ADMA ADMA Biologics Inc

1.73
+0.01  (+1%)
Previous Close 1.72
Open 1.72
52 Week Low 1.45
52 Week High 4.2
Market Cap $221,768,056
Shares 128,189,628
Float 104,580,291
Enterprise Value $262,233,707
Volume 2,912,633
Av. Daily Volume 8,423,687
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Drug Pipeline

Drug Stage Notes
BIVIGAM
Primary humoral immunodeficiency
CRL
CRL
FDA issued Complete Response Letter for PAS drug substance, but approved PAS for drug product.
ASCENIV (RI-002)
Primary Immune Deficiency Diseases
Approved
Approved
FDA Approval announced April 1, 2019.

Latest News

  1. Achieved First Quarter 2021 Total Revenues of $16.0 Million, a 57% Increase Over First Quarter 2020

    Significantly Expanded Total Asset Value to $235.7 Million, Including $94.1 Million in Inventories

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

    RAMSEY, N.J. and BOCA RATON, Fla., May 12, 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 first quarter 2021 and provided an overview of recent progress and accomplishments.

    "ADMA has successfully transformed its business in the early months of 2021…

    Achieved First Quarter 2021 Total Revenues of $16.0 Million, a 57% Increase Over First Quarter 2020

    Significantly Expanded Total Asset Value to $235.7 Million, Including $94.1 Million in Inventories

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

    RAMSEY, N.J. and BOCA RATON, Fla., May 12, 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 first quarter 2021 and provided an overview of recent progress and accomplishments.

    "ADMA has successfully transformed its business in the early months of 2021 and in doing so set the stage for what the Company expects to be a strong year of growth and achievements. We remain on track to deliver on several strategic and financial objectives over the near term, and visibility is improving on the Company's path to profitability," said Adam Grossman, President and Chief Executive Officer of ADMA Biologics. "We achieved multiple milestones across business segments during the quarter, while at the same time delivered on operating commitments to shareholders, specifically, generating record quarterly revenues of $16.0 million, a 57% increase over the same period last year. Also on the financial front, ADMA successfully narrowed both gross losses as well as net losses compared to the prior quarter, an encouraging trend the Company will strive to continue in the coming quarters and accelerate throughout 2022."

    ADMA additionally grew its total asset value to a quarter-end balance of $235.7 million, up approximately 13% compared to the year-end 2020 total asset value of $207.7 million. The growth in asset value notably includes approximately $94.1 million in inventories recorded at the Company's cost, which ADMA expects will support continued production ramp-up as well as quarter-over-quarter revenue growth throughout 2021, and to ensure continuity of product supply into an increasingly supply-constrained immune globulin market.

    Mr. Grossman continued, "ADMA substantially strengthened its supply chain during the first quarter of 2021, making significant progress towards its objective to establish end-to-end control of its production operations. Of note, the recent U.S. Food and Drug Administration ("FDA") approval of the Company's Intravenous Immune Globulin ("IVIG") production scale expansion is expected to increase total manufacturing production capacity by up to 50% compared to the Company's prior expectations, ADMA BioCenters remains on track to have 10 or more plasma collection facilities in operation by 2024, and the two fiscal quarter extension of ADMA's existing third-party plasma supply commitment to year-end 2022 is expected to further supplement ADMA's growing internal plasma collections and support the Company in meeting all ongoing, as well as the forecasted, peak IVIG production requirements."

    "The milestones achieved during the first quarter of 2021 establish a strong foundation for ADMA's continued execution as the year progresses. We believe the multi-year remediation and production enhancement objectives will enable ADMA to yield significant returns in the way of margin improvements, and to generate anticipated quarter-over-quarter revenue growth which we expect should continue throughout 2021 and beyond. The pathway to profitability is clearly in focus. We believe that we have executed on all stated commitments to our shareholders and to a large extent de-risked future growth prospects as a result of the Company's achievements during the first quarter. These achievements could not have been completed without the dedication and focus of ADMA's staff and we commend the entire team for their extraordinary efforts," concluded Mr. Grossman.

    Select First Quarter 2021 Achievements & Recent Corporate Developments:

    • Continued Commercial Execution: Achieved first quarter 2021 total revenues of $16.0 million, compared to $10.2 million for the first quarter of 2020, reflecting a 57% increase. 



    • Inventories Continued to Increase to Support Anticipated Quarter-Over-Quarter Revenue Growth. Grew inventories to a first quarter 2021 ending balance of $94.1 million compared to $52.3 million in the first quarter of 2020, which supports 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.



    • Strengthened Internal and Externally Sourced Plasma Supply. ADMA currently has seven plasma collection facilities under its corporate umbrella at various stages of approval and development, including four facilities that are currently operational and collecting plasma, and remains on track to achieve its stated goal of operating 10 or more plasma collection centers by 2024. Over the remainder of 2021, ADMA anticipates to receive approval for one facility presently pending a Biologics License Application ("BLA"), and expects filing BLAs for two additional plasma collection centers. The Company additionally announced an extension of its existing third-party source plasma supply agreement from June 2022 previously through December 2022. We believe ADMA's growing internal plasma collection network coupled with its contractually committed third-party supply obligations position the company well to ensure sufficient quantities of plasma supply to meet both ongoing production requirements as well as the supply needs associated with the upwardly revised peak annual production capacity expectations of up to 600,000-liters.



    • Advanced Supply Chain Enhancement Initiative. The recent FDA approval of the 4,400-liter IVIG plasma pool scale increase for BIVIGAM® will enable ADMA to potentially ramp-up to 600,000-liters of annual production throughput, realize meaningful gross margin improvement as production throughput flows through the standard 7 to 12-month manufacturing cycle for plasma-derived therapies, and allow ADMA to offer BIVIGAM® in two vial sizes, both the 50 mL and 100 mL configurations. The next anticipated regulatory decision as a part of ADMA's supply chain enhancement initiative will be for the installed VanRx SA25 Workcell aseptic fill-finish machine ("VanRx"). Based on recent correspondence with the FDA, a facility site inspection (virtual or in-person per current published FDA guidance) will be required prior to approval, the timing of which will be contingent on COVID-19 policies. ADMA is actively working with the FDA to find a way to expedite the plant inspection, and the Company sees a potential pathway for receiving approval during the fourth quarter of 2021. Importantly, the potential regulatory delay has no impact on the Company's near-term or ongoing operating targets, and ADMA remains confident in its ability to receive FDA approval of its in-house fill-finish machine.



    • Improved ASCENIV's Coverage and Patient Access. Permanent J-code was implemented April 1, 2021, which will provide for a streamlined and permanent reimbursement process in outpatient treatment settings.



    • Launched ADvantage Ig Comprehensive Patient Support Program. ADvantage Ig is a comprehensive patient support program designed to help prevent potential barriers to providers obtaining access to ADMA's therapies for their patients. The launch of this comprehensive patient support program allows for a singular point of contact for patients and providers.



    • Lobbied Stakeholders in the Fight Against Sexually Transmitted Diseases. Presented a poster highlighting the pharmacoeconomic burden of human immunodeficiency virus ("HIV") and Hepatitis B virus ("HBV") infection in sexual assault patients at the 2021 Academy of Managed Care Pharmacy virtual annual meeting. The Company's analysis suggests that amending U.S. Centers for Disease Control and Prevention guidelines in this at-risk population for HBV to mirror those of HIV and specifically mandating a Hepatitis B Globulin intervention such as ADMA's Nabi-HB® hyperimmune, will provide a cost-effective strategy for prophylactic seroprotection of these vulnerable patients.

    First Quarter 2021 Financial Results

    Total revenues for the quarter ended March 31, 2021 were $16.0 million, compared to $10.2 million for the quarter ended March 31, 2020, representing an increase of approximately $5.8 million, or 57%. The revenue growth for the first quarter of 2021, compared to the first quarter of 2020, was favorably impacted by the continued commercial ramp up of our IVIG product portfolio.

    Consolidated net loss for the quarter ended March 31, 2021 was $18.4 million, or $(0.16) per basic and diluted share, compared to a consolidated net loss of $19.2 million, or $(0.26) per basic and diluted share, for the quarter ended March 31, 2020. The $0.8 million narrowing in net loss compared to the prior year period was primarily attributable increased revenues and improved gross margins.

    At March 31, 2021, ADMA had cash and cash equivalents of approximately $62.0 million and accounts receivable of $15.4 million, compared to cash and cash equivalents of $55.9 million and accounts receivable of $13.2 million as of December 31, 2020. ADMA's net working capital as of March 31, 2021 was $156.1 million, compared to $133.8 million as of December 31, 2020.

    Conference Call Information

    ADMA will host a conference call today, May 12, 2021, at 4:30 p.m. Eastern Time, to discuss the fiscal first quarter 2021 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 1063675. 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 in April 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 operates FDA-licensed facilities 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 safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces current good manufacturing practices (cGMP) 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 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. 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," "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 and meaningful gross margin improvement; BIVIGAM® production capacity; the goal of building and opening new plasma collection centers by 2024; the Company's plasma collections and production; our ability to maintain plasma supply; the outcome and timing of our BLA application for our new plasma centers and for FDA inspection and approval of our VanRx aseptic fill finish machine; 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 press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the 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 March 31,
       2021   2020 
         
    REVENUES:    
    Product revenue $16,012,910  $10,164,036 
    License revenue  35,708   35,708 
    Total revenues  16,048,618   10,199,744 
         
    OPERATING EXPENSES:    
    Cost of product revenue (exclusive of amortization expense shown below)  17,770,122   16,829,226 
    Research and development  987,649   1,528,738 
    Plasma center operating expenses  2,242,343   500,644 
    Amortization of intangible assets  178,838   178,838 
    Selling, general and administrative  10,033,915   7,932,084 
    Total operating expenses  31,212,867   26,969,530 
         
    LOSS FROM OPERATIONS  (15,164,249)  (16,769,786)
         
    OTHER INCOME (EXPENSE):    
    Interest income  22,059   248,068 
    Interest expense  (3,195,750)  (2,717,091)
    Other expense  (42,001)  (6,421)
    Other expense, net  (3,215,692)  (2,475,444)
         
    NET LOSS $(18,379,941) $(19,245,230)
         
    BASIC AND DILUTED LOSS PER COMMON SHARE $(0.16) $(0.26)
         
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:    
    Basic and Diluted  115,661,937   73,781,507 



    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

     March 31, December 31,
      2021   2020 
     (Unaudited)  
    ASSETS   
    Current assets:   
    Cash and cash equivalents$61,965,709  $55,921,152 
    Accounts receivable, net 15,362,030   13,237,290 
    Inventories 94,146,200   81,535,599 
    Prepaid expenses and other current assets 5,802,608   3,046,466 
    Total current assets 177,276,547   153,740,507 
    Property and equipment, net 44,175,613   41,593,090 
    Intangible assets, net 2,265,283   2,444,121 
    Goodwill 3,529,509   3,529,509 
    Right to use assets 6,197,295   4,259,191 
    Deposits and other assets 2,222,781   2,106,976 
    TOTAL ASSETS$235,667,028  $207,673,394 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    Current liabilities:   
    Accounts payable$12,152,852  $11,073,708 
    Accrued expenses and other current liabilities 8,592,142   8,365,143 
    Current portion of deferred revenue 142,834   142,834 
    Current portion of lease obligations 317,910   365,682 
    Total current liabilities 21,205,738   19,947,367 
    Senior notes payable, net of discount 93,412,660   92,968,866 
    Deferred revenue, net of current portion 2,082,990   2,118,698 
    Lease obligations, net of current portion 6,419,589   4,334,151 
    Other non-current liabilities 41,965   54,886 
    TOTAL LIABILITIES 123,162,942   119,423,968 
        
    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,   
    123,044,981 and 104,902,888 shares issued and outstanding 12,304   10,490 
    Additional paid-in capital 471,336,826   428,704,039 
    Accumulated deficit (358,845,044)  (340,465,103)
    TOTAL STOCKHOLDERS' EQUITY  112,504,086   88,249,426 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $235,667,028  $207,673,394 


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  2. RAMSEY, N.J. and BOCA RATON, Fla., May 05, 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 first quarter ended March 31, 2021 on Wednesday, May 12, 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…

    RAMSEY, N.J. and BOCA RATON, Fla., May 05, 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 first quarter ended March 31, 2021 on Wednesday, May 12, 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 1063675. 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. ADMA Increases Total Forecasted Plant Manufacturing Capacity from 400,000 Liters up to 600,000 Liters and Increases Total Forecasted Peak Revenues in Excess of $300 Million

    Enhanced Gross Margins and Cost Efficiencies Expected to be Realized Beginning Late 2021 and Accelerate Throughout 2022 on Path to Profitability

    RAMSEY, N.J. and BOCA RATON, Fla., April 28, 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, announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's expanded manufacturing process, enabling fractionation and…

    ADMA Increases Total Forecasted Plant Manufacturing Capacity from 400,000 Liters up to 600,000 Liters and Increases Total Forecasted Peak Revenues in Excess of $300 Million

    Enhanced Gross Margins and Cost Efficiencies Expected to be Realized Beginning Late 2021 and Accelerate Throughout 2022 on Path to Profitability

    RAMSEY, N.J. and BOCA RATON, Fla., April 28, 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, announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin ("IVIG").

    "The FDA approval of the 4,400-liter IVIG plasma pool production scale process is a transformative milestone for the ADMA organization and will allow the Company to produce significantly more IVIG for the U.S. market and for patients living with immune deficiencies," said Adam Grossman, President and Chief Executive Officer of ADMA. "The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022. In addition to the increase in ADMA's multi-year financial guidance, the Company is reiterating its expectation for quarter-over-quarter revenue growth throughout 2021 and beyond. We commend our employees' dedication in achieving this important manufacturing milestone and look forward to increasing our production capacity rapidly over the forward-looking quarters."

    The 4,400-liter IVIG plasma pool scale for BIVIGAM® will allow ADMA to expand its manufacturing plant's total processing capacity from 400,000 liters to an anticipated peak throughput of up to 600,000 liters. ADMA now has FDA approval to produce BIVIGAM® at an expanded capacity with the same high quality as the previous manufacturing scale, while using the same equipment, release testing assays, disposables and labor force. The Company anticipates this will translate into meaningful gross margin improvement as production throughput flows through the standard 7 to 12-month manufacturing cycle for plasma-derived therapies. With this approval, ADMA additionally will now be able to offer BIVIGAM® in two vial sizes, both the 50 mL and 100 mL configurations.

    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 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

    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 production capacity; anticipated timing for reaching profitability and meaningful gross margin expansion and cost efficiencies; our anticipated revenue growth; and the amount of potential peak revenues to be generated by the Company and the related timing associated therewith. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the 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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  4. RAMSEY, N.J. and BOCA RATON, Fla. and GOOSE CREEK, S.C., April 26, 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, announced commencement of operations and initiation of donor plasma collections at its newest ADMA BioCenters plasma collection facility located in Goose Creek, South Carolina.

    "We are honored to have commemorated the opening of our Goose Creek, South Carolina plasma collection facility with South Carolina Governor, Henry McMaster, to whom we are sincerely grateful for his and his administration's support. The state's impressive infrastructure and skilled workforce create…

    RAMSEY, N.J. and BOCA RATON, Fla. and GOOSE CREEK, S.C., April 26, 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, announced commencement of operations and initiation of donor plasma collections at its newest ADMA BioCenters plasma collection facility located in Goose Creek, South Carolina.

    "We are honored to have commemorated the opening of our Goose Creek, South Carolina plasma collection facility with South Carolina Governor, Henry McMaster, to whom we are sincerely grateful for his and his administration's support. The state's impressive infrastructure and skilled workforce create a terrific foundation for ADMA to safely collect and process plasma, and we look forward to continuing to grow our operations in the state now and in the coming years. The Governor's ribbon cutting at our newest plasma collection facility marks the latest achievement in what has been an excellent start to 2021 for ADMA across all of its business units," said Adam Grossman, President and Chief Executive Officer of ADMA. "ADMA currently has seven plasma collection facilities under its corporate umbrella at various stages of approval and development and remains on track to achieve its stated goal of having 10 or more plasma collection centers in operation by 2024."

    "Securing raw material plasma supply has never been more important than it is today, and we believe the series of recent acquisitions of plasma collection facilities validates this scarcity value. We anticipate that our BioCenters' expansion strategy will support our goal of generating quarter-over-quarter revenue growth throughout 2021 and beyond, solidify our objective to establish a fully integrated and self-sufficient plasma supply chain, enable ADMA to ensure continuity of product supply to customers and patients and ultimately create significant asset value for our shareholders," concluded Mr. Grossman.

    Pursuant to updated United States Food and Drug Administration ("FDA") guidance to obtain approval for plasma collection centers, sponsors are now required to collect plasma donations for 3 months prior to submitting a Biologics License Application ("BLA") filing. Accordingly, ADMA expects to file its BLA for the Goose Creek, S.C. plasma collection facility in approximately 3 months from center opening and anticipates a standard 12-month BLA review period by the FDA. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can utilize the plasma collected for further use in the manufacturing of life saving therapies.

    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 up to 50 highly trained healthcare workers.

    Eligible plasma donors can receive $70 on the first donation and up to $650/month. To learn more about the ADMA BioCenters donation process, and to schedule an appointment, please visit www.admabiocenters.com, or visit in person at: 214 Saint James Avenue, Goose Creek, S.C. 29445.

    About ADMA BioCenters

    ADMA BioCenters operates FDA licensed facilities 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 new regulations and guidance and enforces current good manufacturing practices "cGMP" 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-licensed 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 ten or more new plasma collection centers by 2024; and the use of plasma collected at the Goose Creek 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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  5. Poster Presentation Highlights the Unmet Patient Need and Medical Cost Burden Associated with Hepatitis B Infection

    Healthcare Costs Associated with HBV and HIV are Approximately at Parity; HBV Carries 50-100 Times Greater Transmission Risk Compared to HIV

    Pharmacoeconomic Analysis and Unmet Patient Need Strongly Support Harmonization of HBV and HIV CDC Treatment Guidelines for Sexual Assault Victims

    RAMSEY, N.J. and BOCA RATON, Fla., April 13, 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 a poster presentation at the 2021 Academy of Managed…

    Poster Presentation Highlights the Unmet Patient Need and Medical Cost Burden Associated with Hepatitis B Infection

    Healthcare Costs Associated with HBV and HIV are Approximately at Parity; HBV Carries 50-100 Times Greater Transmission Risk Compared to HIV

    Pharmacoeconomic Analysis and Unmet Patient Need Strongly Support Harmonization of HBV and HIV CDC Treatment Guidelines for Sexual Assault Victims

    RAMSEY, N.J. and BOCA RATON, Fla., April 13, 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 a poster presentation at the 2021 Academy of Managed Care Pharmacy Virtual Annual Meeting ("AMCP") taking place April 12-16, 2021.

    "Current CDC guidelines for post-exposure prophylaxis of suspected Hepatitis B infection ("HBV") offer no intervention for sexual assault victims with perpetrators of unknown Hepatitis B surface antigen status," said Adam Grossman, President and Chief Executive Officer of ADMA.  "HBV is significantly more infectious than is HIV, and can be transmitted by any bodily fluid, and amounts to a roughly equivalent cost burden for the US healthcare system. Our analysis suggests that amending CDC guidelines in this at-risk population for HBV to mirror those of HIV and specifically mandating a Hepatitis B Globulin intervention like ADMA's Nabi-HB hyperimmune, will provide a cost-effective strategy for prophylactic seroprotection of these vulnerable patients. It is our hope that lobby groups advocating on behalf of at-risk patients will leverage this analysis to convey to policymakers that failing to address this patient population, and harmonizing treatment guidelines between HIV and HBV, may have considerable clinical and cost implications for the US healthcare system."

    Details for the AMCP 2021 poster presentation are as follows:

    Poster Title: Pharmacoeconomic Analysis Comparing Medical Costs for Prophylaxis of HIV and HBV Infection in Sexual Assault Patients

    Author: Gruenglas, Pantello, Mond

    Session Title: Poster Abstract Sessions

    Session Dates: Tuesday, April 13 – Wednesday, April 14, 2021 (2:30 pm ET)

    Session Location: Virtual Poster Hall

    Poster No: B3   

    View the presentation at the virtual 2021 AMCP Annual Meeting

    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.

    Additional Important Safety Information about Nabi-HB®

    Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB® [Hepatitis B Immune Globulin (Human)] or any other human immune globulin. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB should be given only if the expected benefits outweigh the potential risks. Nabi-HB is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents (e.g., viruses) and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Nabi-HB [Hepatitis B Immune Globulin (Human)], must be administered only intramuscularly for post-exposure prophylaxis. Vaccination with live virus vaccines (e.g., MMR) should be deferred until approximately three months after administration of Nabi-HB. The most common adverse reactions associated with Nabi-HB in clinical trials were erythema and ache at the injection site as well as systemic reactions such as headache, myalgia, malaise, nausea and vomiting. No anaphylactic reactions with Nabi-HB have been reported. Please see the full Prescribing Information for Nabi-HB [Hepatitis B Immune Globulin (Human)].

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

    Warnings and Precautions:

    In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks. Nabi-HB is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses. The Nabi-HB manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton® X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB is filtered using a Planova® 35 nm Virus Filter that is effective in reducing the levels of some enveloped and non enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Biotest Pharmaceuticals at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.

    Nabi-HB, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post-exposure prophylaxis. The preferred sites for intramuscular injections are the anterolateral aspect of the upper thigh and the deltoid muscle. If the buttock is used due to the volume to be injected, the central region should be avoided; only the upper, outer quadrant should be used, and the needle should be directed anterior (i.e., not inferior or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve22. The 50 healthy volunteers who received Nabi-HB in pharmacokinetic studies were followed for 84 days for possible development of anti-HCV antibodies. No subject seroconverted.

    Drug Interactions

    Vaccination with live virus vaccines should be deferred until approximately three months after administration of Nabi-HB, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate persons who received Nabi-HB shortly after live virus vaccination. There are no available data on concomitant use of Nabi-HB and other drugs; therefore, NabiHB should not be mixed with other drugs.

    Pregnancy Category C

    Animal reproduction studies have not been conducted with Nabi-HB. It is also not known whether Nabi-HB can cause fetal harm when administered to a pregnant woman or can affect a woman's ability to conceive. Nabi-HB should be given to a pregnant woman only if clearly indicated.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nabi-HB is administered to a nursing mother.

    Pediatric Use

    Safety and effectiveness in the pediatric population have not been established for Nabi-HB. However, the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants and children.

    Geriatric Use

    Clinical studies of Nabi-HB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

    Adverse Reactions:

    Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials20. The number of patients with reactions related to the administration of Nabi-HB included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myalgia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the pharmacokinetics trials and were considered probably related to Nabi-HB: elevated alkaline phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events. No anaphylactic reactions with Nabi-HB have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins.

    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.

    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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