UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

Commission file number 001-36728

ADMA BIOLOGICS, INC.

(Exact name of registrant as specified in its charter)


Delaware		56-2590442
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)


465 State Route 17, Ramsey, New Jersey		07446
(Address of principal executive offices)		(Zip Code)

(201) 478-5552

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

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	ADMA	Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


	Large accelerated filer ☒	Accelerated filer ☐
	Non-accelerated filer ☐	Smaller reporting company ☐
		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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 1, 2025, there were 238,630,719 shares of the issuer’s common stock outstanding.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

INDEX


PART I FINANCIAL INFORMATION

	Item 1.	Financial Statements

		Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024	1

		Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024	2

		Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024	3

		Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024	4

		Notes to Unaudited Condensed Consolidated Financial Statements	5

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	22

	Item 3.	Quantitative and Qualitative Disclosures About Market Risk.	35

	Item 4.	Controls and Procedures.	35

PART II OTHER INFORMATION			36

	Item 1.	Legal Proceedings.	36

	Item 1A.	Risk Factors.	36

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds.	66

	Item 3.	Defaults Upon Senior Securities.	66

	Item 4.	Mine Safety Disclosures.	66

	Item 5.	Other Information.	66

	Item 6.	Exhibits.	66

SIGNATURES			68

This Quarterly Report on Form 10-Q includes our trademarks, trade names and service marks, such as “ASCENIV^™,” “Nabi-HB^®” and “BIVIGAM^®,” which are protected under applicable intellectual property laws and are the property of ADMA Biologics, Inc., or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this report may appear without the ^®, ^™ or ^SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Exchange Act”), and such forward-looking statements involve risks and uncertainties. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions that are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project,” “continue,” or the negative thereof, or other variations or comparable terminology, although some forward-looking statements are expressed differently. The forward-looking statements included herein represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. These statements include, among others, statements about:

●

our ability to further commercialize ASCENIV and BIVIGAM;

●

our plans to develop, manufacture, market, launch and expand our commercial infrastructure and commercialize our current and future products and the success of such efforts;

●

the safety, efficacy and expected timing of and our ability to obtain and maintain regulatory approvals for our current products and product candidates, the labeling or nature of any such approvals, and whether any of our current products may be subject to post-marketing restrictions or withdrawal from the market;

●

the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulatory approvals for our product candidates;

●

our dependence upon our third-party customers, suppliers and vendors and their compliance with applicable regulatory requirements;

●

our belief that we have addressed the delays experienced with final drug product current Good Manufacturing Practices (“cGMP”) release testing by our third-party vendors by adding additional release testing laboratories to our U.S. Food and Drug Administration (“FDA”)-approved consortium listed in our drug approval documents;

●

our ability to obtain adequate quantities of FDA-approved plasma with proper specifications;

●

our plans to increase our supplies of source plasma (including source plasma containing certain levels of antibodies to Respiratory Syncytial Virus), our ability to obtain and maintain regulatory compliance and reliance on third-party supply agreements as well as any extensions to such agreements;

●

the potential indications for our products and product candidates;

●

potential investigational new product applications;

●

the acceptability of any of our products, including ASCENIV, BIVIGAM and Nabi-HB, for any purpose, including FDA-approved indications, by physicians, patients or payers;

●

our plans to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses;

●

Federal, state and local regulatory and business review processes and timing by such governmental and regulatory agencies of our business and regulatory submissions;

●

concurrence by the FDA with our conclusions concerning our products and product candidates;

●

the comparability of results of our hyperimmune and immune globulin (“IG”) products to other comparably run hyperimmune and immune globulin clinical trials;

●

the potential for ASCENIV and BIVIGAM to provide meaningful clinical improvement for patients living with Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, or other immune deficiencies or any other condition for which the products may be prescribed or evaluated;

●

our ability to market and promote Nabi-HB in a highly competitive environment with increasing competition from other antiviral therapies and to generate meaningful revenues from this product;

●

our intellectual property position and the defense thereof, including our expectations regarding the scope of patent protection with respect to ASCENIV, SG-001 or other future pipeline product candidates;

●

our ability to develop, manufacture, receive regulatory approval and commercialize our potential pipeline of any new hyperimmune globulins, including SG-001;

●

our manufacturing capabilities, third-party contractor capabilities and vertical integration strategy;

●

our plans related to the expansion and efficiencies of our manufacturing capacity, yield improvements, supply-chain robustness, in-house fill-finish capabilities, distribution and other collaborative agreements and the success of such endeavors;

●

our estimates regarding revenues, earnings, expenses, capital requirements, capital expenditures, ASCENIV’s growth, ability to maintain profitability and positive cash flows and the potential need for and availability of additional financing;

●

production yield and revenue and earnings benefits following FDA approval of our innovative yield enhancement production process, and the timing associated with realizing such benefits;

●

our ability to realize our deferred tax assets or the need for a valuation allowance, or the effects of changes in tax laws on our deferred tax assets;

●

our estimates of future taxable income, which could have a material impact on our financial condition or financial results;

●

our estimates of future effective tax rates and corresponding tax obligations and expenses, including our expectations for the One Big Beautiful Bill Act’s impact on our financial condition or financial results;

●

possible or likely reimbursement levels for our currently marketed products;

●

estimates regarding market size, projected growth and sales of our existing products as well as our expectations of market acceptance of ASCENIV and BIVIGAM;

●

intended uses and benefits of the recently acquired real estate in Boca Raton, FL;

●

the recent refinancing of our senior credit facility;

●

the potential for pandemics, or a resurgence of a pandemic, to adversely affect our business, financial condition, liquidity or results of operations; and

●

future domestic and global economic conditions including, but not limited to, supply chain constraints, inflationary pressures or performance or geopolitical conditions, including the continuing conflicts in Europe and in the Middle East and surrounding areas, and any anticipated effects of such factors on the pricing and availability of imported raw materials used in the production of our products.

iii

These statements may be found under the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 (this “Form 10-Q”). Our actual results could differ materially from those contained in the forward-looking statements due to the factors described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 10-K”) and in this Form 10-Q. Any forward-looking statement included or incorporated by reference in this Form 10-Q reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions related to our operations, industry and future growth. These forward-looking statements speak only as of the dates such statements are made, and we undertake no obligation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

PART I

FINANCIAL INFORMATION

Item 1. Financial Statements.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS


		June 30,			December 31,
		2025			2024
		(Unaudited)
	(In thousands, except share data)
ASSETS
Current assets:
Cash and cash equivalents	$	90,285		$	103,147
Accounts receivable, net		109,726			49,999
Inventories, net		191,464			170,235
Prepaid expenses and other current assets		8,088			8,029
Total current assets		399,563			331,410
Property and equipment, net		57,501			54,707
Intangible assets, net		527			460
Goodwill		3,530			3,530
Deferred tax assets, net		79,235			84,280
Right-to-use assets		8,961			8,634
Deposits and other assets		9,063			5,657
TOTAL ASSETS	$	558,380		$	488,678

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	29,769		$	20,219
Accrued expenses and other current liabilities		43,902			33,962
Current portion of deferred revenue		143			143
Current portion of lease obligations		1,127			1,218
Total current liabilities		74,941			55,542
Senior notes payable, net of discount		73,397			72,337
Deferred revenue, net of current portion		1,476			1,547
End of term fee		938			1,313
Lease obligations, net of current portion		9,301			8,561
Other non-current liabilities		2			360
TOTAL LIABILITIES		160,055			139,660

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 shares authorized, June 30, 2025: 239,383,545 issued and 238,567,308 outstanding; December 31, 2024: 236,620,545 issued and outstanding		24			24
Treasury stock, at cost, 816,237 and 0 shares as of June 30, 2025 and December 31, 2024, respectively		(15,148	)		-
Additional paid-in capital		660,909			657,577
Accumulated deficit		(247,460	)		(308,583	)
TOTAL STOCKHOLDERS' EQUITY		398,325			349,018
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	558,380		$	488,678

The accompanying notes are an integral part of these condensed consolidated financial statements.

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)


	Three Months ended June 30,						Six Months ended June 30,
		2025			2024			2025			2024
	(In thousands, except share and per share data)

REVENUES	$	121,984		$	107,191		$	236,786		$	189,066
Cost of product revenue		54,757			49,738			108,463			92,505
Gross profit		67,227			57,453			128,323			96,561

OPERATING EXPENSES:
Research and development		1,031			560			1,858			1,010
Plasma center operating expenses		1,152			942			2,438			1,947
Amortization of intangible assets		32			142			57			335
Selling, general and administrative		22,214			16,608			46,292			32,247
Total operating expenses		24,429			18,252			50,645			35,539

INCOME FROM OPERATIONS		42,798			39,201			77,678			61,022

OTHER INCOME (EXPENSE):
Interest income		400			449			1,008			833
Interest expense		(1,834	)		(3,783	)		(3,809	)		(7,552	)
Loss on extinguishment of debt		(1,159	)		-			(1,159	)		-
Other expense		(108	)		(16	)		(172	)		(51	)
Other expense, net		(2,701	)		(3,350	)		(4,132	)		(6,770	)

INCOME BEFORE INCOME TAXES		40,097			35,851			73,546			54,252

Provision for income taxes		5,878			3,789

SEC Form 10-Q filed by ADMA Biologics Inc