ADMA Biologics, Inc. Aktie

Good afternoon, and welcome to the ADMA Biologics First Quarter 2026 Financial Results and Business Update Conference Call on Wednesday, May 6, 2026. [Operator Instructions] 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 2 hours following the end of the call.

At this time, I would like to introduce the company. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the first quarter of 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 first quarter 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 first quarter 2026 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com.

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 obligation 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 31, 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?

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 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 ASCENIV demand, expanding margins and continued strong cash generation.

ASCENIV end market demand reached record levels in the first quarter with revenue growth of approximately 28% year-over-year. We saw continued strength and 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 the first quarter 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.

Operationally, during the period, we completed the monetization of 3 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 0.5x, 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. 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 back half of 2025, in 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 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 first quarter 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. 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 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 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 the 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. In our view, this is clear evidence that the first quarter 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.

These near-term competitive and pricing dynamics do not change our conviction in the forecast of 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. Our yield enhancement manufacturing process allows us to maximize the high-titer plasma 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 strep 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 method 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 development.

ADMA remains on track to submit its pre-IND package for SG-001 to the FDA later this year, and 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 a 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 immunocompromised patients remains unchanged. ASCENIV 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 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. 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 will begin with our first quarter 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 first quarter 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 $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. 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 facility draw and accelerated stock repurchase deployment, and we retained 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 31, resulted in ADMA 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 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, and we ended the quarter with $138 million of 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, and we believe DSOs 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 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. 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 have when the IG landscape was less competitive and in a period of undersupply.

Overall, we believe ADMA remains exceptionally well positioned. 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.

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 the first quarter. Additionally, we see meaningful long-term opportunity in SG-001 and in the broader platform we have built.

We remain focused on disciplined execution and 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. 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 U.S. immune globulin 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.

[Operator Instructions] Our first question comes from Anthony Petrone at Mizuho Financial Group.

So maybe the standard IG backdrop comments, Adam, different pressure in that segment. Wholesalers and distributors are changing their ordering patterns. We have competitive dynamics. It appears certainly supply has built up in the channel, and then you have price pressure being triggered by some of the competitors out there.

So I guess at what point did this really start to build within the channel? When did you sort of see it on the radar screen? And you're sort of referencing the April patterns here 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? And I'll have a couple of follow-ups.

Sure. Thanks, Anthony. We appreciate the question. So 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 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, BIVIGAM has now been on the market for 5-plus years. 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.

And I think that we've really done a good job at 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. But 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.

For BIVIGAM, April was the best utilization month of the year so far. But with respect to ASCENIV, ASCENIV has been largely insulated. We saw record utilization in Q1 and April, and we don't typically speak about individual months utilization, but we think this is a pretty unique period here. But we hit 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 this is a recent dislocation with respect to ordering patterns and discounting, but I do think that this could persist for some period of time. We are seeing trends of reversion for BIVIGAM, and again, ASCENIV -- our confidence is unwavering with ASCENIV. We feel that this product is going to continue to grow quarter-over-quarter.

So 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.

Our next question comes from Gary Nachman of Canaccord Genuity.

A few questions for me. So what is factored in your revised guidance with respect to both ASCENIV and BIVIGAM 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 BIVIGAM, if you can quantify that? And how are you adjusting your plans for manufacturing of that product versus ASCENIV? And I mean, do you think it pays to still compete in the standard IG space going forward?

And then just a bit more on what the demand queue looks like for ASCENIV. So 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 going to see this sequential growth going forward for it.

So 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.

So with respect to guidance, this updated framework is really based on the recent dislocation and the competitive pressures. So this assumes that there's going to 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, 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 are happy to do. There was a lot of thought that went into this.

And 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. And 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.

So 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. So we're very pleased with our third-party positive 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.

With respect to your questions about BIVIGAM, look, I've always said it, Gary. I never wanted to be in the standard IG business. But when we acquired this manufacturing facility about 9 years ago, we inherited this product. And 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.

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 ASP reported to CMS level, they've discounted in the order of between 15% to 20% they've eroded from their original pricing. So that's pretty substantial.

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. And to certain sites of care into certain books of business, that is valuable. So does it pay to compete in this market? I think the best way I could say it to you, Gary, is we're not going to go out and provide high levels of discounting just to make some sales. It doesn't benefit you into the future.

As I mentioned, we're already seeing BIVIGAM revert to very, very strong utilization levels here in April. So my guess is that some of these new entrants have some short-dated material. I hear anecdotal reports of that.

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. But I don't think it's a strategy that's going to benefit these competitors long-term.

I think the strategy that ADMA has taken, and we're playing a long game here, focused on long-term growth and value creation for stockholders and, ultimately, providing good products that help patients. So I do think it pays. We 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 will come out the other side stronger. So I don't know, Terry, if there's anything you want to add regarding guidance or anything like that.

But the variability is really just ordering patterns, Gary. ASCENIV demand remains strong. Guidance is conservative, but it really takes into account these competitive pressures. And it doesn't take into consideration any change in our outlook for ASCENIV demand as a later-line therapy in the refractive complex immunodeficient patients.

Yes, Gary, I'll just echo that. I mean, really, the primary assumptions I think you're getting at is that for BIVIGAM we're assuming in this guidance is a sustained level of this increased competition. ASCENIV, 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.

Okay. And 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 DSO. So just -- you're expecting that to get to a more reasonable level of 90 to 105 days from where it is currently.

So just, how you expect to get there and in what time frame 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 going to play into the continued increases in cash flow generation that you talked about?

Sure. So as I said, DSOs in the quarter were 107 days. We want to target between 90 and 105 days. 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 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, then they are favorable to our overall DSO performance. And we believe that, that will push us down into a range that is within our target. That's a big piece of it.

We also believe that -- although we believe that this competition, and it will lead you for the rest of the year, we do believe that ordering patterns will normalize, and so that's baked into that as well. And as you said, some of the concessions that we have provided a normal course to distribution partners over the first part of this year, 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, if I could just touch on one thing. 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. Secondary immune deficiency is really the largest driver of growth of IG.

And when Terry was speaking, I was thinking about the fact that we're in this period right now where -- my entire adult life, I've been in the IG space. And ADMA Biologics has been a company, call it, 20 years. And for that entire time, 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. 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 in a period of, be it consistent supply or maybe a period of oversupply.

And for the last decade-plus, IG has been growing at 10% -- 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, they're forecasting low single-digit growth.

So you're talking about 2%, 3%, 4% growth year-over-year. And I don't think this is something that our brethren IG companies are out there talking about publicly. But it's also factored into our guidance and why we're targeting the secondary immune deficient population and going after that book of business. So I thought it was something important to say.

But IG is still growing. It's still a highly durable business. The use of immune globulin 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. And 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 is robust. It's still growing. It's just growing a little slower.

And Gary, I think your other part of that question was on cash generation. And so obviously, in the quarter, we generated a substantial amount of cash. Our cash from operations was $58 million, which is greater than all of 2025. We believe that our cash generation is going to continue to be strong over the course of this year. And so 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 two more quick ones because I know I get these questions. So I 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 ASCENIV, that it's going to hold up in terms of pricing.

And then 001, you highlighted a bunch of times. But just how long you think it would take you to run that in the clinicals if you start it next year and when realistically it could reach the market?

Thanks, Gary. I'm just making notes so I don't miss a beat here. So look, we take this disciplined pricing approach across all of our products. So as I mentioned, ASCENIV has been largely insulated. We've seen growth from a utilization standpoint. You see that broken out product level revenues, ASCENIV is still a strong, 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. So I don't think you're going to see us discounting heavily any time soon. It's not a practice that we want to engage in. I think the product speaks for itself.

I think that the data that we have published, that others have published independently of ADMA, I think that, that really demonstrates and speaks volumes for the utility of this drug in the refractive highly complex immune-deficient patients that is chronically ill and suffers from persistent infections. So it's a differentiated drug. No one has anything like it out there in the market.

And 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. So we all know how the game works with the commercial payers. There are a couple of points there depending upon how much utilization there is, but we're very proud of the positioning for both our products, 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. So 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. But assuming that all of our animal work, all the preclinical testing that we're doing, all the assay testing, all of the pilot scale lot production that we're doing pans out.

When we are ready to start a clinical trial, there are multiple shots on goal with a product like this. 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. But 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 in immune globulin 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 is less than one serious bacterial infection per patient per year, then you will be to have -- deemed to have met the primary endpoint of less than one serious bacterial infection per patient.

Pretty much every IG that I am aware of that has run a TID study has met the primary endpoint. So it is a 12-month study. To run a 12-month study, I'm pretty sure I've been quoted in the public setting as saying, doing a 12-month study takes about 18 months to do. But if that is the pathway, that could give you some idea.

But we have not yet provided timing 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 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.

So stay tuned. But very encouraged by the data. 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.

Our next question comes from Kristen Kluska at Cantor.

So when we think about the prior revenue guidance, do you 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. But 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?

And then 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 conversations, but if it could also help with the payer and reimbursement piece as well.

Thanks for the question, Kristen. So 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.

So the payers are seeing this real world evidence in their own patient population. They're seeing these patients staying out of the hospital. They're seeing less frequent ER visits and doctors visits, and they're seeing less concomitant medications in the patients that switch from standard IG to a ASCENIV because of their chronic persistent infection. So this real-world data is really adding value for us from a commercial payer perspective, full stop.

With respect to, I think, the first part of your question, 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. There's a large amount of clinicians that are in the buy-and-bill space with respect to UTI, IVIg administration.

And 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 the ASCENIV to 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.

As I said in the prepared remarks, we're seeing increasing new prescribers. We're seeing new patient adds all the time. And 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.

And also, we haven't spoken about it much, but with the pediatric indication, we think that this is certainly gaining some very good conversations with pediatric teaching hospitals. We hear some are even discussing putting this on formulary for hospitalized immunocompromised children.

So, while we've always given -- 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. 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 will help fund all of the capital deployment initiatives that we have with share buybacks. ASCENIV is going to 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. So 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 guiding to right now is there are some challenges in the market. But will the product grow? We believe it will.

So thanks for that question. And 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 going to continue to do so.

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

Just hopping across some calls 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. When you just think of that totality, again, you sort of mentioned it's going to take a little bit of time to work itself out.

But if you had to estimate it, is that 2 quarters? Could it last a year? Just how long does it take the supply chain to straighten out? And just 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. So with respect to IG inventories, I mean, the Plasma Protein Therapeutics Association publishes data on IG sales from reporting manufacturers into the U.S. market. And if you go on their website, you can see the data for the fourth quarter of 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.

And 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. I don't have that data in front of me. I'm recalling that from memory. But the point being, I don't think utilization grew, call it, 20% between October, November and December.

So 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. 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.

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 going to be closing some centers.

ADMA in the quarter monetized our centers. We signed a new third-party agreement with that collector. But these other larger fractionators are choosing to close them down. 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. So I think that, that may persist longer than the IG oversupply situation that's there.

But that would be a better question for others than me. We are pretty much self-sufficient from a standard normal sourced plasma perspective. We collect that plasma from our current 7 centers. And again, 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. This is -- it's in line, I would say, with expectations. But you put a forecast together, and when you hit it, you're happy. So the McKesson book of business is starting. We had a strong April, and we're anticipating that this is going to continue to grow in compound as we progress in the coming period. So hopefully, that answers your questions. Thanks, Anthony.

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

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

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

Good afternoon, and welcome to the ADMA Biologics Full Year 2025 Financial Results and Business Update Conference Call on Wednesday, February 25, 2026. [Operator Instructions] Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately 2 hours following the end of the call.

At this time, I would like to introduce the company. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the fourth quarter and full year 2025 and recent corporate updates.

I'm joined today by Adam Grossman, our President and Chief Executive Officer; Brad Tade, our retiring CFO and Treasurer; and Terry Kohler, our incoming CFO and Treasurer.

During today's call, Adam will provide some introductory comments and provide an update on corporate progress. Brad will then provide an overview of the company's fourth quarter and full year 2025 financial results, and Terry will make some introductory comments. Finally, Adam will then provide some brief summary remarks before opening up the call for questions.

Earlier today, we issued a press release detailing the full year 2025 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com.

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 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 any such statements, except as required by the federal securities laws. We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section in our annual report on Form 10-K for the year ended December 31, 2025, 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.

And with that, I would now like to turn the call over to Adam Grossman. Adam, go ahead.

Thank you. Good afternoon, everyone. ADMA delivered a strong finish to 2025, reflecting disciplined execution across our commercial, manufacturing and financial platforms.

For the full year, total revenue was $510 million, representing 20% year-over-year growth. Adjusted EBITDA was $231 million, increasing 40% year-over-year, and adjusted net income was $161 million, increasing 35% year-over-year. These results underscore the durability of our growth engine and the expanding operating leverage within our fully integrated U.S.-based business model.

Importantly, 2025 was a defining year for ADMA. We expanded margins, improved our balance sheet and executed several strategic initiatives that enhance the long-term durability and earnings power of our company as we enter the next phase of growth.

ASCENIV continues to drive our growth. For full year 2025, ASCENIV achieved $363 million in net revenue, representing 51% year-over-year growth. Our differentiated patent-protected specialty immunoglobulin exited the year at record utilization levels, driven by high demand and strong prescriber adoption.

With ASCENIV still forecasted to be early in its penetration curve within its total addressable market, driven by broad payer access and increasing confidence in long-term supply continuity, ASCENIV is well positioned for sustained utilization growth throughout 2026 and beyond.

Before turning to additional operating highlights, I want to briefly address working capital. We expect accounts receivable and days sales outstanding to improve over the course of 2026, trending toward and potentially improving beyond industry benchmarks over time. The recent increase in working capital primarily reflects the growth in ASCENIV and the acceleration in revenue growth we are guiding to as we continue to make meaningful inroads into ASCENIV's still significantly underpenetrated addressable market. As demand builds and our McKesson distribution agreement ramps up alongside further anticipated diversification of our distribution network, we expect improving working capital efficiency and cash conversion throughout 2026.

We are also seeing continued validation of ASCENIV's differentiation in real-world settings. Independent data sets generated during 2025 reinforce ASCENIV's unique biologic profile. A peer-reviewed study by Tan et al., presented at the ACAAI 2025 Conference and published in the Journal of Clinical Immunology, demonstrated statistically significant reductions in infections and hospitalizations among patients who failed prior IVIG therapy and transitioned to ASCENIV.

71% of these patients showed clinical improvement. These outcomes, along with additional publications expected throughout 2026, should further enhance physician confidence, support constructive payer engagement and expand medical education and drive sustained utilization growth.

From a manufacturing and supply perspective, 2025 marked a major inflection point as yield enhanced production transitioned into routine commercial practice with continued FDA lot releases. This makes 2026 the first full year of yield enhanced output, a structural improvement to our business model, supporting meaningful gross margin growth and increasing earnings power.

In parallel, we strategically repositioned our plasma collection network to improve capital efficiency, while securing our long-term high-titer plasma supply. In December, we entered into an agreement to monetize 3 plasma centers while retaining ownership of 7 centers and concurrently executed a long-term supply agreement that continues to diversify our high-titer plasma sourcing base.

With newly forged supply contracts with the purchaser of ADMA 3 centers, in total, the company now has access to over 280 plasma collection centers, and we have improved supply visibility through the late 2030s and beyond. This transaction remains on track to close this quarter. I want to thank the entire ADMA team for their exceptional execution and commitment throughout 2025. Their discipline and dedication continue to drive our performance and position us for sustained success.

Before I turn the call over to Brad, I also want to share an important leadership update. After a successful tenure and meaningful contributions to ADMA's growth and financial transformation, including the successful onboarding of KPMG as the company's independent auditor, Brad has informed the company of his intention to retire as Chief Financial Officer and Treasurer. We are grateful for Brad's contributions and partnership, and we are pleased that he will remain with ADMA in a consulting capacity through a structured transition period to ensure continuity of operations, which will extend through July of this year.

Today, we are excited to announce the appointment of our incoming Chief Financial Officer and Treasurer, Terry Kohler. He brings extensive public company experience, deep expertise in working capital optimization and cash conversion and a proven track record of disciplined capital allocation and financial execution. This leadership transition further solidifies our ability to scale efficiently, enhance financial flexibility and maximize long-term stockholder value creation.

Importantly, there have been no changes to our previously issued financial statements, no changes to our internal control conclusions and our forward-looking guidance remains strong. Our financial foundation remains robust, and our priorities are clear. drive commercial execution, invest in our capital-efficient pipeline and maintain balance sheet discipline.

With that, I'll now turn the call over to Brad to review our fourth quarter and full year financial results in greater detail.

Thank you, Adam. Our full year 2025 financial results demonstrate ADMA's consistent execution, expanding profitability and earnings power.

Total revenue for the year was $510.2 million, representing 20% year-over-year growth. Gross margin expanded to 57.4% compared to 51.5% in 2024, driven primarily by ASCENIV's growing mix contribution and the successful transition of yield-enhanced production into routine commercial execution.

Adjusted net income totaled $160.8 million, representing 35% growth and adjusted EBITDA reached $231 million, increasing 40% year-over-year. These results reflect continued operating leverage, cost management and the structural margin improvements anticipated by yield enhancement and embedded in our vertically integrated model.

Fourth quarter 2025 total revenue was $139.2 million, reflecting 18% year-over-year growth. Importantly, we exited the fourth quarter of 2025 with corporate gross margins of 63.8%, representing approximately 10% year-over-year improvement. Fourth quarter 2025 adjusted EBITDA grew by 52% to $73.6 million and adjusted net income for the fourth quarter of 2025 grew by 57% to $52.6 million.

ASCENIV's continued growth through these broader market dynamics is a testament to the product's differentiation and relative insulation from standard IVIG market contours. ADMA ended 2025 with $88 million in cash, largely excluding proceeds from the previously announced plasma center divestiture, which remains on track to close in the first quarter of 2026. We maintain a healthy balance sheet and expect improved cash generation in 2026, driven by higher margins, improving working capital dynamics and disciplined capital allocation.

Turning to our outlook. Our 2026 and 2027 financial guidance forecasts continued ASCENIV strength, favorable product mix shift, full year yield enhanced production efficiencies and sustained operating leverage. For 2026, total revenue is expected to exceed $635 million. Adjusted net income is expected to exceed $255 million, and adjusted EBITDA is expected to exceed $360 million.

For 2027, total revenue is expected to exceed $775 million. Adjusted net income is expected to exceed $315 million, and adjusted EBITDA is expected to exceed $455 million. For 2029, total revenue is expected to exceed $1.1 billion and adjusted EBITDA is expected to exceed $700 million. These targets are driven by continued ASCENIV penetration into its addressable patient market, full realization of yield enhancement efficiencies, continued mix improvement and disciplined operational execution.

Importantly, these projections exclude potential contributions from SG-001 and future capacity expansion, which represent meaningful potential long-term upside. We believe ADMA is entering 2026 from a position of strength with strong demand in a growing U.S. IG market, higher margins, increasing cash generation and a structurally improved earnings profile.

As I've shared with our Board and leadership team, it has been a privilege to serve as ADMA's Chief Financial Officer and Treasurer during a period of meaningful growth and financial transformation. With record ASCENIV utilization, yield enhanced production now fully integrated into our commercial operations and improving long-term plasma supply visibility, I believe ADMA is exceptionally well positioned for sustained revenue growth, continued margin growth and increasing cash generation in the years ahead. I am proud of what the team has accomplished, and I'm exceedingly confident in the company's outlook.

With that, prior to turning the call back to Adam, I'd like to introduce Terry to say a few words. Terry?

Thanks, Brad. I'm excited to join ADMA's management team at a time of significant momentum and forward-looking opportunities. The company has built a differentiated platform with high demand, increasing margins and a clear path to increasing cash generation. My focus will be on supporting disciplined execution, strengthening working capital performance and cash conversion and enhancing financial strategy as we scale. I look forward to partnering with Adam, Kaitlin, our COO, and the entire ADMA team to continue to drive growth, profitability and long-term shareholder value.

Thanks, Terry. Adam, I'll pass it back to you.

Thank you, Brad and Terry. Stepping back, ADMA is entering 2026 with strong momentum and increasing financial strength. We are scaling a differentiated growth platform with the highest margins in the plasma-derived therapeutics complex.

The company is committed to improving its capital efficiency, while forging ahead with our focus on generating increasing cash flow, which we believe will unlock meaningful stockholder value. ASCENIV remains the core of our growth strategy. In 2026, we expect continued demand and market penetration, expanding prescriber adoption, durable and now expanded payer access and growing market confidence in our IG supply continuity.

With ASCENIV still forecast to be early in its penetration curve, we believe the runway for sustained utilization and growth remains significant. Yield enhance production is now fully integrated into commercial operations, making 2026 our first full year of structurally higher-margin IG output. Combined with continued mix shift towards ASCENIV, we are well positioned for outside gross margin growth, increasing operating leverage and continued earnings power.

The strategic repositioning of our plasma collection network enhances capital efficiency and secures diversified long-term supply visibility through the late 2030s. These actions are expected to generate accretive cost savings beginning in 2026 and further improve the durability of our platform.

Beyond our commercial business, our lead pipeline asset, SG-001, represents meaningful long-term optionality. We anticipate submitting a pre-IND package in 2026, potentially enabling direct progression into a cost-efficient registrational trial. We continue to view SG-001 as a potential $300 million to $500 million peak annual revenue opportunity.

In closing, ADMA has never been better positioned. We are forecasting substantial revenue growth, continued margin growth and increasing cash generation, driven by disciplined execution across the organization. Thank you for your time today. We appreciate your continued interest and support.

And with that, operator, let's open up the call for questions.

[Operator Instructions] Our first question comes from the line of Kristen Kluska from Cantor Fitzgerald.

This is Rick Miller on for Kristen. Now that we can -- good to talk to you guys. So now that we can kind of clearly see into the proportion of sales that ASCENIV accounts for, is there any updated color you can give us on how you're expecting ASCENIV to sort of fit into the product mix as it relates to the revenue guidance that you've lined out going forward?

Yes. I was trying to figure out what the first question was going to be, Rick, and that was certainly one of the top ones.

But look, very proud of ASCENIV growth year-over-year, 51%, $363 million. We've -- this is our first time breaking out product level revenue. We certainly have been very, very bullish at ASCENIV's opportunity. And for the last period of time, right, Brad, we've been talking about mix shift.

And I believe the ratio is about a 70-30-ish split between ASCENIV and BIVIGAM in 2025. We just believe that, that's going to continue to grow. We've given guidance around revenue, EBITDA, net income for next year. We think that, that's going to grow. And in the fourth quarter, we were 63.8% gross margins. We expect that to continue to grow quarter-over-quarter. Full year, certainly with the 57.2% gross margin that we achieved, very proud of that.

But the ASCENIV mix is going to continue to shift. As we've said, Rick, we're buying more high-titer plasma. We're making more ASCENIV. We continue to forecast that BIVIGAM should be flat to down throughout the calendar year 2026. So we expect margins to improve. We expect ASCENIV to continue to progress with strong utilization and demand, and we're very proud of the results.

Yes. And Rick, just to expand on the gross margin piece that Adam just hit on, right? So in 2025, we had Q4 that had yield enhanced product being sold. So exiting Q4 2025 with a 63.8% gross margin. Looking into 2026, we feel strongly about our margin profile. We're going to continue to see the mix shift from BIVIGAM to ASCENIV, and we're going to have a full year of yield enhanced product being sold for both BIVIGAM and ASCENIV. So again, we're feeling pretty confident about our gross margin profile.

Okay. And maybe then to kind of follow-up on something you brought up there. It sounded like heading into this year; you would really look to expand your third-party supply contracts to really get more of the RSV plasma. So is there any update on these efforts? Could you give us any color on finding additional supply on that front?

Well, with respect to the third-party supply agreements, they're continuing to perform in good standing. We're collecting more plasma each and every month. Testing is ongoing and routine. In connection with the plasma center divestiture that we announced at the JPMorgan conference in January, we also signed an additional third-party supply contract with the acquirer of those 3 centers.

So that operator is an independent collector of plasma. They're not connected to any fractionation capacity whatsoever. They just sell plasma to third parties. And we're very pleased to be partnering with them. They've got a robust network. What we said is it adds about 30 centers today, and they have plans to grow and expand their network. They've -- they've given us projections to about 50 additional centers.

So all in all, we are collecting high-titer plasma from more than about 280 centers is what I think we've put in print. And it's going really, really well. Look, we're very pleased and proud of our partnership with Grifols. They're a great partner. They're working well with us. Kedrion as well, another great partner, working very well. And to the ADMA team here. I mean, look, we test a lot of samples. We test an enormous amount of samples when you really look at it.

And look, as we've said, less than 10% of the donor population has the antibody profile that we're looking for. So it's a labor of love, and we're collecting more raw material, and we're going to make more product.

Rick, I would just add that just like the team has operationalized yield enhanced manufacturing into normal course of business and normal course of manufacturing, I would say the same is true with RSV collections, right? The third-party agreements have exceeded our expectations. And I think it's fair to say that we have normalized the collection of RSV plasma into normal course of operations.

Great. Okay.

[Operator Instructions] Our next question comes from the line of Anthony Petrone from Mizuho Americas.

And congrats on the strong end of the year here. Great working with you, Brad, and welcome, Terry.

Maybe, Adam, just the ASCENIV number, clearly was an outbreak in 4Q, at least by our math, and we'll scrub it a bit with these new disclosures. But when you think about the offensive strategy here, I think in the past, you've shared there's really 900 target immunology sites that you're going after. There's a decent amount of penetration into those sites. There's probably more than one prescriber per site.

So on the offensive strategy, how many more new centers do you think you can add in 2026? And by what level do you think the prescriber base specifically can increase this year? And I'll have one follow-up question.

No, thank you so much, Anthony. We're very proud of the results, as you know. We actively call on about 300 immunologists. We have a large majority of that number who have prescribed ASCENIV to at least one or more patients. We feel very good about our ability to continue to grow both from a reach perspective, getting more prescribers writing their first script, getting more institutions using their first doses of ASCENIV on these problematic refractive PI patients.

But we are seeing the depth in the existing same institutions growing rapidly. With commercial payer access opening up a bit in certain territories, we're very, very proud of the work that our team has done there. We think that's going to open up more lives for us to treat.

And then we've mentioned the recent distribution agreement, which expands and diversifies our distribution network to McKesson and a number of the institutions that buy strictly from McKesson. This is -- we don't make the rules. People do what they want, and there's a large number of users of immunoglobulin in the PI space and other secondary immune-deficient populations that buy exclusively through McKesson and their related entities.

So we're very pleased now to be in a position where we've got a robust supply of raw material, which gives us visibility into the forward-looking throughput that we'll have in our plant and be able to distribute. And we're excited about the opportunity to expand to additional institutions that we have not yet even tapped.

So I feel that with the guidance that we've given this year, $510 million for calendar year 2025 was achieved. Next year, we're guiding to $635 million on the top line. Substantially all that growth, we believe, is going to come from ASCENIV utilization. And it will come from a mix of new institutions getting experienced, new prescribers as well as expanding the reach into the existing same institution.

So the drug continues to work well. The data that we're seeing from the investigator-initiated studies. [indiscernible] so we're very pleased with how the company performed, and we're really excited about '26. I mean a lot of this feels like we announced it already, save for my colleague, Brad and Terry here. But we're very excited about the future that we've really unlocked the value creation driver, which is yield enhancement with the third-party plasma supply, you're going to continue to see quarter-over-quarter growth.

Very helpful. And the quick follow-up would be, you mentioned, Adam and Brad as well on receivables, on track to get to a normalized level. I guess a quick 2-parter. When does McKesson show up in receivables? And if you can kind of just kind of define what that normalized level looks like once we get there, that would be helpful. Congrats.

Thanks, Anthony. So maybe I'll just start off about when we're going to see McKesson. We're actively working. We got the agreement set up. We're working with their partners and the customers that we know there. And I think we'll start to see it in the first half of the year, but I really think you're going to really see it materialize in the back part of the year.

My team, I know, has been working very, very closely since -- there are a number of steps that you have to go through to get sort of access with a number of these customers. And I can say that my team has been working very closely with McKesson and a number of the constituents that procure from there with respect to receiving formulary approval, P&T committee approval at certain buying groups and certain infusion consortiums.

So I know that we're making substantial progress. I know that the team is working very, very hard. And I'm optimistic that we're going to see this not only with McKesson, but we're also going to see the rightsizing of inventory, AR, et cetera, normalize towards the middle back part of the year. That's what we've been messaging.

And Anthony, when I look at the numbers and for the first -- like I was saying this earlier today, I know the numbers. I've known the numbers since day 1. I know how much ASCENIV we've been selling. I know how much BIVIGAM we sell. But actually, looking at the 10-K for the first time with product level revenue broken out and seeing 51% year-over-year growth, I mean, it makes me understand a little bit more about what my distribution partners, what the specialty pharmacies who buy from us, what the end users have been experiencing.

ASCENIV is an extremely important product in the lives of these patients. It has a higher cost per infusion than standard IG. As we've said, ASCENIV sells for about 5.5, 6x other standard IG products. And I think that our customers believe us that we say, "Hey, we see all this growth. We need you to prepare for this level of demand." And I think that they believe us to a point, but with that substantial growth, the working capital requirements on our distributors on some of our end-user customers has been robust.

So give us some time to work through this. It's going to normalize this year. Very excited about the new relationship with McKesson and all the opportunities that brings. And yes, we're just going to keep growing.

We are growing revenues and reducing AR, I should say. Thanks, Anthony.

Thank you. Ladies and gentlemen, this will conclude our question-and-answer portion of the call. I'd like to turn it back over to Adam Grossman now for additional closing remarks.

Thank you very much. With that, I'd like to thank everyone for dialing into today's call. Again, donate plasma help save lives, and we appreciate all the support from the investor community and the team at ADMA. Have a great evening.

Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation, and you may now disconnect.

Good morning, everyone. We're excited to be continuing our 44th Annual JPMorgan Healthcare Conference. My name is Roland Ye, and I'm associate on the Healthcare Investment Banking team here at JPMorgan. Today, it's my pleasure to introduce ADMA Biologics and its Founder, President and CEO, Adam Grossman. We'll have time for Q&A at the end. And with that, I'll turn it over to Adam.

Thank you very much, Roland. Thank you very much to the entire JPMorgan Healthcare Banking team for the invitation. We are a public company. We trade under the symbol ADMA on the NASDAQ. Please refer to our forward-looking statements and other disclosures on our website and in our Form 10-K and 10-Q filings.

So who we are? ADMA is a specialty producer of unique plasma-derived biologic products. We mainly produce IVIG products, which are basically extracting all of the antibodies out of human plasma. We have 3 FDA-approved commercial products. We just preannounced this morning a $510 million or more in total revenue of our commercial organization. And we're very pleased with how the year ended up, based on this pre-announcement, this would include a fourth quarter revenue number of greater than $139 million with EBITDA of $77 million, $78 million or more and net income of about $50 million or more, which is a substantial step-up from the third quarter of 2025.

We've got IP that protects our lead product ASCENIV through June of 2035. This IP is around how we test and identify which donors have high titers to respiratory virus antibodies as well as we have IP around the composition by which we formulate the product and the resulting antibody profile of the drug. So we feel that we've got a really good moat around what we do and that we're protected for long term and ensuring long-term growth and viability of our drugs from third-party competitors.

We have a capital-efficient R&D pipeline. We also announced this morning that we're advancing SG-001 in the preclinical setting. We have planned later this year to hold pre-IND meetings and get a lot of that work out of the way with FDA so that we can advance this product. It's not currently in our 2029 multiyear guidance. We are forecasting $1.1 billion in revenue or more by 2029. And we did preannounce today that we anticipate EBITDA margin or EBITDA generation of about $700 million in 2029, and that does not include any accretion from SG-001.

We have a diversified network for plasma collection. We currently operate 10 plasma centers. We did announce also this morning that we are divesting off 3 of those centers. In combination with the divestiture of these 3 centers, we're also signing another long-term third-party supply contract, taking our total number of plasma centers that we collect from 250 up to 280. About 85% of the raw material that we use to make ASCENIV is collected from these third parties. And then we have control over all of the normal source plasma that we used to make BIVIGAM and other plasma for R&D in our existing collection network.

Headquartered in Ramsey, New Jersey, our manufacturing campus and operations and the majority of admin staff is in Boca Raton, Florida and our headquarters for our plasma center has moved to North Carolina. We are a U.S.-based producer of these products. Our most favored nation is the U.S. We are the last U.S. domiciled producer of intravenous immunoglobulins in the U.S. And we have end control of all of our supply chain in the United States. So we have a very low risk of any tariff implication. We have no import-export issues. And we're also insulated from any potential MFN issues because we only sell our products commercially in the United States.

We're among an elite group of specialty biologic manufacturers. There are 7 companies that can produce these products. All products sold in the United States must be produced from U.S. plasma in FDA-approved manufacturing facilities. So there's really very little risk from low-cost competition coming from the developing world or emerging markets. And we're really very proud of the growth that we've seen in the U.S.

Most recently, we are, or I should say, we are the first company to receive FDA approval for a yield enhancement manufacturing strategy. I'll talk a little bit in more detail about the financial implications, but from the same starting raw material, we have invented a process to allow us to extract 20% more finished goods from the same starting plasma, providing more product to sell from this scarce raw material as well as expanding gross margins and profitability.

645 hard-working full-time dedicated employees, again, all based in the U.S. And again, we've got an infrastructure that supports insulation from a number of the noise out there that maybe affecting others in our industry. We talked a little bit about our plasma supply network. Again, this morning, we announced the divestiture of 3 of these plasma centers. These centers, we carry on our financials at about $1.9 million in total for the 3 of them. We're selling these centers for $12 million in gross proceeds. We'll bring $10 million into the company. And also following the divestiture, we will retain the ability to collect the high-titer RSV plasma from these centers as well as expand our third-party plasma collection network.

Last year at JPMorgan, we were very proud to announce the signing of long-term agreements with 2 very stable and well-known companies in the plasma space, Grifols and Kedrion. We're very thankful for their partnership. They've been great suppliers, they're great companies to work with. And now we're going to be augmenting that supply base with this new third-party contract, expanding the total number of centers to over 280. It's about a 5% hit rate of plasma donors that have the antibody profile that we're looking for. All of the science and testing we do in-house using our patented and proprietary microneutralization assay. So we control all the science and the identification of these donors and our third parties have agreed to all of our volume requests for 2026, and we feel very, very bullish about the forward-looking opportunity with them.

To give you some background on the IG space. In 2024, it's reported to be greater than $13 billion market. This market is forecasted to grow to over $30 billion by 2033. And pie chart on the bottom of this slide, ADMA is growing. We now represent about a 3% slice of the U.S. immunoglobulin pie. There was about 135 million grams of IG infused in 2024. And we're very proud of our ability to continue to penetrate this market and run between the toes of some giant companies with our differentiated immune globulin portfolio.

PI is a significant market opportunity. At a high level, there are about 250,000 or more of these patients that suffer from one or more forms of a genetic condition called primary humoral immune deficiency. This renders your immune system to not function properly. And the only way that you can live a normal healthy life is to receive immune globulin infusions every 3 to 4 weeks for the rest of your life. So this market continues to grow.

IVIG products are also widely used in secondary immune deficient populations. So these are areas like cancer, bone marrow transplant, solid organ transplant therapy as well as in autoimmune disease patients where we're seeing robust utilization of monoclonal antibodies that knock out T and B cell function.

When we dig a little deeper into the primary immune deficiency market, we look at the patient profile for ASCENIV differently. We take a different approach to segmenting the appropriate use case for a primary immune-deficient patient. And not all of these patients who receive IVIG thrive, they survive. They don't die, but they're not thriving. They continue to experience chronic and persistent recurrent respiratory virus infections. They get hospitalized, about 10% of these patients or more suffer from bronchiectasis, which may lead them to need a lung transplant throughout their treatment journey. And about 30% of PI patients are diagnosed with some type of chronic lung condition.

So when you put all of this together, we really believe that we're -- we have a total addressable market of about 25,000 of these 250,000 patients that we target with ASCENIV. ADMA's unique IG offering is ASCENIV. ASCENIV is a polyclonal immunoglobulin that's manufactured by blending donors that are tested to have high titers against respiratory syncytial virus, blended with normal source plasma. Again, we are the only company globally that has this IP and this technology to make a product in this methodology.

The expanding real-world evidence, we announced this morning in the press release that we've really been seeing dramatic improvements in the outcomes in the real-world clinical setting. And these are very hard things to put together in a clinical trial because the majority of patients who would benefit from ASCENIV would potentially be excluded from these types of clinical trials. They are problematic patients. They have tons of comorbidities. They're on a multitude of different concomitant medications, but we really are excited about compelling real-world evidence that is demonstrating significant reductions in infections, switching from standard IG to ASCENIV as well as a reduction in hospitalizations. Many of these publications report that in as early as 6 months, they're seeing these benefits.

So this is what is going to continue to expand and drive utilization and growth of ASCENIV both in the government pay and the commercial payer setting.

As I talked about, we have a battery of patient advocates. The company has recently started direct-to-patient medical education programs, and these are proving to be extremely fruitful and beneficial in the U.S., the right way to get good care from your clinician is to advocate for yourself. And we are now teaching, educating and arming the patient and the patient advocacy community with more data to be able to present to their clinicians to see if ASCENIV is the right drug for them.

This slide really breaks down the total addressable market. Again, patients that have recurrent refractive -- they're just not responding well to their standard IG, they've had their dose increase, they've had the frequency of infusion increased. They've changed brands. They've switched to subcu and back to IV, back to subcu, there are thousands of these patients in the U.S. So we are focused on about 10% of this population. So we estimate, and again, based on some analysts and some other industry reports, that we are low in our estimates, but we feel pretty good that there are at least 25,000 patients that are in our total addressable market. There's high demand for ASCENIV especially in light of the real-world data and evidence that is being published. And we're pleased that we've grown penetration, and we're now about over 4% of our total addressable market.

What's been the barrier to growth as we entered JPMorgan last year was raw material supply. And throughout 2025, we really alleviated that raw material supply burden, and we're seeing that continue to unfold favorably for the business. So we are -- not only are we generating more revenue from ASCENIV than we were previously, our production mix throughout the back half of '25 was shifting more heavily to ASCENIV production, and you're going to see that continue throughout 2026.

As we push towards the end of the decade to the 2029 target guidance of $1.1 billion or more, about 90% of our revenue, we believe, would be generated from ASCENIV at that time. And we'd be a little bit over 50%, potentially closer to 60% of production throughput. So there is additional capacity and growth beyond that $1.1 billion number from ASCENIV, and we believe that, that is an opportunity that we're going to capitalize on.

We have an innovative commercial model. About 99% of our business is in the outpatient ambulatory infusion setting. These are patients that are receiving home infusion or they go to a freestanding independent infusion clinic. There are national and regional infusion companies who we partner with to service immunoglobulin for the primary immune and secondary immune deficient patient populations. And we announced this morning in our press release that we have diversified our distribution base even further. We announced that we've signed an agreement with McKesson Specialty. They have a very large presence in the immunology and oncology setting. And we think that by adding McKesson, this is going to help expand the reach for different sites of care that we haven't been able to reach with our existing big 3 distributors. And we're very proud to be working with all of our distribution partners.

We target clinical immunologists primarily as well as infectious disease physicians who see immune deficient patients, and we do call on. And we do see some sporadic inpatient hospital base used mainly in pediatrics for rescue therapy of treating an immune-compromised person with a respiratory tract infection that is not responding well to antibiotics and antivirals that are out there.

So upside and growth opportunities. I talked about our yield enhancement strategy. So we received approval for this strategy in April '25. We commenced commercial scale production of yield enhancement in May of '25 and in fourth the quarter and what you -- I mean what's attributing to the revenue growth from a product perspective as well as the outsized EBITDA contribution is all coming from mix being more ASCENIV sales, but also 100% of the ASCENIV sold in the fourth quarter was from yield-enhanced batches and the majority of BIVIGAM sold in the fourth quarter was from yield-enhanced batches.

So we've successfully commenced commercial scale production. 2026 is going to be our first full year of yield enhanced production. Again, the production cycle time of our business is very different. So just to make sure for anybody new to the story here, it takes us 7 to 9 months to produce a batch of drug. We can't do it any faster than that. That's the industry. That's all fractionators, large and small. So 7 to 9 months. So the product that we are selling today, we made 9 months ago. So that is, call it, May.

There's significant upside here. Again, 20% more finished goods from the same starting raw material plasma. We believe that there is significant revenue and earnings upside potential from yield enhancement and outside EBITDA contribution, again, with our out year 2029 guidance, we're currently guiding to a 64% EBITDA contribution which I feel very excited about this. Hats off to our team for being the first company to get this approved by the FDA.

We've talked a little bit about our capital efficient pipeline, and we gave some updates this morning. I'll touch on ASCENIV for pediatrics. We expect to expand the label for ASCENIV in the pediatric population, adding age group 2 to 12 sometime this year. So we think that, that will assist with commercial payers, getting access. And also there could be additional upside from utilization in pediatrics from a hospital-based therapy.

But our lead pipeline program is something that I'm truly excited about. We successfully demonstrated the proof of concept in preventing and treating the infection in an animal model. And we've been working very, very diligently on the formulation of the drug. So this is a product that's slightly easier to make than ASCENIV. It's not naturally occurring antibody. We take commercially available streptomonas vaccines, of which there are 2 that are preferred and we immunized 1 group of donors with vaccine A and other group of donors with vaccine B. And then we combine that plasma together to manufacture a hyperimmunoglobulin that also meets the FDA criteria for IVIG.

So in our pre-announcement or in our business update press release this morning, we announced that we plan to submit a pre-IND package in 2026. And we believe that we've got some pretty good shots on goal to get this drug directly into registrational studies. And it's not currently contemplated in our 2029 out-year guidance forecast. But we do think that there's a potential that should things go right that we could have the product approved within that time frame.

Again, capital efficient. We think it could be at least a $300 million to $500 million or more revenue-generating opportunity for the business, in line with the margin profile of a product like ASCENIV. We have IP on SG-001 that runs through 2037 and again, as we continue to develop and learn more about the plasma donors and on how we're manufacturing the product, we feel very good about the ability to extend these patents into the future.

We have an experienced senior leadership team and Board of Directors that has successfully commercialized a number of biotech companies. We feel that we are rightsized and that we've got all the experience in place to continue to create value for shareholders, buying back stock, returning capital in a very efficient manner.

Our financials, just to put some graphics around some of the growth that we are experiencing here, but all financial metrics that we guided to for 2025, we believe that we've met or exceeded; $510 million of revenue, $235 million of EBITDA and greater than $158 million of net income; forecasting $635 million top line for 2026, $360 million of EBITDA. And for 2027, we've just provided guidance for the first time for '27 of $775 million in top line revenue and $455 million of EBITDA.

This is being driven by, again, mix shift of selling more ASCENIV, production mix shift of making more ASCENIV and in extracting more operational efficiencies in costs. With the sale of these plasma centers, we're extracting about $13 million to $15 million of operating costs out of the business as well as we feel that there are other opportunities for us to realize more margin accretion from additional areas of our manufacturing process that we do see losses in further enhancing yield enhancement as we continue to mark down the field to the end of the decade.

2025 Preliminary Unaudited Financials. Again, these are not audited numbers, but we're guiding over $510 million to $511 million of revenue, $88 million of cash at the end of the quarter, which implies a greater than $40 million operating cash flow. We did buy back stock all throughout last year, and we continue to believe that the stock is undervalued, and we have a very supportive Board of Directors that is going to continue to return capital to shareholders through share buybacks.

That's who we are. I'm very proud of the work that we're doing. Again, thank you to JPMorgan and to all the ADMA folks out there. Thanks for giving me good stuff to talk about. So with that, we can open up to some questions.

[Operator Instructions]

Just a clarification on 4Q. Did you guys have any plasma sales that were unrelated to BIVIGAM or ASCENIV? And also with the new McKesson relationship, did you have any stocking in 4Q relating to the new distributor?

No stocking from McKesson in the fourth quarter, was down to the wire signing that agreement. That agreement got done right before Christmas, but they did not place any stocking order. And you will see some plasma revenue. But as I alluded to earlier in the talk, you will see a product step-up at least $15 million from third quarter to fourth quarter revenue. We sold some hepatitis B plasma in the fourth quarter. This is under a contract that we have with a South Korean fractionator where we collect this high-titer plasma and sell it to them. The majority of the plasma revenue that quarter came from that contract. There were no bolus sales, if you will, of any meaningful size of normal source plasma in the quarter.

Thank you very much. [indiscernible] from Tuborg Pharmaceutical, the leading Saudi pharma company. A question for ADMA in relation to export from the U.S. for markets in the emerging markets like Saudi. Is there any strategy towards expanding into these markets? Understand there is raw material issues. In case there is plasma collected for contract at your site with using the dossier, would you consider export to Saudi?

So we certainly would consider any and all business opportunities that are out there. But what I can say is that we have -- we still are not able to support the demand that is in the United States. So from our perspective, all of our capacity is being earmarked to growing our penetration in the U.S. domestic market. And at the present time, our strategy is focused solely on making products for the U.S.

However, if there is an opportunity ex U.S., there is certainly something that we can talk about. But at the present time, we're dealing with an IG market in the U.S. that is historically undersupplied and especially as it pertains to ASCENIV, there are more patients out there that want to be on therapy than we can produce drug for right now. So we're continuing to expand our raw material collections. We're continuing to manufacture and shift our production mix to make more ASCENIV. And as we continue to grow, maybe we'll get there, but that 4% plus penetration into our TAM leaves a lot of headroom for us to grow here domestically in the U.S.

Okay. Maybe I'll ask the next question. So you provided a strong fiscal year 2025 guidance and operated a multifaceted revenue model. Can you walk us through the drivers behind that sizable step-up between Q3 and Q4 in production product level revenue?

Sure. In the third quarter, as the gentleman in the audience asked and as you're referring to, we had a $13.8 million sale of normal source plasma at a negative gross margin in the third quarter. Product level revenues from Q2 to Q3 were relatively flat, around $120 million, $121 million.

In the fourth quarter, what you're seeing is that step up at least $15 million from a product level perspective. BIVIGAM in the third quarter, we spoke about, got hit from some competitive market dynamics, some new entrants we're launching into the market. And it was just high single digits, low double-digit millions in revenue that we did not see in the third quarter that occurred in the second.

We did see BIVIGAM recover meaningfully in the fourth quarter. But really, the outsized revenue growth and contribution was from yield enhancement. Again, 100% of the ASCENIV sold in the fourth quarter is from yield enhanced drug. And that's why you're seeing not only that $15 million plus in product level sales but you're seeing -- we didn't report gross margins. I know you know what the number is, but the only way that you could get to the EBITDA guide that we have put out this morning of about $77 million, $78 million is from outsized contribution from yield enhancement. Again, fourth quarter, the majority of product sales were from yield enhanced ASCENIV and BIVIGAM. All ASCENIV was yield enhanced. And for 2026, the current guidance is for a full year of yield enhanced product revenue generated .

And maybe just a follow-up to that. Fourth quarter margins also expanded meaningfully as you may have mentioned. And how should investors think about that margin profile as a baseline within your forward-looking guidance framework?

Sure. We're guiding to -- I want to say -- keep me honest here, Skyler. It's 20% revenue CAGR. Well, 20% revenue CAGR to 2029, 30% EBITDA CAGR to 2029. So we believe that there is certainly more room for margin to expand on us being more efficient from an operational basis, you see us divesting of these plasma centers, reducing operating costs. I mean that should drop straight to the bottom line. And there are other levers that we can pull with additional waste streams that we can recapture more yield, I think, as we get into the out years. So we think gross margins are going to continue to expand. We're guiding to, I guess, 64% EBITDA contribution margin in 2029. We think that, that is certainly conservative based on everything that we see out there. But we like to give conservative guidance, that certainly reasonable and meaningful and we're going to do everything we can in our power to beat these guidance estimates that we're providing today. .

Any questions from the room or... I want to ask a follow-up to that as well. So in terms of guidance beyond 2029 and on your pipeline optionality, how should we think about long-term growth opportunities, including the potential contribution and development pathway of SG-001?

Sure. So I think that the $1.1 billion target for 2029 is just a milestone. Certainly, with all the data that I've seen and the conversations with KOLs and our Scientific Advisory Board, I feel that SG-001 has the potential to even be a bigger product and reach a broader set of patients than ASCENIV does today. As I've been speaking about our manufacturing production mix, it's running. It will run this year at about a 50-50 mix between ASCENIV and BIVIGAM. I like BIVIGAM. It's a good drug. It's profitable, but it's highly competitive. I think investors saw that it is subject to some of the competitive dynamics that are out there in the standard IG space where ASCENIV is insulated from those competitive dynamics. We've only seen ASCENIV grow in the face of this increased competition.

So I look at our plant as, well, I've got 50% of the capacity or so that I can use to make either more ASCENIV or SG-001 or other follow-on products. I mean -- in light of some of the noise coming out of Washington D.C., we're really taking a critical look out there at the conversations around vaccinations and we think that we are really uniquely positioned to capitalize on some of the dislocations that we may see into the future here. And we've got a capital efficient R&D pipeline.

I mean we already make IG, our plant -- whether you're making BIVIGAM, ASCENIV, SG-001, essentially, it's the same manufacturing process from a manufacturing plant perspective. All the science is done upfront in identifying or securing the raw material that has the high-titer antibodies in it. So we've got a plant that loves to make IG, and it's making it very efficiently right now with some of the best yields in the industry, if not the best.

So substituting that standard Ig BIVIGAM capacity for higher-margin, unique, differentiated, patented immune globulin products into the future, I think could compound growth substantially well north of the $1.1 billion that we're guiding to for 2029.

Right. So I guess another question on your decision to sell the plasma center. Could you walk us through the strategic rationale behind that decision? And how you're thinking about the operational and efficiency benefits you expect to realize from that?

Sure. It's interesting. And look, we listen to our shareholders, plain and simple. Look, we don't -- from my perspective and whether I should be saying this on a recorded line, I mean, I look at plasma -- it's got a 10-year shelf life. I love it. I want all the plasma I can have because if I have that inventory, I know I can continue to make drug into the future.

If you look at COVID as an example, the reason why the industry was able to continue to keep up with supply is that all manufacturers stock 6 to 12 months of raw material inventory. But the -- again, not to keep referring to the gentlemen who asked the question about the plasma sale, but that took some investors by surprise. We don't want to be in the business of collecting inventory, and it's sitting there and then we sell it at a negative margin. I mean that doesn't do anybody any favors. And it's not the right way to run a public company.

So in lieu of us building inventory that we just don't believe we're going to use, I mean, we're making less BIVIGAM, plain and simple. BIVIGAM is made from normal source plasma. So the hit rates that I've referred to about 5% of plasma donors have the antibody profile that we're looking for to make ASCENIV. So that means you have to collect a lot of normal source plasma in order to get that 5% or so of high-titer plasma.

So by divesting of these 3 centers, we are managing the amount of normal source that we're going to be vertically integrated and collecting. We still have access to the high- donors that we've cultivated relationships and goodwill with at these centers. So we have a 10-year supply agreement for plasma from those centers, plus additional plasma from this third-party collector.

So we're just taking a critical look at the business. I think it's a maturation of the way our Board and management team is looking at the company. There's no sense in keeping dead weight just because we've invested in it and we built it. If it makes sense to keep, we're going to keep it. If it doesn't make sense to keep, you see that we're going to monetize it and provide long-term benefits for the business.

So the rationale there is that we don't want to over collect. We don't want to build inventory bigger than it needs to be. And we feel really proud of getting this done. And quite frankly, the diversification of our third-party procurement provider network is something that is extremely valuable to the Board of Directors and the management team here because that's our life. 85% plus of our raw material now is coming from our third-party suppliers. So the more the better. If someone has a problem, we still can ensure the continuity of supply.

All right. Question on the room or Adam, you mentioned earlier that you were able to achieve a 20% increase in manufacturing yield. Would you be able to talk about the significance of that, especially in the backdrop of the competitive landscape nowadays in the U.S?

Sure. So there's yield enhancement across the entire plasma landscape. You're seeing a number of new devices and new methodologies in plasma collection where you're able to collect more plasma per donation. A number of the large fractionators out there, the global multinational fractionators have announced these yield enhancement strategies. They announced that many years ago at JPMorgan. I think some of them have some portions of their yield enhancement coming online, but a lot of them aren't going to come online until 2030 or beyond.

Our ability to bring yield enhancement on as quickly as possible, I think, just speaks to our nimble footprint. We've got 1 plant. We make IVIG and we only sell it in the domestic market. So we don't have a number of different geographies that we have to get regulatory approval in. And really, I just think it speaks to the innovation and manufacturing prowess that we have at ADMA Biologics. We come up with very creative ways to extract this and we announce it, we execute it. There's no BS at our company. We just get it done. And I think it also speaks to the relationship that we have with the U.S. FDA. This was all done in conjunction with getting feedback from the agency. And I think that we've done a great job at being able to demonstrate the commercial scalability and viability of yield enhancement.

And really, what we got approved last year is really just Phase I. I love when I see our lab people every month, and they give me an update on what's next and what's next. But I think we've got a couple of tricks up our sleeves and I think that the team, if they have anything to say about it, they want to extract even more yield out of the plasma that we have.

So I think that this behooves itself well for fractionators, I think that we are getting better at what we do in being able to extract more bulk drug and finished goods out of the same starting raw material. I think that from a plasma collection standpoint, you're seeing more efficiency there. I think the number of plasma collections are coming down. You're seeing other manufacturers and collectors of plasma shutting down their plasma centers, whereas ADMA is monetizing them. But I do think that yield enhancement is here to stay and you're going to see it across the industry in a broad way very, very soon.

Can we have the mic to move over here.

Maybe just to clarify. So I think you mentioned that there's about 10% of the PI population that can be targeted by ASCENIV. Is the target to get from 4% penetrated today to that 10% level, I guess, ADMA's target to get to that level? And what gives you the visibility to, I guess, reach that? And do you need I guess, more novel indications that you kind of mentioned in pneumonia to get there? Or like whether you can sort of break that down in terms of patient types or disease types?

Sure. So we're -- we believe that there are 25,000 PI patients that are not doing well on their current IG therapy. Again, we penetrated about 4%, so over 1,000 patients or so we have on drug today. Our plant has a 400,000 liter capacity with our manufacturing yields, this side of yield enhancement, that would give us probably enough product to support, call it, maybe 8,000 to 10,000 patients, it is weight-based dosing.

So yes, it's my goal to provide ASCENIV to every patient that wants it. But with our existing manufacturing infrastructure, we can only supply roughly about half of our total addressable market. I'm not guiding to it, but you're asking the question. If 100% of ADMA's current manufacturing capacity, was earmarked to ASCENIV, this would be well north of a $1.5 billion to $1.8 billion revenue opportunity. So certainly much more than what we're guiding to for 2029.

Our goal is -- and we have visibility into the fact that our specialty pharmacy partners, the home infusion partners, clinical immunologist, they tell us that they've got patients that want drug. And I think as we're able to collect more plasma, manufacture more drug, there is no manufacturer of IG that outdates their product. If you make it, it gets utilized and sold. So we're going to continue to keep blinders on, block and tackle, make more drug, collect more plasma, make more drug, sell more drug.

And we're going to march down the field to get as close to hitting that 25,000 patients as we possibly can. I did announce last year that we acquired a building a few doors down from our existing manufacturing campus, and the strategy there is we need more cold chain storage, supply chain warehousing capabilities. But our existing plant, there are some offices in that plant. My office is in the same building as the plant. It doesn't need to be there.

So if we move offices to the new building, we believe that we've got the ability to potentially expand the GMP manufacturing footprint at least 30% to maybe even 50% or 100% doubling of our manufacturing capacity for modest capital investment in a very shortened time line from greenfielding a new plant. So we really think that we're setting the business up for long-term success. And I'm getting all these hands waving and signals, and I just want to thank JPMorgan and everybody for their attention and time. And go ADMA. Thank you team so much for doing a great job. I love you all.

Thank you, Adam.

Good afternoon, and welcome to the ADMA Biologics Third Quarter 2025 Financial Results and Business Update Conference Call on Wednesday, November 5 2025. [Operator Instructions] Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately 2 hours following the end of the call. At this time, I would like to introduce the company. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the third quarter of 2025 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer; and Brad Tade, Chief Financial Officer and Treasurer.

During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brad will provide an overview of the company's third quarter 2025 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions.

Earlier today, we issued a press release detailing the third quarter 2025 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com. 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 any such statements, except as required by federal securities laws. We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section in our SEC filings and our quarterly report on Form 10-Q for the quarter ended September 30, 2025, 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, go ahead.

Good afternoon, everyone. ADMA delivered another record quarter of sequential and year-over-year growth, underscoring the strength of our business model and disciplined execution. We delivered total revenue of $134.2 million, representing a 10% quarter-over-quarter increase and 12% growth year-over-year. GAAP net income reached $36.4 million, up 6% quarter-over-quarter and 1% year-over-year, and adjusted EBITDA grew to $58.7 million, representing 16% quarter-over-quarter growth and a 29% increase year-over-year. These results demonstrate the durability of our growth engine and the expanding leverage in our fully integrated U.S. domiciled business model.

Our performance continues to be led by ASCENIV, our differentiated and patent-protected specialty IG exclusively targeting complex immunodeficient patients. ASCENIV delivered record utilization this quarter, driven by strong prescriber adoption and sustained patient demand. 2026 payer negotiations are progressing positively and are expected to further expand coverage, improving access and accelerating growth. For select payers where restrictions previously existed, we anticipate improved ASCENIV reimbursement access beginning next year.

Equally important, a retrospective cohort analysis in an investigator-initiated study of primary immunodeficiency patients demonstrated statistically significant reduction in infection rates following transition from standard immunoglobulin therapy to ASCENIV. Patients experienced 2.1 infections per year while receiving prior lines of standard IG therapy compared with 0.9 infections per year on ASCENIV, representing a reduction of greater than 50% with a p-value considerably inside of 0.05.

These findings suggest that ASCENIV provides enhanced protection against infections in real-world clinical practice. Data validation and extended analyses are ongoing. ADMA plans to submit these results for peer-reviewed publication in the near term with additional findings planned to be submitted at the Clinical Immunology Society 2026 Annual Meeting.

Operationally, the FDA's lot release of our first yield enhanced production batches represents a major inflection point. This process innovation is expected to improve per batch output by 20% or more, driving sustained gross margin expansion beginning in the fourth quarter of 2025 and continuing through 2026 and beyond. Regulatory release of these batches was achieved in the ordinary course, positioning us to realize our first full year of yield enhancement production in the entirety of 2026.

In addition to strengthening our commercial operating model, we continue to invest in innovation and pipeline advancement. Our SG-001 program is progressing as planned, and we recently submitted a CNPV voucher application to the FDA. If approved, this voucher could meaningfully accelerate further regulatory review timelines, giving us a clear advantage as we move into registrational clinical development.

SG-001 remains a meaningful long-term opportunity with the potential to address significant unmet medical needs in patients vulnerable to Streptococcus pneumonia infection. Preclinical data for SG-001 demonstrated broad serotype-specific antibody activity, encompassing a wider range of pneumococcal serotypes than those targeted by any currently available pneumococcal vaccine, underscoring the potential for SG-001 to provide enhanced protective coverage. We view this program as a natural extension of our core competencies in hyperimmune IG development and manufacturing and as a potential key value driver for ADMA's next phase of growth.

Although SG-001 is excluded from our $1.1 billion or more fiscal year 2029 revenue guidance, we believe approval could occur within this time frame. And if successful, we believe the new product could rapidly scale to peak revenues following potential commercial launch. We believe SG-001 represents a potential $300 million to $500 million in annual high-margin revenue opportunity with IP protection through at least 2037.

Turning to capital deployment. Our approach remains disciplined and strategic, focusing on creating stockholder value. Following our successful JPMorgan-led debt refinancing earlier this year, ADMA maintains an undrawn $225 million revolving credit facility, providing flexibility to fund growth and stockholder value initiatives. We continue to repurchase ADMA shares under our authorized program, funded organically to date through free cash flow and maintain a strong capital position to potentially reinvest in high-return initiatives that enhance stockholder value.

Looking forward, our focus remains clear: expand ASCENIV access and utilization, scale yield enhanced production and product mix shift, drive continued margin expansion, advance our capital-efficient pipeline and return capital to stockholders through share repurchases. We believe these priorities will collectively position us to achieve more than $1.1 billion or more in annual revenue in 2029 with a clear line of sight to durable earnings growth. With that, I'll now turn the call over to Brad to review our third quarter financials in more detail.

Thank you, Adam. Our third quarter results highlight ADMA's consistent execution and expanding profitability. Total revenue for the quarter was $134.2 million, up 10% from the second quarter and an increase of 12% year-over-year. Gross margins expanded to approximately 56.3% compared to 49.8% last year, driven by ASCENIV's growing mix and early yield enhancement benefits.

Excluding the plasma sale of $13.8 million during the quarter, product level gross margins reached 63.7% during the third quarter of 2025. GAAP net income totaled $36.4 million compared to $35.9 million in the prior year period, while adjusted EBITDA increased to $58.7 million, representing 16% growth quarter-over-quarter and 29% year-over-year, reflecting continued operating leverage and cost efficiencies.

Year-over-year, net income growth was tempered by a higher effective tax rate and temporary competitive dynamics in the standard IVIG markets, mainly impacting BIVIGAM. Enabled by the company's outperforming third-party plasma suppliers, ADMA opportunistically completed a sale of approximately $13.8 million of normal source plasma on the spot market at a negative margin contribution to optimize working capital and go-forward cash flow.

These factors are short term. Post quarter, standard IVIG market conditions are stabilizing and record ASCENIV demand continues to drive margin expansion. ADMA ended the quarter with a strong balance sheet and liquidity position. Third quarter cash reflected approximately $23 million in share repurchases settled during the period, planned inventory build and a $12.6 million facility expansion investment. Working capital dynamics are expected to normalize in the coming quarters, supporting accelerated cash growth through 2026. We maintain a strong balance sheet with an undrawn $225 million revolver, providing ample flexibility for growth.

Turning to our outlook. ADMA's full year 2025 and 2026 financial outlook reflects continued ASCENIV demand strength, yield enhancement production efficiencies and disciplined operational execution. For 2025, total revenue is now expected to be $510 million, up from prior guidance of more than $500 million. 2025 adjusted net income is modestly adjusted to $158 million due to a higher effective tax rate. Fiscal year 2025 adjusted EBITDA guidance remains expected to be $235 million. These forecasted annualized 2025 results position the company strongly to end the year on a high note and enter 2026 from a position of strength.

For 2026, total revenue is now expected to be at least $630 million, up from $625 million or more previously. Adjusted net income has increased to more than $255 million, up from $245 million previously, and adjusted EBITDA is raised to more than $355 million, up from $340 million or more from previous guidance. The increased 2026 adjusted net income guidance now considers a full corporate tax rate for fiscal year 2026.

Looking longer term, ADMA expects fiscal year 2029 total annual revenue to exceed $1.1 billion, supported by yield enhancement efficiencies, expanding ASCENIV demand and continued gross margin gains. Potential contributions from SG-001 and capacity expansion are excluded from this outlook and represent meaningful upside to ADMA's long-term earnings power.

Following its JPMorgan-led refinancing, ADMA maintains a strong balance sheet with an undrawn $225 million revolver and forecasted robust cash generation. Share repurchases continue to be funded organically, reflecting disciplined capital allocation and long-term shareholder value focus. With that, I'll turn the call back to Adam for closing remarks.

Thank you, Brad. Before we open the call for questions, I wanted to take a step back and reflect on how far we've come and where we're heading. Just 3 years ago, ADMA was at the early stages of its commercial expansion. Today, we're generating record revenue and profitability, achieving best-in-class gross margins with substantial expansion forecasted from here and setting the stage for what should be sustained earnings growth across the next decade while advancing a compelling new product cycle.

Our yield enhancement milestone is a defining moment in that journey. It not only validates our technical capabilities but also positions us among the most efficient plasma fractionators in the industry. With FDA released yield enhanced production lots now flowing through our supply chain, we believe we are strongly positioned to finish 2025 on a high note and accelerate year-over-year growth rates in 2026 from a position of operational strength with line of sight expected meaningful cost savings, improved production mix throughput and the potential to add incremental manufacturing capacity without significant capital investment provides optimism for our future.

On the commercial side, ASCENIV continues to outperform expectations and remains at the center of our growth story. We are witnessing both expanding utilization in existing accounts and growing interest from new treatment centers. As payer access improves in 2026, we expect adoption to accelerate further, supporting our expectations of strong double-digit revenue growth well into the back half of the decade. The combination of expanding coverage, real-world data validation and increased patient acceptance is creating durable, powerful momentum across ADMA's health care ecosystem.

Looking further ahead, our R&D platform continues to progress. The SG-001 program is advancing on schedule, and we remain enthusiastic about its long-term potential. We believe we can advance this pipeline program directly into registrational trials following continued and successful preclinical development and potential ultimate IND submission. When combined with our manufacturing know-how and regulatory expertise, SG001 has the potential to expand ADMA's leading position in the specialty immunoglobulin space while adding meaningful high-margin revenue in the out years.

Financially, ADMA has never been stronger. We are operating with a clean balance sheet, a fully funded growth plan and forecasted accelerating cash generation. Our capital allocation priorities are clear, reinvest for growth, maintain balance sheet flexibility and return capital to our stockholders through opportunistic share repurchases. This strategy reflects our confidence in the business and our commitment to building enduring value.

In closing, I want to thank the entire ADMA team for another exceptional quarter. Your hard work, expertise and passion make all of this possible. To our investors and stakeholders, thank you for your continued confidence in our company and partnership as we execute against our mission to improve patient lives while creating durable stockholder value. With that, operator, please open up the call for questions.

[Operator Instructions] Our first question comes from Anthony Petrone with Mizuho.

Maybe to start with the data. I want to congratulate you and the team there. 50 -- greater than 50% reduction in infections using ASCENIV versus standard IG therapy. You have a plan to publish those data, present next year at Clinical Immunology in April. Maybe a little bit on some of the constructs of what we should expect in the publication. What types of adverse events maybe were avoided with ASCENIV? Will there be cost-benefit analysis in those -- in that study publication? And then I'll have a couple of follow-ups.

Thanks for the question, Anthony. So I was very pleased that our compliance group allowed us to talk about this data. So I can't give away too much, but we evaluated a robust patient cohort that was appropriately sized, and we were able to generate statistically significant data. Very, very proud of this. The data demonstrates a significant reduction in infections in these patients that are switching off of their standard IG and moving to ASCENIV. This is the real-world setting. These are complex PI patients that are switching. And again, we're just very pleased. I mean, 2.1 infections while they were on standard IVIG compared to less than 1 infection per year with a p-value of less than 0.05.

We think that this is really just a very clear way of demonstrating what clinicians have been reporting to us and what we've been reporting as a company about the clear clinical differentiation that ASCENIV provides compared to standard IG and why these complex and refractive and comorbid PI patients seem to do better on ASCENIV. We expect that the data is going to reinforce prescriber confidence. It's going to strengthen payer coverage. Our negotiations with payers have progressed very nicely throughout 2025, and we're anticipating expanded access into 2026.

So we're continuing to analyze this data. We plan for a peer-review publication, as you mentioned, early in 2026. And we expect this and other investigator-initiated studies that are ongoing to further validate ASCENIV's utility and really define the patient profile that we're targeting. In 2026, we really plan to ramp up medical education and publications. We plan to provide continued real-world outcomes data. And we think all this is going to bode well for ASCENIV's growth in 2026 and beyond.

All right. That's very helpful. The follow-up here would be, we've picked up from physicians that with data and this certainly -- with data indication -- indicating that you can get efficacy benefits with ASCENIV that perhaps there's a percent of the immunologists out there that would consider using ASCENIV sooner to treat some of these complex PI patients. So what do you think this data can do for demand into next year? And how should we be thinking about the growth curve once this data is digested and of course, your supply situation has improved. And I'll get back in queue. Again, congrats on the study.

Thank you so much, Anthony. Look, we've seen record utilization of ASCENIV throughout the third quarter, and that has continued to be observed as we enter the fourth and are in the middle of the fourth quarter. This data is really just reinforcing everything that we've experienced.

Payer negotiations, I mean, look, we still stand firm on our position that ASCENIV should not be used as a first-line therapy. We think that your question about, could this in the minds of prescribers be used earlier in the treatment cycle, possibly. We do see some private payers moving ASCENIV up where you don't have to fail as many step edits, there could be less. So we think that payer expansion is going to improve. And again, the more data that we can put and publish in the public domain, the better it's going to be to reinforce and maintain ASCENIV's strong position.

We do expect strong double-digit growth. We do think that the data that we're putting out there, the patient testimonials, our medical education strategy and our enhanced publication strategy for next year is all going to work together to continue to drive utilization. Regarding the growth curve, I mean, look, we've, we've increased guidance for 2026 top line and earnings metrics. Very proud of where we are with yield enhancement with our first FDA released commercial batches of yield enhanced product now flowing through the supply chain. So we think that you're going to see continued accelerating utilization of ASCENIV continued growth of our IG portfolio throughout 2026 and beyond.

Our next question comes from Kristen Kluska with Cantor Fitzgerald.

This is Rick Miller on for Kristen. We've got 2 here for you. You've been saying back half of this year, you're expecting an acceleration and then into next year. So is there any additional color you can give us on what you were seeing that sort of gave you the confidence around raising the revenue guidance? And then we'll have one more for you after that.

I mean the confidence is that we see it in the redistribution data. I mean the product pull-through at record levels, exceeding internal expectations throughout the third quarter. Fourth quarter is no different. We feel very confident in ASCENIV's utility. I think the data that I was just speaking about, this is what physicians and patients are experiencing in the real-world setting. So we're making a good drug. We're making more of it than we ever have before. We had more product available in the third quarter than we have had historically, and we see it continuing to pull through at a rapid pace. So very encouraging.

I mean, look, again, Rick, we've talked about, and I don't like to sound like a broken record, but the patients who are switching to ASCENIV are patients that are not thriving on their standard IG, and they're looking for alternatives. One thing I can say is that in the late summer, we started our first direct-to-patient medical education programs, and we think that those are starting to have a meaningful impact as well. The key is if you're an immune-compromised patient receiving IG and you just don't feel well, have a conversation with your doctor, talk to your nurse practitioners, advocate for yourself, you're your best advocate and see if ASCENIV is the right product for you to switch to.

So all these factors combined are what's contributing. Our field team is working in unison. We've had some great hires throughout 2025. And we continue to just knock down doors and uncover new institutions that are starting their first patients. And it's everything that we've really described is that same institutions are now starting to add patients that they've identified in their queue, if you will. We've got more product available, and that's been the message throughout the third quarter that, look, we've got more product for you. You can start putting patients on therapy. And we see it in our supply chain that we've got the ability to ensure the continuity of care for these patients. So we're starting them. They're staying on therapy, and they're doing well.

That's what contributes to this growth. And that's why in our fifth plus year or so from launch, we're forecasting very robust acceleration as we wind down 2025 and enter 2026.

Yes, exactly. Adam, just to expand on that. I mean, we're talking about the guidance that we just raised for 2026, and that represents 24% year-over-year growth on revenue. It represents 51% year-over-year growth on adjusted EBITDA and 61% year-over-year growth on adjusted net income. So exactly what Adam was saying is those are the things that are providing us confidence to raise that guidance, and we are feeling pretty good and strong about 2026.

Okay. And then maybe one more. After the FDA lot release for the yield enhanced product, are there any other gating factors here before we start to see the impact on 4Q?

No. We're going to see this flow through. The majority of product sales in the fourth quarter, we think, will be from yield enhanced product. ASCENIV certainly, most of it, again, we think will be from yield enhance. But very excited about this. Again, it was something that was an unknown that we said probably will go off in the normal course, which it did. And we're very pleased. Dialogue with the agency has been good, and it's business as usual. So very excited for what the fourth quarter should bring in 2026.

Our next question comes from Gary Nachman with Raymond James.

Congrats on the progress. Just following up on that last point, with the FDA releasing the first lots of the yield enhanced batches, just give us a sense of how long that process takes? And will it now be a lot easier going forward for new batches, just how that all works? And then just also give us a sense of how much gross margin will expand in 4Q and into next year, what that cadence will look like, I guess, off the 63.7% in 3Q that was normalized?

Sure. So FDA lot release, as we've said, can be as short as, call it, 2 to 3 weeks to as long as, call it, 6 to 8 weeks. There is no -- there was nothing different that occurred with the yield enhanced batches, Gary. It was just -- we just wanted to make sure that everything went through in the normal course, which it did. So we're receiving FDA lot releases routinely. No issues there, and we continue to have ample inventory and supply available of our IG product portfolio to meet the demands for the market. With respect to gross margins, I mean, we reported -- we reported this quarter that if you back out the plasma revenue, Brad, keep me honest here, product level gross margins were 63.7%. So we're feeling very good about product level gross margins. And we feel that it should continue to expand as we continue with ASCENIV mix shift from a revenue and a unit perspective.

Our goal is, again, to get to using half the plant's capacity at least to make ASCENIV, if not more. And that's what's going to drive us to our out-year guidance for 2029 now. that is $1.1 billion or more in revenue. So we're feeling very positive about it. Everything is going very well from a lot release perspective. And the visibility with our third-party supply contracts is what's giving us this encouragement to get more patients on drug. We're making more ASCENIV. We're producing more batches than we originally planned for 2025, and that's going to ultimately give us more product to sell in 2026.

And Gary, just to expand on that, on the gross margin piece. mean as we get into 2026, we've always been saying that we're going to see margin expansion. And at 63.7% less the plasma sale, we're at the beginning -- I believe we're at the beginning of that, right? We're at the beginning of that margin expansion journey. The operations team is constantly looking for cost savings initiatives, and they're getting after it and they're getting after it hard. And as we continue to see this mix shift between BIVIGAM and ASCENIV, and we continue to see the yield enhancement lots roll out, if everything goes in our direction in 2026, we'll be potentially hitting the plus 70% gross margin line, and that's going to be very nice from a drop-through to net income and adjusted EBITDA.

Okay. That's helpful. And then with the payer discussions that you're having to improve access next year, just talk a little bit more on that because you previously said that was in pretty good shape. So I just want to get a sense, do you have to give up any discounts or rebates to get more favorable access? And then how much of the HEOR data is actually a factor there? We're obviously very excited to see that data as well. So I'm curious if you started having discussions yet with the payers or that's still to come in terms of that new data?

So we are always in active discussions with a number of different commercial payers, Gary. You couldn't see me smiling when you were asking your question, but I was smiling. I mean the payers certainly like their rebates. We're in active negotiations around this. We don't think that anything is going to be so significant that it's going to change our gross margin outlook or our product level margins significantly. But we all understand how it works. So the negotiations with the payers have actually been pretty positive over the last couple of months as we ended the third quarter and enter the fourth quarter. My field reimbursement and market access team is seeing some, I don't know if you can ever use the word acceleration in approvals with commercial payers, but appropriately defined use case patients are getting approvals. Some payers are working more rapidly with us than others, and we're trying to alleviate the bottlenecks across the entire commercial payer landscape.

Again, the majority of ASCENIV especially, BIVIGAM as well is through Medicare, where it's a lot easier to get reimbursement more rapidly. But from a commercial payer perspective, which is about, call it, 40-ish, 45% of utilization, we're seeing movement from some payers who had us restricted. We're coming off restricted less, we're moving up from a step edit perspective. And I think as these negotiations transpire, if there's things to report, we'll certainly keep the street informed.

But data, obviously, the more data helps. You asked about the outcomes data. The payers are seeing this in their own patient profiles. I mean they're seeing that these are patients that have cost their plans money. These are patients that do get hospitalized maybe once or twice per year, and they're staying out of the hospital. They're not getting as sick. We're reporting today that in this investigator-initiated study, we're seeing a significant reduction in infections. This is not a one-off. This is what payers are seeing. And all of this contributes into their decision to approve ASCENIV and approve a switch from standard IG to this product.

So everything seems to be working well. Again, our field reimbursement team is doing a great job and our market access team is negotiating in a very collegial way with a number of different payers right now. And we wouldn't have put it in the prepared remarks or in the press release if we didn't feel confident that we were going to see improvements to our commercial payer profile. So we expect that to occur early in 2026, and we're very optimistic for the growth for the future.

Okay. That's all very helpful. And then just last one, just a follow-up on an earlier question about, also using that data to expand the number of physicians or centers that are going to be using ASCENIV. So just want to confirm, are you still currently around 100 or so, whether it's physicians or centers that are using ASCENIV? And to get to your peak target for 2029 of greater than $1.1 billion, where does that need to go? Does it need to double? Could it -- you've talked about a 300 sort of target, I guess, ultimately? And how long do you think it will take before you get there?

All good questions. Thank you, Gary. we do say that there are about 300 clinical immunologists that follow large groups of these primary immune-deficient patients. It's certainly greater than 100 prescribing docs now. I mean we've really seen rapid uptake throughout the summer of new docs saying, "You know what, I'm readyâ€. And the fact that our commercial team since the start of the third quarter has been out there saying that we've got more product, you can start your patients on therapy.

I mean, people took us seriously. So that certainly helps, Gary, when you're dealing with a scarce raw material like we are with ASCENIV, less than 5% of these plasma donors have the antibody profile that we're looking for. But the clinician universe that we target, they're well aware of our partnerships with Grifols, Kedrion and others to access a wider group of collection centers to get more plasma. So folks have been listening to our messaging. They know that Grifols, Kedrion and others are reliable suppliers. And I think we've really been able to do a great job at building the confidence for the continuity of supply throughout 2025. And that's what's been encouraging for new docs to put patients on and existing prescribers to add more patients in their queue.

Look, we're -- we increased 2025 revenue, I believe, right, from $500 million to $510 million. We feel confident about this. We feel good that our ability to supply product to the health care community is solid. And that's really what's helping to drive this, is the confidence of our commercial team, telling the prescribers that, look, we've got the product available. They're accelerating the accession of these patients, getting them on therapy, starting the payer conversations earlier.

Our field reimbursement team has grown this year, and it will probably grow a little bit next year, but they're all working very, very hard to expedite new patient starts. And that's what's ultimately going to drive growth. You're asking me about the full year 2029 revenue. I mean, I feel good that -- we're in a good position, Gary, both from who the physicians are and where the patients are to hit $1.1 billion. We feel good about our ability to collect the raw material. I mean you've seen inventory step up. We're swapping out normal source plasma, replacing it with high titer plasma inventory to make more ASCENIV. We're elbows deep in the budget for 2026, and we're forecasting more ASCENIV production than we had in 2025, and that's ultimately going to drive increasing revenues in 2026 and 2027. So is there an opportunity to achieve the $1.1 billion earlier than 2029? I think it's possible. But at this point in time, we feel confident that we should hit this in 2029. And in normal ADMA fashion, if we can do it faster, we certainly will.

We have a question from Anthony Petrone with Mizuho.

I was following up on the experience you're seeing with the new centers from earlier this year. You mentioned a 5% hit rate on collections at those new centers. I'm just wondering, as time goes on and perhaps with your partnerships either with Grifols or Kendrion, you train those sites to sort of have more proactive donor outreach, do you think that the donor -- the 5% RSV hit rate in those additional centers can improve over time?

So the hit rate will always be the hit rate, but the amount of plasma that our third-party suppliers will collect of high titer, I think, will grow, Anthony. Look, the third-party suppliers have meaningfully outperformed, full stop. The team at ADMA that does our proprietary RSV screening assay and testing, they've got it under control. They've ramped up. I mean we invested time, money, effort, blood, sweat, tears to get to this point. And we feel really, really good about the supply chain continuity and the ability to rapidly identify these donors and collect that plasma from our third-party providers. As I mentioned, and I think folks can see in the contracts, I know that there are some terms that are redacted, but there are financial incentives for our third-party suppliers to hit our target collection goals. They all want their bonuses and by [dollar ], we want to pay their bonuses.

So I think it's a very symbiotic relationship. I think it's going very, very well. And again, I cannot emphasize enough about how good the team has done here at ADMA, but our third-party suppliers have meaningfully outperformed. 2026 conversations with our third-party suppliers are going well. We feel like we're in a great position to collect more plasma than we did this year for next year. And that's ultimately going to give us confidence into '27, '28 and '29. So things are going very, very well from a plasma supply standpoint. We're building inventory. We've got the inventory we need to be successful. And we feel like we're in a great position to at least meet, if not exceed the upwardly revised guidance targets that we've set for 2026.

Ladies and gentlemen, this will conclude our question-and-answer portion of the call. I'd like to turn it back over to Adam now for additional closing remarks.

Thank you, everybody, for taking the time this afternoon. We really appreciate your continued support of ADMA Biologics. And if you have an ADMA Bio center or one of our third-party centers near you, please go donate plasma, save a life. And to the ADMA team that's listening, thank you for all you do. Let's crush it until the end of the year. Thanks, everybody. Have a good afternoon.

Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation, and you may now disconnect.

Good afternoon, and welcome to the ADMA Biologics Second Quarter 2025 Financial Results and Business Update Conference Call on Wednesday, August 6, 2025. [Operator Instructions] Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately 2 hours following the end of the call. At this time, I would like to introduce the company. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the second quarter of 2025 and recent corporate updates.

I'm joined today by Adam Grossman, President and Chief Executive Officer; Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brad will provide an overview of the company's second quarter 2025 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions.

Earlier today, we issued a press release detailing the second quarter 2025 financial results and summarize certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com.

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 any such statements, except as required by the federal securities laws. We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section in our SEC filings and our quarterly report on Form 10-Q for the quarter ended June 30, 2025, 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, go ahead.

Thank you, Skyler. Good afternoon, everyone. ADMA's second quarter 2025 performance underscores the strength of our operating model, the success of our strategic execution and our unwavering commitment to innovation. During the quarter, we advanced key growth initiatives, enhanced our supply chain infrastructure and further solidified ADMA's leadership position in the specialty biologics market.

We are pleased to report that commercial scale production utilizing our FDA-approved yield enhancement process is now successfully underway. Initial production has achieved the expected 20% or greater increase in bulk IG output, validating this proprietary manufacturing advancement. We expect this efficiency gain to drive meaningful gross margin expansion and improved production throughput beginning in early 2026, with continued benefits expected in the years ahead.

On the commercial front, ASCENIV continues to gain momentum with utilization reaching record highs in the second quarter. With expanded availability of high-titer plasma and strong forward demand indicators, we believe we are well positioned to deepen market penetration and broaden patient access. Medical community feedback remains positive, and the recent acceleration in new patient starts further highlights ASCENIV's differentiated clinical value.

Our financial results for the second quarter reflect substantial growth and operational achievements. Total revenues reached $122 million on a reported basis. On an underlying basis, excluding the nonrecurring $12.6 million Medicaid rebate accrual reversal that benefited the second quarter of 2024, total revenue grew by approximately 29%. On the same underlying basis, second quarter 2025 adjusted net income and adjusted EBITDA grew approximately 85% and 59% year-over-year, respectively.

We are constantly reaffirming all previously issued financial guidance with growth rates anticipated to accelerate significantly in the second half of 2025 and beyond. These results underscore the efficacy of our biologic therapies for immunocompromised patients across the U.S. as well as the dedication and expertise of our leadership team and exceptional staff.

Importantly, this week, we completed a JPMorgan-led debt refinancing, replacing our prior term loan and meaningfully reducing our borrowing costs. The new credit agreement totaling $300 million and comprised of a $75 million term loan to refinance the previously held debt with Ares as well as a $225 million revolving credit facility features leverage-based pricing tiers with revolving credit facility spreads ranging from 1.5% to 2% and term loan spreads from 2.5% to 3%.

This refinancing, which is effective as of August 5, 2025, and therefore, not yet reflected in the second quarter financial statements, is expected to lower ADMA's weighted average cost of debt enhance liquidity and provide additional financial flexibility to support our long-term strategic growth initiatives.

Operationally, in July, we expanded our operating infrastructure with the acquisition of a facility and adjacent land near our Boca Raton campus. This investment is expected to provide additional operating flexibility to support our growth trajectory through expanded cold storage, warehousing and inventory management, in-house testing and potential new distribution opportunities as well as could enable up to a 30% expansion of cGMP manufacturing space over time.

Importantly, this acquisition further entrenches our fully U.S.-based supply chain and should enhance our scalability and resilience in alignment with rising demand for American-made health care solutions. We expect go-forward capital expenditures supporting this infrastructure expansion to remain modest and ultimately expect to deliver a highly compelling return on investment.

In the second quarter, we also activated our authorized $500 million share repurchase program and repurchased approximately $15 million of ADMA common stock. Supported by strong free cash flow, we view these repurchases as a highly value accretive use of capital and intend to remain opportunistic in future periods. Including a proactive $19.3 million increase in inventories, primarily consisting of raw material to support accelerating ASCENIV production, we generated meaningfully positive free cash flow during the quarter, ending the period with $90.3 million in total cash.

Internal and external plasma collection volumes reached new highs, positioning us well to support ongoing commercial expansion. These achievements reinforce our confidence in delivering on our long-term growth targets, including reaching $1.1 billion or more in annual revenue prior to 2030, while continuing to expand access to our differentiated IG therapies. Beginning in the back half of 2025 and continuing on our pathway to this intermediate-term revenue target, we anticipate significant margin expansion on a go-forward basis.

Our R&D pipeline continues to progress. We initiated studies in a first-of-its-kind animal model designed to evaluate S. pneumonia infection in both normal and immunocompromised hosts. In initial pilot testing, SG-001 treated animals exhibited no clinical signs of pneumonia 24 hours post bacterial challenge, while placebo-treated animals developed observable symptoms.

Establishing this model is expected to accelerate ADMA's preclinical research and development of SG-001. If successful, the product could represent a potential $300 million to $500 million annual revenue opportunity, supported by strong gross margins and patent protection through at least 2037. Following the initial data readout, we expect to be in a position to rapidly advance SG-001 into clinical and registrational studies, leveraging our existing commercial platform to drive a potentially accelerated path to peak sales.

Before turning over the call to Brad, I'd like to express my sincere appreciation to our exceptional team at ADMA. Your continued dedication, ingenuity and mission-driven focus continue to power our momentum. The progress we are reporting today is a direct reflection of your hard work and passion. And together, we are shaping a stronger future for patients and the broader health care ecosystem.

With that, I'll now hand it over to Brad to walk through our second quarter financials in more detail.

Thank you, Adam. Earlier today, we issued a press release outlining our second quarter 2025 financial results. I'll now summarize key highlights from the quarter. Total revenue was $122 million, up 14% year-over-year or approximately 29% when adjusting for the nonrecurring $12.6 million Medicaid rebate accrual reversal that benefited the second quarter of 2024. This growth was driven primarily by continued strong adoption and utilization of ASCENIV across physicians, payers and patients.

Gross profit increased to $67.2 million with gross margins improving to 55.1% from 53.6% a year ago. Adjusted for the prior year Medicaid rebate accrual, underlying gross margin expanded by 7.7%, reflecting a favorable mix of higher-margin IG sales and improved manufacturing efficiencies.

GAAP net income was $34.2 million, while adjusted net income increased to $36 million, representing an 85% underlying growth year-over-year when normalizing for the prior year Medicaid rebate accrual.

Adjusted EBITDA grew to $50.8 million, up 59% on an underlying basis after adjusting for the Medicaid rebate accrual benefit. Including a strategic step-up in inventory of $19.3 million quarter-over-quarter to support ASCENIV demand, we delivered robust free cash flow, ending the quarter with $90.3 million in cash.

Continued EBITDA growth and cash generation are expected to further strengthen our balance sheet in the second half of 2025, positioning ADMA to weather broader credit and equity market volatility. Reflecting this financial strength, we repurchased approximately $15 million of common stock under our $500 million program during the second quarter. We continue to view buybacks as a value-enhancing capital allocation strategy, supported by our growth trajectory and our earnings outlook.

As Adam mentioned, this week, we executed a new $300 million senior secured credit facility led by JPMorgan, consisting of a $75 million term loan drawn at closing to replace previously held debt as well as an undrawn $225 million revolving credit facility. The facility features a 3-year tenor and is secured by a blanket lien on all assets and stock, consistent with customary market terms. Pricing is based on total leverage with drawn spreads ranging from adjusted SOFR plus 250 basis points to 300 basis points and commitment fees of 30 to 35 basis points. We intend to utilize the revolving credit facility opportunistically, primarily to support share repurchases, working capital needs and other general corporate purposes while maintaining flexibility in our capital structure.

Importantly, the refinancing replaces our prior indebtedness, lowers our overall cost of capital and enhances liquidity to support long-term growth initiatives. These terms, combined with anticipated strong cash generation, provide ADMA with meaningful flexibility and capacity to execute on our strategy and priorities. Building on our strong year-to-date performance, we are reaffirming our previously provided financial guidance for both 2025 and 2026. For 2025, we continue to expect total revenue of $500 million or more adjusted EBITDA of at least $235 million and adjusted net income of $175 million or more.

This guidance does not include any potential accretion from the monetization of products sold using our now approved enhanced yield process, reflecting conservative assumptions regarding the timing of production ramp-up and lot releases. Looking ahead to 2026, we are reaffirming our financial outlook underpinned by the recent FDA approval of our enhanced yield production process and continued commercial momentum.

For 2026, we reaffirm our expectation of at least $625 million in total revenue, adjusted EBITDA of $340 million or more and adjusted net income of at least $245 million. This outlook remains consistent with our historical financial targets and reflects anticipated margin expansion driven by our growing ASCENIV revenue mix. Additionally, we reaffirm our expectation that annual revenue prior to 2030 will exceed $1.1 billion compared to our previously communicated expectation of $1 billion with meaningful margin expansion expected over the same period.

Looking ahead, we believe we are well positioned to accelerate our revenue and growth and earnings growth rates in the back half of 2025, grow free cash flow and continue to reduce our weighted average cost of capital, all of which we are confidently executing on while concurrently advancing all our growth initiatives.

With that, I'll turn the call back over to Adam for closing remarks.

Thank you, Brad. ADMA is executing across all fronts, commercially, operationally and strategically. The success of our yield enhancement production process, record ASCENIV utilization, debt refinancing and infrastructure investments all provide clear visibility into anticipated sustained margin expansion and earnings growth in the immediate quarters ahead.

As we scale toward both our near-term and long-range financial goals, our focus remains centered on operational excellence, disciplined capital allocation and innovation that puts patients first. We believe our fully U.S. domestic vertically integrated model continues to provide us with unique supply chain control and long-term resilience. We remain unwavering in our mission to deliver high-quality differentiated IG therapies to those who need the most.

Every investment we make, whether advancing SG-001, expanding U.S.-based operations or strategically repurchasing shares is guided by a long-term growth mindset focused on maximizing value for stockholders and patients alike. With strong stakeholder partnerships, a growing base of treated patients and a passionate team driving us forward, we believe ADMA is uniquely situated to be one of the most durable and compelling growth stories in all of biopharma. We're proud of what we achieved and are energized for what lies ahead.

With that, I'd now like to open up the call for questions. Thank you.

First question comes from the line of Rick Miller at Cantor Fitzgerald.

This is Rick on for Kristen Kluska. I've got a couple here. You mentioned seeing record high ASCENIV utilization. Are you seeing any changes in trends in how physicians are deploying the specialized product and prioritizing different cases for ASCENIV?

Thanks, Rick. We're seeing the same thing that we've been seeing throughout ASCENIV's growth period, and we're seeing it into the third quarter. We've defined appropriate use. Again, it's this refractive highly comorbid PI patient that has been on IG, and we're seeing new patient starts, patients switching off of standard IG therapies, moving on to ASCENIV, and we're seeing the same trends continuing. Same-store utilization looks great.

We're adding new docs all the time. We've got more product coming off the line. And everything we said, Rick, is happening right now. All the guidance that we provided previously is coming to fruition, and we're seeing really good utilization uptake in the market and expanding into new clinics. So it's pretty much the same as it has been, and we expect it to continue to compound as we progress throughout the second half of this year and into 2026.

Okay. And hoping to ask a question also on the science behind yield enhancement. What does the actual process here for the yield enhancement process look like? Is your team basically working with different purification columns to sort of get back some of the IVIG that was previously lost? Anything to kind of help us understand what's going on sort of under the hood?

Sure. As we've explained previously, so when you produce IG, there are certain waste streams that are separated out of the final product. These waste streams contain some IgG. They also contain different aggregates and impurities that you want to remove. So the team here at ADMA developed a methodology where we can take one of the waste streams where we lose the largest portion of IG in the manufacturing process, resuspend that paste, purify it, put it over some chromatography columns, some filtration steps and then blend it back together with the original part of the process.

So really, what it's doing is it's taking something that was waste and really bringing it back into the downstream purification part of our process. And we are seeing the anticipated gains of 20% or more from every batch of product that we are producing. We've been producing at this yield enhanced scale since I believe it's the middle of May, and we're seeing great results as expected.

So taking something that was trash and turning it into 20% more bulk IG yield, again, this is going to enhance gross margins for our IG portfolio, BIVIGAM and ASCENIV and ultimately provide more product to patients that still seem to be in an undersupply situation in a growing IG market in the U.S.

Our next question comes from Anthony Petrone with Mizuho Americas.

Maybe Ad am and/or Brad want to just kind of go through moving parts on the reaffirmed guidance and the outlook through '26. You are getting the record RSV collections from, I would assume, the external supply contracts signed earlier in the year. Yield enhancement is now here. You're not baking it in. Just curious the calculus there. It sounds like there's more visibility on the supply front. What is going to be the trigger to sort of seeing that come through to fruition in the guidance as we look into the second half of the year and the start of next year?

Sure. I mean I'll just start off by saying, Anthony, our guidance was strong as we ended last year and entered this year. We're conservative as always. The approach that we take to guidance construction has not changed. We are aiming to beat the guidance that we currently have out there, but we feel really, really good about where we are from a raw material perspective. Manufacturing has been going extremely well, especially with yield enhancement now. We're seeing that step-up in inventory valuation.

And we're working expeditiously to work through all of the previous process produced product that we would be selling at a lower margin and trying to accelerate to where we can realize revenue from the new FDA-approved yield enhancement process. It's not in 2025 guidance. It's heavily risk-adjusted for '26. And as we continue to progress, I mean, we do expect to see accelerating margin expansion and obviously, top line sales in the back half of this year. And that's the guidance that we've been given since January.

So again, conservative approach. We always said the beginning part of 2025, we're going to see growth, but it's going to be modest growth. And where you're going to see that acceleration is in the back half of this year. We've been making more ASCENIV. We made more ASCENIV at the end of last year, beginning of this year, working down some of our inventories.

Our third-party suppliers, as you mentioned, have been delivering really, really well for us. Really very, very pleased with the relationship between Grifols and Kedrion. We're getting more plasma than we anticipated, and we feel really good about the inventory levels, and we're turning it into finished goods and the finished goods are moving off the shelf. So everything is coming together as we planned.

Exactly. And I mean, you saw the strategic $19.3 million RSV investment. And obviously, we're doing that as we anticipate accelerated growth in the back half of 2025 and to support 2026 as well.

That's helpful. Just a couple of follow-ups here. One would be on just kind of looking at how it's set now, if you take your first half and look at the second half of the year with the guidance unchanged, it's a little bit of a deceleration. So again, you don't have yield enhancement in there or the benefit of supply, but I would assume you're not signaling any major change in sort of the demand picture in the back half of the year.

And the last one, if I could just sneak it in. Can you give just a high-level overview, Adam, of the cost benefit analysis to hospitals specifically here with an ASCENIV patient. These patients are typically hospitalized for quite a bit. It does appear there's literature out there that you get a sooner discharge. I'm just wondering if there's any numbers you can put around that.

Anthony, can you repeat that part again? This is with respect to ASCENIV in the hospital?

Yes. So first is on the guide, just again, there's an implied decel in the second half. Just want to make sure that the demand picture is steady. And then just the cost benefit of using ASCENIV. You're certainly getting the benefit with these patients. Just wondering when you compare that head up to standard therapy, whether it's IG or combination therapy, how that stacks up?

Sure. Understood. So first half of the year, total revenues are -- I'm just doing the math, like $236 million. Back half of the year will be growing at least, call it, $265 million. So there is growth that is going that is baked into our current guidance. Again, as I've said, we take a conservative approach, and we are expecting to beat. And the way it looks from my vantage point is we've got the inventory in work in process and coming off the line, and we should have more product to deliver to the market.

As I stated with Rick's question, the demand indicators are still very, very strong. We're still working through our health economics outcomes work, Anthony. So we'll have information on that hopefully later this year. But I can tell you from a clinical perspective, patients that are on standard IG and that continue to suffer chronic and persistent infections costing the health care system money, taking up time at their physicians' offices, in and out of the ER, that are getting hospitalized for serious bacterial and viral infections, when these patients are switched from standard IG to ASCENIV, they don't go to the hospital. They don't suffer from these chronic and persistent infections that they have been experiencing for sometimes years.

So the value proposition is still there. You're taking these problematic patients that are causing tremendous problems for their treaters, for their families that are not living a normal quality of life. And we're giving them a renewed chance to live a productive and normal life while keeping them out of the hospital. So from my view, we're modeling a reacceleration of growth starting in the third quarter, that's what our guidance outlook tends to.

Yes, Anthony, I would say it's similar to how Adam is saying it is our guidance implies we are confidently reiterating a growth reacceleration in the third quarter and beyond. And we are preparing our supply chain and our manufacturing processes to meet and exceed that reaccelerated growth.

Next question comes from Gary Nachman with Raymond James.

So first, Adam, you noted more physicians are using ASCENIV. So maybe talk about some of the initiatives that you have to expand physician use of ASCENIV. If it's currently about 100 physicians or so, that's a number you've said in the past that are using it and maybe the target group is about 300, how do you bridge that gap? And when can you be more aggressive promoting to the docs? I mean do you need to have the supply in a certain place before you do that? And as they're putting new patients on, are they getting any pushback at all from the payers? So just give us an update also on the whole reimbursement situation.

Sure. So Gary, new docs are coming online all the time. From an aggressive standpoint, I mean, look, we've alleviated what we believe have been the bottlenecks in producing product. And for the forward-looking periods, we believe that we've got product on the shelf ready to go to start these patients aggressively, and you're going to see that again beginning what we believe is this period in the third quarter throughout the back half of this year into 2026.

Nothing is easy with payers. But again, in the appropriate use cases, we're seeing limited payer pushback. We do have to jump through hurdles like all IGs do. Again, about 70% of IG requires prior authorization. And we built out our team from a field reimbursement perspective, and we're working hand-in-hand with these clinicians, providing them with data from the literature and helping them to alleviate any reimbursement hurdles that they may find.

Patients who should be on ASCENIV are getting on to the product. It may take a couple of weeks, it may take a couple of months. But ultimately, these patients, if their doctors are advocating for it, they're getting therapy. Again, about half of our business for the immunoglobulin portfolio is through Medicare. The other half is through commercial payers. It's spread across 60 to 100 different commercial payers. So there isn't one payer bearing the burden. But things look very good.

Medical education is really what triggers the light bulb in these patients', in these doctors' minds, targeting the IG infusion nurses, the nurses that are dealing with the patients directly or their families. And we're seeing no decline in level of interest or excitement about the product. And certainly, the experiences that have been reported to me from new clinics and new clinicians in the field when they've started with ASCENIV have nothing but been positive feedback to me.

Okay. And then just on that point regarding medical education and what you just responded before to Anthony regarding the HEOR data, you said you should have that later this year. Can you put a little bit of a time frame around that and what maybe we hope to see with that data? And how important you think that might be going out to the physicians and the payers, so they have a little bit more data and evidence about the benefit with ASCENIV?

Sure. We're continuing to generate data all the time through investigator-initiated grant studies and investigations A number of publications have been coming out poster presentations at various conferences around. We are culling the database and looking at claims data. And look, what I'm hoping to see is exactly what I've been explaining over the last couple of years is that you're going to see a large clinical benefit when you take an appropriate use patient who's been receiving IG and is in and out of the hospital, when you put them on ASCENIV. You're keeping them out of the hospital, you're reducing all total health care expenditures. And obviously, we believe that the clinical outcomes for ASCENIV in this patient population are certainly going to be great data.

So later this year is all I can tell you. I'm not the statisticians, and I'm not the one digging in there, but we will keep you and the Street abreast of data as it comes available, and we'll make appropriate publications and presentations at medical conferences throughout the rest of this year and into next year.

Okay. Great. And then just on the gross margins, which obviously are expected to improve. Just as we're thinking about the pace of this improvement, are there any headwinds maybe just in terms of, I don't know if just the cost of ensuring that you have appropriate plasma supply or rebates that you're offering your customers or things like that? So is there anything going in the other direction that might be holding back gross margin a little bit? And I don't know if maybe you could bookend so we have a sense of how to think about gross margin expansion this year and maybe the magnitude of how that can improve next year?

Gary, right now, we are not seeing any headwinds to gross margin. We have secured RSV plasma supply, which allows us to make the ASCENIV and products that we need. We will start monetizing yield-enhanced production batches, hopefully at the end of this year, certainly all of 2026. You'll continue to see margin accretion with yield enhancement and with IG mix shift. But again, right now, we are not seeing anything in our way from expanding and accreting gross margins. And we are expecting as we continue to accelerate our growth in Q3 and beyond, we will continue to expect and you will see margin accretion in a meaningful way.

Okay. And then just last question regarding the new facility that you acquired, which I think is sort of a bullish statement that you think potentially there's a lot more to grow here. When you talk about expanding capacity by 30% potentially, and you're only going to have a modest level of CapEx behind that. what's a realistic time frame for you to be able to achieve that level of capacity expansion? Just so we could also think of how much you're going to be allocating in terms of your cash flow towards that capacity expansion?

Thank you, Gary. So you're obviously referring to the real estate that we announced that we purchased in July, 5-acre piece of land, there's a building on it. In the near term, our focus is scalability. This building is going to provide us the ability to enhance supply chain, cold storage, testing distribution. It was a reasonable purchase price. And the capacity expansion is really because we're looking at the future here. We are operating in a market that continues to grow rapidly. IG utilization is not slowing down. The demand for our products in that is growing at a very rapid clip.

You see with yield enhancement, we're reporting that we are experiencing the 20% plus increase in both drug as well as finished goods. We need a place to keep it while it's finishing its testing and a place to distribute it from. So we're looking at this as it's really going to help support and sustain the durable growth outlook that we're looking for.

With regard to capacity expansion, we figured someone would ask this question. We're thinking about the future. And the press release today talks about some encouraging developments with SG-001. That's our follow-on high-titer hyperimmune product with high levels of neutralizing antibodies targeting strep pneumonia. The data is very encouraging there. And we want folks to understand that our Board and the management here is looking at building a highly durable cash-generating business into the future.

And I think everyone understands this, at least those that are following ADMA, we've got multiple buildings on our existing campus. And I'm speaking to you today from an office in the building that houses our GMP manufacturing area. Well, the best thing to do is to get rid of all the offices at some point in time and move those offices and turn what is office space today into GMP production space. So we don't have any plans to start it today, Gary.

So from a CapEx perspective, we're not looking at expanding capacity today. But what this infrastructure enhancement has done by acquiring this building adjacent to our campus here is allowing us to plan for the future, allowing us to really think about -- we don't want to take away capacity from one of our existing products if and when SGL-1 comes on board. If ASCENIV continues to outperform like it has been, our current capacity, we now can look at investors and other constituents straight in the face and say, we've got the ability to really expand here in a meaningful way. So we've given top line guidance of $1.1 billion. That doesn't bake in anything from this. So it could -- this is going to help us to support a multibillion-dollar revenue entity.

Yes. Gary, just to further Adam's point. So we mentioned a $1.1 billion top line prior to 2030. We do not need this building or additional capacity to achieve that $1.1 billion, and I'll call it a milestone because it's a milestone. What this additional capacity does is it turns that milestone certainly not into a ceiling. This is part of our journey. This is part of what Adam is talking about, our future growth. So again, I just want to reiterate that, that $1.1 billion top line is not dependent on this additional capacity. This additional capacity will continue to help and grow our future.

This will conclude our question-and-answer portion of the call. I'd like to turn it back over to Adam for additional closing remarks.

Thanks again, everyone. Thanks for dialing into our call. Again, really excited about the performance. I want to take my hat off to the ADMA team. Yield enhancement is a tremendous achievement, and now we've got more product to treat more patients. So thank you to everybody. Donate plasma, and we look forward to speaking to you next quarter. Take care.

Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation, and you may now disconnect.