ADMA Biologics (NASDAQ:ADMA) Q1 2026 Earnings Call

0:00 Good afternoon and welcome to the ADMA Biologics First Quarter twenty twenty six Financial Results and Business Update Conference Call on Wednesday, 05/06/2026. At this time, all participants are in a listen only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately two hours following the end of the call. At this time, I'd 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 twenty twenty six and recent corporate updates.

0:49 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 twenty twenty six 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 twenty twenty six 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.

1:55 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 03/31/2026, for a discussion of important factors that could cause actual results to differ materially from these forward looking statements.

2:51 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 $58,000,000 of operating cash flow during the quarter.

3:42 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 incentive demand, expanding margins and continued strong cash generation. Ascentive end market demand reached record levels in the first quarter, with revenue growth of approximately 28% year over year. We saw continued strength in record metrics across new patient starts, prescriber adoption, product pull through, and patient adherence. As a reminder, our distributors not only have to maintain safety stock levels to ensure the continuity of patient care, 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.

4:48 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, incentive 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 three plasma centers, enhancing liquidity while further diversifying our plasma sourcing by adding a new third party plasma supplier. We are also actively reducing expenses in a targeted manner to improve profitability without adversely impacting our core operations.

5:40 Importantly, with a balanced mix of internal and third party plasma procurement, we believe we have ample supply of high titer plasma to support both our near and long term incentive growth objectives. Our balance sheet remains strong with pro form a net leverage below 0.5 times, driven by continued cash generation and adjusted EBITDA growth, which should provide us with the flexibility needed to support growth and activate on our capital allocation priorities. Now, 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.

6:34 Over the back half of twenty twenty five and the first quarter of twenty twenty six, 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 products within the quarter.

7:23 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 Ascentive, where fundamentals remained strong and continued 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.

8:11 This reinforces a key point. Record incentive 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 Ascentiv. We continue to believe Ascentiv 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 Ascentive's differentiated clinical profile and favorable real world outcomes.

9:09 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 US IG market or Ascentive's differentiated position in the later line setting for refractory immunodeficient patients. Looking ahead, we believe we have several important catalysts, our recent approval for Ascentiv's pediatric label expansion and the associated commercial opportunity, an upcoming preclinical data publication for our lead pipeline program SG-one, which will be presented at the International Society of Pneumonia and Pneumococcal Diseases Conference.

10:09 We expect this SG-one 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, and that we have a specialized, innovative, and forward thinking R and D engine, which translates into growth opportunities and expanded product margins. Our yield enhancement manufacturing process allows us to maximize the high titer RSV plasma we collect required to meet Ascentive's increasing demand. Yield improvement was designed to enhance our R and D pipeline programs, including SG-one, so that in the same way we are able to maximize value on the hyperimmune plasma used to produce SG-one.

11:03 We have identified a proprietary way of blending the highest titer plasma containing strep pneumonia antibodies from donors, and will rely on the yield enhancement IG production methods for future clinical trials and potential future commercialization. To design the most effective methods for SG-one 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 and D developments. ADMA remains on track to submit its pre IND package for SG-one to the FDA later this year, and we believe if approved, SG-one represents an approximately $300,000,000 to $500,000,000 in annual market opportunity at peak that can be ramped to in short order leveraging our existing platform infrastructure and commercial footprint.

12:07 All told, our confidence in Ascentive's growth trajectory and our mission to meet unmet medical needs for immune compromised patients remains unchanged. Ascentive demand is strong, fundamentals are intact, and the IG market's growth outlook remains robust. And we believe we are well positioned to drive sustained growth, expand margins, and increase cash generation moving forward. Before I turn the call over, I want to recognize and thank our entire ADMA team for their continued dedication and execution during what has been a dynamic and evolving market environment. Their focus on patients, operational discipline, and commitment to excellence continues to drive our performance and position the company for expected long term success.

12:56 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 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 $114,500,000 compared to $114,800,000 in the prior year period, representing flat trends year over year. Ascenib revenue was $97,500,000 representing 28% growth year over year, while BIVIGAM revenue was $15,400,000 down 54% and disproportionately impacted by the competitive market dynamics discussed.

13:42 Revenue from the sale of intermediates and other products also declined year over year by $3,000,000 Gross profit for the quarter was $80,800,000 resulting in gross margin of 71% compared to 53% in the prior year period. Adjusted EBITDA was 59,700,000 representing 24% year over year growth and adjusted net income was $40,700,000 GAAP net income for the quarter was $45,300,000 Turning to the balance sheet, we exited the quarter with substantial flexibility. Pro form a net leverage remains below 0.5 times, even following the revolving credit facility draw and accelerated stock repurchase deployment, and we retain approximately $100,000,000 of additional borrowing capacity to support future growth initiatives and return capital to stockholders.

14:36 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 $58,000,000 in cash from operations during the quarter and received an additional $5,000,000 in proceeds from the sale of three plasma centers in the period. The accounts receivable declined 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 $138,000,000 of cash and cash equivalents. As has been the case historically, the quality of our accounts receivable remains strong.

15:26 DSOs, which represents accounts receivable as of the balance sheet date divided by net sales per day in the quarter increased in Q1 twenty twenty six to approximately one hundred and seven 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 ninety and one hundred and five 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 $530,000,000 to $560,000,000 This outlook reflects continued incentive growth, partially offset by the expectation of sustained competitive pressure in the standard IG space over the course of 2026.

16:26 Full year 2026 expectations for adjusted EBITDA are now $265,000,000 to $300,000,000 and adjusted net income is expected to be between $170,000,000 and $200,000,000 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 and D spend related to our SG-one program, but also a step up in SG and 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 arsenide as a later line therapy for refractive and complex immune compromised patients, which remains strong.

17:20 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 the Senate, a strong balance sheet and a continued commitment to return capital stockholders, expanding margins, positive free cash flow and multiple levers to drive long term value creation. With that, I'll turn the call back over to Adam for closing remarks. Thank you, Teri. In summary, we believe the most important takeaway from this quarter is that underlying incentive 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.

18:17 We remain focused on what matters, incentive patient outcomes, product pull through, patient adherence, prescriber expansion, and long term margin expansion and earnings power. Across each of those dimensions, we continue to see encouraging trends even beyond the first quarter. Additionally, we see meaningful long term opportunity in SG-one and in the broader platform we have built. We remain focused on disciplined execution and creating long term stockholder value. Our confidence in SG-one's market potential remains unwavering, as we continue to see a potentially rapid path to commercially scaling the SG-one product to $300,000,000 to $500,000,000 on an annual basis if approved.

19:06 Despite recent competitive challenges, we believe we are operating from a position of relative strength. Our business is highly differentiated and specialized. Yield NHANZE 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. Immunoglobulin environment. And we are confident ADMA and ASCENIV will emerge even stronger as market conditions normalize. Thank you for your time today, and thank you for your continued support of ADMA Biologics.

19:54 With that, operator, please open up the call for questions. Thank you. At this time, we will conduct a question and answer session. Our first question comes from Anthony Petrone at Mizuho Financial Group. Thanks. Good afternoon, everyone. So, the standard IG backdrop comments, Adam, different some pressure in that segment, wholesalers and distributors are changing their ordering patterns.

20:45 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 twenty twenty five, 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.

21:48 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 five 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.

22:38 We've seen some dramatic ASP erosion as I spoke about in the prepared remarks there. But primarily it was impacting Vivigand. From a utilization standpoint, we did see Vivigand 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. BIVIGAM, April was the best utilization month of the year so far. But with respect to incentive, incentive has been largely insulated. We saw record utilization in Q1 and April and we don't typically speak about individual month 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.

23:55 We are seeing trends of reversion for BIVIGAM and again, Ascentive, our confidence is unwavering with Ascentive. 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, Ascentive 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 Ascentive. Our next question comes from Gary Nachman at Canaccord Genuity.

24:43 Hi, good afternoon. 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 incentive? 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 Ascended. So, you know, describe the key metrics that you're seeing on that and how soon do you think new patients will be coming off that queue and getting treated with incentives, if you're confident that you're going to see this sequential growth going forward for it?

25:39 So thank you, Gary. That's a lot of questions. And one, I was taking notes feverishly. So if I don't hit on something, 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, 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're happy to do. There was a lot of thought that went into this. And again, we really wanna reiterate that we are collecting the raw material plasma from our third party providers.

26:40 We are working on producing as much incentive 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 incentive 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 nine years ago, we inherited this product. And again, it's a good product. It's a safe product.

27:41 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 an 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.

28:27 It doesn't move around a lot. And to certain sites of care and to 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 ADMAs from utilization to get people familiar with the product.

29:22 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, focus on long term growth and value creation for stockholders and ultimately providing good products that help patients. So I do think it pays to continue to manufacture Vivigand. 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 will weather this storm and will come out the other side stronger. So I don't know Terry if there's anything that you want to add regarding guidance or anything like that but the variability is really just ordering patterns, Gary. Ascentive demand remains strong.

30:10 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 Ascenive demand as a later line therapy in the refractive complex immunodeficient patient. Yeah, Gary, I just echo that. I mean, really the primary assumptions I think you're getting at is that for Bivigam, what we're assuming in this guidance is a sustained level of this increased competition. Ascentiv, 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, sorry, maybe explain a little bit more since there has been so much focus on the DSOs.

31:01 So just, you know, you're expecting that to get to a more reasonable level of ninety to one hundred and five days from where it is currently. So just, you know, how you expect to get there and in what timeframe and the initiatives you're putting in place with your current customers, how important McKesson is to help you get there as well, and how much that's going to play into the continued increases in cash flow generation that you talked about? Thank you. Sure. So as I said, DSOs in the quarter were one hundred and seven days. We want to target between ninety and one hundred and five days. We are we believe that in the back half of this year, we're going to be able to drive improvement in our DSOs.

31:46 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 will continue for the rest of the year, we do believe that ordering patterns will normalize. And so that's baked into that as well. And as you said, some of the concessions that we had 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.

32:35 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 twenty 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.

33:31 This is the first time and I think I said this in the prepared remarks, 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 23%, 4% growth year over year. And I don't think this is something that our brethren IG companies are out there talking about publicly.

34:19 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. I thought it was something important to say but IG is still growing. It's still a highly durable business. 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's 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.

35:08 And so obviously, the quarter, we generated a substantial amount of cash. Our cash from operations was $58,000,000 which is greater 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 normally get these questions. So 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 incentives, you know, that it's going to hold up in terms of pricing? And then one, you highlighted a bunch of times, but just how long you think it would take you to run the clinicals if you started next year, and when realistically it could reach the market? Thank you.

36:02 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, Ascendant has been largely insulated. We've seen growth from a utilization standpoint. You see that the broken out product level revenues Ascendant is still a strong product for us generating substantial margin opportunity for us. And I think that that really does speak to the durability of 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 anytime 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 have published that others have published independently of ADMA.

36:57 I think that that really demonstrates and speaks volumes for the utility of this drug in the refractive highly complex immune deficient patient that is chronically ill and suffers from persistent infections. 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 points there depending upon how much utilization there is. But we're very proud of the positioning for both our products of the Sen and Endivagam.

37:45 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 a sense to answer your question. With respect to SG01 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 Asenib, which was then known as Ri002. But assuming that all of our animal work, all the preclinical testing that we're doing, all the assay testing, all the pilot scale lot production that we're doing pans out, When we are ready to start a clinical trial there are multiple shots on goal with a product like this.

38:43 Are we going to go for something similar to what we've done with Asenov? 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 Ascentis clinical trial, the FDA has published guidance for industry on how to bring an 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 twelve months.

39:32 And if the primary endpoint of that study, if there is less than one serious bacterial infection per patient per year, you will be deemed to have met the primary endpoint of less than one serious bacterial infection per patient. Pretty much every IG that I'm aware of that has run a TID study has met the primary endpoint. So it is a twelve month study to run a twelve month study. I'm pretty sure I've been quoted in the public setting as saying to do a twelve month study takes about eighteen 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.

40:37 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. Okay thank you for taking all my questions. Appreciate it. Our next question comes from Kristen Kluska at Cantor. Hi, everyone. Thank you so much for taking the questions. So when we think about the prior revenue guidance, I think the underlying assumption was always that a vast majority of it was going to be driven by incentives. And I understand a lot of the color you provided to us today on Vivigand, 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 Ascentive is going to have a lot more of the revenue share in the future.

41:40 And then, you know, the other question I had was just understanding the real world benefits. I know CIS is this weak. 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. Thank you. Thanks for the questions, Kristin. 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 populations.

42:28 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 Ascentive 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 TI IVIG administration.

43:22 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 this incentives 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.

44:09 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 Ascended 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.

44:57 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'll help fund all of the capital deployment initiatives that we have with share buybacks. The center is going to continue to fund our R and D and it's going to potentially fund any future clinical trials from our very capital efficient R and D engine. So it's a great drug. The poor message of our business and the core message of today is that Vivigan got hit, Sennav is largely insulated, the growth outlook we are unwavering in the forward looking growth opportunity.

46:05 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, Pristin, and it's going to continue to do so. Thank you, Adam. Our last question comes from Anthony Petrone at Mizuho Financial Group. Thanks. Just hopping across some calls here. Madam, you mentioned just excess plasma supply as well that's out there. So it sounds like there's elevated finished IG on the shelf and and maybe some elevated plasma.

47:00 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 two 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, how quickly can the McKesson addition actually result in net new prescribers for Asenov? Thanks. Thanks, Anthony. So with respect to IG inventories, the Plasma Protein Therapeutics Association publishes data on IG sales from reporting manufacturers into The US market.

47:47 And if you go on their website, you can see the data for the fourth quarter of twenty twenty five. 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 12,000,000 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 16,000,000 grams or so sold.

48:33 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.

49:21 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, 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 Asenov 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.

50:10 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 source plasma perspective. We collect that plasma from our current seven 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.

51:03 You asked about McKesson and its ability to materialize. We're already seeing increased utilization. April was a good month. 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 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.

51:48 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 into 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.