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

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the third quarter of 2025 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer; and Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brad will provide an overview of the company's third quarter 2025 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions. Earlier today, we issued a press release detailing the third quarter 2025 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com. Before we begin our formal comments, I'll remind you that we will be making forward-looking assertions during today's call that represent the company's intentions, expectations or beliefs concerning future events, which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements, except as required by federal securities laws. We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section in our SEC filings and our quarterly report on Form 10-Q for the quarter ended September 30, 2025, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. Please note that the discussion on today's call includes certain non-GAAP financial measures, including adjusted EBITDA and adjusted net income. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam, go ahead.

Good afternoon, everyone. ADMA delivered another record quarter of sequential and year-over-year growth, underscoring the strength of our business model and disciplined execution. We delivered total revenue of $134.2 million, representing a 10% quarter-over-quarter increase and 12% growth year-over-year. GAAP net income reached $36.4 million, up 6% quarter-over-quarter and 1% year-over-year, and adjusted EBITDA grew to $58.7 million, representing 16% quarter-over-quarter growth and a 29% increase year-over-year. These results demonstrate the durability of our growth engine and the expanding leverage in our fully integrated U.S. domiciled business model. Our performance continues to be led by ASCENIV, our differentiated and patent-protected specialty IG exclusively targeting complex immunodeficient patients. ASCENIV delivered record utilization this quarter, driven by strong prescriber adoption and sustained patient demand. 2026 payer negotiations are progressing positively and are expected to further expand coverage, improving access and accelerating growth. For select payers where restrictions previously existed, we anticipate improved ASCENIV reimbursement access beginning next year. Equally important, a retrospective cohort analysis in an investigator-initiated study of primary immunodeficiency patients demonstrated statistically significant reduction in infection rates following transition from standard immunoglobulin therapy to ASCENIV. Patients experienced 2.1 infections per year while receiving prior lines of standard IG therapy compared with 0.9 infections per year on ASCENIV, representing a reduction of greater than 50% with a p-value considerably inside of 0.05. These findings suggest that ASCENIV provides enhanced protection against infections in real-world clinical practice. Data validation and extended analyses are ongoing. ADMA plans to submit these results for peer-reviewed publication in the near term with additional findings planned to be submitted at the Clinical Immunology Society 2026 Annual Meeting. Operationally, the FDA's lot release of our first yield enhanced production batches represents a major inflection point. This process innovation is expected to improve per batch output by 20% or…

Thank you, Adam. Our third quarter results highlight ADMA's consistent execution and expanding profitability. Total revenue for the quarter was $134.2 million, up 10% from the second quarter and an increase of 12% year-over-year. Gross margins expanded to approximately 56.3% compared to 49.8% last year, driven by ASCENIV's growing mix and early yield enhancement benefits. Excluding the plasma sale of $13.8 million during the quarter, product level gross margins reached 63.7% during the third quarter of 2025. GAAP net income totaled $36.4 million compared to $35.9 million in the prior year period, while adjusted EBITDA increased to $58.7 million, representing 16% growth quarter-over-quarter and 29% year-over-year, reflecting continued operating leverage and cost efficiencies. Year-over-year, net income growth was tempered by a higher effective tax rate and temporary competitive dynamics in the standard IVIG markets, mainly impacting BIVIGAM. Enabled by the company's outperforming third-party plasma suppliers, ADMA opportunistically completed a sale of approximately $13.8 million of normal source plasma on the spot market at a negative margin contribution to optimize working capital and go-forward cash flow. These factors are short term. Post quarter, standard IVIG market conditions are stabilizing and record ASCENIV demand continues to drive margin expansion. ADMA ended the quarter with a strong balance sheet and liquidity position. Third quarter cash reflected approximately $23 million in share repurchases settled during the period, planned inventory build and a $12.6 million facility expansion investment. Working capital dynamics are expected to normalize in the coming quarters, supporting accelerated cash growth through 2026. We maintain a strong balance sheet with an undrawn $225 million revolver, providing ample flexibility for growth. Turning to our outlook. ADMA's full year 2025 and 2026 financial outlook reflects continued ASCENIV demand strength, yield enhancement production efficiencies and disciplined operational execution. For 2025, total revenue is now expected to…

Thank you, Brad. Before we open the call for questions, I wanted to take a step back and reflect on how far we've come and where we're heading. Just 3 years ago, ADMA was at the early stages of its commercial expansion. Today, we're generating record revenue and profitability, achieving best-in-class gross margins with substantial expansion forecasted from here and setting the stage for what should be sustained earnings growth across the next decade while advancing a compelling new product cycle. Our yield enhancement milestone is a defining moment in that journey. It not only validates our technical capabilities but also positions us among the most efficient plasma fractionators in the industry. With FDA released yield enhanced production lots now flowing through our supply chain, we believe we are strongly positioned to finish 2025 on a high note and accelerate year-over-year growth rates in 2026 from a position of operational strength with line of sight expected meaningful cost savings, improved production mix throughput and the potential to add incremental manufacturing capacity without significant capital investment provides optimism for our future. On the commercial side, ASCENIV continues to outperform expectations and remains at the center of our growth story. We are witnessing both expanding utilization in existing accounts and growing interest from new treatment centers. As payer access improves in 2026, we expect adoption to accelerate further, supporting our expectations of strong double-digit revenue growth well into the back half of the decade. The combination of expanding coverage, real-world data validation and increased patient acceptance is creating durable, powerful momentum across ADMA's health care ecosystem. Looking further ahead, our R&D platform continues to progress. The SG-001 program is advancing on schedule, and we remain enthusiastic about its long-term potential. We believe we can advance this pipeline program directly into registrational trials following continued and successful preclinical development and potential ultimate IND submission. When combined with our manufacturing know-how and regulatory expertise, SG001 has the potential to expand ADMA's leading position in the specialty immunoglobulin space while adding meaningful high-margin revenue in the out years. Financially, ADMA has never been stronger. We are operating with a clean balance sheet, a fully funded growth plan and forecasted accelerating cash generation. Our capital allocation priorities are clear, reinvest for growth, maintain balance sheet flexibility and return capital to our stockholders through opportunistic share repurchases. This strategy reflects our confidence in the business and our commitment to building enduring value. In closing, I want to thank the entire ADMA team for another exceptional quarter. Your hard work, expertise and passion make all of this possible. To our investors and stakeholders, thank you for your continued confidence in our company and partnership as we execute against our mission to improve patient lives while creating durable stockholder value. With that, operator, please open up the call for questions.

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

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

Thanks for the question, Anthony. So I was very pleased that our compliance group allowed us to talk about this data. So I can't give away too much, but we evaluated a robust patient cohort that was appropriately sized, and we were able to generate statistically significant data. Very, very proud of this. The data demonstrates a significant reduction in infections in these patients that are switching off of their standard IG and moving to ASCENIV. This is the real-world setting. These are complex PI patients that are switching. And again, we're just very pleased. I mean, 2.1 infections while they were on standard IVIG compared to less than 1 infection per year with a p-value of less than 0.05. We think that this is really just a very clear way of demonstrating what clinicians have been reporting to us and what we've been reporting as a company about the clear clinical differentiation that ASCENIV provides compared to standard IG and why these complex and refractive and comorbid PI patients seem to do better on ASCENIV. We expect that the data is going to reinforce prescriber confidence. It's going to strengthen payer coverage. Our negotiations with payers have progressed very nicely throughout 2025, and we're anticipating expanded access into 2026. So we're continuing to analyze this data. We plan for a peer-review publication, as you mentioned, early in 2026. And we expect this and other investigator-initiated studies that are ongoing to further validate ASCENIV's utility and really define the patient profile that we're targeting. In 2026, we really plan to ramp up medical education and publications. We plan to provide continued real-world outcomes data. And we think all this is going to bode well for ASCENIV's growth in 2026 and beyond.

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

Thank you so much, Anthony. Look, we've seen record utilization of ASCENIV throughout the third quarter, and that has continued to be observed as we enter the fourth and are in the middle of the fourth quarter. This data is really just reinforcing everything that we've experienced. Payer negotiations, I mean, look, we still stand firm on our position that ASCENIV should not be used as a first-line therapy. We think that your question about, could this in the minds of prescribers be used earlier in the treatment cycle, possibly. We do see some private payers moving ASCENIV up where you don't have to fail as many step edits, there could be less. So we think that payer expansion is going to improve. And again, the more data that we can put and publish in the public domain, the better it's going to be to reinforce and maintain ASCENIV's strong position. We do expect strong double-digit growth. We do think that the data that we're putting out there, the patient testimonials, our medical education strategy and our enhanced publication strategy for next year is all going to work together to continue to drive utilization. Regarding the growth curve, I mean, look, we've, we've increased guidance for 2026 top line and earnings metrics. Very proud of where we are with yield enhancement with our first FDA released commercial batches of yield enhanced product now flowing through the supply chain. So we think that you're going to see continued accelerating utilization of ASCENIV continued growth of our IG portfolio throughout 2026 and beyond.

Our next question comes from Kristen Kluska with Cantor Fitzgerald.

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

I mean the confidence is that we see it in the redistribution data. I mean the product pull-through at record levels, exceeding internal expectations throughout the third quarter. Fourth quarter is no different. We feel very confident in ASCENIV's utility. I think the data that I was just speaking about, this is what physicians and patients are experiencing in the real-world setting. So we're making a good drug. We're making more of it than we ever have before. We had more product available in the third quarter than we have had historically, and we see it continuing to pull through at a rapid pace. So very encouraging. I mean, look, again, Rick, we've talked about, and I don't like to sound like a broken record, but the patients who are switching to ASCENIV are patients that are not thriving on their standard IG, and they're looking for alternatives. One thing I can say is that in the late summer, we started our first direct-to-patient medical education programs, and we think that those are starting to have a meaningful impact as well. The key is if you're an immune-compromised patient receiving IG and you just don't feel well, have a conversation with your doctor, talk to your nurse practitioners, advocate for yourself, you're your best advocate and see if ASCENIV is the right product for you to switch to. So all these factors combined are what's contributing. Our field team is working in unison. We've had some great hires throughout 2025. And we continue to just knock down doors and uncover new institutions that are starting their first patients. And it's everything that we've really described is that same institutions are now starting to add patients that they've identified in their queue, if you will. We've got more product available, and that's been the message throughout the third quarter that, look, we've got more product for you. You can start putting patients on therapy. And we see it in our supply chain that we've got the ability to ensure the continuity of care for these patients. So we're starting them. They're staying on therapy, and they're doing well. That's what contributes to this growth. And that's why in our fifth plus year or so from launch, we're forecasting very robust acceleration as we wind down 2025 and enter 2026.

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

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

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

Our next question comes from Gary Nachman with Raymond James.

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

Sure. So FDA lot release, as we've said, can be as short as, call it, 2 to 3 weeks to as long as, call it, 6 to 8 weeks. There is no -- there was nothing different that occurred with the yield enhanced batches, Gary. It was just -- we just wanted to make sure that everything went through in the normal course, which it did. So we're receiving FDA lot releases routinely. No issues there, and we continue to have ample inventory and supply available of our IG product portfolio to meet the demands for the market. With respect to gross margins, I mean, we reported -- we reported this quarter that if you back out the plasma revenue, Brad, keep me honest here, product level gross margins were 63.7%. So we're feeling very good about product level gross margins. And we feel that it should continue to expand as we continue with ASCENIV mix shift from a revenue and a unit perspective. Our goal is, again, to get to using half the plant's capacity at least to make ASCENIV, if not more. And that's what's going to drive us to our out-year guidance for 2029 now. that is $1.1 billion or more in revenue. So we're feeling very positive about it. Everything is going very well from a lot release perspective. And the visibility with our third-party supply contracts is what's giving us this encouragement to get more patients on drug. We're making more ASCENIV. We're producing more batches than we originally planned for 2025, and that's going to ultimately give us more product to sell in 2026.

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

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

So we are always in active discussions with a number of different commercial payers, Gary. You couldn't see me smiling when you were asking your question, but I was smiling. I mean the payers certainly like their rebates. We're in active negotiations around this. We don't think that anything is going to be so significant that it's going to change our gross margin outlook or our product level margins significantly. But we all understand how it works. So the negotiations with the payers have actually been pretty positive over the last couple of months as we ended the third quarter and enter the fourth quarter. My field reimbursement and market access team is seeing some, I don't know if you can ever use the word acceleration in approvals with commercial payers, but appropriately defined use case patients are getting approvals. Some payers are working more rapidly with us than others, and we're trying to alleviate the bottlenecks across the entire commercial payer landscape. Again, the majority of ASCENIV especially, BIVIGAM as well is through Medicare, where it's a lot easier to get reimbursement more rapidly. But from a commercial payer perspective, which is about, call it, 40-ish, 45% of utilization, we're seeing movement from some payers who had us restricted. We're coming off restricted less, we're moving up from a step edit perspective. And I think as these negotiations transpire, if there's things to report, we'll certainly keep the street informed. But data, obviously, the more data helps. You asked about the outcomes data. The payers are seeing this in their own patient profiles. I mean they're seeing that these are patients that have cost their plans money. These are patients that do get hospitalized maybe once or twice per year, and they're staying out of the hospital. They're not getting as sick. We're reporting today that in this investigator-initiated study, we're seeing a significant reduction in infections. This is not a one-off. This is what payers are seeing. And all of this contributes into their decision to approve ASCENIV and approve a switch from standard IG to this product. So everything seems to be working well. Again, our field reimbursement team is doing a great job and our market access team is negotiating in a very collegial way with a number of different payers right now. And we wouldn't have put it in the prepared remarks or in the press release if we didn't feel confident that we were going to see improvements to our commercial payer profile. So we expect that to occur early in 2026, and we're very optimistic for the growth for the future.

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

All good questions. Thank you, Gary. we do say that there are about 300 clinical immunologists that follow large groups of these primary immune-deficient patients. It's certainly greater than 100 prescribing docs now. I mean we've really seen rapid uptake throughout the summer of new docs saying, "You know what, I'm readyâ€. And the fact that our commercial team since the start of the third quarter has been out there saying that we've got more product, you can start your patients on therapy. I mean, people took us seriously. So that certainly helps, Gary, when you're dealing with a scarce raw material like we are with ASCENIV, less than 5% of these plasma donors have the antibody profile that we're looking for. But the clinician universe that we target, they're well aware of our partnerships with Grifols, Kedrion and others to access a wider group of collection centers to get more plasma. So folks have been listening to our messaging. They know that Grifols, Kedrion and others are reliable suppliers. And I think we've really been able to do a great job at building the confidence for the continuity of supply throughout 2025. And that's what's been encouraging for new docs to put patients on and existing prescribers to add more patients in their queue. Look, we're -- we increased 2025 revenue, I believe, right, from $500 million to $510 million. We feel confident about this. We feel good that our ability to supply product to the health care community is solid. And that's really what's helping to drive this, is the confidence of our commercial team, telling the prescribers that, look, we've got the product available. They're accelerating the accession of these patients, getting them on therapy, starting the payer conversations earlier. Our field reimbursement team has grown this year, and it will probably grow a little bit next year, but they're all working very, very hard to expedite new patient starts. And that's what's ultimately going to drive growth. You're asking me about the full year 2029 revenue. I mean, I feel good that -- we're in a good position, Gary, both from who the physicians are and where the patients are to hit $1.1 billion. We feel good about our ability to collect the raw material. I mean you've seen inventory step up. We're swapping out normal source plasma, replacing it with high titer plasma inventory to make more ASCENIV. We're elbows deep in the budget for 2026, and we're forecasting more ASCENIV production than we had in 2025, and that's ultimately going to drive increasing revenues in 2026 and 2027. So is there an opportunity to achieve the $1.1 billion earlier than 2029? I think it's possible. But at this point in time, we feel confident that we should hit this in 2029. And in normal ADMA fashion, if we can do it faster, we certainly will.

We have a question from Anthony Petrone with Mizuho.

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

So the hit rate will always be the hit rate, but the amount of plasma that our third-party suppliers will collect of high titer, I think, will grow, Anthony. Look, the third-party suppliers have meaningfully outperformed, full stop. The team at ADMA that does our proprietary RSV screening assay and testing, they've got it under control. They've ramped up. I mean we invested time, money, effort, blood, sweat, tears to get to this point. And we feel really, really good about the supply chain continuity and the ability to rapidly identify these donors and collect that plasma from our third-party providers. As I mentioned, and I think folks can see in the contracts, I know that there are some terms that are redacted, but there are financial incentives for our third-party suppliers to hit our target collection goals. They all want their bonuses and by [dollar ], we want to pay their bonuses. So I think it's a very symbiotic relationship. I think it's going very, very well. And again, I cannot emphasize enough about how good the team has done here at ADMA, but our third-party suppliers have meaningfully outperformed. 2026 conversations with our third-party suppliers are going well. We feel like we're in a great position to collect more plasma than we did this year for next year. And that's ultimately going to give us confidence into '27, '28 and '29. So things are going very, very well from a plasma supply standpoint. We're building inventory. We've got the inventory we need to be successful. And we feel like we're in a great position to at least meet, if not exceed the upwardly revised guidance targets that we've set for 2026.

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

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

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