ADMA ADMA Biologics Inc

2.38
-0.03  -1%
Previous Close 2.41
Open 2.4
52 Week Low 1.45
52 Week High 5.45
Market Cap $205,512,955
Shares 86,349,981
Float 62,847,318
Enterprise Value $229,453,941
Volume 2,758,379
Av. Daily Volume 7,007,855
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Drug Pipeline

Drug Stage Notes
ASCENIV (RI-002)
Primary Immune Deficiency Diseases
Approved
Approved
FDA Approval announced April 1, 2019.
BIVIGAM
Primary humoral immunodeficiency
CRL
CRL
Response to Complete Response Letter submitted January 7, 2019.

Latest News

  1. 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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  2. 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 |  

    Primary Logo

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  3. 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 |

    Primary Logo

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  4. 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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  5. 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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