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ADMA Biologics Q3 2026 Earnings Call Transcript

Benzinga·11/04/2026 22:36:53
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ADMA Biologics (NASDAQ:ADMA) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below.

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View the webcast at https://edge.media-server.com/mmc/p/q25i4eju/

Summary

ADMA Biologics reported strong third-quarter 2026 financial results, with total revenue of $141.1 million, a 13% sequential increase. ASCENIV revenue grew significantly by 31% year over year, while BIVIGAM revenue faced pressures from competitive pricing.

The company is experiencing robust demand for ASCENIV, supported by increased physician adoption and new patient starts, particularly in primary immunodeficiency. ADMA is optimistic about growth opportunities in secondary immunodeficiency populations.

ADMA Biologics reiterated its full-year revenue guidance of at least $530 million, while raising its minimum adjusted EBITDA and net income expectations. The company is also advancing its SG001 candidate, with positive FDA feedback, suggesting a promising development pathway.

Operational highlights include a significant increase in gross profit and margin expansion to 71%, driven by favorable product mix and enhanced manufacturing efficiency.

Management emphasized a disciplined approach to capital allocation, with $181.4 million spent on share repurchases year-to-date, reducing outstanding shares by 6.3%.

Full Transcript

OPERATOR

Wednesday, November 4, 2026. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company’s request and will be available on the company’s website approximately two hours following the end of the call. At this time, I would like to introduce the company. Please begin.

Adam S. Grossman (Founder, President & CEO)

Good afternoon everyone and thank you for joining us. Our third quarter performance highlights two key items. First, we are seeing accelerating ASCENIV demand and second, we are demonstrating our ability to translate commercial momentum into substantial earnings growth. Favorable product mix, yield, enhanced manufacturing, and disciplined execution are driving expanding profitability and meaningful earnings per share growth. We believe these two facts show the enduring strength of our business and ability to create value for stockholders.

ASCENIV revenue reached 124.7 million, increasing 31% year over year and 21% sequentially. Total revenue grew 13% sequentially to 141.1 million, and corporate gross margin reached 71% year to date. Through September 30, 2026, the company has repurchased 16.5 million shares, representing approximately 6.3% of the shares outstanding at year-end 2025. We continue to execute against our previously reported target of $200 million or more in total share repurchases during 2026.

Terry will review the financial results and our capital allocation strategy in greater detail shortly. ASCENIV’s momentum reflects underlying patient demand supported by broader physician adoption, new patient starts, and increasing end-user utilization. Favorable distributor-reported pull-through continued into the fourth quarter, providing further confidence in the durability of ASCENIV’s growth trajectory. We continue to experience strong momentum within the primary immunodeficiency patient population, where sustained growth in ASCENIV utilization is contributing to an increasingly durable and expanding foundation of recurring patient demand.

Importantly, we believe significant additional growth opportunities remain within secondary immunodeficiency patient populations where recent growth has been moderate. However, we believe this population represents a potentially meaningful and largely untapped opportunity for ASCENIV as awareness of ASCENIV’s differentiated clinical profile continues to expand among treating physicians, supported by our focused medical education and commercial initiatives.

Coupled with the growing body of scientific evidence, we are optimistic that adoption within these patient populations could accelerate in coming periods, providing a potential additional catalyst for sustained long-term product growth. We believe ASCENIV remains early in its penetration of later-line refractory and medically complex primary immunodeficiency patients. Its differentiated profile and expanding clinical evidence base support a significant long-term commercial opportunity.

Turning to BIVIGAM, third-quarter revenue was $15.4 million compared with $19.4 million in the second quarter as standard IG pricing and competitive pressures persisted. While reported BIVIGAM revenue declined sequentially, underlying end-user utilization showed encouraging signs of stabilization entering into the fourth quarter. We continued to prioritize sustainable commercial participation rather than matching aggressive competitor rebating and discounting.

Our strategies reflect the distinct opportunities for each product—expanding ASCENIV adoption through clinical engagement and real-world health outcomes evidence while supporting BIVIGAM through disciplined contracting, manufacturing quality, and product-specific scientific differentiation. Our scientific evidence base continues to expand. At the upcoming ACAAI Annual Conference in November, we will be presenting real-world health outcomes data from 127 medically complex primary immunodeficiency patients, most of whom had previously received other immunoglobulin therapies. Comparing the 12 months before and after ASCENIV initiation, the analysis identified statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use, and corticosteroid use.

These findings add important evidence to physician and payer discussions regarding ASCENIV’s role in treating appropriate patients. Separately, recently published peer-reviewed research examining thrombosis-related product attributes represents an important advancement in ADMA’s scientific differentiation strategy, with particular relevance to BIVIGAM’s competitive positioning in the U.S. standard immunoglobulin market. As healthcare providers increasingly evaluate product quality, manufacturing consistency, and safety-related attributes alongside pricing and access, we believe these findings provide objective scientific evidence to support informed product evaluations and establish a more rigorous framework for assessing clotting-related activity and potential thrombotic risk across immunoglobulin products. We believe the totality of these data underscores the strength of ADMA’s manufacturing capabilities, enhances our commercial education efforts, and provides an additional point of differentiation for BIVIGAM.

We anticipate the scientific evidence will improve BIVIGAM’s positioning in the competitive standard U.S. IG market, and this growing body of evidence will contribute to continued utilization stabilization and potential revenue growth for BIVIGAM in the coming periods. During the third quarter, we advanced SG001, our investigational pneumococcal hyperimmune globulin candidate, through preclinical assay development and manufacturing readiness activities. ADMAlytics, our proprietary AI platform, has helped accelerate SG001’s development by using computational modeling, artificial intelligence, and predictive analytics to forecast final titer values from limited experimental data. We believe this capital-efficient and data-driven approach can improve analytical efficiency and reduce laboratory testing requirements as we pursue SG001’s development using our established processes.

Additionally, we are encouraged by the constructive FDA feedback the company received in late October on our SG001 pre-IND meeting package, which we believe represents an important milestone for the pipeline program. Notably, we received constructive feedback from the FDA regarding the proposed clinical development strategy, including key elements of the planned clinical study. Based on the FDA’s feedback, we intend to incorporate the recommendations into the final clinical protocol and advance preparations for an IND submission.

The FDA also indicated that our proposed assay would be acceptable for product testing, subject to appropriate validation. Collectively, we believe this regulatory feedback supports advancing this program forward with a potentially efficient development pathway that leverages ADMA’s established manufacturing capabilities and clinical development experience. As we move SG001 towards a registrational clinical trial, we continue to believe SG001 represents potential for $300 to $500 million annual revenue opportunity, and we will continue to keep investors informed as the program progresses in the normal and ordinary course.

We are reiterating our full-year revenue guidance of at least $530 million and increasing our minimum expectations for adjusted EBITDA and adjusted net income. We believe continued ASCENIV momentum, disciplined execution, and our financial position provide a strong foundation as we approach year-end. I’d like to thank our employees for their dedication to the patients which our products serve and continued execution across all functions of the business.

Terry will now provide comments and dive into the financials. Terry.

Terry Kohler (Chief Financial Officer)

Thank you, Adam. I’ll review our third quarter financial results and cash generation and capital allocation, followed by our outlook for the remainder of 2026. Third quarter revenue totaled $141.1 million compared to $134.2 million a year ago and $124.4 million in the second quarter, increasing 5% year over year and 13% sequentially. ASCENIV revenue of $124.7 million grew 31% year over year and 21% sequentially and remained the primary driver of our performance. BIVIGAM revenue was $15.4 million compared with $23.8 million one year ago and $19.4 million in the second quarter. Pricing and channel pressures continued to weigh on reported revenue, although underlying end-user utilization showed encouraging signs of stabilization into the fourth quarter.

Our guidance does not depend on the broad recovery of the standard IG market. Gross profit increased to $99.9 million from $75.6 million a year ago and $86.3 million in the second quarter. Gross margin reached 71% compared to 56% a year ago and 69% in the second quarter, representing approximately 1,450 basis points of year-over-year expansion. Favorable ASCENIV mix and yield‑enhanced manufacturing were the principal drivers. Adjusted EBITDA was $77.3 million, increasing 32% year over year and 25% sequentially. For the first nine months, adjusted EBITDA totaled $198.8 million.

Profitability growth exceeding revenue growth illustrates the operating leverage in our model. GAAP net income reached $49.9 million, increasing 37% year over year and 32% sequentially. Adjusted net income was $51.1 million, up approximately 31% both year over year and sequentially. GAAP basic EPS was $0.22, increasing 47% year over year and 29% sequentially. Adjusted basic EPS was $0.23, increasing 44% year over year and 35% sequentially. Strong earnings growth, together with ongoing share repurchases, is translating into meaningful growth in earnings per share.

Research and development expense was approximately $4.5 million compared to $1.5 million a year ago and $6 million in the second quarter as we continued SG001 development with lower sequential plasma collection activity. Selling, general and administrative expense was approximately $26.6 million, essentially flat sequentially and supporting commercial initiatives. As of September 30, cash and cash equivalents totaled approximately $124.6 million. This liquidity provides flexibility to fund growth initiatives and return capital to stockholders. Net leverage continues to be under half a turn. We continued repurchasing shares during the quarter. For the first nine months of 2026, total stock repurchases amounted to $181.4 million, with 16.5 million shares repurchased year to date through September, representing a reduction of 6.3% in ADMA shares outstanding versus the end of 2025.

Our capital allocation approach balances per‑share value creation with efficient investment in the core business. Cash and cash equivalents increased approximately $36.9 million during the first nine months, despite significant share repurchases. Cash from operations was $105 million year to date through September 30, 2026, an increase of over 600% versus the first nine months of 2025. Accounts receivable totaled $159.2 million at the end of the quarter, with DSOs increasing in the period to 110 days, which is modestly higher than our previously discussed DSO target of between 90 to 105 days.

The driver of the DSO increase in the period was primarily the timing of orders from authorized distributors. We continue to collect all receivables with no history of bad debts, and we’ll continue to work to drive DSOs back down into our target range over time. Turning to our updated full‑year 2026 outlook, we continue to expect revenue of at least $530 million. We are increasing our minimum adjusted EBITDA guidance to at least $275 million from $265 million previously and our minimum adjusted net income guidance to at least $180 million from $170 million previously. Our outlook reflects continued ASCENIV momentum and prudent assumptions for the competitive standard IG market. We believe ASCENIV growth, favorable mix, manufacturing efficiencies, and disciplined spending continue to generate substantial operating leverage.

We believe our balance sheet and capital allocation strategy position us to execute through year end and beyond. With that, I’ll turn the call back over to Adam.

Adam S. Grossman (Founder, President & CEO)

Thank you, Terry. The third quarter demonstrates ADMA’s ability to pair a differentiated commercial franchise with attractive margins, meaningful cash generation, and growing earnings per share. Today, ASCENIV remains our primary growth engine. Increasing physician adoption, new patient starts, and favorable pull‑through into the fourth quarter support our confidence in continued commercial expansion, particularly among medically complex patients who may benefit from a differentiated treatment option.

For BIVIGAM, recent underlying utilization is encouraging, even as standard IG pricing and channel conditions remain challenging. We intend to compete responsibly, supported by product‑specific scientific evidence and consistent manufacturing execution. We believe the initiatives implemented will ultimately stabilize the BIVIGAM franchise and potentially return to product‑level revenue growth in the coming periods. Our evidence generation efforts support distinct commercial priorities. ASCENIV’s real‑world health outcomes data help inform treatment decisions for medically complex patients, while the peer‑reviewed thrombosis‑related research provides additional scientific context for BIVIGAM evaluations. Both efforts reflect our commitment to evidence‑led commercial execution. We believe our yield‑enhanced manufacturing process, diversified plasma sourcing, and disciplined cost structure provide a durable foundation for profitability and cash generation alongside thoughtful capital returns.

These advantages support our commitment to long‑term per‑share value creation. SG001 represents an additional potential growth opportunity. We are advancing the program based on recently received constructive FDA feedback, and we believe it will be a capital‑efficient program that leverages our existing production and laboratory infrastructure and ADMAlytics predictive modeling capabilities. Looking ahead, our priorities are clear: sustain ASCENIV growth, navigate standard IG competition with discipline, convert earnings into cash, and allocate capital to its highest‑value uses. Our reiterated revenue outlook and increased minimum earnings guidance underscore our confidence in ADMA’s profitability and the opportunities beyond 2026. I’d like to thank our employees for their continued dedication to patients and operational excellence and our stockholders for their continued support.

Thank you for joining us on today’s call. Operator, we’re ready to take the questions.

OPERATOR

Thank you. Today’s question and answer session will be conducted electronically. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. We’ll pause just a moment while we compile the roster. Our first question is from Brian Deschner of Raymond James. Your line is now open.

Brian Deschner (Analyst)

Congrats on the quarter. Two for me. The first one: can you give us a little more color on what the main drivers behind the ASCENIV revenue beat in 3Q26 were and how they contrast with the dynamics behind the weakness we saw a few quarters ago? And thoughts on going into the fourth quarter?

Adam S. Grossman (Founder, President & CEO)

Sure. Thanks for the question. I mean it really is just a culmination of all of our commercial efforts and medical education activities. You take all the real‑world evidence that we’ve been publishing over the last year plus, coupled with enhanced medical education presence, some increases in our sales force presence throughout the year. We’re really just very pleased with how the market is absorbing our data and looking at the real‑world outcomes, and they want to experience this for their patients.

So we’re seeing an increase in the number of prescribers, we’re seeing an increase in new patient starts. And, you know, we continue to reiterate that we feel ASCENIV still has a long, long commercial life ahead of it, and we’re early in the penetration curve, and we’re just very proud of the fact that we make good products that help these patients that are refractory and that are failing standard IG products, and they have continued complications and chronic and persistent infections.

And when they switch to ASCENIV, we’re seeing tremendous improvements in this population. So, you know, I know I sound like a broken record, Ryan, I’ve said it before. But, you know, these are the results that happen when you make good products that help patients and deliver value to the payers.

Brian Deschner (Analyst)

Appreciate it. What are your thoughts on how the days sales outstanding trajectory has progressed up to this point, what the impact going forward might be from the McKesson deal, and have your thoughts evolved at all on the DSO trajectory going forward?

Terry Kohler (Chief Financial Officer)

Hey Ryan, it’s Terry. Thanks for the question. So very strong revenue growth, obviously quarter over quarter, year over year. That split drove the accounts receivable up in the period. All our receivables are good. All of our receivables continue to be collected. To DSOs, as you know, they did increase in the period. They were above the target range that we have of the 90 to 105 days. You know, we’re going to continue to work to push those back into that target range.

In terms of McKesson, you know, we spoke about, obviously earlier in the year, one of the ways for us to work the DSOs down over time is to grow our volumes through distributors like McKesson who have, you know, better‑than‑average payment terms. McKesson’s been a great partner. We still believe that this strategy is going to be effective. It may take a little bit longer than we previously expected. So we’re not expecting a big impact to DSOs based on McKesson over the rest of 2026, but we will still continue to work to push DSOs down.

Brian Deschner (Analyst)

Thank you very much.

OPERATOR

Thank you. Our next question is from Anthony Petrone of Mizuho. Your line is now open.

Anthony Petrone (Analyst)

Good afternoon. Thanks, and hi Adam, and congrats on a nice print here. Maybe a couple on ASCENIV and one on BIVIGAM. Maybe just to dig into the rebound in ASCENIV a little bit more: Adam, on prior calls you mentioned that secondary immune deficiencies are a growth driver, and I think you also referenced the idea that McKesson has a pretty big presence in oncology, and so you can see a comorbidity with oncology relative to a secondary primary immunodeficiency.

So to what extent is McKesson now in the numbers for ASCENIV, and are you actually seeing any uptake from the oncology channel? And then I’ll have a follow‑up on BIVIGAM.

Adam S. Grossman (Founder, President & CEO)

Sure. Thanks for the question. You know, we are really pleased with the performance of ASCENIV in the quarter. The main drivers of growth, as I stated during the prepared remarks portion, primary immune deficiency continues to lead the charge with growth. Anthony, certainly there is opportunity with respect to the secondary immune‑deficient population. In our prepared remarks we said that it’s slower than what we would have hoped or anticipated, but the opportunity still exists and it still remains.

We’re continuing to work through those channels, and we do expect on a go‑forward basis that there is opportunity for ASCENIV to continue to grow and penetrate in that market. But the growth drivers have been across the entire immunocompromised patient landscape, primarily in the PI population.

Anthony Petrone (Analyst)

That’s helpful. And then just going back to BIVIGAM, some of your competitors were out there. You had CSL was August and Grifols had a nice print as well. And they’re still talking about an underlying immunoglobulin market globally that can sustain at least mid to high single digits, I guess. At what point do you think the channel actually normalizes? And from the vantage point of ADMA Biologics, where do you see the underlying growth rate for the US immunoglobulin market?

Adam S. Grossman (Founder, President & CEO)

Sure. From a global perspective, I think what you’re saying and what some of the other plasma companies are saying is there is unmet demand throughout the ex-US markets. That’s not a market that ADMA plays in. So I don’t really have that much clarity there. But from the industry reports that we read and from speaking with folks throughout the industry, the global need for IG still is in an undersupply situation. The US from our vantage point, it’s a little bit of a different story. Certainly the market has more IG products than ever before. We play primarily in the outpatient alternate site infusion landscape. That’s a highly competitive landscape right now. That’s where a lot of the new entrants are trying to break in with their deep discounting. We’ve heard reports of short-dated products still persisting, although we’re hearing that things are stabilizing.

From a BIVIGAM utilization perspective, we saw a nice rebound as we exited the third quarter into the start of the fourth quarter. And we’re pretty optimistic that some of this short-dated material and this deep discounting that is impacting the ASP for some of these new-entrant competing IG products, it’s going to turn around and put BIVIGAM back into a position that we think it certainly should not drop below these levels. But we do think that there’s opportunities to grow.

I’ve said it before, we feel that the market certainly is growing, albeit not where it’s been historically. I think low single digits is what we’re hearing and what we’re seeing. But I would defer to the companies that are selling tens of millions of grams into the market compared to ADMA’s 1.5 to 2 million grams into the market. But I think the market should grow. But we think it’s going to be low, maybe to mid single digits.

Anthony Petrone (Analyst)

Thank you.

OPERATOR

Thank you. Our next question is from Gary Nockman of Canaccord Genuity. Your line is now open.

Gary Nockman (Analyst)

Thanks. Good afternoon, guys. Nice quarter and really good to see the ASCENIV growth. Yeah. So on ASCENIV, just to quantify things a bit, how has the month-on-month utilization been relative to the 2 to 4% growth expectation you talked about previously? Has that been accelerating and also continuing into 4Q? And how much are you expanding use across physicians? And how many patients are currently on ASCENIV, giving us a sense of the increasing demand for it?

Adam S. Grossman (Founder, President & CEO)

Sure. Thanks, Gary. ASCENIV end-user pull-through demand has been growing on a month-to-month basis. We’re still within the ranges that we stated previously. Some months are a little bigger than others, but across the balance of the calendar year so far, we’re very pleased with the growth trajectory. You know, year over year it’s up about 31%. I think we’re looking at, you know, probably for the full year it’s going to be about 25%, maybe a little more than that for the full year.

But again, this is all being driven by new patient starts, new prescribers. You know, I’ve said previously, Gary, it’s a 25,000-patient target market. That’s roughly 10% of the total 250,000 PI population. Previously we’ve given statements that we penetrated about 4%. We’re certainly above that number today. Regarding prescribers, we’ve got more prescribers as we exit the third quarter into the fourth quarter than we’ve ever had prescribing the drug previously. And that’s a testament to our marketing, medical affairs team that’s out there generating all this data, getting these publications out there. And we want to thank all the clinicians and the infusion companies who we partner with on investigator-initiated work. We’re very pleased with the data that is being published and that’s what’s really driving uptake demand, prior authorization approvals.

Very pleased with ASCENIV’s commercial coverage and we expect that to continue throughout the remainder of this year and into next year.

Gary Nockman (Analyst)

Okay, so yeah, I was just going to follow up. So there really been no changes in the payer environment at all for ASCENIV with the pricing pressure that you’re seeing in the standard IG market? And just to be clear, so there are no more lingering impacts from the oversupply on the standard IG side with respect to ASCENIV, or is there still maybe a little bit left there?

Adam S. Grossman (Founder, President & CEO)

I’m just writing down your questions. So with respect to the payers, we have pretty broad access with respect to ASCENIV coverage on commercial plans. We are seeing growth in the commercial payer landscape. You know, that’s really what is helping to accelerate the ASCENIV utilization that we’re seeing as reported from our distribution partners. But we don’t see any changes during the third quarter to reimbursement. We continue to have good negotiations, we continue to see good coverage across all geographies.

And, you know, the prior authorization process is still the same. It’s a process that requires the clinician, the infusion company, sometimes nurses and our field reimbursement team to get involved. But in appropriate use cases, we’re not seeing any difficulties with getting commercial payer reimbursement. I have not said that the lingering pressures are over. What I am saying is that we are seeing certainly signs of stabilization with respect to BIVIGAM’s utilization. We are still seeing in ASP-reported declines from some of these new entrants and competing products. We are seeing discounting and steep rebating continuing. You know, that’s just not something that ADMA is doing. You can see that in our reported ASP. ASP for ASCENIV and BIVIGAM are pretty stable entering into the fourth quarter here.

So the effects are still there. I think the short-dated product pressures, these new entrants selling that product into the channel, I’m hearing that there are signs that that is alleviating a little bit. But by no means am I saying that it’s over and it’s smooth sailing ahead. There still is a competitive headwind there for BIVIGAM and that’s part of the reason why we did the work, did the testing, put the data together and had the publication regarding BIVIGAM’s safety profile.

We think that that scientific differentiation and being able to now combat some of the messaging from some of the new-entrant competitors, it really puts BIVIGAM on an equal playing field and we’re very optimistic about a reversion for BIVIGAM into 2027. Hopefully that answers

Gary Nockman (Analyst)

Maybe I wasn’t—yeah, no, it probably wasn’t clear enough. I totally understand the dynamic with BIVIGAM. I just wanted to make sure that with utilization of ASCENIV—like that was one of the issues with oversupply in the market—ASCENIV continues

Adam S. Grossman (Founder, President & CEO)

To be largely insulated. You know, we’re really doing a very good job this year of carving out that true, focused, appropriate use case patient. And we are seeing good utilization, durable recurring patient demand month over month.

Gary Nockman (Analyst)

Okay. And then just lastly, very quickly on 001. Just great that you got the constructive feedback from FDA. So just in terms of timing, when you think you could file the IND and then start a clinical study. And I don’t know if you want to just comment about the R&D spend as you go into that. Thanks.

Adam S. Grossman (Founder, President & CEO)

Sure. So, you know, really, really pleased. I mean my team worked extremely hard and hats off to them for getting the pre-IND package in. Sometimes you plan and sometimes it works out for you. And we got feedback a short while ago and really pleased with the constructive engagement and feedback from the agency regarding clinical trial design, regarding how we’re going to manufacture, regarding how we’re going to test and release the product using an assay.

And, you know, all this bodes well for us from a, you know, full IND package preparation. You know, I’m not prepared to give guidance on that yet, but you can imagine, and I think in the prepared remarks, I was pretty clear on manufacturing preparedness. You know, we’ve been collecting plasma. You see that step-up. And Terry can talk in more detail about the R&D in a second. But we’ve been collecting plasma, special plasma from immunized donors using Capvaxib and Prevnar.

And we are moving this program forward. I mean, the feedback was extremely encouraging. And I do believe that there are some things that we asked for that will be quite novel and in due course we’ll make that public again. The agency reserves the right to change their mind at any time, but we are going to work expeditiously to have an IND filed in a shorter time period as we possibly can. But I’m not prepared to give guidance yet on when that’s going to be filed.

But I would anticipate that sometime next year. We’re updating the street at providing firm timelines around clinical trials, product development and regulatory timelines. You want to talk about R&D spend, Terry?

Terry Kohler (Chief Financial Officer)

Sure, Gary. We’re not going to talk yet about what we might have for future R&D spend in 2027. But what I can tell you, as Adam said and I mentioned before, you know, we are going to be producing our performance lots here in Q4. So there is going to be a significant step up in Q4 R&D versus what we had in Q3. So probably close to $10 million of spend in the quarter as we have additional plasma costs in manufacturing.

Adam S. Grossman (Founder, President & CEO)

And just to clarify, Gary, the clinical trials that we’ve done in the past and that other companies have done for IG are registrational. And we believe that the trial that we will prepare and put together has the potential to be abbreviated and will be a registrational phase three study.

Gary Nockman (Analyst)

Okay, that’s great. Thank you.

OPERATOR

Thank you. Thank you. Our next question comes from Kristin Kluska of Cantor Fitzgerald. Your line is now open.

Kristin Kluska (Analyst)

Hi, everyone. Thank you for taking my questions. I had two. The first question is, now that you’re seeing a lot of growth with ASCENIV in particular, including new patient adds, I’m curious if the mix of number of months patients are on drug is any different as we think about doing some of the back-of-the-envelope math there. And then the second question is good to see certain things are stabilizing. Not out of the clear yet, but I know you guys typically give us guidance in early 2027.

So do you think, based on everything going on, that you’ll be in a good position to share that, or are there still dynamics that you still need to work out before you feel like you’ll be able to provide those numbers? Thank you so much.

Adam S. Grossman (Founder, President & CEO)

Sure. Thanks. Kristin, you broke up a little bit on my line regarding the first question, but I think you were asking about how many months patients are staying on drug. Okay. Yeah. I mean, patients are staying on drug. In the prepared remarks, you know, I believe I used language where I said, you know, these are durable, recurring patient demand, patient utilization. Patients are switching to incentive therapy and they’re. And they’re staying on drug. Some data I’ve seen internally throughout the year. I mean, the average patient is staying on therapy for a year or longer. And we’re seeing this compounding, if you will, of utilization, and we’re building off of that base.

So what we really were trying to convey in the prepared remarks on this earnings call is that the business that we’re building, we believe is a durable base of business, and it’s going to grow from that base in the subsequent months. So we’re very encouraged by utilization. Again, the real world outcomes that have been published in multiple, multiple studies in different sites and different geographies. We’re not seeing differentiation in the data. Reducing infections, reducing hospitalizations, reducing overall healthcare utilization. You know, these are real benefits that have never before been seen with an IG product. And this is contributing to incentives, durability, and the growth trajectory of the product. So we’re very, very pleased.

OPERATOR

Okay, 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 for additional closing remarks.

Adam S. Grossman (Founder, President & CEO)

Thank you, everyone, for dialing into today’s call. If there’s no further questions, we appreciate it. Donate plasma. Please help us save a life. And thank you again to all the ADMA Biologics employees for your hard work and for the investors, for your. For your investment into our company. That noise is not me. Not sure who it is, but everybody have a great day. Thank you.

OPERATOR

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

Stephanie

Hi. I just saw Adam’s message in the chat about Gary, but Gary did. He left. Right. Oh, I thought he was. We brought him forth, though, already. He was from Canaccord Genuity, right? I brought him. Oh, he was in the queue. And I brought him to stage, though. Oh, I didn’t know. Sorry, I just distinctly announced them though, too, so that’s why I’m like, did he not. Okay. I… Sorry, I’m just. I guess it was him. And then. Okay, yeah, maybe he left. So He did, yeah. Yeah. That’s why I’m like, losing my. I’m like, am I going crazy here? And then I looked and saw he had left the queue, but that’s because he had already answered the question. He was like a long. Yeah, it was Anthony. It was Ryan, then Anthony. And then I brought Gary and announced him, and then Jenny was the last one. So all four of them were brought to stage. Yeah, Okay. Adam might have just been confused. Yeah. Okay. Okay. So. Yeah, and then when I saw him leave the queue, I’m like, did he mean. I thought Adam may have meant he was coming back for another question, so I don’t know. But All four of them. Yeah, yeah, all four of them definitely asked questions and were on stage.

Thank you. Appreciate it. Have a good night. Okay, take care. Bye.

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