UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 21, 2024
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction
of incorporation)
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(IRS Employer
Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (201 ) 478-5552
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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| Item 8.01 |
Other Events
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On February 21, 2024, ADMA Biologics, Inc. issued a press release announcing the successful initial use of its Artificial Intelligence program, named
ADMAlytics. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein.
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Exhibits.
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(d) Exhibits
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Exhibit No.
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Description
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ADMA Biologics, Inc. Press Release, dated February 21, 2024
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104
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Cover Page Interactive Data File (embedded with the Inline XBRL document)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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February 21, 2024
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ADMA Biologics, Inc.
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By:
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/s/ Brian Lenz
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Name:
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Brian Lenz
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Title:
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Executive Vice President and Chief Financial Officer
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Exhibit 99.1
ADMA Biologics Successfully Implements Innovative AI Program, Named ADMAlytics
ADMAlytics Combines Generative AI and Machine Learning to Optimize Production Processes
ADMA Successfully Utilized ADMAlytics’ New Capabilities for the First Time to Automate and Realize Efficiency Improvements for Commercial Production
Plasma Pooling
Broader Implementation of ADMAlytics Expected to Provide Efficiencies Across the Organization
RAMSEY, NJ and BOCA RATON, FL, February 21, 2024 –
ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty biologics, today
announced the successful initial use of its Artificial Intelligence (“AI”) program, named ADMAlytics. ADMAlytics combines AI and machine learning to improve and predict outcomes for production and operational processes. Recently, ADMA
successfully produced its first batch of ASCENIV™ utilizing this innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during
commercial manufacturing. ADMA expects broad implementation of the new ADMAlytics capabilities has the potential to provide for rapid realization of efficiencies across the Company’s supply chain and production operations.
“We’re proud to announce the successful development and implementation of our innovative ADMAlytics AI
program,” said Adam Grossman, President and Chief Executive Officer of ADMA. “This achievement aligns seamlessly with our overarching mission to continuously innovate our production processes for specialty
biologics, while also building on our reputation as a thought leader within the commercial specialty biologics markets for the patients our therapies serve.”
Mr. Grossman continued, “The robust ADMAlytics AI program is designed to optimize and streamline our intricate production processes, delivering significant efficiencies
throughout the organization. In the complex landscape of specialty biologics production, maintaining uninterrupted operations is paramount, and we believe that ADMAlytics will further bolster our commitment to ensuring continuity of patient care.
We anticipate the program’s rollout across the entirety of the ADMA organization will, in due course, bring far reaching improvements and efficiencies across our operations and further support the Company’s earnings growth trajectory. We applaud
our internal Information Technology team for their execution and success bringing this innovative software to commercial readiness and real-world application. ADMAlytics is another testament to our commitment to lead a new age of immunotechnology
for specialty biologics.”
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About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing
specialty 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 blood plasma for the manufacture of its
products. ADMA’s mission is to manufacture, market and develop specialty biologics, 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 holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product
candidates. For more information, please visit www.admabiologics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and
may contain such words as “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or
words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about the Company’s ADMAlytics program, its application and its impact on the Company’s patients, operations and financial
performance. 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
Senior Director, Business Development & 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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