ADMA ADMA Biologics Inc

1.25
-0.01  -0%
Previous Close 1.25
Open 1.25
52 Week Low 1.15
52 Week High 3.1105
Market Cap $165,297,991
Shares 132,769,471
Float 109,160,134
Enterprise Value $224,889,170
Volume 375,222
Av. Daily Volume 3,337,945
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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. Expected to Provide Improved Gross Margins, Enhanced Patient Supply Consistency, Accelerated Inventory Production Cycle Time and Increased Control and Visibility of Commercial Product Lot Releases

    Additional Opportunity for Contract Manufacturing Filling Services and Capabilities to Third Parties

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 08, 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 in-house aseptic fill-finish machine, the VanRx SA25 ("VanRx").

    "The FDA approval…

    Expected to Provide Improved Gross Margins, Enhanced Patient Supply Consistency, Accelerated Inventory Production Cycle Time and Increased Control and Visibility of Commercial Product Lot Releases

    Additional Opportunity for Contract Manufacturing Filling Services and Capabilities to Third Parties

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 08, 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 in-house aseptic fill-finish machine, the VanRx SA25 ("VanRx").

    "The FDA approval of the VanRx marks the successful completion of ADMA's multi-year supply chain enhancement initiative, firmly establishing ADMA as the only American domiciled end-to-end producer of specialty plasma-derived biologic drugs. Today's announcement is expected to have transformative financial and strategic implications for ADMA as the Company now joins an elite group of U.S.-based drug manufacturers with comprehensive in-house control of its critical manufacturing functions," said Adam Grossman, President and Chief Executive Officer of ADMA. "The VanRx approval provides ADMA with internal fill-finish operations, capable of sufficiently addressing all forecasted production requirements for our commercial products. With the VanRx operational, we are anticipating meaningfully improved gross margins, enhanced patient supply consistency, accelerated inventory production cycle times, and increased control and visibility of commercial product lot releases, creating more predictable near-term revenue results.

    "The approval of the VanRx will also provide ADMA with the opportunity to onboard new fill-finish contract manufacturing opportunities with third parties. This additional revenue stream can provide the Company with the ability to potentially exceed previous financial targets, which we will update as progress unfolds. With extensive vertical integration successfully established and the Company's more meaningful capital investment initiatives having now concluded, ADMA is entering the next phase of its profit-focused growth strategy. We look forward to sustaining quarter-over-quarter revenue growth for the foreseeable future as well as meaningfully improving profitability metrics in the periods ahead," concluded Mr. Grossman.

    The VanRx fill-finish machine utilizes a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients. The VanRx machine has the capability of rapidly switching between different container and closure formats, enabling aseptic filling in a variety of different fill volumes and presentation sizes. The combination of the FDA-approved increased BIVIGAM® manufacturing production scale earlier this year as well as the enhanced vertical integration resulting from this approval of the VanRx machine is expected to allow ADMA to bring its products to market faster, improve gross margins and substantially increase ADMA's end-to-end control over its critical manufacturing process. ADMA will continue to work with its third-party contract manufacturing organization (CMO) fill-finish partner who will continue to fill a portion of ADMA's production at their site. The CMO's site will remain in ADMA's FDA-approved product Biologics License Applications to provide the Company with alternatives on a go-forward basis to ensure continued supply-chain robustness.

    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; and the expected financial, strategic and commercial benefits of the VanRx approval. 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 | sbloom@admabio.com

    INVESTOR RELATIONS CONTACT:

    Michelle Pappanastos

    Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com 



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  2. RAMSEY, N.J. and BOCA RATON, Fla., Sept. 02, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (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 virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 12:30 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 American commercial biopharmaceutical…

    RAMSEY, N.J. and BOCA RATON, Fla., Sept. 02, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (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 virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 12:30 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 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| sbloom@admabio.com

    INVESTOR RELATIONS CONTACT:

    Michelle Pappanastos

    Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com



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  3. RAMSEY, N.J. and BOCA RATON, Fla. and MARYVILLE, Tenn., Aug. 16, 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 Maryville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the fourth quarter of 2020. With today's approval, this facility is now FDA-licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.

    "The approval…

    RAMSEY, N.J. and BOCA RATON, Fla. and MARYVILLE, Tenn., Aug. 16, 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 Maryville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the fourth quarter of 2020. With today's approval, this facility 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 represents both another milestone regulatory achievement as well as an important step in ADMA's ambitions to further secure raw material plasma supply and enhance end-to-end control of manufacturing operations," said Adam Grossman, President and Chief Executive Officer of ADMA. "ADMA has eight plasma collection facilities under its corporate umbrella, including three FDA-approved facilities, with five of those facilities now open and collecting plasma and two additional Biologics License Applications ("BLA") filings anticipated over the remainder of 2021. In total, ADMA remains on track to have 10 or more FDA-approved plasma collection facilities by 2024. Along with the extension of third-party supply agreements through year-end 2022, as well as the anticipated yield enhancements resulting from our recent implementation of the Haemonetics' NexSys Persona® technology, ADMA believes it is insulated from broader market plasma collection and pricing fluctuations. The Company remains well-positioned to ensure the continuity of our supply chain and our plasma products supply."

    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 Persona® plasma collection system.

    New 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: 1412 Sevierville Road, Maryville, Tennessee 37804.

    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 "anticipate," "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 (including, but not limited to, insulation from any broader market plasma collection and pricing fluctuations); expansion plans and the goal of operating ten or more FDA-approved plasma collection centers by 2024; our expectation to file additional BLAs and the timing thereof; the yield enhancements anticipated to result from the implementation of Haemonetics' NexSys Persona® technology; and the expected staff count at the Maryville facility. 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 | sbloom@admabio.com 

    INVESTOR RELATIONS CONTACT:

    Michelle Pappanastos

    Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com 

     



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  4. Achieved Record Total Revenues of $17.8 Million in Second Quarter 2021, a 129% Increase Over Second Quarter 2020

    Narrowed Gross and Net Losses Year-over-Year

    ADMA Now Anticipates Exiting 2021 Approaching an Annualized Revenue Run Rate of Approximately $100 Million or More; Reiterates All Previously Communicated Strategic and Financial Objectives

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

    RAMSEY, N.J. and BOCA RATON, Fla., Aug. 11, 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 the three months ended…

    Achieved Record Total Revenues of $17.8 Million in Second Quarter 2021, a 129% Increase Over Second Quarter 2020

    Narrowed Gross and Net Losses Year-over-Year

    ADMA Now Anticipates Exiting 2021 Approaching an Annualized Revenue Run Rate of Approximately $100 Million or More; Reiterates All Previously Communicated Strategic and Financial Objectives

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

    RAMSEY, N.J. and BOCA RATON, Fla., Aug. 11, 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 the three months ended June 30, 2021, its fiscal second quarter, and provided an overview of recent progress and accomplishments.

    "ADMA continues to achieve milestones and execute on its commercial and operational strategies as evidenced by the strong second quarter financial results and regulatory successes. The totality of the year-to-date accomplishments across business segments has the Company well-positioned to sustain quarter-over-quarter revenue growth with improving margins for the foreseeable future," said Adam Grossman, President and Chief Executive Officer of ADMA.

    "Less than two years into ADMA's commercial launch of its intravenous immune globulin ("IVIG") product portfolio, the Company generated record quarterly revenues of $17.8 million, representing an increase of 129% year-over-year. This top-line growth is particularly impressive in light of the pandemic-related headwinds that continue to persist throughout the product launch period, which impacted industry supply chains and limited engagement with physicians and providers. Additionally, these results do not reflect the substantial benefits anticipated from the recently approved BIVIGAM® expanded production scale, increasing our facility's total annual peak production capacity from 400,000 liters to 600,000 liters, as well as the expected approval of the VanRx SA25 Workcell aseptic fill-finish machine ("VanRx") in the second half of 2021. We are confident that our underlying business trends have demonstrated strength and resilience year-to-date and can continue improving in the second half of 2021 and beyond as operating efficiencies materialize and production ramp-up further progresses.

    "ADMA has also seen a substantial strengthening of its supply chain in the first half of the year. The recent receipt of zero Form 483 observations as a part of the pre-approval inspection ("PAI") for the VanRx machine paves the way for an anticipated approval over the coming months. When approved, it will cap a multi-year remediation and end-to-end supply chain initiative at the Boca Raton, FL manufacturing facility, and will propel ADMA into an elite group of U.S.-based drug manufacturers with comprehensive in-house control of a majority of its critical manufacturing functions.

    "The ADMA BioCenters team, through its year-to-date accomplishments, has made significant strides towards ensuring uninterrupted raw material plasma supply. The enhanced yield anticipated from the recent implementation of Haemonetics' Persona® technology, the extension of the Company's primary third-party plasma supply contract to the end of 2022 and the continued expansion of the BioCenters plasma collection network establishes a solid foundation for ADMA to ensure continuity of product supply into an increasingly supply-constrained immune globulin market. With the current industry-wide pressures on plasma collection operations, ADMA's strategic emphasis on building an internal collection network and solidifying third-party supplemental supply should yield significant returns in the periods ahead and largely insulate the Company from supply and pricing fluctuations.

    "Over the past 4 years, ADMA has also been diligently building a vertically integrated commercial biologics manufacturing organization since acquiring its manufacturing facility and assets in June 2017 and is now successfully emerging from its multi-year investment, regulatory and remediation phase. The majority of substantive investments are now in the rearview, the wholly owned manufacturing plant is now fully remediated and collectively, positions the Company to meet or exceed all longer-term financial targets. These accomplishments could not have been realized without the dedication and focus of ADMA's staff, leadership and advisors. We commend the entire team for their extraordinary efforts focused on improving healthcare for U.S. patients," concluded Mr. Grossman.

    Select Second Quarter 2021 Achievements & Recent Corporate Developments:

    • Continued Commercial Execution: Achieved second quarter 2021 total revenues of $17.8 million, compared to $7.8 million for the second quarter of 2020, reflecting a 129% increase. 



    • Successful PAI Paves the Way for Second Half 2021 VanRx Approval. We anticipate the successfully completed PAI, during which the U.S. Food and Drug Administration (FDA) issued no Form 483 observations, will facilitate a VanRx approval over the coming months. In addition to the significant operating efficiencies expected to result from the expected VanRx approval, the fill-finish capabilities will propel ADMA into an elite class of U.S. drug manufacturers with complete end-to-end control of critical manufacturing functions. As previously stated, we are actively evaluating new business opportunities with these fill-finish capabilities and intend to update the market as appropriate.



    • On Track BioCenters Network Expansion. ADMA currently has eight plasma collection facilities under its corporate umbrella at various stages of approval and development, including five facilities that are currently operational and collecting plasma. The Company 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 receiving approval for one facility presently pending a Biologics License Application ("BLA") and expects to file BLAs for two additional plasma collection centers.



    • Expanded Suite of IG Product Offerings with Introduction of Additional Vial Sizes. The availability of the additional NABI-HB® and BIVIGAM® vial sizes meaningfully enhance ADMA's go-to-market offering for its immunoglobulin product portfolio and allows for more versatile utilization by providers and patients.



    Second Quarter 2021 Financial Results

    Total revenues for the quarter ended June 30, 2021, were approximately $17.8 million, compared to approximately $7.8 million for the quarter ended June 30, 2020, representing an increase of approximately $10.0 million, or 129%. The revenue growth for the quarter ended June 30, 2021, compared to the quarter ended June 30, 2020, was favorably impacted by the continued commercial ramp-up of ADMA's IVIG product portfolio.

    Consolidated net loss for the quarter ended June 30, 2021 was approximately $18.9 million, or $(0.15) per basic and diluted share, compared to a consolidated net loss of approximately $20.2 million, or $(0.23) per basic and diluted share, for the quarter ended June 30, 2020. The $1.3 million narrowing in net loss compared to the prior year period was primarily attributable to increased revenues and improved gross margins. The net loss incurred during the second quarter of 2021 includes a one-time, non-recurring charge related to a separation and transition agreement in the amount of approximately $0.8 million.

    At June 30, 2021, ADMA had cash and cash equivalents of approximately $42.4 million and accounts receivable of approximately $23.5 million, compared to cash and cash equivalents of approximately $75.8 million and accounts receivable of approximately $6.5 million as of June 30, 2020. ADMA's net working capital as of June 30, 2021 was approximately $153.2 million, compared to approximately $130.1 million as of June 30, 2020.   

    Conference Call Information

    ADMA will host a conference call today, August 11, 2021, at 4:30 p.m. Eastern Time, to discuss the fiscal second 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 8992329. 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 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 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 a 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 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 our expected revenue run rates, meaningful gross margin improvement and operating efficiencies; the impact of COVID-19 on the Company's financial results and business operations; expected benefits from the VanRx aseptic fill-finish machine, including cost efficiencies and contract manufacturing opportunities; the anticipated benefits from the recent implementation of Haemonetics' Persona® technology combined with our plasma collection network; BIVIGAM®'s 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 approval of our VanRx aseptic fill-finish machine; and the expected benefits of additional NABI-HB® and BIVIGAM® vial sizes. 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 |sbloom@admabio.com

    INVESTOR RELATIONS CONTACT:

    Michelle Pappanastos

    Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com



    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)



      Three Months Ended June 30, 
       2021   2020  
          
    REVENUES:     
    Product revenue $17,794,881  $7,751,885  
    License revenue  35,709   35,709  
    Total revenues  17,830,590   7,787,594  
          
    OPERATING EXPENSES:     
    Cost of product revenue (exclusive of amortization expense shown below)  18,832,624   13,495,629  
    Research and development  1,158,866   1,656,420  
    Plasma center operating expenses  2,803,326   877,902  
    Amortization of intangible assets  178,838   178,838  
    Selling, general and administrative  10,438,168   8,702,630  
    Total operating expenses  33,411,822   24,911,419  
          
    LOSS FROM OPERATIONS  (15,581,232)  (17,123,825) 
          
    OTHER INCOME (EXPENSE):     
    Interest income  5,926   19,411  
    Interest expense  (3,246,680)  (3,067,306) 
    Other expense  (83,317)  (6,371) 
    Other expense, net  (3,324,071)  (3,054,266) 
          
    NET LOSS $(18,905,303) $(20,178,091) 
          
    BASIC AND DILUTED LOSS PER COMMON SHARE $(0.15) $(0.23) 
          
    WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:     
    Basic and Diluted  127,416,126   86,347,467  
          



    ADMA BIOLOGICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)



     June 30, December 31, 
      2021   2020  
    ASSETS    
    Current assets:    
    Cash and cash equivalents$42,408,958  $55,921,152  
    Accounts receivable, net 23,544,594   13,237,290  
    Inventories 99,699,743   81,535,599  
    Prepaid expenses and other current assets 5,701,863   3,046,466  
    Total current assets 171,355,158   153,740,507  
    Property and equipment, net 46,486,980   41,593,090  
    Intangible assets, net 2,086,445   2,444,121  
    Goodwill 3,529,509   3,529,509  
    Right to use assets 6,829,040   4,259,191  
    Deposits and other assets 2,526,660   2,106,976  
    TOTAL ASSETS$232,813,792  $207,673,394  
         
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    Current liabilities:    
    Accounts payable$6,167,465  $11,073,708  
    Accrued expenses and other current liabilities 11,490,239   8,365,143  
    Current portion of deferred revenue 142,834   142,834  
    Current portion of lease obligations 385,858   365,682  
    Total current liabilities 18,186,396   19,947,367  
    Senior notes payable, net of discount 93,877,017   92,968,866  
    Deferred revenue, net of current portion 2,047,281   2,118,698  
    Lease obligations, net of current portion 7,073,415   4,334,151  
    Other non-current liabilities 36,151   54,886  
    TOTAL LIABILITIES 121,220,260   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, 300,000,000 and 150,000,000 shares authorized,    
    131,872,026 and 104,902,888 shares issued and outstanding 13,187   10,490  
    Additional paid-in capital 489,330,692   428,704,039  
    Accumulated deficit (377,750,347)  (340,465,103) 
    TOTAL STOCKHOLDERS' EQUITY  111,593,532   88,249,426  
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $232,813,792  $207,673,394  
         

     



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  5. RAMSEY, N.J. and BOCA RATON, Fla. and CONYERS, Ga., Aug. 10, 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 the commencement of operations and initiation of donor plasma collections at its newest ADMA BioCenters plasma collection facility located in Conyers, Georgia. In conjunction with the plasma collection center opening, ADMA also announced the implementation of the Haemonetics' Persona® Plasma Collection Solution for the NexSys PCS® system ("Persona") across its plasma collection center network.

    "We are pleased that ADMA has chosen to adopt the Haemonetics Persona…

    RAMSEY, N.J. and BOCA RATON, Fla. and CONYERS, Ga., Aug. 10, 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 the commencement of operations and initiation of donor plasma collections at its newest ADMA BioCenters plasma collection facility located in Conyers, Georgia. In conjunction with the plasma collection center opening, ADMA also announced the implementation of the Haemonetics' Persona® Plasma Collection Solution for the NexSys PCS® system ("Persona") across its plasma collection center network.

    "We are pleased that ADMA has chosen to adopt the Haemonetics Persona® Plasma Collection Solution for the NexSys PCS® system. We share their commitment to a personalized and improved donor experience and striving to meet the growing demand for plasma-derived medicines to help patients in need," said Dr. Jan Hartmann, Chief Medical Officer of Haemonetics Corporation ("Haemonetics").

    "The implementation of Persona® technology and the opening of ADMA's newest plasma collection center directly advances the Company's near term and ongoing strategic objectives," said Adam Grossman, President and Chief Executive Officer of ADMA. "With today's plasma collection center opening, ADMA now has eight collection facilities under its corporate umbrella at various stages and remains on track to have 10 or more centers in operation by 2024. The anticipated yield enhancement resulting from Persona® implementation, in combination with our growing BioCenters' network, has ADMA well-positioned to sustain quarter-over-quarter revenue growth throughout 2021 and beyond. These activities will add to ensuring continuity of our commercial product supply to customers and patients in the growing Immune Globulin market.  

    "The collective impact of today's developments is anticipated to improve gross margins and enhance overall corporate profitability. ADMA continues to execute across all business units and, as a result, confidently reiterates all previously provided financial and strategic objectives. We look forward to continuing to build on the business momentum over the remainder of 2021 and beyond," concluded Mr. Grossman.

    ADMA BioCenters' newest, state-of-the-art plasma collection center located in Conyers, Georgia 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 center expects to maintain a staff of up to 50 highly trained healthcare workers. 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 three months prior to submitting a Biologics License Application ("BLA") filing. Accordingly, ADMA expects to file its BLA for the Conyers, Georgia plasma collection facility in approximately three months 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 the site is FDA approved, ADMA can utilize the plasma collected for further use in the manufacturing of life saving therapies.

    New 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: 1820 Highway 20 SE, Conyers, Georgia 30013

    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.

    About Haemonetics

    Haemonetics (NYSE: "HAE") is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com. Persona®, a proprietary, patented solution built upon Haemonetics' NexSys PCS® platform, tailors plasma collections to each donor's individual characteristics and is clinically shown to yield +9% to 12% (based on baseline device, software configuration and donor population) more plasma per donation on average to maximize both cost-efficient output and patient impact from plasma collection centers. To learn more about Haemonetics, visit www.haemonetics.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 "anticipate," "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; yield enhancement resulting from the Persona® technology implementation; expansion plans and the goal of opening ten or more new plasma collection centers by 2024; timing relating to the filing of a Biologics License Application for the Conyers, Georgia facility and the number of employees at such location; and the use of plasma collected at the Conyers, Georgia facility for production of immunoglobulin products. 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 | sbloom@admabio.com

    INVESTOR RELATIONS CONTACT:

    Michelle Pappanastos

    Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com



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