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Item 2 — Management's Discussion and Analysis
Adma Biologics, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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The following discussion of our financial condition and results of operations, which refers to our historical results, should be read in conjunction with the other sections of this Quarterly Report on Form 10-Q, including “Risk Factors” and our unaudited consolidated financial statements and the notes thereto appearing elsewhere herein, and in conjunction with the Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in our Annual Report on Form 10-K for the year ended December 31, 2025, filed on February 25, 2026 (the “2025 10-K”). The various sections of this discussion contain a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risk factors described throughout or referenced within this Quarterly Report on Form 10-Q. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from our current expectations.
OVERVIEW
Our Business
ADMA Biologics, Inc. (the “Company,” “ADMA,” “we,” “us” or “our”) 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. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.
Through our ADMA
BioManufacturing business segment, we currently have three products with U.S.
Food and Drug Administration (the “FDA”) approval, all of which are currently
marketed and commercially available: (i) ASCENIV (Immune Globulin Intravenous,
Human – slra 10% Liquid), an intravenous immune globulin (“IVIG”) product
indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also
known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity
in adults and children ages two and above, for which we received FDA approval
in April 2019 and commenced first commercial sales in October 2019; (ii)
BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the
treatment of PI in adults and children ages two and above, and for
which we received FDA approval in May 2019 and commenced commercial sales in
August 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is
indicated for the treatment of acute exposure to blood containing Hepatitis
B surface antigen (“HBsAg”) and other
listed exposures to Hepatitis B. In addition to our
commercially available immunoglobulin products, we generate revenues from the
sale of intermediate by-products that result from the immunoglobulin production
process and from time to time provide contract manufacturing and laboratory
services for certain clients.
We are also developing a
pipeline of plasma-derived therapeutics, including a product related to its
issued U.S. Patent Nos. 10,259,865, 11,084,870, 11,897,943 and 12,612,450
pertaining to methods of treatment and prevention of S. pneumoniae infection
using an immunoglobulin manufactured to contain standardized antibodies to S.
pneumoniae serotypes. We have successfully completed production of a
pilot-scale batch and are conducting animal studies for our S.
pneumoniae hyperimmune globulin program, SG-001. We anticipate
submitting a pre-Investigational New Drug (“IND”) package to the FDA in fiscal
year 2026, which could enable us to progress development of SG-001 directly
into a registrational clinical trial.
We manufacture our commercial products
at our FDA-licensed, plasma fractionation and purification facility located in
Boca Raton, Florida with a peak annual processing capability of up to 600,000
liters (the “Boca Facility”). Based on current production yields, our completed
and ongoing supply chain enhancements and capacity expansion initiatives, we
believe this facility has the potential to produce sufficient quantities of our
immune globulin products.
Through our ADMA BioCenters
subsidiary, we currently operate seven source plasma collection facilities in
the U.S., all of which hold FDA licenses. This business unit, which we refer to
as our Plasma Collection Centers business segment, provides us with a
significant portion of the blood plasma required for the manufacture of our
products, and also allows us to sell certain quantities of source and
hyperimmune plasma to third-party customers for further manufacturing. In
addition, each of our FDA-approved plasma collection centers also has approval
from the Korean Ministry of Food and Drug Safety, and ADMA BioCenters has FDA
approval to operate a Hepatitis B immunization program. A typical plasma
collection center, such as those operated by ADMA BioCenters, can collect
approximately 30,000 to 50,000 liters of source plasma annually, which may be
sold for different prices depending upon the type of plasma, quantity of
purchase and market conditions at the time of sale. Plasma collected from ADMA
BioCenters’ facilities that is not used to manufacture our products is sold to
third-party customers in the U.S. and in other locations outside the U.S. where
we are approved under supply agreements or in the open “spot” market.
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From time to time, we may provide contract manufacturing services for certain third-party clients. We also provide laboratory contracting services to certain customers and may provide contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish capabilities.
Trends and Developments
For the year ended December
31, 2024, we achieved net income of $197.7 million, the first time in our
history that we achieved net income in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”), and generated
positive cash flows from operations of $118.7 million. Positive cash flows from
operations continued throughout fiscal year 2025. Our improved operating
results were primarily the result of the substantial revenue growth and
continued physician, patient and payer acceptance of ASCENIV.
In April 2025, the FDA
approved our Prior Approval Supplement (a “PAS”) for our innovative yield
enhancement production process benefiting both ASCENIV and BIVIGAM. This PAS
approval amends the Biologics License Application (“BLA”) approvals for ASCENIV
and BIVIGAM and will continue to be the process by which we will manufacture
these products on a go-forward basis. The production methods approved in this
PAS have resulted in additional bulk drug yield from the same starting raw
material source plasma volumes and we believe we should experience meaningful
revenue and earnings accretion accelerating further into 2026 and beyond. This
innovative process has demonstrated an ability to increase ASCENIV and BIVIGAM
production yields by 20% or more from the same starting source plasma volume.
Fiscal year 2026 is our first full year of yield-enhanced production,
supporting anticipated sustained margin expansion.
In July 2025, the One Big
Beautiful Bill Act ("OBBBA") was enacted, which includes numerous
changes to existing tax law including extending or making permanent certain
business provisions initially established under the 2017 Tax Cuts and Jobs Act,
which were set to expire. The OBBBA permanently eliminates the requirement to
capitalize and amortize U.S.-based research and experimental expenditures,
making these expenditures fully deductible in the period incurred. The OBBBA
also permanently extends recognition of the accelerated bonus depreciation on
qualifying assets in the period acquired. In 2025, these provisions resulted in
a reduction of current income tax liabilities and a corresponding reduction to
income tax expense.
In July 2025, we completed the
acquisition of real estate in Boca Raton, Florida for a total purchase price of
$12.6 million. This real estate purchase is intended to allow us to expand our
production operations and related activities as well as provide for certain
redundancies for ambient and cold-chain storage of raw materials, work in
process and finished goods inventory.
In December 2025, we entered
into an agreement for the divestiture of three of our plasma collection centers
for an aggregate purchase price of $12.0 million. The sale of these plasma
centers was completed during the first quarter of 2026. We continue to own and
operate seven plasma collection centers. In conjunction with the divestiture
agreement, we entered into a long-term respiratory syncytial virus (“RSV”) plasma supply agreement with the purchaser of
the three plasma collection centers, further diversifying our third-party
high-titer plasma supply base. Collectively, these actions reflect a deliberate
focus on a more flexible, capital-efficient supply model and are expected to
deliver accretive cost savings in fiscal year 2026, improve capital efficiency,
support increased ASCENIV production capacity, and provide durable plasma
supply confidence through the late 2030s.
Beginning in the second half of 2025 and continuing
into 2026, new FDA-approved IVIG products, and other pharmaceutical products
which compete with certain IVIG product uses, entered the market with
aggressive pricing tactics, including extended payment terms, rebates and
discounts. This has led to increases in raw material plasma supply and finished
goods inventory across the distribution network. This created competitive
intensity and distribution recalibration across the industry which has impacted
our results for the first half of 2026, mainly as it relates to BIVIGAM, but
broadly across the IVIG complex. If this trend of competitive pricing tactics
continues, future results and market adoption for our products may be adversely
impacted.
Our Products
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ASCENIV
ASCENIV
is a plasma-derived IVIG product that contains naturally occurring polyclonal
antibodies, which are proteins that are used by the body’s immune system to
neutralize microbes, such as bacteria and viruses, and prevent against
infection and disease. We manufacture ASCENIV under U.S. Department of Health
and Human Services (“HHS”) License No. 2019 using a process known as
fractionation. The Centers for Medicare and Medicaid Services (“CMS”) has
issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare
Common Procedure Coding System, the J-code (J1554) became effective in April 2021.
As part of our proprietary manufacturing process for ASCENIV, we leverage our
unique, patented plasma donor screening methodology and tailored plasma pooling
design, which blends normal source plasma and plasma from donors tested to have
high levels of neutralizing antibody titers to RSV using our proprietary
microneutralization testing assay. With our patented testing methods and assay,
we are able to identify the high-titer or “hyperimmune” plasma that meets our
internal and required specifications for ASCENIV. This type of high-titer
plasma is typically found in less than 10% of the total donor collection
samples we test.
ASCENIV is approved for the treatment of
PIDD or PI, a class of inherited genetic disorders that causes a deficient or
absent immune system in adults and children ages two and above. Our pivotal
Phase III clinical trial in 59 PIDD patients met the primary endpoint of no
Serious Bacterial Infections (“SBI”) reported during 12 months of treatment.
Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in
the low incidence of infection, therapeutic antibiotic use, reduced days missed
from work, school and daycare and reduced unscheduled medical visits and
hospitalizations. We believe this clinical data together with the FDA approval of
ASCENIV for the treatment of PIDD better positions ADMA to potentially further evaluate ASCENIV in immune-compromised patients infected with
or at-risk for RSV infection or potentially other respiratory viral pathogens
at an appropriate time. In the future, we may elect to work with the FDA and
the immunology and infectious disease community to design an appropriate
clinical trial to evaluate the use of ASCENIV in this patient population.
Following FDA approval in April 2019, commercial sales of ASCENIV commenced in
October 2019 and in 2023 we commenced manufacturing ASCENIV at the 4,400 liter
production scale. This expansion has improved the product’s margin profile and
increased plant production capacity as fewer batches are needed to support our
revenue goals. ASCENIV’s prescriber and patient base continued to expand during
2024 and 2025, which drove record end-user utilization for this product. These elevated
demand trends have sustained into 2026, and we currently expect that this
product’s rapid growth will continue throughout 2026 and beyond.
In May 2026, we announced that the FDA approved the expansion of ASCENIV’s label to include the pediatric setting for those two years of age and older.
BIVIGAM
BIVIGAM is a plasma-derived IVIG product that contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin G antibodies indicated for the treatment of PI, a group of genetic disorders. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency. Based on recent estimates, these disorders are no longer considered to be very rare, with as many as one in every 2,000 people in the United States having some form of PI.
In
May 2019, the FDA approved our PAS for the use of our IVIG manufacturing
process (known as fractionation), thereby enabling us to re-launch and
commercialize this product in the United States. Following our acquisition of
the Boca Facility, which included BIVIGAM and Nabi-HB, in June 2017, we resumed production of BIVIGAM
during the fourth quarter of 2017 and commercial production is ongoing, using
our FDA-approved IVIG manufacturing process under HHS License No. 2019. The
commercial re-launch and first commercial sales for this product under our
leadership commenced in August 2019.
In April 2021, we announced that the FDA granted approval for our expanded plasma pool production scale process, allowing for a 4,400-liter plasma pool for the manufacture of our BIVIGAM IVIG product. This increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has had a favorable impact on our gross margins, manufacturing efficiencies and operating results.
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In December 2023, we announced that the FDA approved the expansion of BIVIGAM’s label in the United States to now include the pediatric setting for those two years of age and older.
Nabi-HB
Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB is indicated for the treatment of acute exposure to blood containing HBsAg, prenatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection in specific, listed settings. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus, which is a major global health problem. The Hepatitis B virus can cause chronic infection and places people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented record of long-term safety and effectiveness since its initial market introduction. The FDA approved Nabi-HB in March 1999. Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017. In early 2018, we received authorization from the FDA for the release of our first commercial batch of Nabi-HB for commercial distribution in the United States and we continue to manufacture Nabi-HB under HHS License No. 2019.
RESULTS OF OPERATIONS
Critical Accounting Policies and Estimates
This
Management’s Discussion and Analysis of Financial Condition and Results of
Operations is based on our condensed consolidated financial statements, which
have been prepared in accordance with U.S. GAAP. The preparation of these
condensed consolidated financial statements requires us to make estimates and
assumptions that affect the reported amounts of assets, liabilities, revenues
and expenses. On an ongoing basis, we evaluate these estimates and assumptions,
including those described below. We base our estimates on our historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances. These estimates and assumptions form the basis for
making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results and experiences may
differ materially from these estimates. Significant estimates include estimates
related to the Company’s effective tax rate.
Some of the estimates and assumptions we are required to make under U.S. GAAP require difficult, subjective and/or complex judgments about matters that are inherently uncertain and, as a result, actual results could differ from those estimates. Due to the estimation processes involved, the following summary of accounting estimates and their application are considered to be critical to understanding our business operations, financial condition and results of operations. For a description of our significant accounting policies, see Note 2 to the consolidated financial statements included in our 2025 10-K.
Revenue Deductions for Rebates and Chargebacks
Our gross product revenues are subject to a variety of deductions which are estimated and recorded in the same period that the revenues are recognized. These deductions primarily consist of rebates, distribution fees, chargebacks and sales allowances. These deductions represent estimates of the related obligations, some of which are contractual in nature and do not require extensive judgment to be exercised by management, while other estimates require complex or subjective matters of knowledge and judgment when estimating the impact of these revenue deductions on net revenues for a reporting period.
Effective Tax Rate
Our provision for income taxes and the determination of our effective tax rate are subject to significant judgment and complexity. We estimate our income tax expense based on enacted tax laws and statutory tax rates in the jurisdictions in which we operate, as well as our interpretation of relevant tax regulations. The effective tax rate includes the impact of various estimates and judgments. Changes in these estimates or in tax laws could significantly affect our effective tax rate and results of operations. Due to the complexity of tax regulations and the potential for differing interpretations, it is reasonably possible that the ultimate resolution of these matters could result in material adjustments to our effective tax rate in future periods.
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Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025
The following table presents a summary of the changes in our results of operations for the three months ended June 30, 2026, compared to the three months ended June 30, 2025:
Three Months Ended June 30,
(in thousands) 2026 2025 Increase (Decrease)
Revenues $ 124,395 $ 121,984 $ 2,411
Cost of product revenue 38,118 54,757 (16,639 )
Gross profit 86,277 67,227 19,050
Research and development expenses 6,014 1,031 4,983
Plasma center operating expenses 1,026 1,152 (126 )
Amortization of intangibles 55 32 23
Selling, general and administrative expenses 26,737 22,214 4,523
Income from operations 52,445 42,798 9,647
Interest and other income 1,238 400 838
Interest expense (3,424 ) (1,834 ) (1,590 )
Loss on extinguishment of debt - (1,159 ) 1,159
Other expense, net (22 ) (108 ) 86
Income before taxes 50,237 40,097 10,140
Provision for income taxes 12,415 5,878 6,537
Net income $ 37,822 $ 34,219 $ 3,603
Adjusted EBITDA* $ 61,846 $ 50,769 $ 11,077
Adjusted Net Income* $ 38,957 $ 36,035 $ 2,922
* - See Non-GAAP Financial Measures appearing at the end of this discussion
Revenues
We recorded total revenues of $124.4 million for the three months ended June 30, 2026, as compared to $122.0 million for the three months ended June 30, 2025, an increase of $2.4 million, or approximately 2.0%. Revenues by product for the three months ended June 30, 2026 and 2025 were as follows:
Three Months Ended June 30,
2026 2025 Increase/ (Decrease) Increase/ (Decrease) %
(in thousands)
ASCENIV $ 102,921 $ 83,321 $ 19,600 23.5 %
BIVIGAM 19,419 37,710 (18,291 ) (48.5 )%
Intermediates and other products(1) 1,297 917 380 41.4 %
ADMA BioManufacturing 123,637 121,948 1,689 1.4 %
Plasma Collection Centers 723 - 723 100.0 %
License revenue 35 36 (1 ) (2.7 )%
Total Revenues $ 124,395 $ 121,984 $ 2,411 2.0 %
(1) Due to Nabi-HB historically representing less than 10% of the Company’s revenue within the ADMA BioManufacturing segment, it has been included under intermediates and other products.
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The increase in total revenue was primarily driven by the $19.6 million increase in ASCENIV sales, reflecting continued growth in market acceptance of the product, alongside an increase of $0.7 million in Plasma Collection Centers sales and a $0.4 million increase in intermediates and other products. These increases were partially offset by $18.3 million reduction in BIVIGAM sales, reflecting continued competitive pressures in the standard immune globulin market.
Cost of Product Revenue and Gross Profit
Cost of product revenue was $38.1 million for the three months ended June 30, 2026, as compared to $54.8 million
for the three months ended June 30,
2025. This decrease is primarily attributable to lower volume of BIVIGAM and lower
product losses, partially offset by the increase in ASCENIV volume.
For the three months ended June 30, 2026, we had gross profit of $86.3 million, as compared to
$67.2 million for the same period of a year ago, which represents gross margin
in the second quarter of 2026 of 69.4%, as compared to 55.1% in the second quarter
of 2025. The improvement in gross margin is primarily driven by the favorable product
mix, along with the margin benefits of the yield enhancement manufacturing
process.
Research and Development Expenses
Research
and development expenses totaled $6.0 million for the second quarter of 2026, as compared to $1.0 million for the second quarter of 2025. The increase of $5.0 million is mainly due to the
ramp-up of clinical development and trial activities related to our SG-001
development project.
Plasma Center Operating Expenses
Plasma
center operating expenses, which primarily consist of compensation and benefits
for plasma center management and administrative staff, decreased from $1.2 million
for the three months ended June 30, 2025 to $1.0 million for the three months ended June 30, 2026, primarily due to the sale of three plasma centers in the first
quarter of 2026.
Amortization of Intangibles
Amortization expense mainly pertains to internally
developed software and was $0.1 million and less than $0.1
million for the three months ended June 30, 2026 and 2025, respectively.
Selling, General and Administrative Expenses
Selling,
general and administrative (“SG&A”) expenses were $26.7
million for the three months ended June 30, 2026. This increase of $4.5
million, or 20.4%, was primarily driven by higher employee-related costs, increased
software maintenance costs and higher professional and legal fees associated
with ongoing litigation and related matters and strategic initiatives
supporting corporate growth.
Interest and Other Income
Interest
and other income for the three months ended June 30, 2026 was $1.2 million, as
compared to $0.4 million for the three months ended June 30, 2025, driven by the higher average cash balances in 2026 and
refinement of our cash investment strategy.
Interest Expense
Interest
expense for the three months ended June 30, 2026 was $3.4 million, as
compared to $1.8 million for the three months ended June 30, 2025. This increase of $1.6 million was driven by the March 2026 borrowing
under our credit facility to support the accelerated share repurchase agreement
(the "ASR Agreement").
Loss on Extinguishment of Debt
We
recognized no loss on extinguishment of debt for the three months ended June
30, 2026, as compared to a loss of $1.2 million for the three months ended June
30, 2025. Loss on extinguishment of debt recorded during the three months ended
June 30, 2025 was driven by the early partial paydown of debt outstanding under
our former senior secured credit facility with Ares Capital Corporation and
certain affiliated credit funds (the “Ares Credit Agreement”).
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Other Expense
Other expense was less than $0.1 million for the three months ended June 30, 2026 and $0.1 million for the three months ended June 30, 2025.
Income Tax Expense
The provision for income taxes of $12.4 million for the three months ended June 30, 2026 represented an effective tax rate of 24.7%, as compared to the provision of $5.9 million for the three months ended June 30, 2025, with an effective tax rate of 14.7%. The increase was primarily driven by lower year-over-year excess tax benefits on stock-based compensation.
Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
The following table presents a summary of the changes in our results of operations for the six months ended June 30, 2026, compared to the six months ended June 30, 2025:
Six Months Ended June 30,
(in thousands) 2026 2025 Increase (Decrease)
Revenues $ 238,888 $ 236,786 $ 2,102
Cost of product revenue 71,861 108,463 (36,602 )
Gross profit 167,027 128,323 38,704
Research and development expenses 8,611 1,858 6,753
Plasma center operating expenses 2,088 2,438 (350 )
Amortization of intangibles 110 57 53
Gain on sale of plasma centers (7,980 ) - (7,980 )
Selling, general and administrative expenses 53,479 46,292 7,187
Income from operations 110,719 77,678 33,041
Interest and other income 2,331 1,008 1,323
Interest expense (5,524 ) (3,809 ) (1,715 )
Loss on extinguishment of debt - (1,159 ) 1,159
Other expense, net (161 ) (172 ) 11
Income before taxes 107,365 73,546 33,819
Provision for income taxes 24,215 12,424 11,791
Net income $ 83,150 $ 61,122 $ 22,028
Adjusted EBITDA* $ 121,499 $ 98,706 $ 22,793
Adjusted Net Income* $ 79,636 $ 69,333 $ 10,303
* - See Non-GAAP Financial Measures appearing at the end of this discussion
Revenues
We recorded total revenues of $238.9 million for the six months ended June 30, 2026, as compared to $236.8 million for the six months ended June 30, 2025, an increase of $2.1 million, or approximately 0.9%. Revenues by product for the six months ended June 30, 2026 and 2025 were as follows:
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Six Months Ended June 30,
2026 2025 Increase/ (Decrease) Increase/ (Decrease) %
(in thousands)
ASCENIV $ 200,407 $ 159,653 $ 40,754 25.5 %
BIVIGAM 34,841 71,222 (36,381 ) (51.1 )%
Intermediates and other products(1) 2,130 4,790 (2,660 ) (55.5 )%
ADMA BioManufacturing 237,378 235,665 1,713 0.7 %
Plasma Collection Centers 1,439 1,050 388 37.0 %
License revenue 71 71 - 0.0 %
Total Revenues $ 238,888 $ 236,786 $ 2,101 0.9 %
(1) Due to Nabi-HB historically representing less than 10% of the Company’s revenue within the ADMA BioManufacturing segment, it has been included under intermediates and other products.
The
increase in total revenue was primarily driven by the $40.8 million increase in
ASCENIV volume reflecting robust and continued market acceptance. This increase
was offset by the $36.4 million decrease in the volume of BIVIGAM driven by the
competitive pressures in the standard immune globulin industry.
Cost of Product Revenue and Gross Profit
Cost of product revenue was $71.9 million for the six months ended June 30, 2026, as compared to $108.5
million for the six months ended June 30, 2025. This decrease is primarily attributable to lower
volume of BIVIGAM and lower product losses, partially offset by the increase in
ASCENIV volume.
For the six months ended June 30, 2026, we had gross profit of $167.0 million, as compared
to $128.3 million for the same period of a year ago, which represents gross
margin in the first half of 2026 of 69.9%, as compared to 54.2% in the first
half of 2025. The improvement in gross margin is primarily driven by favorable
product mix in 2026, along with the margin benefits of the yield enhancement
manufacturing process optimizations.
Research and Development Expenses
Research
and development expenses totaled $8.6 million for the six months ended June 30,
2026, as compared to $1.9 million for the six months ended June 30, 2025. The
increase is mainly due to the ramp-up of clinical development and clinical
trial activities related to our SG-001 development project.
Plasma Center Operating Expenses
Plasma
center operating expenses, which primarily consist of compensation and benefits
for plasma center management and administrative staff, decreased from $2.4
million for the six months ended June 30, 2025 to $2.1 million for
the six months ended June 30, 2026. The decrease is primarily due to the sale of
three plasma centers in the first quarter of 2026.
Amortization of Intangibles
Amortization expense mainly pertains to internally developed software and was $0.1 million and less than $0.1 million for the six months ended June 30, 2026 and 2025, respectively.
Gain on sale of plasma centers
Gain on sale of plasma centers was $8.0 million for the six months ended June 30, 2026, as result of the sale of three of our plasma centers completed during the first quarter of 2026.
Selling, General and Administrative Expenses
SG&A
expenses were $53.5 million for the six months ended June 30, 2026, an increase of $7.2 million as compared to the
six months ended June 30, 2025. The increase is primarily driven by the
increase in personnel costs, including stock-based compensation, and an
increase in professional and consulting fees associated with ongoing litigation
and related matters and strategic initiatives supporting corporate growth.
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Interest and Other Income
Interest
and other income for the six months ended June 30, 2026 was $2.3 million, as
compared to $1.0 million for the six months ended June 30, 2025, driven by the higher average cash balances in 2026 and
refinement of our cash investment strategy.
Interest Expense
Interest expense for the six months ended June 30, 2026 was $5.5 million, as compared to $3.8 million for the six months ended June 30, 2025, driven by higher average outstanding debt balances under our senior secured credit facility.
Loss on Extinguishment of Debt
We recognized no loss on extinguishment of debt during the six months ended June 30, 2026. Loss on extinguishment of debt of $1.2 million recognized during the six months ended June 30, 2025 was driven by the early partial paydown of debt outstanding under the Ares Credit Agreement.
Other Expense
Other
expense was $0.2 million for the six months ended June 30, 2025 and 2026.
Income Tax Expense
The provision for income taxes of $24.2 million for the six months ended June 30, 2026 represented an effective tax rate of 22.6%, as compared to the provision of $12.4 million for the six months ended June 30, 2025, with an effective tax rate of 16.9%. The increase in income tax expense is driven by lower excess tax benefits on stock-based compensation.
Non-GAAP Financial Measures
Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”), Adjusted EBITDA and Adjusted Net Income
EBITDA,
Adjusted EBITDA and Adjusted net income are important non-GAAP financial
measures used by our management and our board of directors (our “Board”) to
assess our operating performance. We use EBITDA, 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, in the
case of Adjusted net income, items that are expected to be non-recurring, and
in the case of EBITDA and Adjusted EBITDA, 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
one-time and non-recurring items. In addition, we believe that EBITDA, Adjusted
EBITDA and Adjusted net income and similar measures are widely used by
investors, securities analysts, ratings agencies and other parties in
evaluating companies in our industry as a measure of financial performance and
debt-service capabilities. See below for a reconciliation of our EBITDA,
Adjusted EBITDA and Adjusted net income to net income, the most directly
comparable financial measure calculated and presented in accordance with U.S. GAAP.
Because
EBITDA, Adjusted EBITDA and Adjusted net income are measures not deemed to be
in accordance with U.S. GAAP and are susceptible to varying calculations, our
EBITDA, Adjusted EBITDA and Adjusted net income may not be comparable to
similarly titled measures of other companies, including companies in our
industry, because other companies may calculate EBITDA, Adjusted EBITDA and
Adjusted net income in a different manner than we calculate these measurements.
Although we use Adjusted EBITDA as one of several financial measures to assess our
operating performance, our use is limited as we exclude certain significant
operating expenses. EBITDA, Adjusted EBITDA and Adjusted net income are not
intended to represent cash flows for the periods presented, nor have they been
presented as an alternative to operating income, net income or as an indicator
of operating performance and should not be considered in isolation or as a
substitute for measures of performance prepared in accordance with U.S. GAAP. The following table presents the
reconciliation of net income to EBITDA and Adjusted EBITDA for the three and
six months ended June 30, 2026 and 2025:
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Index
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
(In thousands)
Net income $ 37,822 $ 34,219 $ 83,150 $ 61,122
Depreciation 1,726 2,027 3,510 3,970
Amortization 55 32 110 57
Income taxes 12,415 5,878 24,215 12,424
Interest expense, net 2,186 1,834 3,169 3,809
EBITDA 54,204 43,990 114,154 81,382
Stock-based compensation 6,135 4,963 12,464 9,587
Voluntary Withdrawal and product replacements - 164 - 4,001
Yield enhancement 429 493 841 1,395
Gain on sale of plasma centers - - (7,980 ) -
Loss on extinguishment of debt - 1,159 - 1,159
Non-recurring professional fees 1,078 - 2,020 1,182
Adjusted EBITDA $ 61,846 $ 50,769 $ 121,499 $ 98,706
Adjusted
EBITDA increased for the three and six months ended June 30, 2026, as compared
to the same period of a year ago, by $11.1 million and $22.8 million,
respectively. The improvement is primarily due to the increase in operating
income.
The following table presents the reconciliation of Net income to Adjusted net income for the three and six months ended June 30, 2026 and 2025:
Three Months Ended Six Months Ended
June 30, 2026 June 30, 2025 June 30, 2026 June 30, 2025
(In thousands)
Net income $ 37,822 $ 34,219 $ 83,150 $ 61,122
Stock-based compensation modifications - - 609 474
Customer credits related to the Voluntary Withdrawal - 164 - 4,001
Loss on extinguishment of debt - 1,159 - 1,159
Yield Enhancement 323 493 650 1,395
Gain on sale of plasma centers - - (6,332 ) -
Non-recurring professional fees 812 - 1,559 1,182
Adjusted net income (a) $ 38,957 $ 36,035 $ 79,636 $ 69,333
(a) Add-backs reflected during the three and six months ended June 30, 2025 exclude estimated tax effect of $0.3 million and $1.4 million, respectively. Add-backs reflected during the three months and six months ended June 30, 2026 were tax affected using the respective effective tax rates.
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2026, we had working capital of $452.4 million, primarily consisting of $239.3 million of inventory, cash and cash equivalents of $136.0 million and $138.2 million of accounts receivable, partially offset by current liabilities of $75.8 million, as compared to working capital at December 31, 2025 of $397.0 million, primarily consisting of $206.5 million of inventory, cash and cash equivalents of $87.6 million and accounts receivable of $158.4 million, partially offset by current liabilities of $69.5 million. Our material cash requirements are primarily comprised of:
●
The collection and procurement of raw material source plasma, which includes plasma donor fees and plasma center supplies, and other raw materials necessary to maintain and scale up our manufacturing operations;
● The purchase of RSV plasma under our purchase agreements with third parties;
● The purchase of our common stock pursuant to our Board-approved share repurchase program;
●
Employee compensation and benefits;
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Index
●
Capital expenditures for equipment upgrades and capacity expansion at the Boca Facility and to maintain our plasma collection facilities;
●
Interest on our debt;
●
Marketing programs, medical education and continued commercialization efforts;
●
Boca Facility maintenance, improvements, repairs and supplies;
●
Research and development, including studies and development activities relating to SG-001;
●
Expansion and renovation-related improvements for the real estate acquired in July 2025 in Boca Raton, Florida, as further described below; and
●
Ongoing improvements and updates to our IT infrastructure, laboratory equipment and assays, and facilities and engineering equipment.
In July 2025, we completed the acquisition of real estate in Boca Raton, Florida for a total purchase price of $12.6 million. This real estate purchase is intended to allow us to expand our production operations and related activities as well as provide for certain redundancies for ambient and cold-chain storage of raw materials, work in process and finished goods inventory. Our end-to-end production cycle time from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial inventories of raw material plasma and other manufacturing and laboratory testing materials and single use disposables.
We
currently anticipate, based upon our projected revenue and expenditures, that
our current cash, cash equivalents and accounts receivable, along with our
projected future operating cash flow, will be sufficient to fund our
operations, as currently conducted, for the next twelve months and foreseeable
future. Based on current operations and assuming continued market acceptance
and utilization of our finished drug products, we do not anticipate the need to
raise additional capital at this time. However, should the market for our
products or political, economic or inflationary conditions change, we may need
to seek additional capital which may not be available due to a variety of
potential factors beyond our control (see “Risk Factors” appearing elsewhere in
this report).
We continue to evaluate a variety of
strategic alternatives, and the exploration of value-creating opportunities
remains a top corporate priority.
JPM Credit Agreement
On August 5,
2025 (the “JPM Closing Date”), we entered into a Credit Agreement (the “JPM
Credit Agreement”) with the lenders party thereto and JPMorgan Chase Bank,
N.A., as administrative agent. The JPM Credit Agreement provides for
$300 million of senior secured credit facilities, consisting of (a) a term
loan in the aggregate principal amount of $75 million (the “JPM Term Loan
Facility”), which was drawn in full on the JPM Closing Date, and (b) a
revolving credit facility in the aggregate principal amount of
$225 million (the “JPM Revolving Facility”). We may also request, subject
to customary conditions, additional incremental revolving commitments or term
loans in an aggregate principal amount not to exceed $100 million
(together with the JPM Term Loan Facility and the JPM Revolving Facility, the “JPM
Credit Facilities”). The JPM Term Loan Facility has a maturity date
of August 5, 2028 (the “JPM Term Maturity Date”), and the JPM
Revolving Facility has a maturity date of August 5, 2028 or any earlier date on
which the commitments under the JPM Revolving Facility are reduced
to zero or otherwise terminated pursuant to the terms of the JPM
Credit Agreement.
On March 2, 2026, we borrowed $125.0 million under the JPM Revolving Facility, used to fund the ASR Agreement. See Note 8 in our unaudited condensed consolidated financial statements for further details.
Interest
on borrowings under the JPM Credit Facilities accrues at an applicable rate
equal to (i) an alternate base rate plus an applicable spread (each such
borrowing, an “ABR Borrowing”) or (ii) Term Secured Overnight Financing Rate (“SOFR”)
plus an applicable spread (each such borrowing, a “Term Benchmark Borrowing”),
in each case based on the lower of the applicable rates set forth in the JPM
Credit Agreement, which are based on the Company’s total leverage ratio. These
applicable spreads range from 150 basis points to 200 basis
points over the alternate base rate and 250 basis points
to 300 basis points over Term SOFR, in each case, as determined in
accordance with the provisions of the JPM Credit Agreement. We have agreed to
pay a commitment fee at specified rates set forth in the JPM Credit Agreement,
which, based on our total leverage ratio, ranges from 30 basis points
to 35 basis points on the daily amount of the undrawn portion of the
aggregate commitments of the lenders under the JPM Revolving Facility. At our
request, each borrowing initially shall be either an ABR Borrowing or a Term
Benchmark Borrowing, and we may thereafter elect to convert any such borrowing
to a different type. During the occurrence and continuance of an Event of
Default (as defined in the JPM Credit Agreement), all borrowings shall accrue
interest at a rate per annum equal to 2% plus the applicable rate. As of June
30, 2026, the interest rate on the JPM Term Loan Facility and the JPM Revolving
Facility was approximately 6.12%.
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Index
On the JPM Revolving Facility Maturity Date, we will repay the unpaid principal amount outstanding under the JPM Revolving Facility. Under the JPM Term Loan Facility, we will make principal payments in accordance with and on the dates specified in the amortization schedule set forth in the JPM Credit Agreement, with the remaining unpaid principal amount to be paid in full on the JPM Term Maturity Date. We may prepay at any time and from time to time any borrowing in whole or in part, without premium or penalty (other than, if applicable, any break funding expenses), subject to customary notice requirements.
All of our obligations under the JPM Credit Agreement are secured by a first-priority lien and security interest in substantially all of our tangible and intangible assets, including intellectual property and equity interests.
The JPM Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar debt financings. The negative covenants include certain financial covenants, including a maximum total leverage ratio of 2.50 to 1.00 and a minimum fixed charge coverage ratio of 1.20 to 1.00. The negative covenants also restrict or limit our ability to, among other things and subject to certain exceptions contained in the JPM Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes; make certain investments; dispose of certain assets; engage in sale and leaseback transactions or swap agreements; make dividend payments and other certain Restricted Payments (as defined in the JPM Credit Agreement); engage in certain affiliate transactions; enter into any other agreements that have the impact of restricting our ability to make loan repayments under the JPM Credit Agreement; or amend certain material documents.
As of June 30, 2026, we were in compliance with all of our debt covenants in the JPM Credit Agreement.
Repurchase Program
In May 2025, the Board
authorized a share repurchase program of up to $500.0 million of our
outstanding shares of common stock (the “Repurchase Program”). The Repurchase
Program does not obligate us to acquire any particular amount of our common
stock, and may be modified, suspended, or terminated at any time. The
Repurchase Program has no expiration date. As of June 30, 2026, a total of $187.2 million
of common stock had been repurchased over the lifetime of the Repurchase
Program.
On March 2, 2026, we entered
into the ASR Agreement with JPMorgan to repurchase $125.0 million of shares of
our common stock under the Repurchase Program. During the three and six months
ended June 30, 2026, we received 4,337,879 and 10,760,487 shares of common
stock, respectively, pursuant to the terms of the ASR Agreement.
During
the three and six months ended June 30, 2026, in addition to the shares
repurchased under the ASR Agreement, we repurchased 2,723,659 and 3,055,207
shares of common stock under the Repurchase Program at a total cost of $25.1
million and $30.2 million, respectively.
We
remain active with share repurchases under the Repurchase Program and are on
track to complete our previously stated $200 million or more 2026 share
repurchase target.
Cash Flows
The following table sets forth a summary of our cash flows for the periods indicated:
Six Months Ended June 30,
(in thousands) 2026 2025
Net cash provided by operating activities $ 87,788 $ 1,464
Net cash provided by (used in) investing activities 148 (7,247 )
Net cash used in financing activities (39,546 ) (7,079 )
Net change in cash and cash equivalents 48,390 (12,862 )
Cash and cash equivalents - beginning of period 87,630 103,147
Cash and cash equivalents - end of period $ 136,020 $ 90,285
Net Cash Provided by Operating Activities
Cash provided in operations for the six months ended June 30, 2026 was $87.8 million, an increase of $86.3 million from the same period of a year ago, primarily driven by growth in net income and favorable timing of cash collections from accounts receivable. The following table illustrates the primary components of our cash flows from operations:
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Index
Six Months Ended June 30,
(in thousands) 2026 2025
Net income $ 83,150 $ 61,122
Non-cash expenses, gains and losses 11,752 20,097
Changes in accounts receivable 20,198 (59,726 )
Changes in inventories (32,848 ) (21,229 )
Change in prepaid expenses and other current assets (1,181 ) -
Changes in accounts payable and accrued expenses 7,369 4,203
Other (652 ) (3,003 )
Net cash provided by operating activities $ 87,788 $ 1,464
Net Cash Provided by (Used in) Investing Activities
Net cash used in investing activities for the six months ended June 30, 2026 decreased by $7.4 million from the same period of a year ago. The decrease is primarily due to the proceeds received from the sale of the three of our plasma centers during the first quarter of 2026 and reduction in capital expenditures.
Net Cash Used in Financing Activities
Net cash used in financing activities was $39.5 million and $7.1 million for the six months ended June 30, 2026 and 2025, respectively. The increase is primarily driven by the share repurchases made during the six months ended June 30, 2026.
Effect of Inflation
Inflation impacted a number of facets of our business during the six months ended June 30, 2026 and 2025 at each of our business segments. Disruptions in the global economy have impeded global supply chains, resulted in longer lead times and delays in procuring certain raw materials, and resulted in inflationary cost increases in certain raw materials, labor and transportation. We also experienced price increases for, among other items, consumable supplies, services for repairs and maintenance of our facilities, utilities, shipping and freight charges, fuel surcharges and labor costs, among other expenses. Based upon the macroeconomic environment, publicly available information and reports from the U.S. government, we expect this trend to continue in the second half of 2026. Although we cannot predict the extent to which future domestic and global economic conditions, including, but not limited to, supply chain constraints, tariffs or trade wars, changes in federal regulatory policies or priorities, general economic and geopolitical conditions, or the continuing conflicts in Europe, the Middle East and surrounding areas will impact us, such factors could have a significant impact on our future results of operations. In addition, some of our third-party inventory purchase agreements provide for scheduled price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price increases and could result in higher source plasma and other raw material and supplies costs throughout the second half of 2026 and beyond. Also, in a higher inflationary environment, we may not be able to raise the prices of our products to maintain the rate of inflation and this may affect our product margins.
Off-Balance Sheet Arrangements
None.