ADMA Biologics, Inc. (ADMA) Q1 2026 Earnings Report, Transcript and Summary

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.