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): May 21, 2020
| ADMA BIOLOGICS, INC. | ||
| (Exact name of registrant as specified in its charter) | ||
| Delaware | 001-36728 | 56-2590442 |
|
(State or other jurisdiction 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
| (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):
o 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, par value $0.0001 per share | ADMA | Nasdaq Global Market |
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. ¨
| Item 8.01 | Other Events. |
On May 21, 2020, ADMA Biologics, Inc. issued a press release entitled “ADMA Biologics Commences Collection of COVID-19 Plasma from Recovered Patients.” The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release dated May 21, 2020, entitled “ADMA Biologics Commences Collection of COVID-19 Plasma from Recovered Patients.” |
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.
| May 21, 2020 | ADMA Biologics, Inc. | ||
| By: | /s/ Brian Lenz | ||
| Name: | Brian Lenz | ||
| Title: | Executive Vice President and Chief Financial Officer | ||
Exhibit 99.1
ADMA Biologics Commences Collection of COVID-19 Plasma
from Recovered Patients
RAMSEY, N.J. and BOCA RATON, Fla. – May 21, 2020 – ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA”), today announced it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia Inc. (“ADMA BioCenters”), from individuals who have recovered from COVID-19. ADMA 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 is seeking US citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. People who have recovered from COVID-19 can have antibodies in their plasma that may be helpful in treating the virus. Immune globulin is a plasma derived medicine that is comprised of polyclonal antibodies and is routinely used for the prevention and treatment of certain infectious diseases. Currently, six producers of immune globulin, including ADMA Biologics, supply products to the US market.
“During this unprecedented time, ADMA has risen to the challenge of helping confront the growing coronavirus pandemic, while fulfilling our mission to help patients battle infectious diseases,” stated Adam Grossman, President and Chief Executive Officer. “Immune globulin and hyperimmune globulin therapy have the potential to be one of the earliest and best treatment options for patients with COVID-19 infections. The key to developing an immune globulin with high antibody levels to COVID-19 is the collection of plasma from patients that have recovered from COVID-19 infection. We encourage anyone who has recovered from COVID-19 without symptoms for 14 days to come forward and donate plasma to this worthy cause.”
ADMA is a member of the CoVIg-19 Plasma Alliance, a plasma industry alliance established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19. You can learn more about the CoVIg-19 Plasma Alliance here www.covig-19plasmaalliance.org.
To find out more about donating plasma, including eligibility requirements and location, please visit www.admabiocenters.com or www.donatingplasma.org.
About ADMA BioCenters
ADMA BioCenters is a wholly-owned subsidiary of ADMA Biologics, which operates as a source plasma collection business. ADMA BioCenters is an FDA-licensed facility specializing in the collection of human plasma to make special medications for the treatment and prevention of diseases. A typical plasma collection center can collect between 30,000 to 50,000 liters of source plasma annually. Plasma collected from ADMA BioCenters' facility that is not used to manufacture ADMA’s products or development-stage candidates is sold to customers under an existing supply agreement or in the open market, generating revenues for the Company.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. 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,” “intend,” “anticipate,” “plan,” “expect,” “believe,” “will,” “can,” “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 manufacturing of a potential hyperimmune globulin; the use of donated plasma to produce an immune globulin to potentially help infected patients with COVID-19; the potential for antibodies from those who have recovered from COVID-19 can be helpful in treating COVID-19; the potential for immune globulin and hyperimmune globulin therapy to be one of the earliest and best treatment options for patients with COVID-19 infections; and the importance of collecting plasma from patients that have recovered from COVID-19 infection for developing an immune globulin with high antibody levels to COVID-19. Actual events or results may differ materially from those described in this document due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY CONTACT:
Brian Lenz
Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com
INVESTOR RELATIONS CONTACT:
Sam Martin
Managing Director, Argot Partners | 212-600-1902 | sam@argotpartners.com
MEDIA RELATIONS CONTACT:
David Rosen
Managing Director, Media, Argot Partners | 212-600-1902 | david.rosen@argotpartners.com