ADMA ADMA Biologics Inc

2.35
-0.13  -5%
Previous Close 2.48
Open 2.5
52 Week Low 1.45
52 Week High 4.2
Market Cap $222,187,922
Shares 94,548,052
Float 71,045,389
Enterprise Value $274,038,922
Volume 3,273,866
Av. Daily Volume 4,412,514
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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., Feb. 22, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Raymond James Institutional Investor Conference on Monday, March 1, 2021, at 10:50 a.m. ET.

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

    About ADMA Biologics, Inc. (ADMA)

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

    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 22, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that Adam Grossman, President and Chief Executive Officer, will participate in a fireside chat at the Raymond James Institutional Investor Conference on Monday, March 1, 2021, at 10:50 a.m. ET.

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

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA's mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    COMPANY CONTACT:

    Skyler Bloom

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

    INVESTOR RELATIONS CONTACT:

    Sam Martin

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



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  2. RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration ("FDA") approval for its ADMA BioCenters plasma collection facility located in Knoxville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2020, and with today's approval, it is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.

    "The approval of this…

    RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration ("FDA") approval for its ADMA BioCenters plasma collection facility located in Knoxville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2020, and with today's approval, it is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.

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

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

    About ADMA BioCenters

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

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA's mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. ("we," "our" or the "Company"). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as "intend," "target," "plan," "expect," "believe," "will," "is likely," "will likely," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; expansion plans and the goal of opening up to ten new plasma collection centers by 2024; our expectation to receive an FDA approval for our Maryville, Tennessee plasma collection center and the timing thereof; our expectation to file additional BLAs; and the receipt of additional FDA approvals during 2021 and the effects on our business of such approvals. Actual events or results may differ materially from those described in this document due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

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

    INVESTOR RELATIONS CONTACT:

    Sam Martin

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



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

    "The issuance of this…

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

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

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

    About ASCENIV™

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

    About ADMA Biologics, Inc.

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA's mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Forward-Looking Statements

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

    COMPANY CONTACT:

    Skyler Bloom

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

    INVESTOR RELATIONS CONTACT:

    Sam Martin

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



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

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

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

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 19, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its preliminary…

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

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

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

    RAMSEY, N.J. and BOCA RATON, Fla., Jan. 19, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its preliminary unaudited fourth quarter and full year 2020 revenues. The Company also provided commercial updates for its immune globulin product portfolio, as well as introduced its 2021 strategic and operational outlook.

    Fourth Quarter and Full Year 2020 Highlights

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

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

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

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

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

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

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

    Fourth Quarter and Full Year 2020 Financial Results Conference Call

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

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

    About ADMA Biologics, Inc. (ADMA)

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and Nabi-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA's mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. ("we," "our" or the "Company"). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as "estimate," "project," "intend," "forecast," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "should," "could," "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA's future results of operations; timing of revenue and profitability; execution of corporate objectives and achievement of goals, including but not limited to, the Company's key strategic priorities for 2021; receipt of future regulatory approvals; realization of shareholder value; and future appreciation of the asset value of manufactured plasma and plasma collection centers. Actual events or results may differ materially from those described in this document due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

    COMPANY CONTACT:

    Skyler Bloom

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

    INVESTOR RELATIONS CONTACT:

    Sam Martin

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



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

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

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

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

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

    About ASCENIV™

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

    About ADMA Biologics, Inc.

    ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA's mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

    Forward-Looking Statements

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

    COMPANY CONTACT:

    Skyler Bloom

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

    INVESTOR RELATIONS CONTACT:

    Sam Martin

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



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