Q1 2026 ADMA Biologics Inc Earnings Call

May 6, 2026

Operator 2: Good afternoon, and welcome to the ADMA Biologics Q1 2026 Financial Results and Business Update Conference Call on Wednesday, 6 May 2026. At this time, all participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately two hours following the end of the call. At this time, I would like to introduce the company. Please go ahead.

Operator: Good afternoon, and welcome to the ADMA Biologics' Q1 2026 Financial Results and Business Update Conference Call on Wednesday, 6 May 2026. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request, and will be available on the company's website approximately two hours following the end of the call. At this time, I would like to introduce the company. Please go ahead.

[Company Representative] (ADMA Biologics): Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for Q1 2026 and recent corporate updates. I'm joined today by Adam Grossman, our President and Chief Executive Officer, Terry Kohler, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and Terry will provide an overview of the company's Q1 2026 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the Q1 2026 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com.

[Company Representative] (ADMA Biologics): Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for Q1 2026 and recent corporate updates. I'm joined today by Adam Grossman, our President and Chief Executive Officer; Terry Kohler, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and Terry will provide an overview of the company's Q1 2026 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the Q1 2026 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com.

[Company Representative] (ADMA Biologics): Before we begin our formal comments, I'll remind you that we will be making forward-looking assertions during today's call that represent the company's intentions, expectations, or beliefs concerning future events which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks, and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements, except as required by the federal securities laws.

All 4 looking statements are subject to factors risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements.

In addition any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date.

[Company Representative] (ADMA Biologics): We refer you to the Disclosure Notice section in our earnings release that we issued today and the Risk Factors section in our Annual Report on Form 10-Q for the quarter ended 31 March 2026, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. Please note that the discussion on today's call includes certain non-GAAP financial measures, including adjusted EBITDA and adjusted net income. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam.

We specifically disclaim any obligations to update, such statements, except as required by the federal Securities laws.

We refer you to the disclosure notice section in our earnings release that we issued today, and the risk factors section in our annual report on form. 10 Q for the quarter ended, March, 31st, 2026,

For a discussion of important factors that could cause actual results to differ materially from these forward-looking statements,

Please note that the discussion on today's call includes certain non-gaap Financial measures including adjusted Ava and adjusted net income.

A Reconciliation of these non-gaap Financial measures to the most directly comparable. Gaap metric is available in our earnings release.

Adam Grossman: Thank you. Good afternoon, everyone. We had a strong start to the year with earnings growth and margin expansion, despite total revenue being essentially flat, underscoring the resilience of the business. We grew adjusted net income by 22% year-over-year, expanded corporate gross margins to 71%, and generated approximately $58 million of operating cash flow during the quarter. This was in spite of top-line pressures primarily impacting BIVIGAM. We believe the Q1 results likely represent the trough revenue baseline from which we would expect to be able to drive growth in the coming quarters. Key drivers of that, in our view, will be enduring ASCENIV demand, expanding margins, and continued strong cash generation. ASCENIV end market demand reached record levels in Q1, with revenue growth of approximately 28% year-over-year.

With that, I would now like to turn the call over to Adam Grossman. Adam?

Thank you. Good afternoon everyone.

We had a strong start to the year with earnings growth and margin expansion. Despite total revenue being essentially flat, this underscores the resilience of the business.

We grew adjusted net income by 22% year-over-year.

Expanded corporate growth margins to 71%.

And generated approximately 58 million of operating cash flow during the quarter.

This was in spite of topline pressures, primarily impacting dividend.

we believe the first quarter results, likely represent the trough Revenue Baseline

From which we would expect to be able to drive growth. In the coming quarters.

Key drivers of that. In our view will be enduring incentive demand.

Expanding margins and continued, strong, cash generation.

Adam Grossman: We saw continued strength in record metrics across new patient starts, prescriber adoption, product pull-through, and patient adherence. As a reminder, our distributors not only have to maintain safety stock levels to ensure the continuity of patient care, but we understand these specialty distributors also typically keep extra stock available for immediate administration and to guard against any potential supply chain, manufacturing, testing, or regulatory disruptions. We see our distributors' inventory and pull-through sales data on a regular basis and believe these levels are consistent with those of our industry peers and are appropriately sized. At the same time, ASCENIV demand is growing. Competitive dynamics in Q1, as well as the variability in ordering patterns, created a challenging commercial backdrop, in particular for BIVIGAM. I will discuss these competitive dynamics in a moment.

A senate and market demand reached record levels in the first quarter with Revenue growth of approximately 28% year-over-year.

We saw continued strength, in record metrics across new patient starts, prescriber adoption, product pull-through, and patient adherence.

As a reminder.

Our Distributors, not only have to maintain Safety stock levels to ensure the continuity of patient care.

Or regulatory disruptions.

We see our distributors' inventory and pull-through sales data on a regular basis.

And believe these levels are consistent with those of our industry peers and our appropriately sized.

At the same time, Ascent of demand is growing.

Competitive dynamics in the first quarter, as well as the variability in ordering patterns, created a challenging commercial backdrop, in particular for BIVIGAM.

Adam Grossman: Operationally, during the period, we completed the monetization of three plasma centers, enhancing liquidity while further diversifying our plasma sourcing by adding a new third-party plasma supplier. We are also actively reducing expenses in a targeted manner to improve profitability without adversely impacting our core operations. Importantly, with a balanced mix of internal and third-party plasma procurement, we believe we have ample supply of high-titer plasma to support both our near and long-term ASCENIV growth objectives. Our balance sheet remains strong, with pro forma net leverage below 0.5 times, driven by continued cash generation and adjusted EBITDA growth, which should provide us with the flexibility needed to support growth and activate on our capital allocation priorities. Now, let me take a step back and explain why we believe we are experiencing an extraordinarily unique moment in our industry.

I will discuss these competitive dynamics in a moment.

Operationally During the period, we completed the monetization of 3 plasma centers. Enhancing the liquidity, while further diversifying our plasma sourcing by adding a new third-party plasma supplier.

We are also actively reducing expenses in a targeted manner to improve profitability without adversely impacting our core operations.

Importantly, with a balanced mix of internal and third-party plasma procurement.

We believe we have ample supply of high titer plasma to support both our near and long-term incentive growth objectives.

Our balance sheet remains strong.

With pro forma net leverage below 0.5 times, driven by continued cash generation and adjusted EVA growth.

Which should provide us with the flexibility needed to support growth and activate on our Capital allocation priorities.

Adam Grossman: We believe that historically, the plasma fractionation industry has been in a dislocated state where IG utilization demand has outpaced the industry's ability to supply. Over the H2 2025 and the Q1 2026, new IG products have entered the US market. During the Q1, the industry also saw a surplus of raw material plasma supply, increased PDT and IG finished goods inventory across the distribution network, and aggressive pricing tactics, including discounting and rebating from newer entrants. This drove greater than expected competitive intensity and distribution recalibration. We believe there was and continues to be a rapid shift in the ordering patterns occurring at the wholesaler and distributor level, which adversely impacted reported Q1 revenue and created additional variability in ordering patterns for ADMA's products within the quarter. We believe these dynamics were timing-related and are transitory in nature.

Now, let me take a step back and explain why. We believe we are experiencing an extraordinarily unique moment in our industry.

we believe that historically the plasma fractionation industry has been an dislocated state where IG utilization demand has outpaced the industry's ability to supply

Over the back half of 2025 and the first quarter of 2026, new IG products have entered the U.S. market.

During the first quarter, the industry also saw a surplus of raw material plasma Supply increased PDT. And I've finished goods inventory across the distribution Network and aggressive pricing tactics, including discounting and rebating from newer entrance.

This drove greater than expected competitive intensity and distribution recalibration.

We believe there was and continues to be a rapid shift in the ordering patterns occurring at the wholesaler and distributor level, which adversely impacted reported first quarter Revenue.

And created additional variability in ordering patterns for admin products within the quarter.

Adam Grossman: Although it's still early, we are observing signs of reversion in Q2. We see these as industry-wide dynamics, not only specific to ADMA, and again, we believe they primarily impacted distributor behavior rather than end-market demand. While these dynamics impacted near-term ordering patterns, there was no deterioration in underlying demand for ASCENIV, where fundamentals remained strong and continued to improve with record utilization growth throughout the quarter. We are particularly encouraged that the Q2 run rate based on April demand is in line with the level of Q1 direct sales. This reinforces a key point. Record ASCENIV demand and utilization, which is a forward-looking indicator, is robust and growing despite the broader standard IG and plasma products market competitive pressures.

We believe these Dynamics were timing related and are transitory in nature.

And although it's still early we are observing signs of reversion in the second quarter.

We see these as industry-wide Dynamics, not only specific.

Adma.

and again, we believe

primarily impacted distributor Behavior rather than end market demand.

While these dynamics impacted near-term ordering patterns, there was no deterioration in underlying demand or incentive for fundamentals. Fundamentals remain strong and continue to improve, with record utilization growth throughout the quarter.

We are particularly encouraged that the second quarter run rate based on April demand is in line with the level of first quarter direct sales.

This reinforces a key point.

Adam Grossman: In our view, this is clear evidence that the Q1 variability was driven by distribution and inventory dynamics primarily affecting BIVIGAM, not by any change in demand or forward-looking growth outlook for ASCENIV. We continue to believe ASCENIV remains early in its penetration curve and that we have multiple durable growth drivers. We believe we still benefit from record new patient adds, a growing prescriber base, expanding distribution network, strong payer access, and increasing physician confidence driven by ASCENIV's differentiated clinical profile and favorable real-world outcomes. In review of the reported ASP declines from certain competitor IG products, we know that the market is seeing elevated levels of aggressive discounting and rebating across standard IG. We remain disciplined in our pricing strategy and are committed to building a durable and sustainable growth model.

Record incentive demand and utilization, which is a Thor. Looking indicator is robust and growing despite the broader standard IG and plasma products Market competitive pressures.

In our view. This is clear evidence that the first quarter variability was driven by distribution and inventory. Dynamics, primarily affecting dividends

Not by any change in demand or forward-looking growth outlook for authentic.

We continue to believe a Senate remains early in its penetration curve.

And that we have multiple durable growth drivers.

We We believe We Still benefit from record. New patient adds a growing prescriber base, expanding distribution Network, strong payer access and increasing physician confidence driven by incentives differentiated clinical profile in favorable real world outcomes.

In review of the reported ASP declines from certain competitors' IG products.

We know that the market is seeing elevated levels of aggressive, discounting and rebating across standard IG.

Adam Grossman: These near-term competitive and pricing dynamics do not change our conviction in the forecasted long-term growth and durability of the U.S. IG market or ASCENIV's differentiated position in the later line setting for refractory immunodeficient patients. Looking ahead, we believe we have several important catalysts, including our recent approval for ASCENIV's pediatric label expansion and the associated commercial opportunity and upcoming preclinical data publication for our lead pipeline program, SG-001, which will be presented at the International Society of Pneumonia and Pneumococcal Diseases conference. We expect this SG-001 preclinical data presentation, including oral and poster sessions, to further illuminate the product's novel profile and market as we advance our capital-efficient development pathway. ADMA is a unique company in the plasma-derived therapies complex in that we have a specialized, innovative, and forward-thinking R&D engine, which translates into growth opportunities and expanded product margins.

We remain disciplined in our pricing strategy and our committed to building a durable and sustainable growth model.

Your line setting for refractory immunodeficient patients.

Looking ahead.

We believe we have several important catalysts including our recent approval for incentives. Pediatric label expansion and the associated commercial opportunity.

And upcoming pre-clinical data publication for our lead pipeline program sg01.

Which will be presented at the International Society of Pneumonia and Pneumo Diseases Conference.

We expect this sg01 pre-clinical data presentation, including oral and poster sessions to further illuminate. The product's novel profile and Market as we advance our Capital efficient development pathway

Adma is a unique company in the plasma, derived therapy therapies complex.

And that we have a specialized Innovative and forward-thinking R&D engine.

Adam Grossman: Our yield enhancement manufacturing process allows us to maximize the high titer RSV plasma we collect required to meet ASCENIV's increasing demand. Yield improvement was designed to enhance our R&D pipeline programs, including SG-001, so that in the same way, we are able to maximize value on the hyperimmune plasma used to produce SG-001. We have identified a proprietary way of blending the highest titer plasma containing Streptococcus pneumoniae antibodies from donors and will rely on the yield enhancement IG production methods for future clinical trials and potential future commercialization. To design the most effective methods for SG-001 production, we have developed and designed proprietary blends of plasma that are already showing strong proof of concept in preclinical studies for two virulent and prevalent serotypes of pneumonia. As data becomes available, we will keep the market apprised of our R&D developments.

Which translates into growth opportunities and expanded product margins.

Our yield enhancement manufacturing process allows us to maximize the high titer RFC plasma we collect, required to meet incentives and increasing demand.

Yield Improvement was designed to enhance our R&D pipeline programs, including SG01.

so that in the same way, we are able to maximize value on the hyperimmune cloud may use to produce s2001

We have identified a proprietary way of blending. The highest tighter plasma containing strep, pneumonia antibodies from donors.

And will rely on the yield enhancement IG production methods for future clinical trials and potential future commercialization.

To design the most effective methods for sg1 production.

We have developed and designed for proprietary blends of plasma that are already showing strong. Proof of concept in pre-clinical, studies for 2 Vehr and prevalent stereotypes of the monia.

Adam Grossman: ADMA remains on track to submit its pre-IND package for SG-001 to the FDA later this year. We believe if approved, SG-001 represents an approximately $300 million to $500 million in annual market opportunity at peak that can be ramped to in short order, leveraging our existing platform, infrastructure, and commercial footprint. All told, our confidence in ASCENIV's growth trajectory and our mission to meet unmet medical needs for immune-compromised patients remains unchanged. ASCENIV demand is strong, fundamentals are intact, the IG market's growth outlook remains robust, and we believe we are well-positioned to drive sustained growth, expand margins, and increase cash generation moving forward. Before I turn the call over, I want to recognize and thank our entire ADMA team for their continued dedication and execution during what has been a dynamic and evolving market environment.

As data becomes available, we will keep the market apprised of our R&D developments.

Adma remains on track to submit its pre-ind package for sg01 to the FDA later this year.

And we believe if approved sg01 represents an approximately 300 million to 500 million dollars in annual Market opportunity at Peak,

that can be ramped to in short order by leveraging our existing platform infrastructure and commercial footprint.

All told.

Our confidence in incentives. Growth trajectory and our mission to meet unmet medical needs for immune compromised, patients remains unchanged

Incentive demand is strong. Fundamentals are intact and the IG Markets growth Outlook remains robust.

And we believe we are well, positioned to drive sustained growth.

Expand margins and increased cash generation moving forward.

Before I turn the call over,

Adam Grossman: Their focus on patients, operational discipline, and commitment to excellence continues to drive our performance and position the company for expected long-term success. We are grateful for your contributions and proud of the progress we are making together. With that, I'll turn the call over to Terry.

I want to recognize and thank our entire admin team for their continued dedication and execution. During what has been a dynamic and evolving Market environment.

their focus on patients, operational discipline and commitment to Excellence continues to drive our performance

and position the company for expected long-term success.

We are grateful for your contributions and proud of the progress. We are making together.

Terry Kohler: I will begin our Q1 financial performance and then provide an update on our balance sheet, cash generation, and the outlook for the remainder of 2026. Total revenue for the Q1 was $114.5 million, compared to $114.8 million in the prior year period, representing flat trends year over year. ASCENIV revenue was $97.5 million, representing 28% growth year over year, while BIVIGAM revenue was $15.4 million, down 54% and disproportionately impacted by the competitive market dynamics discussed. Revenue from the sale of intermediates and other products also declined year over year by USD 3 million. Gross profit for the quarter was $80.8 million, resulting in gross margin of 71% compared to 53% in the prior year period.

With that, I'll turn the call over to Terry.

I will begin our first quarter financial performance. A member will provide an update on our balance sheet, cash generation, and the outlook for the remainder of 2026.

Total revenue for the first quarter was $114.5 million compared to $114.8 million.

Representing flat trends year-over-year.

Percent of Revenue was 97.5 million representing 28% growth year-over-year while Biv. Again, Revenue was 15.4 Million down 54% and disproportionately impacted by the competitive market dynamics discussed

Revenue from the sales, intermediates and other products also decline year-over-year by $0.

Growth profit for the quarter.

Terry Kohler: Adjusted EBITDA was $59.7 million, representing 24% year-over-year growth, and adjusted net income was $40.7 million. GAAP net income for the quarter was $45.3 million. Turning to the balance sheet, we exited the quarter with substantial flexibility. Pro forma net leverage remains below 0.5x, even following the revolving credit facilities draw and accelerated stock repurchase deployment. We retain approximately $100 million of additional borrowing capacity to support future growth initiatives and return capital to stockholders. Additionally, the company has been actively executing share repurchases, which we will continue deploying opportunistically, and through March 31st, resulted in ADMA converting approximately 3.6% of the outstanding share count into treasury stock.

Was $80.8 million, resulting in a gross margin of 71%, compared to 53% in the prior year period.

Adjusted ibida was 59.7. Million representing 24%, year-over-year growth and adjusted. Net income was 40.7 Million.

GAAP net income for the quarter was $45.3 million.

Turning to the balance sheet we exited the quarter with substantial flexibility.

Pro forma, leverage remains below 0.5 times even following the revolving credit facility draw and accelerated stock repurchase deployment. And we retain approximately $100 million of additional borrowing capacity to support future growth initiatives and return capital to stockholders.

Additionally, the company has been actively executing share repurchases, which we will continue to deploying opportunistically.

Terry Kohler: ADMA generated $58 million in cash from operations during the quarter and received an additional $5 million in proceeds from the sale of 3 plasma centers in the period. The accounts receivable decline during the quarter was driven by the change in revenue quarter-over-quarter. All of our accounts receivable from the year-end 2025 balance sheet have now been collected. We ended the quarter with $138 million cash and cash equivalents. As has been the case historically, the quality of our accounts receivable remains strong. DSOs, which represents accounts receivable as of the balance sheet date, divided by net sales per day in the quarter, increased in Q1 2026 to approximately 107 days. As we have referenced in the past, working capital remains a focus for the company. We believe DSOs stabilized during Q1.

And through March 31st, resulted in admin converting approximately 3.6% of the outstanding share count into treasury stock.

Adma generated 58 million in cash from operations during the quarter and received an additional 5 million in proceeds from the sale of 3 plasma centers in the period.

The accounts receivable declined during the quarter was driven by the change in Revenue quarter of a quarter.

all of our accounts receivable from the year end, 2025 balance sheet have now been collected and we ended the quarter with 138 million cash and cash equivalents

As has been the case historically, the quality of our accounts receivable remains strong.

Dsos, which represents accounts receivable as of the balance sheet date divided by net sales per day in the quarter increased in q1 2026 to approximately 107 days.

Terry Kohler: Going forward, we believe the appropriate level of DSOs for ADMA is between 90 and 105 days, and we will target that range with expected improvement from current levels over the back half of the year as ordering patterns normalize and as the McKesson specialty distribution agreement continues to ramp up. For full year 2026, we now expect total revenue in the range of $530 million to $560 million. This outlook reflects continued ASCENIV growth, partially offset by the expectation of sustained competitive pressure in the standard IG space over the course of 2026. Full year 2026 expectations for adjusted EBITDA are now $265 million to $300 million, and adjusted net income is expected to be between $170 million and $200 million.

As we have referenced in the past working capital remains a focus for the company and we believe dso's stabilized during q1.

Going forward, we believe the appropriate level of dsos for adma is between 90 and 105 days and we will Target that range with expected improvement from current levels over the back half of the year as ordering patterns normalized. And as the McKesson specialty, distribution agreement continues to ramp up

for full year 2026. We now expect total revenue in the range of 530 million to 560 million.

This Outlook reflects continue to set up growth partially offset by the expectation of sustained competitive pressure in the standard IG space, over the course of 2026.

Terry Kohler: These expectations reflect not only the reduced revenue expectations in the year, but also an expected step-up in operating expense, primarily driven by R&D spend related to our SG-001 program, but also a step-up in SG&A as we continue to invest in our commercial operations. Given the uncertainty in the competitive landscape, which Adam described earlier, we are withdrawing longer-term guidance at this time. To be clear, this updated outlook does not reflect any change in our confidence regarding the underlying demand fundamentals for ASCENIV as a later line therapy for refractive and complex immunocompromised patients, which remains strong. However, from where we sit today, we simply do not have the longer-term visibility that we had when the IG landscape was less competitive and in a period of undersupply. Overall, we believe ADMA remains exceptionally well-positioned.

Full year 2026 expectations for adjusted EBITDA are now $265 million to $300 million, and adjusted net income is expected to be between $170 million and $200 million.

These expectations reflect not only the reduced Revenue expectations in the year, but also an expected step up and operating expense primarily driven by R&D, spend related to our SG 0001 program.

But also a step up in sgna, as we continue to invest in our commercial operations.

Given the uncertainty in the competitive landscape, which atom described earlier, we are withdrawing longer term guidance at this time.

To be clear.

This updated outlook does not reflect any change in our confidence regarding the underlying demand fundamentals for Asceniv as a later-line therapy for refractory and complex immune-compromised patients, which remain strong.

However, from where we sit today, we simply do not have the longer-term visibility that we had when the IG landscape was less competitive and in a period of undersupply.

Terry Kohler: The company has a differentiated growth asset in ASCENIV, a strong balance sheet, and a continued commitment to return capital to stockholders, expanding margins, positive free cash flow, and multiple levers to drive long-term value creation. With that, I'll turn the call back over to Adam for closing remarks.

overall, We Believe Admiral remains exceptionally well, positioned

The company has a differentiated growth asset in the Senate, a strong balance sheet and a continued commitment to return, Capital stockholders, expanding margins positive, free cash flow and multiple levers to drive long-term value creation.

With that, I'll turn the call back for jadam for closing remarks.

Adam Grossman: Thank you, Terry. In summary, we believe the most important takeaway from this quarter is that underlying ASCENIV growth trends continue to strengthen even as the distributors of plasma-derived therapies, including standard IG, work through a temporary period of dislocation, reinforcing the durability of ADMA's franchise. We remain focused on what matters: ASCENIV patient outcomes, product pull-through, patient adherence, prescriber expansion, and long-term margin expansion and earnings power. Across each of those dimensions, we continue to see encouraging trends even beyond Q1. We see meaningful long-term opportunity in SG-001 and in the broader platform we have built. We remain focused on disciplined execution in creating long-term stockholder value. Our confidence in SG-001's market potential remains unwavering as we continue to see a potentially rapid path to commercially scaling the SG-001 product to $300 million to $500 million on an annual basis if approved.

Thank you, Terry.

In summary, we believe the most important takeaway from this quarter is that underlying incentive growth Trends, continue to strengthen even as a Distributors of plasma derived therapies including standard IG, work through a temporary period of dislocation.

Reinforcing the durability of the Atmos franchise.

We remain focused on what matters.

Incentive patient outcomes product pull through patient adherence, prescriber expansion, and long-term margin expansion and earnings power.

Across each of those Dimensions, we continue to see encouraging Trends even beyond the first quarter.

Additionally, we see meaningful long-term opportunity in sg01 and in the broader platform we have built.

We remain focused on disciplined execution, in creating long-term stockholder value.

our confidence in sg01 Market, potential remains unwavering

Adam Grossman: Despite recent competitive challenges, we believe we are operating from a position of relative strength. Our business is highly differentiated and specialized. Yield-enhanced production remains embedded in our commercial model. Our plasma sourcing strategy has become more capital efficient and more diversified. Our balance sheet remains flexible, and we are generating robust cash while continuing to invest behind the franchise and our capital-efficient pipeline. We believe that combination positions us well to navigate the current and rapidly evolving US immunoglobulin environment, and we are confident ADMA and ASCENIV will emerge even stronger as market conditions normalize. Thank you for your time today, and thank you for your continued support of ADMA Biologics. With that, operator, please open up the call for questions.

As we continue to see a potentially rapid path to commercially scaling the SG 00001 product to $300 million to $500 million on an annual basis, if approved,

Despite recent competitive challenges, we believe we are operating from a position of relative strength.

our business is highly differentiated, and specialized

Yield-enhanced production remains embedded in our commercial model. Our plasma sourcing strategy has become more capital-efficient and more diversified.

Behind the franchise and our capital-efficient pipeline.

We believe that combination positions us. Well to navigate the current and rapidly evolving us immunoglobulin environment.

And we are confident, admah and ascendant, will emerge, even stronger as market conditions. Normalized.

Thank you for your time today and thank you for your continued support of adma biologics.

With that operator, please open up the call for questions.

Operator 2: Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.

Operator: Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.

Thank you. At this time. We will conduct a question and answer session as a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced to withdraw your question. Please, press star, 1 1 1, again please, stand by while we compile the Q&A roster,

Operator 1: Our first question comes from Anthony Petrone at Mizuho Financial Group.

Operator: Our first question comes from Anthony Petrone at Mizuho Financial Group.

Our first question comes from, Anthony petroni at meizuo Financial Group.

Anthony Petrone (Mizuho Financ: Thanks. Good afternoon, everyone. Maybe, you know, the standard IG backdrop comments, Adam, you know, different, some pressure in that segment. Wholesalers and distributors are changing their ordering patterns. We have competitive dynamics.

Anthony Petrone: Thanks. Good afternoon, everyone. Maybe, you know, the standard IG backdrop comments, Adam, you know, different, some pressure in that segment. Wholesalers and distributors are changing their ordering patterns. We have competitive dynamics.

Uh thanks uh good afternoon everyone. So maybe you know the standard IG backdrop comments. Adam

You know, different, um, some pressure in that segment.

Adam Grossman: Yep.

Anthony Petrone (Mizuho Financ: It appears certainly supply, you know, has built up in the channel. Then you have price pressure, you know, being triggered by some of the competitors out there. I guess at what point did this really start to build, you know, within the channel? When did you sort of see it on the radar screen? You're sort of referencing the April patterns here, you know, somewhat reversing. What really is line of sight as to when some of these pressures sort of dissipate and we get back to sort of a normal underlying landscape in the traditional IG space? I'll have a couple of follow-ups.

Anthony Petrone: It appears certainly supply, you know, has built up in the channel. Then you have price pressure, you know, being triggered by some of the competitors out there. I guess at what point did this really start to build, you know, within the channel? When did you sort of see it on the radar screen? You're sort of referencing the April patterns here, you know, somewhat reversing. What really is line of sight as to when some of these pressures sort of dissipate and we get back to sort of a normal underlying landscape in the traditional IG space? I'll have a couple of follow-ups.

Wholesalers and Distributors are changing their ordering patterns. We have competitive Dynamics.

Yep. Uh, it appears certainly Supply, um, you know, has built up in the channel.

And and then and then you have price pressure, you know being triggered by some of the competitors out there. So

You know, I guess at what point did, did this really start to build, you know, within the channel? When did you

Sort of see it on the radar screen.

and you sort of referencing the April patterns here,

You know, somewhat reversing. What really is line of sight as to when some of these pressures sort of dissipate?

and we get back to sort of a normal underlying landscape.

Adam Grossman: Sure. Thanks. Thanks, Anthony. We appreciate the question. As you know, the new entrants launched in the back half of 2025, but we really started to see the competitive nature of some of the rebating and discounting. It was really towards the end of February, beginning of March. Distributors were informing us that they were preparing to place orders and then the market just grew into a state of intense dislocation. As we've said, BIVIGAM was the product that was primarily impacted here. I think if folks recall our commercial history, you know, BIVIGAM's now been on the market 5+ years.

In the traditional IG space, and I'll have a couple of follow-ups.

Sure, thanks. Thanks, Anthony. We appreciate the question. So, um, as you know, the new entrance launched in the back half of 2025, but we really started to see, uh, the, the competitive nature of some of the rebating. And, and discounting it was really towards, uh, um, the end of February, beginning of March, um, Distributors were informing us that they were preparing to to, to place orders and then um,

the market just

grew into a state of intense dislocation. Um,

as we've said, Biv again, was the product that was primarily impacted here. Um,

Adam Grossman: When we launched, it was the most expensive standard IG product and we were afforded some very good utilization based on the reimbursement dynamics in the ambulatory infusion setting. I think that we've really done a good job at, you know, setting a nice model here, but new entrants have the benefit of setting new prices. They set some high ASPs. We've seen some dramatic ASP erosion, as I spoke about in the prepared remarks there. Primarily it was impacting BIVIGAM. From a utilization standpoint, we did see BIVIGAM take a decent hit in Q1 from a utilization standpoint. We are seeing that utilization revert a little bit towards the back part of March and certainly April.

I think if, uh, folks were call our commercial history, you know, Biv again, has now been on the market 5 plus years. Um, when we launched it was a, it was the most expensive standard IG product and, and we were afforded some. Some, some very good utilization based on the reimbursement, Dynamics in the ambulatory infusion setting. And I think that we've really done a good job at, you know, setting a nice model here, but um new entrance have the benefit of setting new prices. They set some high asps, we've seen some dramatic ASP erosion, uh, as I spoke about in the prepared remarks there. But um uh primarily it was impacting Divan from a utilization standpoint. We did see Viv again takes

Adam Grossman: For BIVIGAM, April was the best utilization month of the year so far. With respect to ASCENIV's been largely insulated. We saw record utilization in Q1 and April. We don't typically speak about individual month utilization, we think this is a pretty unique period here. We hit record level of end user utilization in the month of April. What we said during the prepared remarks is that the level of utilization of April is in line with the direct sales that we made in Q1. This is a recent dislocation with respect to ordering patterns and discounting. I do think that this could persist for some period of time. We are seeing trends of reversion for BIVIGAM. Again, ASCENIV, our confidence is unwavering with ASCENIV.

It take a decent hit in in q1 from a utilization standpoint. We are seeing that utilization revert. A little bit towards the back part of March and certainly April, uh, or or bid again, April was the best utilization month of, of the year so far. But with respect to incentive incentive has been largely insulated. Uh, we saw record utilization in q1 and um uh April, and we don't typically uh uh, speak about individual months utilization, but we think this is a pretty unique period.

Period here. But we had record level of end user utilization in the month of April. And what we said during the prepared remarks is that the level of utilization of April is in line with the direct sales that we made in q1. So, um, this is a, a recent

Adam Grossman: We feel that this product is going to continue to grow quarter over quarter. We don't want investors to think that for any reason the core driver of value for our business on a go-forward basis is at risk here. As a later line therapy, ASCENIV is continuing to open up new doors. We're seeing accelerating patient starts, and we're very encouraged by the trends that we're seeing for ASCENIV.

A sense.

Operator 1: Our next question comes from Gary Nachman at Canaccord Genuity.

Operator: Our next question comes from Gary Nachman at Canaccord Genuity.

our next question comes from Gary natman at kennore, genuity

Gary Nachman: Hi, good afternoon. A few questions from me. What is factored in your revised guidance with respect to both ASCENIV and BIVIGAM for 2026? If you could break that out separately. Adam, maybe just describe a bit more how much pricing pressure are you seeing with BIVIGAM, if you can quantify that? How are you adjusting your plans for manufacturing of that product versus ASCENIV? I mean, do you think it pays to still compete in the standard IG space going forward? Just a bit more on what the demand queue looks like for ASCENIV.

Hi, uh, good afternoon. A few questions from me. So, um, what is factored in your revised guidance with respect to both incentives and Vivicam for 2026? If you could break that out separately. And then Adam, maybe just describe a bit more—how much pricing pressure are you seeing with this? Again, if you can quantify that. And how are you adjusting your plans for manufacturing of that product versus incentive? And, I mean, do you think it pays to still compete in the standard IG space going forward?

Gary Nachman: You know, describe the key metrics that you're seeing on that and how soon you think new patients will be coming off that queue and getting treated with ASCENIV if you're confident that you're gonna see this sequential growth going forward for it.

Um, and then just a bit more on what the demand queue looks like for incentives. So, you know, describe the key metrics that you're seeing on that and how soon you think new patients will be coming off that queue and getting treated with incentives. If you're confident that you're going to see this,

Adam Grossman: Thank you, Gary. That's a lot of questions in one. I was taking notes feverishly, so if I don't hit on something, please feel free to ask me again. With respect to guidance, you know, this updated framework is really based on the recent dislocation and the competitive pressures. This assumes that there's gonna be some sustained pressures in the standard IG space, which should persist really we're thinking for the remainder of 2026. Again, it could be a little shorter, it could be a little longer. Again, I, we just don't have the visibility right now. We've certainly taken a conservative approach here. I mean, this is certainly not something that we're happy to do. There was a lot of thought that went into this.

Sequential growth going forward for it.

So uh thank you, Gary. Um, that's a lot of questions in 1. I was taking notes feverishly. So if I don't hit on something, please um, uh, please, please feel free to, um, ask me again. Um, so with respect to guidance, you know, this updated framework is really based on the, um, recent, dislocation and the competitive pressures. So this assumes that there's going to be some sustained pressures in the standard IG space. Um, which should persist

Adam Grossman: Again, we really want to reiterate that we are collecting the raw material plasma from our third-party providers. We are working on producing as much ASCENIV as we possibly can. We are seeing that pull-through is accelerating month over month, and that our production is really just starting to be able to meet that pull-through level here. We are making more batches of ASCENIV in the first part of this year than we ever have in our corporate history at this point in a calendar. We're very pleased with our third-party plasma procurement. We're very pleased with yield enhancement. Again, all the product that we're selling so far this year is yield-enhanced manufactured product.

Really, we're thinking for the remainder of 2026. Again, it could be a little shorter, it could be a little longer again. I, we just don't have the visibility right now. Um, we've certainly taken a conservative approach here. I mean, this is certainly not something that that that we are. We are happy to do. There was a lot of thought that went into this. And um again we we really want to reiterate that we are collecting the raw material Plaza from our third party providers. We are working on producing as much incentive as we possibly can. And we are seeing that pull through is, is accelerating month over month. And that our production is, is, is really just starting to be able to meet that pull through level here. So, um, we are making more batches of incentive. In the first part of this year than we ever have in our corporate history at at, at, uh, this point in a calendar.

Adam Grossman: With respect to your questions about BIVIGAM, you know, look, I've always said it, Gary, I never wanted to be in the standard IG business. When we acquired this manufacturing facility about 9 years ago, we inherited this product. Again, it's a good product. It's a safe product. It's a product that is efficacious, and doctors like it. Unfortunately, right now we're seeing heavy discounting from new entrants. If you look at the ASP of some of the new products out there, you can see that from their launch to where they are now in Q2 from an ASP re-reported to CMS level, they've discounted in the order of between 15% to 20% they've eroded from their original pricing. That's pretty substantial.

So, um, we're very pleased with our third party positive procurement. We're very pleased with yield enhancement. Again, all the products that we're selling. Um, so far this year, is yields, enhanced manufactured product, um, with respect to your questions about vitamins, you know. Look, I've always said it. Gary, I I I never wanted to be in the standard IG business but we when we acquired this manufacturing facility about 9 years ago, uh, we inherited this product and again, it's it's it's a good product. It's a safe product. Uh, it it's a product that that is efficacious and doctors like it. Unfortunately, right now, we're seeing heavy discounting from new entrance. And if you look at the ASP of some of the new products out there, you can see that from their launch to where they are now. In the second quarter from an asp, uh, reported to CMS level. They've discounted in the order of between 15 to 20%. They

Adam Grossman: It's not a game or a tactic that ADMA Biologics has ever chosen to play. We've pretty much been pretty consistent from a pricing standpoint. Our ASP is very predictable. It doesn't move around a lot. To certain sites of care and to certain books of business, that is valuable. Does it pay to compete in this market? I think the best way I could say it to you, Gary, is we're not gonna go out and provide high levels of discounting just to make some sales. It doesn't benefit you into the future. You know, as I mentioned, we're already seeing BIVIGAM revert to very, very strong utilization levels here in April. You know, my guess is that some of these new entrants have some short-dated material. I hear anecdotal reports of that.

Eroded from their original pricing so uh that's that's pretty substantial. Um it's not a game or a tactic that adma biologics has ever chosen to play. Um, we've pretty much been pretty consistent from a pricing standpoint. Um, our ASP is very predictable, it doesn't move around a lot and to certain sites of care and to certain books of business that is valuable.

Adam Grossman: My guess here is that they're just trying to play a game to dislocate products like ADMA's from utilization to get people familiar with the product. I don't think it's a strategy that's going to benefit these competitors long term. I think the strategy that ADMA's taken, and we're playing the long game here, focused on long-term growth and value creation for stockholders, and ultimately providing good products that help patients. I do think it pays to continue to manufacture BIVIGAM. It's a good product. It's a safe product. It's a product that is liked very much by our end user customers. I think this is a transitory period in nature, and I think that we'll weather this storm, and we'll come out the other side stronger.

Adam Grossman: I don't know, Terry, if there's anything that you want to add regarding guidance or anything like that, but, you know, the variability is really just ordering patterns, Gary. ASCENIV demand remains strong. Guidance is conservative, but it really takes into account these competitive pressures. You know, it doesn't take into consideration any change in our outlook for ASCENIV demand as a later line therapy in the refractive complex immunodeficient patient.

But I don't think it's a strategy that's going to benefit these competitors long term. I think the strategy that I had mistaken and we're playing a long game here. Focus on long-term, growth and value creation for stockholders, uh, and ultimately providing good products that that help patients. So um, I do think it pays to continue to manufacture Viv again. It's a good product. It's a safe product, it's a product that is liked very much by our end-user customers. I think this is a transitory period in nature, um, and I think that will whether this storm and will come out the other side stronger so um I don't know Terry if there's anything that you want to add regarding guidance or anything like that. But but you know the variability um,

Terry Kohler: Yeah, Gary, I just echo that. I mean, really the primary assumptions I think you're getting at is that for BIVIGAM, you know, what we're assuming in this guidance is a sustained level of this increased competition. ASCENIV, we are, you know, we fully believe in that product and its capabilities, and it will continue to grow quarter-over-quarter, and that's what's baked into the assumptions.

Is really just ordering patterns. Scary incentive demand remains strong, um, guidance is conservative, but really takes into account these these competitive pressures. Um, and, you know, it doesn't take into consideration. Any change in our outlook for incentive demand, as a later, line therapy in the refractive complex, immuno deficient patient.

Gary Nachman: Okay. If I could just follow up with one more. Just, Terry, maybe explain a little bit more, since there has been so much focus on the DSOs. Just, you know, you're expecting that to get to a more reasonable level of 90 to 105 days, from where it is currently. Just, you know, how you expect to get there and in what timeframe and the initiatives you're putting in place with your current customers, how important McKesson is to help you get there as well, and how much that's gonna play into, you know, the continued increases in cash flow generation that you talked about. Thank you.

Yeah, Gary, I I just Echo that. I mean, that really the primary assumptions. I think you're getting at is that forbid. Again, you know, we're assuming in this guidance is a sustained level of this increased competition. A sense of we are, you know, we're fully believe in that product and its capabilities and it will continue to grow quarter of a quarter, and that's what's baked in at the, uh, assumptions.

Terry Kohler: Sure. As I said, DSOs in the quarter were 107 days. You know, we want to target between 90 and 105 days. You know, we believe that in the back half of this year, we are going to be able to drive improvement in our DSOs. McKesson, as you pointed out, is going to be an important factor in that. As that business continues to grow, as a percentage of our overall distribution partners, you know, they are favorable to our overall DSO performance. We believe that, you know, that will push us down into a range that, you know, is, you know, within our target. That's a big piece of it.

Okay um and if I could just follow up with 1 more and just um sorry maybe explain a little bit more since there has been so much focus on the DSO. So just, you know, you're expecting that to get to a more reasonable level of 90 to 105 days, um, from where it is currently. So just, you know, how you expect to get there and at what time frame and the initiatives you're putting in place with your current customers how how important McKesson is to help you get there as well and how much that's going to play into, you know, the continued increases in cash flow generation. That you talked about, thank you.

Terry Kohler: We also believe that, you know, although we believe that there's competition and it will continue for the rest of the year, we do believe that ordering patterns will normalize, and so that's baked into that as well. As you said, you know, some of the concessions that, you know, we have provided in normal course to distribution partners, you know, over, you know, the first part of this year, you know, we're gonna look to tailor that back in the back half of this year. All those things should help us with our DSOs.

Sure. Um, so as I said, dso's in the quarter, we're 107 days, you know, we want to Target between 90 and 105 days. You know, we are, we believe that in the back half of this year, we're going to be able to drive improvement in our dsos McKesson. As you, as you pointed out, it's going to be important factor in that as that business continues to grow, uh, as a percentage of your overall, uh, distribution partners. Then, you know, they are favorable to our overall, uh, DSO, uh, performance. And we believe that, you know, that will push us down into a range that, um, you know, is, you know, within our Target. Um, that's a big piece of it. We also believe that, you know, although we believe that this competition and it will continue for the rest of the year. We do believe that, uh, ordering Powers will normalize and so that's baked into

Adam Grossman: Gary, if I could.

That as well. And as you said, you know some of the uh concessions that you know we had provided a normal course. Uh to distribution Partners, you know over uh the first part of this year, you know we're going to look to tailor that back in the back half of this year. So all those things should help us with our dsos and

Gary Nachman: Yeah

Adam Grossman: touch on one thing. You know, something else that we're thinking about here, and as Terry was speaking and I was thinking about McKesson and the opportunity from the new book of business that we're able to target now that we've got that distribution partner in place. You know, secondary immune deficiency is really the largest driver of growth of IG. When Terry was speaking, I was thinking about the fact that, you know, we're in this period right now where, you know, my entire adult life I've been in the IG space. You know, ADMA Biologics has been a company, call it 20 years, and for that entire time, you know, you've really seen this dislocation with respect to there's a supply and demand imbalance. There's more demand than the industry was always able to produce.

Gary, if, if I could just touch on 1 thing, you know, something else that we're thinking about here, and as, as Terry was speaking, and I was thinking about McKesson, and, and the opportunity from the, um, um, new book of business that we're able to, um,

Target now that we've got that distribution partner in in place, you know, secondary immune deficiencies is really the largest driver of growth of IG. And um when Terry was speaking I was thinking about the fact that you know, we're we're in this period right now where

Um, you know, my entire adult life I've been in the IG space. Um, and, you know, add biologics has been a company called 20 years. And for that entire time

Adam Grossman: This is the first time, I think I said this in the prepared remarks, right? That this is the first time that the market is in a period of, you know, be it consistent supply or maybe a period of oversupply. You know, for the last decade plus, IG has been growing at 10%, you know, low double digits, 10%, 11%, 12%, 13% year over year. IG has been growing. What we see now, and we see some of the industry expert analyst reports that are coming out, they're forecasting low single digit growth. You're talking about 2%, 3%, 4% growth year over year.

You know, you've really seen this dislocation with respect to there's a supply and demand imbalance, there's more demand and the industry was always able to produce. This is the first time and I think I said this in the prepared remarks, right? That this is the first time that the market is is is in a period of, you know, be it consistent Supply or maybe a period of of of of of oversupply. And you know, for the last decade plus IG has been growing at 10.

%. You know, low double digits 10, 11 12, 13% year-over-year. IG has been growing

and what we see now, and we see some of the industry expert, analyst reports that are coming out their forecasting, low single digit growth,

Adam Grossman: You know, I don't think this is something that our brethren IG companies are out there talking about publicly, it's also factored into our guidance and, you know, why we're targeting the secondary immune deficient population and going after that book of business. I thought it was something important to say, IG is still growing. It's still a highly durable business. The use of immunoglobulin is not going away anytime soon. It's just these periods where we used to see low double digit growth year over year. We're now seeing low single digit growth. I think this is transitory, but I think it's something that's important for us to get out there and that investors are aware of. The market's robust. It's still growing. It's just growing a little slower.

IG companies are out there talking about publicly, but, um,

Terry Kohler: Gary, I think.

Gary Nachman: Okay

Terry Kohler: The other part of that question was on, you know, cash generation. Obviously in the quarter, we generated a substantial amount of cash. Our cash from operations was $58 million, you know, which is greater than, you know, all of 2025. We believe that our cash generation is gonna continue to be, you know, strong over the course of this year. We believe that's just gonna continue over the course of this year.

It's also factored into into our guidance. And you know why? We're targeting these, the secondary immune deficient population and going after that, that book of business. So I thought it was something important to say, but um IG is still growing, it's still a highly durable business. I the the use of immunogen is not going away anytime soon. It's just these periods where we used to see low low double-digit growth year-over-year. We're now seeing low single-digit growth and I think this is transitory but I think it's something that's important for us to, to get out there. And that investors are aware of the Market's robust, it's still growing. It's just growing a little slower.

Gary Nachman: Okay. Actually that was all helpful. If I could just squeeze in two more quick ones, 'cause I normally get these questions. Just wanna make sure that you don't think there's gonna be any spillover in terms of discounts and rebates that you're seeing in the standard IG space over to ASCENIV. You know, that it's gonna hold up in terms of pricing. SG-001, you highlighted a bunch of times, but just how long you think it would take you to run the clinicals if you start it next year and, you know, when realistically it could reach the market? Thank you.

Gary, I think you're your other part of that question was on, you know uh cash generation and so, obviously in the quarter we generate a substantial amount of cash. Our cash from operations was 58 million, you know, which is greater than, you know, all of 2025. Uh we believe that our cash generation is going to continue to be strong, you know, strong over the course of this year. And so we we believe that's just going to continue over the course of this year.

Okay. And actually, that was all helpful. If I could just squeeze in 2 more quick ones, um, because I know I'm going to get these questions. So, um, just want to make sure that you don't think there's going to be any spillover in terms of discounts and rebates that you're seeing in the standard IG space over to incentive. Um you know, that it's going to hold.

Adam Grossman: Thanks, Gary. I'm just making notes so I don't miss a beat here. You know, look, we take this disciplined pricing approach across all of our products. You know, as I mentioned, ASCENIV has been largely insulated. We've seen growth from a utilization standpoint. You see that the broken out product level revenues, ASCENIV is still, you know, a strong product for us, generating substantial margin opportunity for us. And I think that that really does speak to the durability of the drug, the durability of our business model and our ability to be resilient in times of these competitive pressures. I don't think you're gonna see us discounting heavily anytime soon. It's just not a practice that we want to engage in. I think the product speaks for itself.

Up in terms of pricing uh and and then 001 you highlighted a bunch of times but just how long you think it would take you to run that the clinicals if you start it next year and you know when realistically it could reach the market, thank you.

Adam Grossman: I think that the data that we have published, that others have published independently of ADMA, I think that really demonstrates and speaks volumes for the utility of this drug in the refractive, highly complex, immune deficient patient that is chronically ill and suffers from persistent infections. It's a differentiated drug. No one has anything like it out there in the market. Again, our government payer, commercial payer split, it's leaning a little bit more towards the commercial payers. We've certainly been contracting over the course of 2025 into 2026 with some of these commercial payers. You know, we all know how the game works with the commercial payers.

Thanks Gary. I'm just making notes. So I don't, uh, Miss A Beat here. So, you know, look we take this discipline pricing approach across all of our products. So um, you know, as I mentioned incentive has been largely insulated, we've seen growth from a utilization standpoint. Um, you see that the Broken Out product level revenues, percentage is still, you know, a strong strong product for us generating, substantial margin opportunity for us. Um, and I think that that really does speak to the durability of the of the drug, the durability of our business model and, and, and our ability to be resilient in times, of these competitive pressures. So, um, I don't think you're going to see us discounting heavily anytime soon. It's just not a practice that we want to engage in. I think the product speaks for itself. I think that the data of that we we, we, we have published that others have published independently of admah. Um, I think I think that that really demonstrates and speaks volumes for the utility of this.

In the refractive, highly complex.

Adam Grossman: There are a couple points there depending upon how much utilization there is, but we're very proud of the positioning for both our products with ASCENIV and BIVIGAM. We're very proud of the status that we have with the Florida Cancer Group, which works exclusively through McKesson specialty business. I don't anticipate there's going to be any substantial discounting for any of our products, including ASCENIV, to answer your question. With respect to SG-001, so we haven't given any timelines yet, but you asked a question that is reminding me of things I used to say many, many years ago when we were running the clinical trial for ASCENIV, which was then known as RI-002.

Um, immune deficient patient, that, that is chronically ill and suffers from persistent infections. So, um, it's a differentiated drug. No 1 has anything like it out there in the market. Um, and again our, our our government payer commercial payer split. It's leaning a little bit more towards the commercial payers. Uh, we certainly didn't Contracting over the course of 2025 into 2026, but some of these commercial payers. So you know, we all know how the game works with. The commercial payers. There are a couple points there depending upon how much utilization there is. But we're very proud of the positioning for both our products. So that the Senate and bid again, uh, we're very proud of the status that we have with, uh, the Florida Cancer Group, which um, Works exclusively through the cat and Specialty business. So, um, I I don't anticipate there's going to be any, uh, uh, substantial discounting for any of our products including the Senate to answer your question.

Adam Grossman: You know, assuming that all of our animal work, all the preclinical testing that we're doing, all the assay testing, all the pilot scale lot production that we're doing pans out, when we are ready to start a clinical trial, you know, there are multiple shots on goal with a product like this. You know, are we going to go for something similar to what we've done with ASCENIV? Are we going to go for something a little sexier with respect to a potential treatment indication for hospitalized patients? There are a number of avenues that we are seeing benefits in preclinical testing that we could go for this product.

With respect to sg01. So we haven't given any timelines yet, but you asked a question that is, um, reminding me of things. I used to say, many, many years ago when we were running the clinical trial for incentive, which was, uh, uh, then known as r, i 0002. But, um, you know, assuming that all of our animal work, um, all the preclinical testing that we're doing. All the assay testing all the

Um, uh, pilot scale law production that we're doing pans out. Um, when we are ready to start a clinical trial, you know, there are multiple shots on goal with a product like this.

Adam Grossman: Hypothetically, if we were going to go for this like we did for ASCENIV's clinical trial, the FDA has published guidance for industry on how to bring an immunoglobulin to market. Typically you have to take, I believe it's about 50 patients that are well-controlled patients off of their commercial IG. Then you replace their commercial IG with the investigational product for 12 months. And if the primary endpoint of that study, if there's less than 1 serious bacterial infection per patient per year, then you will be deemed to have met the primary endpoint of less than 1 serious bacterial infection per patient. Pretty much every IG that I'm aware of that has run a PID study has met the primary endpoint. It is a 12-month study.

Has published guidance for industry, um, on how to bring in immune globulin to market. Uh, typically you have to take, uh, I believe it's about 50 patients that are well-controlled patients off of their commercial IG.

Um, then you replace their commercial IG with the investigational product for 12 months.

Adam Grossman: To run a 12-month study, I'm pretty sure I've been quoted in the public settings saying to do a 12-month study takes about 18 months to do. If that is the pathway, that could give you some idea. We have not yet provided timing on when that trial will start. We have given guidance that we will plan to meet with FDA this year on a pre-IND meeting so that as we enter 2027, we'll be in a position to provide guidance to the street on what kind of trial we're going to run, how long it's going to take, what it's going to cost. Stay tuned, but very encouraged by the data.

Um, and if the primary endpoint of that study, um, if um, there is less than 1 serious bacterial infection per patient per year, then you will be, um, to have a deemed to have met the primary endpoint of less than 1. Serious bacterial infection for patient. Um, um, pretty much every IG that I'm aware of that has run an eye, uh, a PID study, um, has met the primary endpoint. So, um, it is a 12-month study to run a 12-month study. I'm pretty sure I've been quoted in in the public setting is saying do a 12-month study takes about 18 months to do. Uh but if that is the pathway that that could give you some idea but um we have not yet provided timing um, on when that trial will start. But we have given guidance that we will plan to meet with FDA this year on a pre-ind meeting. So that as we, um, enter 2027, we'll be in a position to provide guidance to the street on. What kind of trial we're going to run, how long it's going to take.

Adam Grossman: We're going to be at this conference in a couple of weeks, and I encourage investors and others to take a look at our website as it gets updated with respect to that preclinical data.

What it's going to cost, so stay tuned, but very encouraged by the data. Uh, we're going to be at this conference in a couple of weeks and, um, I encourage investors, um, and, um, others to take a look at our website as it gets updated with respect to that preclinical data.

Gary Nachman: Okay. Thank you for taking all my questions. I appreciate it.

Okay, thank you for taking all my questions. I appreciate it.

Operator 1: Our next question comes from Kristen Kluska at Cantor.

Operator: Our next question comes from Kristen Kluska at Cantor.

Kristen Kluska: Hi, everyone. Thank you so much for taking the questions. When we think about the prior revenue guidance, I think the underlying assumption was always that a vast majority of it was going to be driven by ASCENIV and understand a lot of the color you provided to us today on BIVIGAM, which was very helpful. Maybe can you just help us understand, are you looking for any specific dynamics in the market over the next few months that will get you comfortable providing guidance, especially again, as it relates to the fact that ASCENIV is going to have a lot more of the revenue share in the future? You know, the other question I had was just understanding the real-world benefits. I know CIS is this week.

Our next question comes from Kristen kluska at kenter.

Kristen Kluska: I know there's been some third-party publications out there and how you plan to maybe utilize these datasets, not just for your physician conversations, but if it could also help with the payer and reimbursement piece as well. Thank you.

Adam Grossman: No, thanks for the questions, Kristen. Maybe I'll take your second question first. Yes, this data that we have been publishing and that other third parties published on their own has been very helpful in our payer conversations throughout the back half of 2025 and into 2026. The payers are seeing this real-world evidence in their own patient populations. They're seeing these patients staying out of the hospital. They're seeing less frequent ER visits and doctor's visits. They're seeing less concomitant medications in the patients that switch from standard IG to ASCENIV because of their chronic persistent infection. This real-world data is really adding value for us from a commercial payer perspective, full stop.

Hi everyone. Thank you so much for taking the questions. So, when we think about the prior Revenue guidance, I think the underlying assumption was always that a vast majority of it was going to be driven by incentive and understand a lot of the color you provided to us today on Viv again, which was very helpful, but maybe can you just help us understand? Are you looking for any specific Dynamics in the market over the next few months? Um, that will get you comfortable providing guidance, especially again, as it relates to the fact that incentive is going to have a lot more of the revenue share in the future. And then, you know, the other question I had was just understanding the real world benefits. I know CIS is this week. I know there's been some third-party Publications out there and how you plan to maybe utilize these data sets, not just for your physician and conversations, but if it could also help with the payer and reimbursement piece as well, thank you.

But thanks for the questions Kristen. So, um, I mean I'll take your your your second question first. Um yes. This data that we have been publishing and that other third parties um uh published on their own um has been very helpful in our payer conversations throughout the back half of uh 2025 and into 2026. So um the payers are seeing this real world evidence in their own patient populations. They're seeing these patients staying out of the hospital. Um they're seeing less frequent, ER visits and doctor's visits. Um and they're seeing less con committed medications in the, in the patients that switch from standard IG to a senate because of their chronic persistent infection. So this real world data is is is really adding value for us from a commercial payer perspective.

Adam Grossman: With respect to, I think the first part of your question, you know, the real-world data is really helping to convert clinicians that have been on the fence. I know, Kristen, we've spoken about this a lot during our conversations together over the years. You know, there's a large amount of clinicians that are in the buy and bill space with respect to TI, IVIG administration. What I can tell you, the feedback from my commercial team has been robust and very, very positive with respect to how the clinicians, if you will, I'm using quote marks, that are on the fence of do they want to take the risk and buy in all this ASCENIV to give it to a patient because they're afraid they might not get reimbursed.

Full stop, uh, with respect to, um, I think the first part of your question, um, you know, the, the the real world data is really helping to convert clinicians that have been on the fence.

Uh I know Kristen we've spoken about this a lot uh during our conversations together over the years. You know, there's a large amount of clinicians that are in the buying Bill space with respect to P um IVIG Administration. And what I can tell you the feedback from my commercial team has been robust and and very very positive with respect to how

Adam Grossman: What I can tell you is that this data has really helped us push a number of clinicians over that line, and they have become converts, and they have started patients this year in 2026. As I said in the prepared remarks, we're seeing increasing new prescribers. We're seeing new patient adds all the time. You know, everything is really coming together. I know it's our fifth plus year of commercial launch here, but we really feel that the opportunity is in front of us, that ASCENIV is really starting to gain traction and momentum in the ambulatory infusion setting. I think that all the reasons that we spoke about the McKesson specialty agreement and the book of business from a secondary immune deficient population perspective, we think that that certainly is a great opportunity for the product.

Know the clinicians, if you will—I'm using quote marks—that are on the fence of, do they want to take the risk and buy in all the percentage to, um, uh, give it to a patient? Because they're afraid they might not get reimbursed. And what I can tell you is that this data has really helped us push a number of clinicians over that line, and they have become converts. And they have started patients this year in 2026. Um, as I said in the prepared remarks, we're seeing increasing

Ads all the time.

Adam Grossman: We haven't spoken about it much, but with the pediatric indication, we think that this is certainly gaining very good conversations with pediatric teaching hospitals. We hear some are even discussing putting this on formulary for hospitalized immunocompromised children. You know, while we've always given, you know, again, because it's weight-based dosing, but I do think that there is a big push right now from a medical education perspective, and doctors are really understanding where the utility is for this product. The outlook for the drug remains positive. We think the forward-looking opportunity is going to drive this company's growth and profitability. It'll help fund all of the capital deployment initiatives that we have with share buybacks.

And you know, everything is really coming together and I know it's our fifth plus year of of commercial launch here, but but we really feel that the opportunity is in front of us, that a senate is really starting to gain traction. And momentum. In the ambulatory infusion setting, I think that all the reasons that we spoke about the McKesson, um, specialty agreement, and the Book of business from a secondary immune deficient. Um, population perspective, we think that that's certainly, is a great opportunity for the product and also, we haven't spoken about it much. But with the Pediatric indication, we think that, that this is certainly gaining, um, some some uh, a very good conversations with uh, pediatric teaching hospitals. Uh, we hear some are even discussing putting this on formulary for hospitalized immuno, compromised children. So, you know, while we've always given, you know, again, because it's weight-based dosing. Um, but I do think that

that there is, um,

Adam Grossman: ASCENIV is gonna continue to fund our R&D, and it's going to potentially fund any future clinical trials from our very capital-efficient R&D engine. It's a great drug. The core message of our business and the core message of today is that BIVIGAM got hit. ASCENIV is largely insulated. The growth outlook, we are unwavering in the forward-looking growth opportunity. How fast it's going to grow, that's what we are sighting to right now, is there are some challenges in the market, but will the product grow? We believe it will. Thanks for that question and, you know, we really do believe in the outcomes and the clinical benefits that patients experience while on the drug. It's a good product that helps patients that have no alternative, Kristen, and it's gonna continue to do so.

A big push right now from a medical education and doctors are really understanding where the utility is for this product. So the outlook for the drug remains positive, we think the forward-looking opportunity is going to drive this company's growth and profitability, it'll help fund. Um, all of the um, Capital deployment initiatives that we have with share BuyBacks.

The same is going to continue to fund our R&D, um, and it's going to, uh, potentially fund any, um, future clinical trials from our very capital efficient R&D engine. So, um, it's a great drug but the core message of our business, and the core message of today, is that

Adam Grossman: Thank you, Adam.

Kristen Kluska: Thank you, Adam.

If again got hit, send of is largely insulated. The growth Outlook, we are unwavering in, in in the forward-looking growth opportunity, how fast it's going to grow. That's what we are starting to right now. Is there are some challenges in the market, but will the product grow we believe it will so, um, thanks for that question. And and um, you know, we we really do believe in the outcomes and the and the clinical benefits that patients experience while on the drug, it's a good product that helps patients, that have no alternative Kristen and it's going to continue to do so.

Thank you, Adam.

Operator 2: Our last question comes from Anthony Petrone at Mizuho Financial Group.

Operator: Our last question comes from Anthony Petrone at Mizuho Financial Group.

Our last question comes from Anthony Petrone and meizuo Financial Group.

Anthony Petrone (Mizuho Financ: Thanks. Just popping across some polls here. Adam, you mentioned just excess plasma supply as well that's out there, so it sounds like there's elevated finished IG on the shelf and maybe some elevated plasma. You know, when you just think of that totality, again, you sort of mentioned it's gonna take a little bit of time to work itself out. If you had to estimate it, you know, is that 2 quarters? Could it last 1 year? Just how long does it take the supply chain to straighten out? Just to McKesson, quickly there, when you think about new sites of care, like how quickly can the McKesson addition actually result in net new prescribers for ASCENIV? Thanks.

Anthony Petrone: Thanks. Just popping across some polls here. Adam, you mentioned just excess plasma supply as well that's out there, so it sounds like there's elevated finished IG on the shelf and maybe some elevated plasma. You know, when you just think of that totality, again, you sort of mentioned it's gonna take a little bit of time to work itself out. If you had to estimate it, you know, is that 2 quarters? Could it last 1 year? Just how long does it take the supply chain to straighten out? Just to McKesson, quickly there, when you think about new sites of care, like how quickly can the McKesson addition actually result in net new prescribers for ASCENIV? Thanks.

Uh, thanks just hopping in Cross some calls here. Madam you mentioned, just excess plasma Supply as well.

That's out there. So it sounds like there's elevated.

Finished IG on the shelf and and maybe some elevated plasma.

you know, when you just think of that totality again, you you sort of mentioned it's going to take a little bit of time to work itself out, but if you had an estimated

You know, is that 2 quarters? Could it last a year just tell on, does it take the supply chain to straighten out and just to McKesson quickly there when you when you think about new sights of care like how quickly?

Adam Grossman: Thanks, Anthony. With respect to IG inventories, I mean, the Plasma Protein Therapeutics Association publishes data on IG sales from reporting manufacturers into the US market. If you go on their website, you can see the data for Q4 2025. That was published, I want to say, at the tail end of March. It really looks to me like there was an enormous amount of push in from the overall industry. You know, I want to say in December, I think the trend was roughly about 12 million grams or so of IG being sold by the industry to distributors or direct customers throughout the year on a monthly basis. I want to say in December, there was about 16 million grams or so sold.

Can the MST in addition actually result in net new prescribers for a senate. Thanks.

Uh, thanks Anthony. So with respect to

IG inventories. I mean, the, uh, plasma protein Therapeutics Association publishes, uh, data on, um, um, IG sales from reporting manufacturers into the US market. And, um, if you go on their website, um, you can see the data for the fourth quarter of 2025 that was, um, published. I want to say at the tail end of March. Um, we really looked to me, like there was an enormous amount of push in, uh, from the overall industry. Um, and, um, you know, I want to say in December. Um, I I, I think the trend was roughly about 12 million grams or so of IG being sold.

Adam Grossman: I don't have that data in front of me. I'm recalling that from memory. The point being, I don't think utilization grew, call it 20% between October, November and December. My crystal ball tells me there's some excess inventory with respect to standard IG from the overall industry in the channel that needs to work its way through. How long that takes, I don't know. IG utilization is robust. What I find encouraging, Anthony, is that BIVIGAM has returned to what I would like to say normal levels in April from a utilization standpoint. It's on the lower bound of what we've seen as normal, but it's back to a place where I'm not pulling the hair out of my head. I'm feeling better about the market situation.

Adam Grossman: How long it persists, I don't know. I don't know how much inventory our competitors have. I don't know how much longer they can continue to provide these aggressive discounts and rebates and how much more they want to erode their ASP. With respect to raw material, you asked the question, I mean, that's anyone's guess. I saw an announcement that one of our contracted third-party providers, while it's not going to impact ADMA's ability to collect raw material plasma to make ASCENIV the high-titer plasma, but Grifols has announced some center closures, and I know some other plasma collection organizations have announced that they're gonna be closing some centers. ADMA in the quarter monetized our centers. We signed a new third-party agreement with that collector, these other larger fractionators are choosing to close them down.

What I find encouraging Anthony is that bibigon has returned to what I would like to say. Normal levels in April, from a utilization standpoint, it's on the lower bound of what we've seen as normal. But it's back to a place where I'm not, you know, pulling the hair out of my head. So I'm feeling better about the market situation. So, how long it persists? I don't know. I don't know how much inventory our competitors have. I don't know how much longer they can continue to provide these aggressive discounts and rebates and how much more they want to erode their asp.

Adam Grossman: I think that there is an oversupply of raw material plasma. I think the spot market has some very attractive and favorable pricing at the lowest levels that I've seen in a while. I think that that may persist longer than the IG oversupply situation that's there. That would be a better question for others than me. You know, we are pretty much self-sufficient from a standard normal source plasma perspective. We collect that plasma from our current seven centers. We're in a pretty good position with respect to the high-titer procurement from our third-party providers and our internal collections. You asked about McKesson and its ability to materialize. We're already seeing increased utilization. April was a good month.

With respect to, uh, raw material, you asked the question? I mean that's anyone's guess. Um, I saw an announcement that, um, 1 of our contracted third party providers. While it's not going to impact adma's ability, to collect raw material, plasma to make incentive, the high titer plasma, but gripples, has announced in Center closures. And I know some other, um, uh, plasma collection organizations have announced that they're going to be closing some centers admin the quarter monetized, our centers. Uh, we signed a new third-party agreement with that collector, but these other larger fractionators are are, are, are are choosing to close them down. Um, I think that there is um, an oversupply of raw material plasma. I think the spot Market has some very attractive and favorable pricing at the lowest levels that I've seen in a while. Um, so I think that, that, that may persuade

Adam Grossman: You know, this is, you know, it's in line, I would say, with expectations, but, you know, you put a forecast together, and when you hit it, you're happy. The McKesson book of business is starting. We had a strong April, and we're anticipating that this is going to continue to grow and compound as we progress in the coming period. Hopefully that answers your questions. Thanks, Anthony.

Process longer than the IG, um, over Supply situation that's there. Um, but uh, that would be a better question for others than, than, than me. You know, we are, um, pretty much self-sufficient from a standard, um, uh, normal Source, plasma perspective, we collect that plasma from our current 7 centers. And again, we're we're in a pretty good position with respect to the um, high tide of procurement from our third party providers, and our internal collections, um, you asked about mesen and its ability to materialize. We're already seeing increased utilization, um, April was a good month. Um, you know, this is, you know, it's in line. I would say with expectations but you know, you put a forecast together and when you hit it, you're happy. So, uh, the McKesson book of business is is starting. Uh, we had a strong April, uh, and we're anticipating that this is going to continue to grow and compound. As we

Progress in the coming period. So um, hopefully that answers your questions. Thanks Anthony.

Operator 2: This concludes the question and answer session. I would now like to turn it back to Adam for closing remarks.

Operator: This concludes the question and answer session. I would now like to turn it back to Adam for closing remarks.

This concludes the question and answer session, I would now like to turn it back to Adam for closing remarks.

Adam Grossman: I just want to thank everybody for taking the time today to dial into today's call. We appreciate your continued support. Again, donate plasma. As I've always said, you can help save many, many lives with just one donation. Thank you again to the ADMA staff and team. Stay healthy, everyone, and have a great evening.

I just want to thank everybody for taking the time today to dial, in to today's call. Um, we appreciate your continued support. And, um, again, donate plasma as I've always said, you can help save many, many lives with just 1 donation. So, um, thank you again to the admin staff and team. Um, stay healthy everyone and have a great evening.

Operator 2: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Thank you for your participation. In today's conference, this does conclude the program. You may now disconnect

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Q1 2026 ADMA Biologics Inc Earnings Call

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Q1 2026 ADMA Biologics Inc Earnings Call

Wednesday, May 6th, 2026 at 8:30 PM

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