering and the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:
    Brian Lenz
    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:
    Sam Martin
    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

    View Full Article Hide Full Article
  37. Achieved Fourth Quarter 2019 Preliminary Unaudited Total Revenues of $11.9 Million, a 193% Increase Over Fourth Quarter 2018

    Full Year 2019 Preliminary Unaudited Total Revenues of $29.2 Million, a 72% Increase Over Full Year 2018

    ADMA to Host Conference Call and Webcast in the First Quarter of 2020 to Report Fourth Quarter and Full Year 2019 Financial Results

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 09, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced its…

    Achieved Fourth Quarter 2019 Preliminary Unaudited Total Revenues of $11.9 Million, a 193% Increase Over Fourth Quarter 2018

    Full Year 2019 Preliminary Unaudited Total Revenues of $29.2 Million, a 72% Increase Over Full Year 2018

    ADMA to Host Conference Call and Webcast in the First Quarter of 2020 to Report Fourth Quarter and Full Year 2019 Financial Results

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 09, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced its preliminary unaudited fourth quarter and full year 2019 revenues. The Company also provided updates on the commercial launches of its marketed intravenous immunoglobulin (IVIG) products, BIVIGAM® and ASCENIV™, as well as introduced its 2020 strategic outlook.

    Fourth Quarter and Full Year 2019 Highlights

    • Achieved fourth quarter 2019 preliminary unaudited total revenues of $11.9 million, compared to $4.1 million during the fourth quarter of 2018, reflecting a 193% increase over fourth quarter 2018
    • Full year 2019 preliminary unaudited total revenues of $29.2 million, compared to $17.0 million for the full year 2018, reflecting a 72% increase over full year 2018
    • Commercial launches for BIVIGAM and ASCENIV progressing in line with expectations. The Company continues to ramp commercial production of these two products and build inventory to support continued growth and market supply. 

    "We are extremely pleased with our preliminary fourth quarter and full year 2019 revenue results, which are primarily attributable to the commercial rollouts of BIVIGAM and ASCENIV, as well as our first sale of intermediate fractions related to our IVIG production process, and we look forward to continuing the upward production ramp throughout the coming year," said Adam Grossman, ADMA's President and Chief Executive Officer. "ADMA made significant progress and achieved a number of milestones over the past year and we believe we are entering 2020 well positioned to execute on several strategic priorities aimed at growing our overall revenues. These strategic priorities include expanding throughput capacity at our manufacturing facility, enhancing our control over the supply-chain for our commercial products, securing new contract manufacturing (CMO) supply agreements, and building and opening new plasma collection centers. We are actively pursuing potential new pipeline assets targeting specialty plasma products and/or hyperimmune immunoglobulin indications and compositions and we will provide further details when available."

    ADMA executed on its 2019 strategic objectives, including:

    • Received FDA approval for BIVIGAM and ASCENIV
    • Commenced commercial sales of both BIVIGAM and ASCENIV in the U.S.
    • Transfer of BIVIGAM and NABI-HB® licenses to ADMA
    • Issuance of new establishment license by the FDA for the Boca Raton, FL manufacturing facility to produce and sell U.S. FDA-approved IVIG products
    • Data presented at IDWeek 2019 highlighting clinical results from the compassionate use of ASCENIV for the treatment of respiratory syncytial virus (RSV) in immunocompromised children
    • Published a peer-review manuscript in the November 2019 issue of Immunotherapy describing the manufacturing process optimization undertaken by the Company
    • Received a U.S. patent for a novel hyperimmune globulin for the treatment and prevention of S. pneumoniae infections

    ADMA is focused on the following key strategic priorities in 2020:

    • Continue to expand the commercial traction of BIVIGAM and ASCENIV for the treatment of patients with primary humoral immunodeficiency (PI) and continued ramp-up of production throughput for the first full fiscal year of commercial sales
    • Evaluate and implement strategies for potential manufacturing capacity expansion as well as strengthening the supply chain capabilities to potentially unlock efficiencies, improve production yields and provide more control and visibility for timing of commercial product releases
    • Execute on fulfilling the newly secured, long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions
    • Expand plasma collection center network to bolster long-term raw material supply and prepare for forward-looking production ramp up and growth to capitalize on the global growing IVIG and source plasma markets
    • Secure new supply contracts for potential CMO opportunities as well as explore business development opportunities with our multi-faceted revenue generation platform
    • Announce potential product development pipeline consisting of additional specialty plasma and/or hyperimmune immunoglobulin products

    ADMA plans to discuss these results with investors while attending the 38th Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2020 in San Francisco, CA.

    Fourth Quarter and Full Year 2019 Financial Results Conference Call

    ADMA plans to host a conference call and webcast to discuss its fourth quarter and full year 2019 financial results during the first quarter of 2020 in conjunction with filing its annual report on Form 10-K, which is expected to be filed with the U.S. Securities and Exchange Commission no later than March 16, 2020.

    The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the Company's fourth quarter and full year financial results for 2019. 

    About Primary Humoral Immunodeficiency

    Primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system. According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI. Some disorders are present at birth or in early childhood and the disorders can affect anyone regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system. PI patients are vulnerable to infections and are more likely to suffer complications from these infections compared to individuals with a normal functioning immune system. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections. Initially thought to be very rare, it is now estimated that the prevalence of PI in the U.S. is 1 in 1,200, which translates to approximately 250,000 people.

    About BIVIGAM®

    BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin (IgG) antibodies.

    About ASCENIV™ (Formerly RI-002)

    ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

    Indication

    ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).

    WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

    Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

    Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.

    Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.

    For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

    For additional safety information about ASCENIV, please see full Prescribing Information.

    Contraindications

    ASCENIV is contraindicated in:

    • Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
    • IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity.

    Warnings and Precautions

    Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

    Thrombosis may occur following treatment with immunoglobulin products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity and ensure adequate hydration before administration. For patients at risk of thrombosis, administer ASCENIV at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

    Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at risk patients, administer ASCENIV at the minimum infusion rate practicable.

    Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.

    Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including ASCENIV. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.

    IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing.

    Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

    Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at (1-800-458-4244).

    After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs') test.

    Adverse Reactions

    The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

    You are encouraged to report side effects of prescription drugs to ADMA Biologics @ 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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. 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to statements about preliminary revenues for the fourth quarter and year-end 2019 and expected revenues in the future; statements about increasing demand for our therapeutic products; statements about ADMA's fractionation plant turnaround; expansion of ADMA's plasma collection center network; statements about ADMA's research and development activities and management's belief regarding implementation of manufacturing strategies and improvements with the ultimate goal of efficiently bringing plasma-derived products to market. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 |www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

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  38. Agreement is Expected to Add $5-10 Million in Annual Revenues for 2020 and 2021, and $10-20 Million Per Year for 2022 Through 2024

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 07, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced its entry into a 5-year manufacturing and supply agreement with an undisclosed partner to produce and sell plasma-derived intermediate fractions from ADMA's U.S. Food and Drug Administration (FDA) approved Immune Globulin (IG) manufacturing process…

    Agreement is Expected to Add $5-10 Million in Annual Revenues for 2020 and 2021, and $10-20 Million Per Year for 2022 Through 2024

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 07, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of certain infectious diseases, today announced its entry into a 5-year manufacturing and supply agreement with an undisclosed partner to produce and sell plasma-derived intermediate fractions from ADMA's U.S. Food and Drug Administration (FDA) approved Immune Globulin (IG) manufacturing process. 

    "A core element of our business strategy is to leverage and maximize the revenue we generate from the available manufacturing capacity at our FDA-approved plasma-derived products production facility.  Through the production of our own marketed assets, BIVIGAM®, ASCENIV™ and NABI-HB®, we will now be able to generate additional revenue over and above the sales of the FDA-approved drugs themselves," said Adam Grossman, ADMA's President and Chief Executive Officer.  "Based on current production and forecasted market sales volumes, we estimate that these additional revenues from the sale of these fractions will add between $5 million and $10 million to our annual revenues for 2020 and 2021 respectively.  Depending on future plant capacity utilization and potential expansion, as well as our forecasted IG production ramp, we believe this contract has the potential to generate between $10 million and $20 million per year from 2022 through 2024.  We are proud to be an emerging partner of choice for plasma-derived intermediate fractions and we look forward to providing high quality products to this new partner and delivering the highest level of service and value to all of our customers to support our overall growth objectives."

    Plasma contains many therapeutic proteins which control a number of processes and functions in the body.  With ADMA's FDA-approved manufacturing process, which the company uses to produce its three FDA-approved and marketed immune globulins, other non-IG proteins that are valuable for other functions in our bodies (also known as "fractions") are removed.  These fractions are used as the starting raw material to produce other plasma-derived biologics such as Factor VIII, Albumin, C1 Esterase Inhibitor and Alpha 1 anti-trypsin amongst others. 

    With this newly executed agreement, ADMA is now able to further maximize the revenue per liter of plasma fractionated in the Boca Raton plant and sell these fractions so they may be processed by a third party into their own therapeutic products under their own licensed manufacturing processes.

    ADMA owns and operates a 400,000 liter annual capacity plasma fractionation and purification facility located in Boca Raton, FL.  This manufacturing plant is licensed by the U.S. FDA.  In addition to manufacturing its three FDA-approved products BIVIGAM®, ASCENIV™ and NABI-HB® at this facility, ADMA provides contract manufacturing services for pharmaceutical and biotech companies as well as produces and sells plasma-derived intermediate fractions.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatments of immunodeficient patients at risk for infection. ADMA currently manufactures and markets three United States Food and Drug Administration 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 hepatitis B. 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 disease, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about increasing demand for our therapeutic products, fractions and other byproducts; ADMA's fractionation plant turnaround; and management's belief regarding making important contributions with the ultimate goal of efficiently bringing plasma-derived products to market. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

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  39. RAMSEY, N.J. and BOCA RATON, Fla., Dec. 17, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ: ^NBI). ADMA's addition the NBI will become effective prior to market open on Monday, December 23, 2019.

    The NASDAQ Biotechnology Index was launched in 1993 and is designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ) that are…

    RAMSEY, N.J. and BOCA RATON, Fla., Dec. 17, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ: ^NBI). ADMA's addition the NBI will become effective prior to market open on Monday, December 23, 2019.

    The NASDAQ Biotechnology Index was launched in 1993 and is designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. Companies in the NBI must meet eligibility criteria, such as an average daily trading volume and minimum market capitalization. The NBI is re-ranked each year and is calculated under a modulated capitalization-weighted methodology. For more information about the NASDAQ Biotechnology Index, including eligibility criteria, please visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

    To view the NBI and its historical data, please visit https://www.nasdaq.com/market-activity/index/nbi.

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatments of immunodeficient patients at risk for infection. ADMA currently manufactures and markets three United States Food and Drug Administration 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 hepatitis B. 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 disease, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain 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 "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about increasing demand for our therapeutic products; ADMA's fractionation plant turnaround; and management's belief regarding making important contributions with the ultimate goal of efficiently bringing plasma-derived products to market. Actual events or results may differ materially from those described in this document 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 U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Brian Lenz

    Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

    INVESTOR RELATIONS CONTACT:

    Sam Martin

    Managing Director, Argot Partners | 212-600-1902 |

    Primary Logo

    View Full Article Hide Full Article
  40. RAMSEY, N.J. and BOCA RATON, Fla., Nov. 13, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced that Adam Grossman, President and Chief Executive Officer, is scheduled to present a corporate overview at the Jefferies 2019 London Healthcare Conference, to be held November 20-21, 2019, at the Waldorf Hilton London, UK. ADMA is scheduled to present on Wednesday, November 20, 2019 at 8:00 AM GMT.

    A webcast of the live presentation w