ADMA August 5, 2026

"ADMA Biologics" Q2 2026 Earnings Call - ASCENIV Utilization Accelerates as Margins Expand and Full-Year Guidance Reiterated

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Summary

ADMA Biologics delivered a quarter defined by structural leverage rather than headline volume growth. ASCENIV revenue jumped 24 percent to $102.9 million, lifting total revenue to $124.4 million and expanding gross margins from 55 percent to 69 percent. The margin expansion is not a temporary accounting adjustment. It reflects a deliberate mix shift toward a higher-margin specialty product, supported by a yield-enhanced manufacturing process that keeps supply costs in check. June recorded the strongest sequential end-user utilization growth for ASCENIV since early 2024, driven by physician adoption and a growing real-world evidence base that highlights reduced hospitalizations and antibiotic use in medically complex primary immunodeficiency patients.

The traditional immunoglobulin market remains a friction point. BIVIGAM stabilized sequentially but continues to face pricing pressure and channel dislocation, with management forecasting it will finish 40 to 50 percent below 2025 levels. Leadership refused to chase volume through unsustainable discounting, choosing instead to protect durable profitability. Cash generation remains robust, enabling 7.1 million shares repurchased in the quarter and keeping the company on track for a $200 million buyback target. With a sub-half-turn net leverage ratio and $136 million in cash, ADMA is funding commercial expansion and advancing its next-gen pneumococcal candidate, SG-001, toward a year-end pre-IND submission. The full-year guidance stands unchanged, and the market is pricing in a company that has successfully transitioned from a legacy plasma play to a specialty biologics compound with a clear growth runway.

Key Takeaways

  • Total Q2 2026 revenue reached $124.4 million, up 2 percent year-over-year, primarily driven by ASCENIV growth.
  • ASCENIV revenue surged 24 percent to $102.9 million, with June recording the strongest sequential end-user utilization growth since the first half of 2024.
  • Gross margin expanded to 69 percent from 55 percent in the prior year period, reflecting favorable product mix shifts and manufacturing efficiency gains.
  • BIVIGAM revenue stabilized sequentially at $19.4 million but remains under pricing pressure, with management forecasting it will finish 40 to 50 percent below 2025 levels.
  • Adjusted EBITDA rose 22 percent to $61.8 million, while adjusted net income increased 8 percent to $39 million, underscoring earnings leverage as ASCENIV scales.
  • New real-world evidence submitted to the AAAAI 2026 meeting shows statistically significant reductions in infection-related hospitalizations, ER visits, and antibiotic use among complex patients switching to ASCENIV.
  • Days sales outstanding improved to approximately 101 days from 107 days in Q1, with management targeting a 90 to 105 day range for the second half of the year.
  • The company repurchased 7.1 million shares in Q2 using internally generated cash, bringing year-to-date buybacks to 13.8 million shares and maintaining the path toward a $200 million annual target.
  • Balance sheet strength remains intact with $136 million in cash, net leverage under half a turn, and $100 million in additional revolver capacity.
  • Full-year 2026 guidance is reiterated at $530 million to $560 million in revenue, $265 million to $300 million in adjusted EBITDA, and $170 million to $200 million in adjusted net income.
  • Pipeline progress continues with SG-001, a pneumococcal therapy targeting immunocompromised patients, on track for a year-end pre-IND submission and a potential $300 million to $500 million annual revenue opportunity if approved.
  • A new distribution agreement with McKesson targets secondary immune deficiency buying groups, offering faster payment terms and non-overlapping call points compared to legacy partners.

Full Transcript

Conference Call Operator: Afternoon. Welcome to the ADMA Biologics second quarter 2026 financial results and business update conference call on Wednesday, August 5th, 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 2 hours following the end of the call. At this time, I would like to introduce the company. Please go ahead.

IR/Corporate Communications, ADMA Biologics: Welcome, everyone. Thank you for joining us this afternoon to discuss ADMA Biologics’ financial results for the second quarter of 2026 and recent corporate updates. I am joined today by Adam Grossman, our President and Chief Executive Officer, Terry Kohler, our Chief Financial Officer and Treasurer. During today’s call, Adam will provide some introductory comments and provide an update on corporate progress. Terry will provide an overview of the company’s second quarter 2026 financial results. Adam will provide some brief summary remarks before opening up the call for questions. Earlier today, we issued a press release detailing the second quarter 2026 financial results and summarized certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com.

Before we begin our formal comments, I will remind you that we will be making forward-looking statements 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. Any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements except as required by the federal securities laws.

We refer you to the Disclosure Notice section in our earnings release we issued today and the Risk Factors section of our quarter report on Form 10-Q for the quarter ended June 30th, 2026, for a discussion of important factors that could cause actual results to differ materially from those 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, which is available on our website at www.admabiologics.com. I would like to now turn the call over to Adam Grossman. Adam?

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Good afternoon, everyone, and thank you for joining us. Our second quarter results reflect strong execution across the business and demonstrate the power of ASCENIV’s long-term growth trajectory. During the quarter, we delivered continued financial progress, strong cash generation, and improving commercial momentum, while ASCENIV utilization strengthened throughout the period. ASCENIV demand accelerated during the second quarter, and June delivered the strongest sequential utilization growth we have experienced since the first half of 2024. This momentum was driven by increasing physician adoption, broader provider engagement, new patient starts, and higher patient utilization. As we have discussed previously, distributor-reported end-user utilization remains our leading indicator of continued revenue growth. Based on the end market utilization data we continuously review, we believe current ASCENIV inventory levels remain appropriate and are consistent with underlying demand.

Importantly, ASCENIV utilization strengthened progressively throughout the quarter across our commercial network, reinforcing our view that ASCENIV remains early in its penetration of the later-line refractory primary immunodeficiency market. While we continue to see competitive pressures in the U.S. immunoglobulin market, BIVIGAM demand stabilized during the quarter, resulting in sequential improvements in both utilization and revenue. Increased supply and competitive pricing pressures remain within the U.S. standard immunoglobulin market. We continue to maintain our disciplined approach that prioritizes durable, profitable growth over unsustainable discounting and other incentives. Importantly, despite this evolving standard IG backdrop, ASCENIV continued to outperform and utilization expanded. Increasing physician adoption, new patient starts, and record utilization further demonstrate the relative insulation provided by ASCENIV’s differentiated product profile and its positioning among later line, refractory, and medically complex primary immunodeficiency patients.

One of the most important developments during the quarter was the continued expansion of ASCENIV’s real-world evidence base. We’ve submitted an abstract for presentation at the 2026 American College of Allergy, Asthma and Immunology annual scientific meeting, highlighting results from a Real-world health outcomes and health resource utilization analysis of 127 medically complex primary immunodeficiency patients, the majority of whom had previously received other immunoglobulin replacement therapies prior to switching to ASCENIV. The analysis compared patient outcomes and healthcare resource utilization during the 12 months before ASCENIV initiation with the 12 months following administration. Following initiation of ASCENIV treatment, patients experienced statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use, and corticosteroid use. The proportion of patients experiencing infection-related emergency room visits also declined.

We believe these results are especially meaningful because they were observed in a medically complex population with significant baseline disease burden and healthcare resource utilization. The study’s cohort included patients with chronic pulmonary and respiratory comorbidities, prolonged use of antibiotics or corticosteroids, and prior infection-related hospitalizations or emergency room utilization. We believe these findings further support ASCENIV’s differentiated clinical profile and growing body of real-world evidence. These findings also reinforce our view of ASCENIV’s positioning as a later line therapy for PI patients whose disease remains inadequately controlled and provides additional support for continued physician adoption, patient access, and payer engagement. We believe these findings complement ASCENIV’s existing broad commercial payer coverage and could further strengthen commercial payer access.

More broadly, we feel payer willingness to engage in these discussions reflects growing recognition of ASCENIV’s differentiated value proposition and the significant clinical and financial burden associated with recurrent infections, hospitalizations, and other healthcare utilization among medically complex patients. Operationally, we believe we are well-positioned to support the continued revenue growth. Our yield-enhanced manufacturing process remains embedded in commercial production and continues to support product availability, manufacturing efficiency, and margin performance. Our diversified plasma sourcing strategy provides reliable access to high-titer plasma, and we believe our current supply infrastructure is sufficient to support anticipated demand. We are confident our financial position also remains a significant strategic advantage. Strong profitability and cash generation provide us with substantial flexibility to invest in commercial expansion, manufacturing initiatives, and our capital-efficient pipeline while continuing to execute on our capital allocation priorities.

During the quarter, we repurchased approximately 7.1 million shares of common stock under our previously authorized share repurchase program. These repurchases were funded through internally generated cash flow. We continue to believe that returning capital to stockholders at attractive value represents an effective use of capital while preserving meaningful financial flexibility. We remain on track to complete our previously stated $200 million or more 2026 share repurchase target. Looking ahead, we continue to see multiple expected durable drivers of ASCENIV growth. These include increasing patient utilization, expanding physician adoption, new patient starts, broader prescriber engagement, growing payer access, and an expanding body of clinical and real-world evidence. Accordingly, we are reiterating our full year 2026 financial guidance and remain confident in our ability to meet or exceed those expectations. Beyond ASCENIV, we continue to advance SG-001 through a capital-efficient development pathway.

We are progressing with plasma collection optimization, potency assay development, and additional preclinical activities supporting planned cGMP conformance lot production during the second half of 2026. It is well documented in the published literature that a significant unmet medical need exists despite current S. pneumonia prevention recommendations. Immunocompromised patients remain at a disproportionately high risk for severe pneumococcal disease. Underlying impairments in functional immunity limit vaccine-mediated protection, leaving a persistent need for alternative targeted preventive strategies in the patients at greatest risk. We believe SG-001 has the potential to mitigate the disease burden and are encouraged by the preclinical studies conducted to date. These activities are intended to support the anticipated submission of our pre-IND meeting package to the FDA by year-end.

Encouraging preclinical findings generated to date continue to support our belief that SG-001 could address a meaningful unmet medical need and represent a substantial long-term growth opportunity for ADMA. If approved, we believe SG-001 represents a $300 million-$500 million annual revenue opportunity. Leveraging ADMA’s existing manufacturing capabilities and commercial infrastructure could support an efficient development program and potentially expeditious commercial launch. We believe ADMA enters the second half of 2026 from a position of increasing strength. ASCENIV demand is accelerating. Differentiated value proposition is becoming increasingly well supported. BIVIGAM demand is stabilizing in the face of increased competitive pressures. We believe our manufacturing and plasma sourcing platforms are positioned to support sustained growth and ensure the continuity of care for patients. Our business is performing across all facets. We are making progress with our stated corporate goals and objectives. We continue to generate significant cash.

Before I turn the call over to Terry, I would like to recognize and thank the entire ADMA team for their continued dedication, efforts, and execution. Our commitment to patients, operational discipline, and focus on excellence remain central to our performance and position the company for sustained long-term success. Terry?

Terry Kohler, Chief Financial Officer and Treasurer, ADMA Biologics: Thank you, Adam. I’ll begin with our second quarter financial results before discussing our balance sheet, cash generation, capital allocation priorities, and outlook for the remainder of 2026. Total revenue for the second quarter was $124.4 million, compared to $122 million in the prior year period, representing 2% year-over-year growth. ASCENIV revenue was $102.9 million, increasing 24% year-over-year, while BIVIGAM revenue was $19.4 million, reflecting sequential improvement from the first quarter as market conditions stabilized. Gross profit for the quarter was $86.3 million, resulting in gross margin of 69%, compared to 55% in the prior year period. Margin expansion primarily reflected continued ASCENIV mix expansion together with the ongoing benefits of our yield enhanced manufacturing process. Adjusted EBITDA was $61.8 million, increasing 22% year-over-year. Adjusted net income totaled $39 million, increasing 8% year-over-year. GAAP net income for the second quarter was $37.8 million, increasing 11% year-over-year.

It is important to note that ADMA’s effective tax rate for the quarter was 24.7%, an increase of approximately 10 percentage points compared to the prior year period. The increase was primarily driven by discrete tax benefits recognized in the prior year quarter. The company continues to anticipate its normalized effective tax rate to be approximately 24% going forward. Taken collectively, the second quarter financial results demonstrate the continued earnings leverage of our business model as ASCENIV becomes an increasingly larger component of our product mix, and our manufacturing platform continues to deliver operating efficiencies. Turning to the balance sheet. We ended the quarter with approximately $136 million in cash and cash equivalents. Net leverage remains less than a half a turn, and we maintain approximately $100 million of additional borrowing capacity under our existing revolving credit facility.

We believe our balance sheet continues to provide significant strategic flexibility to invest in commercial expansion, manufacturing initiatives, and pipeline development while continuing to execute a disciplined capital allocation strategy. As the company continues to remain actively repurchasing its own shares, we repurchased approximately 7.1 million shares during the quarter under our authorized share repurchase program using internally generated cash flow, bringing the year-to-date total repurchases to approximately 13.8 million shares and representing approximately 5.3% of ADMA’s common stock outstanding as of June 30th, 2026. We believe repurchasing shares at attractive valuations represents an effective allocation of capital while maintaining substantial financial flexibility to support long-term growth initiatives. Cash from operations totaled approximately $30 million during the quarter, reflecting continued earnings growth and disciplined working capital management.

Accounts receivable totaled $138.2 million at quarter end and days sales outstanding, or DSOs, of approximately 101 days, improving from approximately 107 days at the end of the first quarter. As we discussed previously, DSOs have stabilized over the first half of 2026, and we will continue to target DSOs between 90 to 105 days in the second half of the year. Importantly, the quality of our receivables remains excellent. All of our receivables from Q1 2026 have been collected, and we continue to expect collection in full of all of our outstanding receivables. Inventory at the quarter end was $239.3 million. Inventory levels remain consistent with our commercial planning assumptions and are intended to support continued growth in ASCENIV and ensure the continuity of care of all patients. Turning to our outlook. We are reiterating our full year 2026 financial guidance.

We continue to expect total revenue of $530 million-$560 million, adjusted EBITDA of $265 million-$300 million, and adjusted net income of $170 million-$200 million. Our outlook continues to assume sustained competitive dynamics and pricing pressure within the standard immune globulin market through the balance of the year. At the same time, it reflects our expectation that ASCENIV will remain the company’s principal driver of revenue growth, profitability, and cash generation. Our guidance also incorporates planned investments supporting commercial expansion manufacturing initiatives, and continued advancement of SG-001, while preserving the financial flexibility to continue returning capital to stockholders. Importantly, our outlook continues to reflect what we believe are prudent planning assumptions, despite the improving commercial indicators discussed today.

Based on our second quarter performance, continued strong cash generation, and the commercial indicators Adam discussed earlier, we remain confident in our ability to meet or exceed our full-year expectations. Overall, we believe ADMA remains exceptionally well-positioned. We believe our differentiated commercial portfolio, expanding profitability, strong cash generation, disciplined capital allocation strategy, and flexible balance sheet provide a solid foundation to continue investing in the business while creating meaningful long-term value for stockholders. With that, I’ll turn the call back to Adam.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Thank you, Terry. As we conclude, we believe the second quarter further validated the strength and durability of ADMA’s business. In the face of ongoing competitive immunoglobulin market pressures, ASCENIV demand strengthened throughout the quarter, with June delivering the strongest sequential month-over-month end-user growth we have experienced since the first half of 2024. At the same time, BIVIGAM demand is stabilizing, resulting in sequential improvement in both utilization and revenue. Together, these trends for our IG product portfolio reinforce our confidence that ASCENIV remains well-positioned to drive continued growth through the balance of 2026 and beyond, and BIVIGAM will maintain its present positioning. Equally important, we believe ASCENIV’s differentiated value proposition continues to strengthen.

This view is supported by the expanded base of real-world evidence that has been published, as well as through a new abstract submitted to the 2026 American College of Allergy, Asthma and Immunology annual scientific meeting, which documents significant improvements in health outcomes and reductions in healthcare resource utilization among medically complex primary immunodeficiency patients. We believe these findings further support increasing physician adoption, payer engagement, and long-term commercial expansion for ASCENIV. Operationally and financially, we believe ADMA remains exceptionally well-positioned to execute on our long-term strategy. Our yield-enhanced manufacturing platform, diversified plasma sourcing strategy, strong balance sheet, and significant cash generation are expected to provide the flexibility to invest in commercial growth, advance our pipeline, and continue returning capital to stockholders through disciplined share repurchases.

Beyond ASCENIV, we continue to execute against our development strategy and remain on track to submit our pre-IND meeting package for SG-001 to the FDA by year-end and produce conformance batches in the second half of 2026. We continue to believe SG-001 represents a compelling long-term opportunity that leverages ADMA’s existing manufacturing platform, commercial infrastructure, and decades of expertise in the specialty plasma-derived biologics in an area of medicine where significant unmet medical needs persist. Commercial momentum continues to build. Our differentiated evidence base continues to expand, our financial profile continues to strengthen. Collectively, these strengths reinforce our confidence in ADMA’s long-term growth trajectory and are expected to position the company to execute against its core mission to continue creating meaningful benefits for patients and healthcare providers, which translates into value creation for our stockholders in the years ahead.

Before opening the call for questions, I would once again like to thank our employees for their extraordinary efforts working for the patients counting on us. At ADMA, we are operating on the forefront of science, rapidly implementing innovative technologies and tackling challenges to address unmet medical needs. Without your efforts, dedication, and unwavering commitment to operational excellence, we would not be achieving all that we have and what is yet to come. We also extend our gratitude to our stockholders for their continued support of our company and its important mission. Thank you for your continued support and interest in ADMA. Operator, we can now open the call for questions.

Conference Call Operator: Thank you. Today’s question and answer session will be conducted electronically. To ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We’ll pause just a moment to assemble the roster. Our first question will be from Ryan Deschner with Raymond James. Ryan, your line is open.

Ryan Deschner, Analyst, Raymond James: Hi, good afternoon, and thanks for the question. Just curious on what your current thinking is on how quickly orders associated with the McKesson deal might develop over the next several quarters, how much overlap on call points with existing customers is there, or you think there will be, and if you can give us an idea of how payment terms compare between McKesson and your other customers. Thanks.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Thanks, Ryan. Thanks for the question. McKesson is an important part of our go-forward Strategy to continue penetrating with ASCENIV. As we’ve discussed previously, some of the GPO buying groups that are associated that buy through McKesson, are primarily focused on secondary immune deficiency, and that does not overlap with the current call points that we have been calling on for ASCENIV through our legacy distribution partners. I can say that we are seeing some very good utilization. We’re having great conversations with a lot of the decision-makers at a number of these parties that buy exclusively through McKesson, through these GPO buying group contracts. It is certainly part of our go-forward growth strategy. With respect to payment terms, their payment terms are a little faster than some of the others who we sell to.

We’re very happy with the partnership thus far, and we expect it to continue throughout the back half of this year into 2027.

Terry Kohler, Chief Financial Officer and Treasurer, ADMA Biologics: Thanks so much.

Conference Call Operator: Thank you, Ryan. Next, our question will be from Kristen Kluska with Cantor Fitzgerald. Kristen, your line is open.

Kristen Kluska, Analyst, Cantor Fitzgerald: Hi, everyone. Thank you so much for taking my questions. Can you provide us with any new statistics or color, just thinking around the reimbursement dynamics that are going on with ASCENIV and with some of the market dislocation that is temporary? Have you noticed any shifts or signals in how those dynamics are going?

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Thanks, Kristen. With respect to reimbursement dynamics, ASCENIV, and BIVIGAM for that matter, both see broad access throughout the commercial reimbursement landscape. We’re not seeing any significant negative changes in the market. We are continuing to see increased utilization through the commercial channel. I think that that’s mostly driven by the body of real-world data and evidence that we’ve published to date. We think that that’s going to continue to grow going forward, especially in light of the new data that we talked about in the prepared remarks, and that’s included in the press release. With respect to some of the market dislocation challenges, we still certainly see large amounts of standard IG throughout the U.S. marketplace. We play in the outpatient setting, which I know that you’re quite familiar with.

Almost 100% of the product that ADMA sells is in the ambulatory infusion, home infusion type setting. We still are seeing some pretty competitive pressures in that market from a supply standpoint, as well as from discounting and rebating. We did see stabilization in the quarter from the first quarter troughs, as we mentioned in the prepared remarks also. BIVIGAM recovered a bit. We are seeing a stronger utilization of BIVIGAM. Again, it still is substantially down year-over-year. ASCENIV continues to grow in the face of all of these competitive pressures. We are extremely encouraged by ASCENIV’s 24% year-over-year growth. Again, June represented the largest month-over-month growth in end user utilization that we’ve seen since the first half of 2024. We’re excited, we’re encouraged. Payer access continues to be open and broad.

Again, this is all predicated on the fact that the product is being used in the refractive, comorbid, immune-compromised patient that is not doing well on standard IG products.

Kristen Kluska, Analyst, Cantor Fitzgerald: Thank you, Adam. Then, sorry, may I ask one more?

Conference Call Operator: Of course.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Yeah, go ahead.

Kristen Kluska, Analyst, Cantor Fitzgerald: Yeah. Okay, thanks. I was just going to ask how we should be thinking about R&D for the next few quarters here as SG-001 continues to advance. Thanks again.

Terry Kohler, Chief Financial Officer and Treasurer, ADMA Biologics: Hi, Kristen, it’s Terry. As you noted, R&D stepped up this quarter as we’re preparing for a potential future state clinical trial for SG-001. The $6 million you saw in the quarter is something that we think will carry throughout the rest of the year. There will probably be a step-up again, although not as large, obviously, in Q4 as we start to manufacture conformance lots.

Kristen Kluska, Analyst, Cantor Fitzgerald: Appreciate all the color. Thanks, everyone.

Conference Call Operator: Thanks for your questions, Kristen. Next, we have Anthony Petrone with Mizuho Financial Group. Anthony, your line is open.

Anthony Petrone, Analyst, Mizuho Financial Group: Thanks. Good afternoon, everyone. Adam, going back to the just traditional IG market, BIVIGAM. Some of the PPTA data out there are still showing kind of an erratic pattern with distributor stocking, and you referred to some competitors out there that perhaps are still putting excess inventory into the channel and discounting. What’s the visibility as to when all of this normalizes? And as we get into 2027, do you think we could be back to modest growth for BIVIGAM and all the couple of follow-ups?

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Thanks, Anthony. We’re seeing some stability with BIVIGAM in our market arena. Certainly there are competitive dynamics that we’ve touched on. Those continue to persist, but we are seeing stabilization there. Guidance is unchanged, and I remember saying during the last quarter call that we’ve taken a pretty conservative approach to the new guidance framework. We still anticipate BIVIGAM being down, call it 40%-50% from 2025. ASCENIV should be in the upper 20s, low 30% range year-over-year growth. We feel very good about ASCENIV’s go-forward utilization growth. It’s plugging the hole from the BIVIGAM downturn, as well as some of the other intermediate fractions in normal source plasma that we no longer are generating revenues from. Could there be some upside, if that’s what you’re asking, from BIVIGAM?

I guess there’s always a chance and an opportunity, but that’s not currently something that we are contemplating. We’ve been working very hard with BIVIGAM, with some of our distribution partners, with some of these new GPOs. BIVIGAM’s been awarded some preferred status across some of these different programs, and we’re optimistic that the drug’s going to continue to be used. Again, it’s a safe, efficacious, good product made by us. We think it has stabilized, we think that this is a run rate that could be anticipated go forward. Could there be a little bit of upside? Sure. That’s not something that we’re guiding to right now. I think if there is upside, I think that could only benefit the business.

Anthony Petrone, Analyst, Mizuho Financial Group: Thanks. The follow-up would be just your comment, Adam, on commercial payer access could potentially further strengthen here. I know that CVS Caremark has a dedicated policy in place for ASCENIV. I think claims do get through via prior authorization with United and Cigna, do you think we actually get another dedicated policy decision, or where do you think that commercial payer access can potentially expand? Is there any milestones we should be looking for? Thanks.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: To the best of my understanding from our market access team, ASCENIV, and BIVIGAM for that matter, are pretty much in parity with a number of the other IG brands out there. We are starting to see additional access and increases throughout different geographic regions and different commercial payers. I know that our team has been engaged in robust discussions with a number of payers trying to secure improved access for ASCENIV as we go forward and continue to publish this data. Again, in the appropriate use case patient population, we are continuing to see more patients get approved through prior authorization process. Again, that’s not unique to us. That’s across the entire IG landscape. About 70+% or so of IG scripts do require prior auth. We feel good about payer access.

We think that we’re in a great position for this to continue to grow, and we are seeing the commercial payer book of business continue to increase quarter-over-quarter.

Conference Call Operator: Thank you for your questions, Anthony. Our next and final individual with a question is going to be Gary Nachman with Canaccord Genuity. Gary, your line is open.

Gary Nachman, Analyst, Canaccord Genuity: Great. Thanks, and good afternoon. Adam, on the increasing demand for ASCENIV, you previously talked about growth of 2%-4% month-on-month. Do you expect it to continue at that rate, or could it possibly be even better than that? Sounded like it accelerated nicely in June.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Yes.

Gary Nachman, Analyst, Canaccord Genuity: Was it actually above that range?

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Yeah.

Gary Nachman, Analyst, Canaccord Genuity: Maybe just some more on what drove that acceleration, then I have a follow-up.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Sure. Yes. June certainly month-over-month was outsized. As we are contemplating guidance for the full year, Gary, we are forecasting in this 2%-4% month-over-month growth if you smooth it out throughout the course of the year. We are seeing an acceleration with respect to ASCENIV end user utilization and end user pull-through from our distribution partners. Again, this is data that they report to us, so it’s only as good as the data that they’re reporting to us. We feel very good about this utilization. What I really think is happening out there, Gary, is we’ve been shouting from the rooftops at all the medical conferences. Medical education, we’ve talked about our grassroots medical education efforts, regional speaker programs, speaker programs at a number of the regional and national meetings. When you say it enough times, people start to pay attention.

When you publish enough papers, people start to believe, okay, there are a number of different institutions in different geographies publishing data that shows improved outcomes, reduction in healthcare resource utilization. We think all of this is what’s changing some of the clinician mindsets, or at least bolstering confidence of the clinicians that maybe have one or two patients on ASCENIV, that they’re willing to now put more patients on ASCENIV. I can tell you that it’s a combination of all the above. I think that it’s been quite a journey for us since we launched the product in the back half of 2019.

I think we’re really at a turning point here where we’ve got real-world data in the public domain that supports the fact that this is a differentiated product with a unique antibody profile that’s demonstrating differentiated clinical benefits from patients who are just not thriving on standard IG therapy. We think this is going to continue to grow. We think it’s going to continue to provide more access to clinicians who want to learn about ASCENIV and want to understand it. I can tell you that our field reimbursement team and medical affairs teams, coupled with national accounts and sales, they’re all working together well, and we’re doing everything we can to grow the business as absolutely fast as possible.

Conference Call Operator: Thank you, Gary.

Gary Nachman, Analyst, Canaccord Genuity: Okay, great. Wait, just a follow-up, if I can.

Conference Call Operator: Of course.

Gary Nachman, Analyst, Canaccord Genuity: You just mentioned the data you’ll be presenting, that new data that looks very good in primary immunodeficiency. Are you working on anything in secondary immunodeficiency that would help uptake in that segment of the market? I’m curious how you’re thinking about how important that’s going to be for the overall growth of ASCENIV moving forward. Thanks.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Sure. I know that I previously mentioned on some calls that we do have some investigator-initiated studies ongoing in certain organ transplant patients, I think mainly lung. That work is still ongoing. I expect it hopefully sometime this year. I do know that there are a couple of other investigator-initiated studies that are either kicking off or will kick off in the oncology setting. With respect to ASCENIV’s growth outlook, for the foreseeable future, we are just scratching the surface in our total addressable market from a penetration perspective. We feel extremely confident in our ability to garner more patients that are refractive to standard IG and that are continuing to experience chronic persistent infections and have the comorbidities that I’ve spoken about.

We certainly think that there is a lot of white space in front of us with respect to growing our on-label market, if you will. You can’t see my quote marks or my fingers, but the on-label market. Certainly as we continue to progress into 2027 and beyond, IG is widely used in secondary immune-deficient patient populations. That is the fastest-growing area of IG growth currently in the U.S., the oncology, the organ transplant setting, and the autoimmune disease setting. While it may not be the most important thing today with respect to what we’re focusing on from a growth perspective, I think over time, as we flip the calendar into the next decade, certainly, we’ve got big hopes and dreams that we’re going to penetrate that market as well.

We are starting to see utilization in that market, again, through the McKesson specialty relationships, through some of the community oncology practices. There is some utilization of BIVIGAM and ASCENIV in that market. Truly what’s driving utilization today just has to do with the fact that there are patients with primary immune deficiency diagnoses that are just not thriving on standard IG, and when they reach the end of their rope and the doctors are throwing their hands up, patients are trying ASCENIV, and they’re doing better. Good outcomes will correlate into continued growth for ASCENIV and our company.

Gary Nachman, Analyst, Canaccord Genuity: Great. That’s helpful. Thank you.

Conference Call Operator: Thank you again, Gary.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Thanks, Jared.

Conference Call Operator: 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.

Adam Grossman, President and Chief Executive Officer, ADMA Biologics: Thank you, everybody, for your time this afternoon. We appreciate it. Donate plasma, help save a life. We look forward to speaking with you soon. Thanks for your support.

Conference Call Operator: Thank you, Adam. This concludes the conference call for today. We appreciate your participation. You may now disconnect.