
| • |
Total Revenue: Raised to at least $510 million, up from more than $500 million previously.
|
| • |
Adjusted Net Income: Modestly adjusted to $158 million for FY 2025 due to a higher effective tax rate, from more than $175 million previously.
|
| • |
Adjusted EBITDA: Reaffirmed at $235 million.
|
| • |
Total Revenue: Raised to at least $630 million, up from $625 million or more previously.
|
| • |
Adjusted Net Income: Increased to more than $255 million, up from $245 million or more previously, which considers a full corporate tax rate for FY 2026.
|
| • |
Adjusted EBITDA: Raised to more than $355 million, up from $340 million or more previously.
|
| • |
Yield‑Enhanced Production Advancing; Gross Margin Expansion Expected to Accelerate Beginning in 4Q
2025. ADMA received U.S. Food and Drug Administration (FDA) lot release authorization for its first yield-enhanced commercial batches, marking a key operational milestone. These lots are expected to
significantly improve manufacturing efficiency and drive gross margin expansion beginning in 4Q 2025, with continued gains through 2026 and beyond.
|
| • |
Record ASCENIV Demand and Expanding Access. ASCENIV
achieved record utilization during the quarter, driven by strong prescriber adoption and growing patient demand. Constructive 2026 payer negotiations are advancing and expected to expand coverage next year, further supporting growth. For
select plans where restrictions existed, broader reimbursement is anticipated in 2026.
|
| • |
Positive, Statistically Significant Real-World Outcomes Demonstrated for ASCENIV. A retrospective cohort analysis of primary immunodeficiency patients demonstrated statistically significant reduction in infection rates following transition from standard immunoglobulin therapy to ASCENIV.
Patients experienced 2.1 infections per year while receiving prior IVIG compared with 0.9 infections per year on ASCENIV; representing a reduction of more than 50% (p < 0.05). These findings suggest that ASCENIV provides enhanced
protection against infections in real-world clinical practice. Data validation and extended analyses are ongoing. ADMA plans to submit these results for a peer-reviewed publication in the near term, with additional findings planned to be
submitted at the Clinical Immunology Society (CIS) 2026 Annual Meeting.
|
| • |
Strengthening and Diversifying Distribution Network. ADMA
is engaged in constructive discussions with potential distributors to further diversify its commercial network. The Company is in active negotiations to onboard additional distribution partners over the coming periods, which would, if
successful, broaden both BIVIGAM’s and ASCENIV’s reach and support continued growth.
|
| • |
Strong Financial Growth and Market Normalization. Year-over-year
net income growth was tempered by a higher effective tax rate and temporary competitive dynamics in standard IVIG markets, mainly impacting BIVIGAM. Enabled by the Company’s outperforming third-party plasma suppliers, ADMA
opportunistically completed a sale of approximately $13.8 million of normal source plasma on the spot market at a negative margin contribution to optimize working capital and enhance go-forward cash flow. These factors are short-term;
post-quarter, standard IVIG market conditions are stabilizing, and record ASCENIV demand continues to drive margin expansion. Excluding this sale of normal source plasma during the quarter, product level gross margins were approximately
63.7% during the third quarter.
|
| • |
Strengthening Balance Sheet and Anticipated Working Capital Normalization. Third-quarter cash reflected approximately $23.0 million in share repurchases settled during the period, planned inventory build, and a $12.6 million facility expansion investment. Working capital is expected to
normalize in coming quarters, supporting accelerating cash growth through 2026.
|
| • |
Disciplined Capital Deployment and Share Repurchases. Following
its J.P. Morgan-led debt refinancing, ADMA maintains a strong balance sheet with an undrawn $225 million revolver and robust cash generation. Share repurchases continue to be funded organically, reflecting disciplined capital allocation
and long-term stockholder value focus.
|
| • |
SG-001 Program Advancing; Demonstrated Broad Serotype Coverage and Regulatory Acceleration Pathway
in Progress. ADMA continues to advance its SG-001 hyperimmune IVIG (hIVIG 10%) program, designed to provide passive immunity against Streptococcus pneumoniae in immunocompromised patients.
Preclinical data demonstrate broad serotype-specific antibody activity, encompassing a wider range of pneumococcal serotypes than those targeted by any currently available pneumococcal vaccine, underscoring the potential for enhanced
protective coverage. A CNPV voucher application has been submitted, and if accepted, could accelerate FDA review by two quarters or more. SG-001 demonstrated preclinical efficacy, and if successfully advanced to market, it could represent
an approximately $300–500 million annual high-margin opportunity protected through at least 2037.
|
| • |
Operational Strength and Macro Resilience. ADMA’s fully
U.S.-based, vertically integrated operations should substantially insulate the Company from global supply chain disruptions, tariffs, and evolving Inflation Reduction Act (IRA)-related pricing frameworks. The Company’s domestic footprint
and U.S.-focused markets should provide continuity, pricing stability, and competitive resilience.
|
|
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.
|
|
(1)
|
Adjusted EBITDA is a non-GAAP financial measure. For a reconciliation of Adjusted EBITDA to the most comparable GAAP measure, see the reconciliation included in
the financial tables.
|
|
(2)
|
Adjusted Net Income is a non-GAAP financial measure. For a reconciliation of Adjusted Net Income to the most comparable GAAP measure, see the reconciliation
included in the financial tables. All non-GAAP adjustments are presented pre-tax.
|
|
|
September 30,
|
December 31,
|
||||||
|
|
2025
|
2024
|
||||||
|
|
(Unaudited)
|
|||||||
|
|
(In thousands, except share data)
|
|||||||
|
ASSETS
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
61,385
|
$
|
103,147
|
||||
|
Accounts receivable, net
|
137,673
|
49,999
|
||||||
|
Inventories, net
|
196,667
|
170,235
|
||||||
|
Prepaid expenses and other current assets
|
6,930
|
8,029
|
||||||
|
Total current assets
|
402,655
|
331,410
|
||||||
|
Property and equipment, net
|
69,509
|
54,707
|
||||||
|
Intangible assets, net
|
491
|
460
|
||||||
|
Goodwill
|
3,530
|
3,530
|
||||||
|
Deferred tax assets, net
|
74,433
|
84,280
|
||||||
|
Right-of-use assets
|
9,271
|
8,634
|
||||||
|
Deposits and other assets
|
8,798
|
5,657
|
||||||
|
TOTAL ASSETS
|
$
|
568,687
|
$
|
488,678
|
||||
|
|
||||||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
24,021
|
$
|
20,219
|
||||
|
Accrued expenses and other current liabilities
|
28,827
|
34,105
|
||||||
|
Current portion of long-term debt
|
2,344
|
-
|
||||||
|
Current portion of lease obligations
|
1,298
|
1,218
|
||||||
|
Total current liabilities
|
56,490
|
55,542
|
||||||
|
Long-term debt
|
70,084
|
72,337
|
||||||
|
Deferred revenue, net of current portion
|
1,440
|
1,547
|
||||||
|
End of term fee
|
-
|
1,313
|
||||||
|
Lease obligations, net of current portion
|
9,397
|
8,561
|
||||||
|
Other non-current liabilities
|
90
|
360
|
||||||
|
TOTAL LIABILITIES
|
137,501
|
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,
|
||||||||
|
September 30, 2025: 239,661,041 issued and 238,332,393 outstanding;
December 31, 2024: 236,620,545 issued and outstanding |
24
|
24
|
||||||
|
Treasury stock, at cost, 1,328,648 and 0 shares as of September 30, 2025 and December 31, 2024, respectively
|
(23,188
|
)
|
-
|
|||||
|
Additional paid-in capital
|
665,382
|
657,577
|
||||||
|
Accumulated deficit
|
(211,032
|
)
|
(308,583
|
)
|
||||
|
TOTAL STOCKHOLDERS' EQUITY
|
431,186
|
349,018
|
||||||
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
568,687
|
$
|
488,678
|
||||
|
|
Three Months ended September 30,
|
Nine Months ended September 30,
|
||||||||||||||
|
|
2025
|
2024
|
2025
|
2024
|
||||||||||||
|
|
(In thousands, except share and per share data)
|
|||||||||||||||
|
|
||||||||||||||||
|
REVENUES
|
$
|
134,224
|
$
|
119,839
|
$
|
371,010
|
$
|
308,905
|
||||||||
|
Cost of product revenue
|
58,598
|
60,180
|
167,061
|
152,685
|
||||||||||||
|
Gross profit
|
75,626
|
59,659
|
203,949
|
156,220
|
||||||||||||
|
|
||||||||||||||||
|
OPERATING EXPENSES:
|
||||||||||||||||
|
Research and development
|
1,528
|
412
|
3,386
|
1,422
|
||||||||||||
|
Plasma center operating expenses
|
1,272
|
1,021
|
3,710
|
2,968
|
||||||||||||
|
Amortization of intangible assets
|
38
|
28
|
93
|
363
|
||||||||||||
|
Selling, general and administrative
|
21,776
|
18,560
|
68,068
|
50,807
|
||||||||||||
|
Total operating expenses
|
24,614
|
20,021
|
75,257
|
55,560
|
||||||||||||
|
|
||||||||||||||||
|
INCOME FROM OPERATIONS
|
51,012
|
39,638
|
128,692
|
100,660
|
||||||||||||
|
|
||||||||||||||||
|
OTHER INCOME (EXPENSE):
|
||||||||||||||||
|
Interest income
|
376
|
666
|
1,384
|
1,499
|
||||||||||||
|
Interest expense
|
(1,675
|
)
|
(3,499
|
)
|
(5,484
|
)
|
(11,051
|
)
|
||||||||
|
Loss on extinguishment of debt
|
(2,177
|
)
|
-
|
(3,336
|
)
|
-
|
||||||||||
|
Other expense
|
(21
|
)
|
(56
|
)
|
(195
|
)
|
(107
|
)
|
||||||||
|
Other expense, net
|
(3,497
|
)
|
(2,889
|
)
|
(7,631
|
)
|
(9,659
|
)
|
||||||||
|
|
||||||||||||||||
|
INCOME BEFORE INCOME TAXES
|
47,515
|
36,749
|
121,061
|
91,001
|
||||||||||||
|
|
||||||||||||||||
|
Provision for income taxes
|
11,087
|
840
|
23,510
|
5,224
|
||||||||||||
|
|
||||||||||||||||
|
NET INCOME
|
$
|
36,428
|
$
|
35,909
|
$
|
97,551
|
$
|
85,777
|
||||||||
|
|
||||||||||||||||
|
BASIC EARNINGS PER COMMON SHARE
|
$
|
0.15
|
$
|
0.15
|
$
|
0.41
|
$
|
0.37
|
||||||||
|
DILUTED EARNINGS PER COMMON SHARE
|
$
|
0.15
|
$
|
0.15
|
$
|
0.40
|
$
|
0.35
|
||||||||
|
|
||||||||||||||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
|
||||||||||||||||
|
Basic
|
238,602,978
|
234,571,376
|
238,408,042
|
231,959,579
|
||||||||||||
|
Diluted
|
244,664,263
|
244,804,065
|
245,491,334
|
241,772,162
|
||||||||||||
|
Three Months ended September 30,
|
Nine Months ended September 30,
|
|||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
|||||||||||||
|
(In thousands)
|
||||||||||||||||
|
Net income
|
$
|
36,428
|
$
|
35,909
|
$
|
97,551
|
$
|
85,777
|
||||||||
|
Depreciation
|
1,987
|
1,912
|
5,957
|
5,738
|
||||||||||||
|
Amortization
|
38
|
28
|
93
|
363
|
||||||||||||
|
Income taxes
|
11,087
|
840
|
23,510
|
5,224
|
||||||||||||
|
Interest expense
|
1,675
|
3,499
|
5,484
|
11,051
|
||||||||||||
|
EBITDA
|
51,215
|
42,188
|
132,595
|
108,153
|
||||||||||||
|
Stock-based compensation
|
5,047
|
3,179
|
14,634
|
8,183
|
||||||||||||
|
Customer credits related to the Voluntary Withdrawal
|
-
|
-
|
4,001
|
-
|
||||||||||||
|
Yield enhancement
|
301
|
-
|
1,696
|
-
|
||||||||||||
|
Loss on extinguishment of debt
|
2,177
|
-
|
3,336
|
-
|
||||||||||||
|
Non-recurring professional fees (a)
|
-
|
-
|
1,182
|
-
|
||||||||||||
|
Adjusted EBITDA
|
$
|
58,740
|
$
|
45,367
|
$
|
157,444
|
$
|
116,336
|
||||||||
| |
Three Months ended September 30,
|
Nine Months ended September 30,
|
||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
|||||||||||||
|
(In thousands, except share and per share data)
|
||||||||||||||||
|
Net income (loss)
|
$
|
36,428
|
$
|
35,909
|
$
|
97,551
|
$
|
85,777
|
||||||||
|
Stock-based compensation modifications (pre-tax)
|
-
|
-
|
474
|
-
|
||||||||||||
|
Customer credits related to the Voluntary Withdrawal (pre-tax)
|
-
|
-
|
4,001
|
-
|
||||||||||||
|
Loss on extinguishment of debt (pre-tax)
|
2,177
|
-
|
3,336
|
-
|
||||||||||||
|
Yield Enhancement (pre-tax)
|
301
|
-
|
1,696
|
-
|
||||||||||||
|
Non-recurring professional fees (pre-tax) (a)
|
-
|
-
|
1,182
|
-
|
||||||||||||
|
Adjusted net income (b)
|
$
|
38,906
|
$
|
35,909
|
$
|
108,240
|
$
|
85,777
|
||||||||
|
(a)
|
Non-recurring professional fees represent incremental costs associated with a vendor change that we do not expect to incur in future
periods.
|
|
(b)
|
Excludes estimated tax effect of the add-backs of $0.6 and $2.1 million for the three and nine months ended September 30, 2025,
respectively.
|