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ADMA Biologics Reports Record Fourth Quarter And Full Year 2025 Financial Results And Provides Business Update
| WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE |
| Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. |
ASCENIVTM Contraindications:
History of anaphylactic or severe systemic reactions to human immunoglobulin.
IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
ASCENIVTM Warnings and Precautions:
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1]
Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4]
In patients at risk of developing acute renal failure. monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9]
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5]
Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6]
Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7]
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
ASCENIVTM Adverse Reactions:
The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea
To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or .
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a U.S.-based, 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: ASCENIVTM (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. Additionally, ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia. ADMA manufactures its immune globulin products and product candidates 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 its blood plasma for the manufacture of its products and product candidates. 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 holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit .
Use of Non-GAAP Financial Measures
This press release includes certain non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The Company believes Adjusted EBITDA and Adjusted Net Income are useful to investors in evaluating the Company's financial performance. The Company uses Adjusted EBITDA and Adjusted Net Income as key performance measures because we believe that they facilitate operating performance comparisons from period to period that exclude potential differences driven by the impact of variations of non-cash items such as depreciation and amortization, as well as, in the case of Adjusted EBITDA, stock-based compensation or certain non-recurring items, and in the case of Adjusted Net Income, certain non-recurring items. The Company believes that investors should have access to the same set of tools used by our management and board of directors to assess our operating performance. Adjusted EBITDA and Adjusted Net Income should not be considered as measures of financial performance under GAAP, and the items excluded from Adjusted EBITDA and Adjusted Net Income are significant components in understanding and assessing the Company's financial performance. Accordingly, these key business metrics have limitations as an analytical tool. They should not be considered as an alternative to net income/loss, cash flows from operations, or any other performance measures derived in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. The estimated Adjusted EBITDA and Adjusted Net Income amounts included herein are preliminary and reconciliations cannot be produced at this time without unreasonable effort. The Company expects to provide a reconciliation of Adjusted EBITDA and Adjusted Net Income to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 audited financial results.
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“confident,”“estimate,”“project,”“intend,”“forecast,”“target,”“anticipate,”“plan,”“planning,”“expect,”“believe,”“will,”“is likely,”“will likely,”“position us,”“positioned,”“support,”“should,”“could,”“would,”“may,”“potential,”“opportunity” 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 total revenue, Adjusted Net Income, Adjusted EBITDA, cash and cash flow, earnings and earnings potential, compound annual growth rate and margins guidance and related timing in connection therewith; our balance sheet, operating leverage and financial position; expected benefits from our new CFO appointment; our long-term plasma supply agreements and impact on both ASCENIV growth and overall financial performance; the recently announced divestiture of three of our plasma collection centers, including the timing for closing such transaction and expected financial and operational benefits; our commercial execution initiatives and intended financial benefits; our yield enhancement production process and its resulting impact on our financial operations; ASCENIV real-world outcomes data; payer coverage of our products; ASCENIV revenue growth, margins, earnings power, addressable market, demand and utilization; our product mix shift; expanding the distribution network and expected financial and operational benefits; [share repurchases or capital structuring;] ability to deliver stockholder value; and statements regarding SG-001, its regulatory filings and clinical trial timeline and revenue potential. 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 SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
(1) Adjusted Net Income is a non-GAAP financial measure. The estimated Adjusted Net Income amounts included herein are preliminary and reconciliations cannot be produced at this time without unreasonable effort. The Company expects to provide a reconciliation of Adjusted Net Income to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 audited financial results.
(2) Adjusted EBITDA is a non-GAAP financial measure. The estimated Adjusted EBITDA amounts included herein are preliminary and reconciliations cannot be produced at this time without unreasonable effort. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 audited financial results.
INVESTOR RELATIONS CONTACT:
Argot Partners | 212-600-1902 | ...
| ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (In thousands, except share data) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 87,630 | $ | 103,147 | ||||
| Accounts receivable, net | 158,429 | 49,999 | ||||||
| Inventories | 206,465 | 170,235 | ||||||
| Prepaid expenses and other current assets | 7,458 | 8,029 | ||||||
| Assets held for sale | 6,530 | - | ||||||
| Total current assets | 466,512 | 331,410 | ||||||
| Property and equipment, net | 65,057 | 54,707 | ||||||
| Intangible assets, net | 632 | 460 | ||||||
| Goodwill | 3,530 | 3,530 | ||||||
| Deferred tax assets, net | 73,261 | 84,280 | ||||||
| Right-of-use assets | 6,650 | 8,634 | ||||||
| Deposits and other assets | 8,600 | 5,657 | ||||||
| TOTAL ASSETS | $ | 624,242 | $ | 488,678 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 22,519 | $ | 20,219 | ||||
| Accrued expenses and other current liabilities | 40,466 | 34,105 | ||||||
| Current portion of long term debt | 2,813 | - | ||||||
| Current portion of lease obligations | 1,096 | 1,218 | ||||||
| Liabilities held for sale | 2,647 | - | ||||||
| Total current liabilities | $ | 69,541 | $ | 55,542 | ||||
| Long-term debt | 69,330 | 72,337 | ||||||
| Deferred revenue, net of current portion | 1,405 | 1,547 | ||||||
| End of term fee | - | 1,313 | ||||||
| Lease obligations, net of current portion | 6,646 | 8,561 | ||||||
| Other non-current liabilities | - | 360 | ||||||
| TOTAL LIABILITIES | 146,922 | 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, | ||||||||
| December, 31, 2025 239,793,566 issued and 237,874,496 shares outstanding: December 31, 2024 236,620,545 issued and outstanding | 24 | 24 | ||||||
| Treasury stock, at cost, 1,919,070 and 0 shares as of December 31, 2025 and December 31, 2024, respectively | (32,090 | ) | - | |||||
| Additional paid-in capital | 671,039 | 657,577 | ||||||
| Accumulated deficit | (161,653 | ) | (308,583 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 477,320 | 349,018 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 624,242 | 488,678 | ||||||
| ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
| Three Months ended December 31, | Year ended December 31, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| (In thousands, except share and per share data) | |||||||||||||||||
| Unaudited | |||||||||||||||||
| REVENUES | $ | 139,163 | $ | 117,549 | $ | 510,173 | $ | 426,454 | |||||||||
| Cost of product revenue | 50,347 | 54,216 | 217,408 | 206,901 | |||||||||||||
| Gross profit | 88,816 | 63,333 | 292,765 | 219,553 | |||||||||||||
| OPERATING EXPENSES: | |||||||||||||||||
| Research and development | 1,376 | 391 | 4,762 | 1,813 | |||||||||||||
| Plasma center operating expenses | 1,126 | 1,277 | 4,836 | 4,245 | |||||||||||||
| Amortization of intangible assets | 51 | 25 | 144 | 388 | |||||||||||||
| Selling, general and administrative | 23,512 | 23,317 | 91,580 | 74,124 | |||||||||||||
| Total operating expenses | 26,065 | 25,010 | 101,322 | 80,570 | |||||||||||||
| INCOME FROM OPERATIONS | 62,751 | 38,323 | 191,443 | 138,983 | |||||||||||||
| OTHER INCOME (EXPENSE): | |||||||||||||||||
| Interest income | 487 | 598 | 1,871 | 2,097 | |||||||||||||
| Interest expense | (1,626 | ) | (2,879 | ) | (7,110 | ) | (13,930 | ) | |||||||||
| Loss on extinguishment of debt | - | (1,243 | ) | (3,336 | ) | (1,243 | ) | ||||||||||
| Other expense | (17 | ) | (86 | ) | (212 | ) | (193 | ) | |||||||||
| Other expense, net | (1,155 | ) | (3,610 | ) | (8,787 | ) | (13,269 | ) | |||||||||
| INCOME BEFORE INCOME TAXES | 61,595 | 34,713 | 182,656 | 125,714 | |||||||||||||
| Income tax expense (benefit) | 12,216 | (77,183 | ) | 35,726 | (71,959 | ) | |||||||||||
| NET INCOME | $ | 49,379 | $ | 111,896 | $ | 146,930 | $ | 197,673 | |||||||||
| BASIC EARNINGS PER COMMON SHARE | $ | 0.21 | $ | 0.47 | $ | 0.62 | $ | 0.85 | |||||||||
| DILUTED EARNINGS PER COMMON SHARE | $ | 0.20 | $ | 0.46 | $ | 0.60 | $ | 0.81 | |||||||||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | |||||||||||||||||
| Basic | 237,971,602 | 236,433,759 | 238,299,024 | 233,084,236 | |||||||||||||
| Diluted | 243,854,484 | 245,900,655 | 244,904,640 | 243,342,466 | |||||||||||||
| NON-GAAP RECONCILIATION RECONCILIATION OF GAAP NET INCOME TO ADJUSTED EBITDA (2) | |||||||||||||||
| Three Months ended December 31, | Year ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| (In thousands) | |||||||||||||||
| Net income | $ | 49,379 | $ | 111,896 | $ | 146,930 | $ | 197,673 | |||||||
| Depreciation | 1,995 | 1,919 | 7,952 | 7,657 | |||||||||||
| Amortization | 51 | 25 | 144 | 388 | |||||||||||
| Income tax expense (benefit) | 12,216 | (77,183 | ) | 35,726 | (71,959 | ) | |||||||||
| Interest expense | 1,626 | 2,879 | 7,110 | 13,930 | |||||||||||
| EBITDA | 65,267 | 39,536 | 197,862 | 147,689 | |||||||||||
| Stock-based compensation | 5,392 | 5,433 | 20,026 | 13,616 | |||||||||||
| Voluntary Withdrawal and product replacements | 2,214 | - | 6,215 | - | |||||||||||
| Yield enhancement expense | 114 | 2,064 | 1,810 | 2,064 | |||||||||||
| Loss on extinguishment of debt | - | 1,243 | 3,336 | 1,243 | |||||||||||
| Non-recurring professional fees(a) | 599 | - | 1,781 | - | |||||||||||
| Adjusted EBITDA | $ | 73,586 | $ | 48,276 | $ | 231,030 | $ | 164,612 | |||||||
| NON-GAAP RECONCILIATION RECONCILIATION OF GAAP NET INCOME TO ADJUSTED NET INCOME (1) | |||||||||||||||
| Three Months ended December 31, | Year ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| (In thousands) | |||||||||||||||
| Net income | $ | 49,379 | $ | 111,896 | $ | 146,930 | $ | 197,673 | |||||||
| Deferred income tax benefit | - | (84,280 | ) | - | (84,280 | ) | |||||||||
| Loss on extinguishment of debt (pre-tax) | - | 1,243 | 3,336 | 1,243 | |||||||||||
| Stock-based compensation modifications (pre-tax) | 283 | 2,518 | 757 | 2,518 | |||||||||||
| Yield Enhancement expense (pre-tax) | 114 | 2,064 | 1,810 | 2,064 | |||||||||||
| Voluntary Withdrawal and product replacements (pre-tax) | 2,214 | - | 6,215 | - | |||||||||||
| Non-recurring professional fees (pre-tax)(a) | 599 | - | 1,781 | - | |||||||||||
| Adjusted Net Income (b) | $ | 52,589 | $ | 33,441 | $ | 160,829 | $ | 119,218 | |||||||
| (a) Non-recurring professional fees represent incremental costs associated with a vendor change that we do not expect to incur in future periods and other one-time professional fees. | |||||||||||||||
| (b) Excludes estimated tax effect of the add-backs of $0.6 million $2.7 million for the three months and year ended December 31, 2025. | |||||||||||||||
| PRODUCT-LEVEL TOTAL REVENUE | ||||||||||||
| Year Ended December 31, | ||||||||||||
| 2025 | 2024 | Increase/ (Decrease) | Increase/ (Decrease) % | |||||||||
| (in thousands) | ||||||||||||
| ASCENIV | $ | 362,531 | $ | 239,594 | $ | 122,937 | 51 | |||||
| BIVIGAM | 122,033 | 142,357 | (20,324 | ) | (14 | ) | ||||||
| Intermediates and other products (1) | 8,579 | 33,998 | (25,419 | ) | (75 | ) | ||||||
| ADMA BioManufacturing | 493,143 | 415,949 | 77,194 | 19 | ||||||||
| Plasma Collection Centers | 17,030 | 10,505 | 6,525 | 62 | ||||||||
| Total Revenues | $ | 510,173 | $ | 426,454 | $ | 83,719 | 20 | |||||
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