8-K

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): January 18, 2022

ADMA BIOLOGICS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-36728	56-2590442
(State or Other Juris- diction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

465 State Route 17 Ramsey, New Jersey	07446
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (201) 478-5552

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

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):

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value	ADMA	Nasdaq Global Market
Preferred Stock Purchase Rights	-	Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company 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. ☐

Item 8.01 Other Events.

On January 18, 2022, ADMA Biologics, Inc. (the “Company”) issued a press release announcing that it has received U.S. Food and Drug Administration approval for its fourth ADMA BioCenters plasma collection facility located in Goose Creek, SC. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

See the Exhibit Index below, which is incorporated by reference herein.

EXHIBIT INDEX

Exhibit Number	Description
99.1	Press release of ADMA Biologics, Inc. dated January 18, 2022
104	Cover Page Interactive Data File (embedded with the Inline XBRL document)

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.

	ADMA BIOLOGICS, INC.
Date: January 18, 2022	By:	/s/ Brian Lenz
		Brian Lenz
		Executive Vice President and Chief Financial Officer

EX-99.1

Exhibit 99.1

ADMA BioCenters Receives FDA Approval for its Fourth Plasma Collection Center Located in Goose Creek, SC

FDA approval positions Company to meet or exceed target of ten or more FDA-licensed plasma collection centers by year-end 2023

RAMSEY, N.J., BOCA RATON, Fla. and GOOSE CREEK, SC. – January 18, 2022 – 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 fourth ADMA BioCenters plasma collection facility located in Goose Creek, South Carolina.  In conjunction, the facility was issued a compliance certification from the International Quality Plasma Program (“IQPP”), confirming the center meets facility and donor criteria for IQPP Certification.  This plasma collection facility commenced operations and initiated source plasma collection in the second quarter of 2021. 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.

“ADMA is off to an excellent start to 2022 across its business segments, and the approval of the Goose Creek plasma collection center represents another regulatory milestone achievement as well as an important step in ADMA’s ambitions to further secure raw material plasma supply,” said Adam Grossman, President and Chief Executive Officer of ADMA.

“ADMA now has four FDA-approved plasma collection centers, two additional centers operational and collecting plasma, and three additional centers in the planning and construction phases. The successful execution by our BioCenters team positions ADMA to meet or exceed the Company’s target of having 10 or more plasma collection centers FDA-licensed by year-end 2023,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.

“ADMA remains on track towards growing its plasma supply, a commitment that is underpinned by the collective benefits of contractually committed third-party supply agreements, yield enhancements being realized from the implementation of the Haemonetics’ NexSys Persona®, and the aggressive BioCenters expansion strategy. With broader industry plasma collection headwinds anticipated to persist in early 2022 due to COVID-19 and other factors, ADMA believes its uniquely strong plasma supply position will support the continued acquisition of new customers in the in the supply-constrained U.S. immunoglobulin market. We thank the FDA for its efforts and expeditious review of the Goose Creek Biologics License Application (“BLA”), which came well in advance of the agency’s targeted approval date,” concluded Mr. Lenz.

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.

To learn more about the ADMA BioCenters donation process, and to schedule an appointment, please visit: www.admabiocenters.com, or visit in person at: 214 Saint James Avenue, Goose Creek, S.C. 29445.

About ADMA BioCenters

ADMA BioCenters 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 and European Patent No. 3375789 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 “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 year-end 2023; the Company’s plasma supply; our expectation to file additional BLAs and the timing thereof; the yield enhancements anticipated to result from the implementation of Haemonetics’ NexSys Persona® technology; the Company’s growing customer base as a result of its strong plasma supply position; and the expected staff count at the Goose Creek 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

Senior Director, Corporate Strategy and Business Development | 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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