ADMA (ADMA) Q1 2026 Earnings Transcript

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DATE

Wednesday, May 6, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• President and Chief Executive Officer — Adam S. Grossman
• Chief Financial Officer and Treasurer — Terry Kohler

TAKEAWAYS

• Total Revenue -- $114.5 million, flat compared to $114.8 million in the prior-year period, with stable top-line performance despite multiyear industry channel disruption.
• ASCENIV Revenue -- $97.5 million, increasing 28%, driven by record patient starts, new prescribers, and accelerating product pull-through.
• BIVIGAM Revenue -- $15.4 million, declining 54%, with management attributing the decrease primarily to aggressive competitive discounting and transitory distributor ordering shifts.
• Gross Profit -- $80.8 million, generating a 71% gross margin, up from 53%, as the product mix shifted further toward margin-accretive ASCENIV.
• Adjusted EBITDA -- $59.7 million, up 24%, with management noting continued margin expansion and underlying operational scale benefits.
• Adjusted Net Income -- $40.7 million, representing 22% year-over-year growth.
• GAAP Net Income -- $45.3 million in the period, as detailed in reported results.
• Operating Cash Flow -- $58 million, surpassing the full-year 2025 figure within one quarter.
• Pro Forma Net Leverage -- Less than 0.5x, even after a revolving credit draw and share repurchases, indicating considerable balance sheet flexibility.
• Share Repurchases -- 3.6% of outstanding shares converted to treasury stock by March 31, reflecting active capital return.
• Cash and Equivalents -- $138 million at the quarter's end, providing substantial liquidity for planned growth and ongoing capital deployment.
• DSOs -- Days sales outstanding reached 107 days, with management targeting a reduction to the 90–105 day range, and noting improvement initiatives are underway.
• Full-Year 2026 Revenue Guidance -- Updated to $530 million–$560 million, factoring ongoing competitive pressure in standard IG and sustained ASCENIV growth.
• Full-Year 2026 Adjusted EBITDA and Net Income Guidance -- Adjusted EBITDA forecasted at $265 million–$300 million; adjusted net income projected at $170 million–$200 million, incorporating expected increases in R&D and SG&A spending linked to the SG-01 program.
• Long-Term Guidance Withdrawal -- Management withdrew extended outlook, citing "uncertainty in the competitive landscape."
• Plasma Center Monetization -- Sale of three plasma centers delivered $5 million in proceeds and further diversified plasma sourcing.
• SG-01 Opportunity -- "SG-01 represents an approximately $300 million to $500 million annual market opportunity at peak," leveraging the company's manufacturing infrastructure and R&D model.
• Pediatric Label Expansion -- ASCENIV pediatric label approval cited as an immediate commercial catalyst.

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RISKS

• Management explicitly reported that "the industry also saw a surplus of raw material plasma supply, increased PDT and IG finished goods inventory across the distribution network, and aggressive pricing tactics, including discounting and rebating from newer entrants," creating pronounced channel instability and pressuring volumes for standard IG products like BIVIGAM.
• Terry Kohler said management is withdrawing long-term guidance "Given the uncertainty in the competitive landscape," highlighting the inability to provide visibility previously seen during periods of market undersupply.

SUMMARY

Management directly reported a significant swing in revenue mix, with record ASCENIV demand offsetting a sharp BIVIGAM sales decline, contributing to persistent margin expansion and positive cash generation. SG-01 was identified as a near-term pipeline catalyst with estimated peak sales potential of $300 million to $500 million, while the recent pediatric label expansion for ASCENIV was presented as an incremental driver. Cash conversion, balance sheet strength, and opportunistic share repurchases were repeatedly referenced as pillars supporting reinvestment and capital return. Executives emphasized ongoing channel turbulence, citing surging industry supply, new market entrants, and pricing pressure, yet they maintained confidence in ASCENIV's insulation and future growth trajectory.

• Management stated that "All of our accounts receivable from the year-end 2025 balance sheet have now been collected," removing near-term credit risk overhang.
• Adam Grossman detailed that new plasma supplier agreements and yield-enhancement processes provided assurance of adequate high-titer plasma supply to sustain ASCENIV's growth, and the divestment of plasma centers increased capital efficiency.
• Commercial execution was reinforced by the successful ramp of the McKesson specialty distribution partnership, supporting the company's entrance into new site-of-care markets.
• Channel inventory and price competition were discussed as temporary headwinds centralized primarily in BIVIGAM, not ASCENIV, with signs of normalization emerging in late March and April based on observed utilization data.

INDUSTRY GLOSSARY

• IG: Immunoglobulin; a class of plasma-derived therapies used to treat immune deficiencies.
• PDT: Plasma-derived therapies; biologics manufactured using donor plasma as the source material.
• DSO: Days sales outstanding; accounts receivable divided by sales per day—used to assess the collection efficiency.
• ASP: Average selling price; the mean net price realized after rebates and discounts, especially important in pharmaceutical channel analysis.
• PIDD: Primary immunodeficiency disease; a condition treated with immunoglobulins such as ASCENIV.

Full Conference Call Transcript

Adam Grossman, our President and Chief Executive Officer, and Terry Kohler, Chief Financial Officer and Treasurer. During today's call, Adam will provide introductory comments and an update on corporate progress, and Terry will provide an overview of the company's first quarter 2026 financial results. Finally, Adam will then provide brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the first quarter 2026 financial results and summarizing certain achievements and recent corporate updates. The release is available on our website at admabio.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.

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 such statements except as required by the federal securities laws. We refer you to the disclosure notice section in our earnings release that we issued today and the Risk Factors section in our Quarterly Report on Form 10-Q for the quarter ended 03/31/2026 for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. 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 metrics is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam?

Adam Grossman: Thank you. Afternoon, everyone. We had a strong start to the year with earnings growth and margin expansion, despite total revenue being essentially flat, underscoring the resilience of the business. We grew adjusted net income by 22% year-over-year, expanded corporate gross margins to 71%, and generated approximately $58 million of operating cash flow during the quarter. This was in spite of top-line pressures primarily impacting BIVIGAM. We believe the first quarter results likely represent the trough revenue baseline from which we would expect to be able to drive growth in the coming quarters. Key drivers of that, in our view, will be enduring ASCENIV demand, expanding margins, and continued strong cash generation.

ASCENIV end-market demand reached record levels in the first quarter with revenue growth of approximately 28% year-over-year. We saw continued strength and record metrics across new patient starts, prescriber adoption, product pull-through, and patient adherence. As a reminder, our distributors not only have to maintain safety stock levels to ensure the continuity of patient care, but we understand these specialty distributors also typically keep extra stock available for immediate administration to guard against any potential supply chain, manufacturing, testing, or regulatory disruptions. We see our distributors' inventory pull-through sales data on a regular basis and believe these levels are consistent with those of our industry peers and are appropriately sized.

At the same time ASCENIV demand is growing, competitive dynamics in the first quarter as well as the variability in ordering patterns created a challenging commercial backdrop, in particular for BIVIGAM. I will discuss these competitive dynamics in a moment. Operationally during the period, we completed the monetization of three plasma centers, enhancing liquidity while further diversifying our plasma sourcing by adding a new third-party plasma supplier. We are also actively reducing expenses in a targeted manner to improve profitability without adversely impacting our core operations. Importantly, with a balanced mix of internal and third-party plasma procurement, we believe we have ample supply of high-titer plasma to support both our near- and long-term ASCENIV growth objectives.

Our balance sheet remains strong, with pro forma net leverage below 0.5x, driven by continued cash generation and adjusted EBITDA growth, which should provide us with the flexibility needed to support growth and activate on our capital allocation priorities. Now let me take a step back and explain why we believe we are experiencing an extraordinarily unique moment in our industry. We believe that historically, the plasma fractionation industry has been in a dislocated state where IG utilization demand has outpaced the industry's ability to supply. Over the back half of 2025 and into 2026, new IG products have entered the U.S. market.

During the first quarter, the industry also saw a surplus of raw material plasma supply, increased PDT and IG finished goods inventory across the distribution network, and aggressive pricing tactics, including discounting and rebating from newer entrants. This drove greater-than-expected competitive intensity and distribution recalibration. We believe there was, and continues to be, a rapid shift in the ordering pattern occurring at the wholesaler and distributor level, which adversely impacted reported first quarter revenue and created additional variability in ordering patterns for ADMA Biologics, Inc.'s products within the quarter. We believe these dynamics were timing-related and are transitory in nature, and although it is still early, we are observing signs of reversion in the second quarter.

We see these as industry-wide dynamics, not only specific to ADMA Biologics, Inc., and, again, we believe they primarily impacted distributor behavior rather than end-market demand. While these dynamics impacted near-term ordering patterns, there was no deterioration in underlying demand for ASCENIV. Our fundamentals remain strong and continue to improve with record utilization growth throughout the quarter. We are particularly encouraged that the second quarter run rate based on April demand is in line with the level of first quarter direct sales. This reinforces a key point: record ASCENIV demand and utilization, which is a forward-looking indicator, is robust and growing, despite the broader standard IG and plasma products market competitive pressures.

In our view, this is clear evidence that the first quarter variability was driven by distribution and inventory dynamics primarily affecting BIVIGAM, not by any change in demand or forward-looking growth outlook for ASCENIV. We continue to believe ASCENIV remains early in its penetration curve and that we have multiple durable growth drivers. We believe we still benefit from record new patient adds, a growing prescriber base, an expanding distribution network, strong payer access, and increasing physician confidence driven by ASCENIV's differentiated clinical profile and favorable real-world outcomes. In review of the reported ASP declines in certain competitor IG products, we note that the market is seeing elevated levels of aggressive discounting and rebating across standard IG.

We remain disciplined in our pricing strategy and are committed to building a durable and sustainable growth model. These near-term competitive and pricing dynamics do not change our conviction in the forecast of long-term growth and durability of the U.S. IG market or ASCENIV's differentiated position in the later-line setting for refractory immunodeficient patients. Looking ahead, we believe we have several important catalysts, including our recent approval for ASCENIV's pediatric label expansion and the associated commercial opportunity, and an upcoming preclinical data publication for our lead pipeline program, SG-01, which will be presented at the International Society of Pneumonia and Pneumococcal Disease Conference.

We expect this SG-01 preclinical data presentation, including oral and poster sessions, to further illuminate the product's novel profile and market as we advance our capital-efficient development pathway. ADMA Biologics, Inc. is a unique company in the plasma-derived therapies complex in that we have a specialized, innovative, and forward-thinking R&D engine which translates into growth opportunities and expanded product margins. Our yield enhancement manufacturing process allows us to maximize the high-titer RSV plasma we collect required to meet ASCENIV's increasing demand. Yield improvement was designed to enhance our R&D pipeline program, including SG-01, so that in the same way we are able to maximize value on the hyperimmune plasma used to produce SG-01.

We have identified a proprietary way of blending the highest-titer plasma containing strep pneumonia antibodies from donors and will rely on the yield enhancement IG production methods for future clinical trials and potential future commercialization. To design the most effective method for SG-01 production, we have developed and designed proprietary blends of plasma that are already showing strong proof of concept in preclinical studies for two virulent and prevalent serotypes of pneumonia. As data becomes available, we will keep the market apprised of our R&D developments.

ADMA Biologics, Inc. remains on track to submit its pre-IND package for SG-01 to the FDA later this year, and we believe, if approved, SG-01 represents an approximately $300 million to $500 million annual market opportunity at peak that can be ramped in short order leveraging our existing platform infrastructure and commercial footprint. All told, our confidence in ASCENIV's growth trajectory and our mission to meet unmet medical needs for immunocompromised patients remains unchanged. ASCENIV demand is strong, fundamentals are intact, and the IG market's growth outlook remains robust. We believe we are well positioned to drive sustained growth, expand margins, and increase cash generation moving forward.

Before I turn the call over, I want to recognize and thank our entire ADMA Biologics, Inc. team for their continued dedication during what has been a dynamic and evolving market environment. Their focus on patients, operational discipline, and commitment to excellence continues to drive our performance and position the company for expected long-term success. With that, I will turn the call over to Terry.

Terry Kohler: I will begin our first quarter financial performance and then provide an update on our balance sheet, cash generation, and the outlook for the remainder of 2026. Total revenue for the first quarter was $114.5 million compared to $114.8 million in the prior-year period, representing flat trends year-over-year. ASCENIV revenue was $97.5 million, representing 28% growth year-over-year, while BIVIGAM revenue was $15.4 million, down 54% and disproportionately impacted by the competitive market dynamics discussed. Revenue from the sale of intermediates and other products also declined year-over-year by $3 million. Gross profit for the quarter was $80.8 million, resulting in gross margin of 71% compared to 53% in the prior-year period.

Adjusted EBITDA was $59.7 million, representing 24% year-over-year growth, and adjusted net income was $40.7 million. GAAP net income for the quarter was $45.3 million. Turning to the balance sheet, we exited the quarter with substantial flexibility. Pro forma net leverage remains below 0.5x, even following the revolving credit facility draw and accelerated stock repurchase deployment, and we retain approximately $100 million of additional borrowing capacity to support future growth initiatives and return capital to stockholders. Additionally, the company has been actively executing share repurchases, which we will continue deploying opportunistically, and through March 31 resulted in ADMA Biologics, Inc. converting approximately 3.6% of the outstanding share count into treasury stock.

ADMA Biologics, Inc. generated $58 million in cash from operations during the quarter and received an additional $5 million in proceeds from the sale of three plasma centers in the period. The accounts receivable decline during the quarter was driven by the change in revenue quarter-over-quarter. All of our accounts receivable from the year-end 2025 balance sheet have now been collected, and we ended the quarter with $138 million in cash and cash equivalents. As has been the case historically, the quality of our accounts receivable remains strong. DSOs, which represent accounts receivable as of the balance sheet date divided by net sales per day in the quarter, increased in Q1 2026 to approximately 107 days.

As we have referenced in the past, working capital remains a focus for the company, and we believe DSOs stabilized during Q1. Going forward, we believe the appropriate level of DSOs for ADMA Biologics, Inc. is between 90 and 105 days, and we will target that range with expected improvement from current levels over the back half of the year as ordering patterns normalize and as the McKesson specialty distribution agreement continues to ramp up. For full year 2026, we now expect total revenue in the range of $530 million to $560 million. This outlook reflects continued ASCENIV growth partially offset by the expectation of sustained competitive pressure in the standard IG space over the course of 2026.

Full year 2026 expectations for adjusted EBITDA are now $265 million to $300 million, and adjusted net income is expected to be between $170 million and $200 million. These expectations reflect not only the reduced revenue expectations in the year but also an expected step-up in operating expense primarily driven by R&D spend related to our SG-01 program, and a step-up in SG&A as we continue to invest in our commercial operations. Given the uncertainty in the competitive landscape, which Adam described earlier, we are withdrawing longer-term guidance at this time.

To be clear, the updated outlook does not reflect any change in our confidence regarding the underlying demand fundamentals for ASCENIV as a later-line therapy for refractory and complex immunocompromised patients, which remains strong. However, from where we sit today, we simply do not have the longer-term visibility that we had when the IG landscape was less competitive and in a period of undersupply. Overall, we believe ADMA Biologics, Inc. remains exceptionally well positioned. The company has a differentiated growth asset in ASCENIV, a strong balance sheet, and a continued commitment to return capital to stockholders, expanding margins, positive free cash flow, and multiple levers to drive long-term value creation.

With that, I will turn the call back over to Adam for closing remarks.

Adam Grossman: Thank you, Terry. In summary, we believe the most important takeaway from this quarter is that underlying ASCENIV growth trends continue to strengthen even as the distributors of plasma-derived therapies, including standard IG, work through a temporary period of dislocation, reinforcing the durability of ADMA Biologics, Inc.'s franchise. We remain focused on what matters: ASCENIV patient outcomes, product pull-through, patient adherence, prescriber expansion, and long-term margin expansion and earnings power. Across each of those dimensions, we continue to see encouraging trends even beyond the first quarter. Additionally, we see meaningful long-term opportunity in SG-01 and in the broader platform we have built. We remain focused on disciplined execution and creating long-term stockholder value.

Our confidence in SG-01's market potential remains unwavering, as we continue to see a potentially rapid path to commercially scaling the SG-01 product to $300 million to $500 million on an annual basis if approved. Despite recent competitive challenges, we believe we are operating from a position of relative strength. Our business is highly differentiated and specialized. Yield-enhanced production remains embedded in our commercial model. Our plasma sourcing strategy has become more capital efficient and more diversified. Our balance sheet remains flexible, and we are generating robust cash while continuing to invest behind the franchise and our capital-efficient pipeline.

We believe that combination positions us well to navigate the current and rapidly evolving U.S. immunoglobulin environment, and we are confident ADMA Biologics, Inc. and ASCENIV will emerge even stronger as market conditions normalize. Thank you for your time today, and thank you for your continued support of ADMA Biologics, Inc. With that, operator, please open the call for questions.

Operator: Thank you. We will now open the call for questions. At this time, we will conduct a question-and-answer session and wait for your name to be announced. To withdraw your question, please press 11 again. Our first question comes from Anthony Petrone at Mizuho Financial Group. Thanks.

Anthony Petrone: Good afternoon, everyone. So maybe to the standardized backdrop comments, Adam, you noted some pressure in that segment. Wholesalers and distributors are changing their ordering patterns. There are competitive dynamics. It appears supply has built up in the channel, and then you have price pressure being triggered by some of the competitors out there. At what point did this really start to build within the channel? When did you see it on the radar screen? You are referencing the April patterns here somewhat reversing—what is your line of sight as to when some of these pressures dissipate and we get back to a normal underlying landscape in the traditional IG space? I will have a couple of follow-ups.

Adam Grossman: Sure. Thanks, Anthony. We appreciate the question. As you know, the new entrants launched in the back half of 2025, but we really started to see the competitive nature of some of the rebating and discounting toward February and March. Distributors were informing us that they were preparing to place orders, and then the market moved into a state of intense dislocation. As we have said, BIVIGAM was the product that was primarily impacted. BIVIGAM has now been on the market five-plus years. When we launched, it was the most expensive standard IG product, and we were afforded very good utilization based on reimbursement dynamics in the ambulatory infusion setting.

We have done a good job at setting a model here, but new entrants have the benefit of setting new prices. They set some high ASPs. We have seen dramatic ASP erosion, as I spoke about in the prepared remarks. From a utilization standpoint, we did see BIVIGAM take a decent hit in Q1. We are seeing utilization revert a bit toward the back part of March and certainly April—April was the best utilization month of the year so far for BIVIGAM. With respect to ASCENIV, ASCENIV has been largely insulated. We saw record utilization in Q1 and April, and we do not typically speak about individual months' utilization, but this is a unique period.

We hit record levels of end-user utilization in April, and the level of utilization in April is in line with the direct sales that we made in Q1. This is a recent dislocation with respect to ordering patterns and discounting, and it could persist for some period of time. We are seeing trends of reversion for BIVIGAM, and our confidence is unwavering with ASCENIV. We feel ASCENIV is going to continue to grow quarter over quarter. The core driver of value for our business on a go-forward basis is not at risk here. As a later-line therapy, ASCENIV is continuing to open up new doors.

We are seeing accelerating patient starts, and we are very encouraged by the trends we are seeing for ASCENIV.

Operator: Our next question comes from Gary Nachman at Canaccord Genuity.

Gary Nachman: Hi. Good afternoon. A few questions for me. What is factored in your revised guidance with respect to both ASCENIV and BIVIGAM for 2026—if you could break that out separately? And then, Adam, maybe describe a bit more how much pricing pressure you are seeing with BIVIGAM, if you can quantify that. Are you adjusting your plans for manufacturing of that product versus ASCENIV, and do you think it pays to still compete in the standard IG space going forward?

And then a bit more on what the demand queue looks like for ASCENIV: describe the key metrics that you are seeing on that, and how soon you think new patients will be coming off that queue and getting treated with ASCENIV, and if you are confident that you are going to see sequential growth going forward for it.

Adam Grossman: Thank you, Gary. That is a lot of questions in one—I was taking notes feverishly, so if I do not hit on something, please feel free to ask me again. With respect to guidance, the updated framework is based on the recent dislocation and the competitive pressures. This assumes there will be sustained pressures in the standard IG space which should persist for the remainder of 2026—it could be shorter or longer; we do not have the visibility right now. We have taken a conservative approach. We are collecting raw material plasma from our third-party providers. We are working on producing as much as we possibly can, and pull-through is accelerating month over month.

Our production is starting to be able to meet that pull-through level. We are making more batches of ASCENIV in the first part of this year than we ever have at this point in a calendar year. We are very pleased with our third-party plasma procurement and yield enhancement—all the product we are selling so far this year is yield-enhanced manufactured product. With respect to your questions about BIVIGAM, I have always said I never wanted to be in the standard IG business, but when we acquired this manufacturing facility about nine years ago, we inherited this product. It is a good, safe, efficacious product that doctors like. Unfortunately, right now we are seeing heavy discounting from new entrants.

If you look at the ASPs of some of the new products, you can see from their launch to now in the second quarter from an ASP reported to CMS level, they have discounted on the order of 15% to 20% from their original pricing. That is substantial. It is not a game ADMA Biologics, Inc. has chosen to play. We have been consistent from a pricing standpoint. Our ASP is predictable and does not move around a lot, and to certain sites of care and books of business, that is valuable. Does it pay to compete in this market?

We are not going to provide high levels of discounting just to make some sales—it does not benefit you into the future. We are already seeing BIVIGAM revert to strong utilization levels in April. My guess is some of these new entrants have short-dated material—anecdotal reports suggest that—and they are trying to dislocate products like ours from utilization to get people familiar with their product. I do not think that strategy benefits them long term. We are playing the long game focused on long-term growth and value creation for stockholders and providing good products that help patients. So yes, it pays to continue to manufacture BIVIGAM—it is a good, safe product liked by our customers. This is a transitory period.

We will weather the storm and come out stronger. The variability is really ordering patterns—ASCENIV demand remains strong. Guidance is conservative but takes into account these competitive pressures, and it does not reflect any change in our outlook for ASCENIV demand as a later-line therapy in refractory, complex immunodeficient patients.

Terry Kohler: Gary, I echo that. The primary assumptions you are getting at are that for BIVIGAM we are assuming a sustained level of increased competition, and for ASCENIV we fully believe in that product and its capabilities, and it will continue to grow quarter over quarter. That is baked into the assumptions.

Gary Nachman: Thanks. Maybe explain a bit more on the DSOs since there has been so much focus there. You are expecting to get to a more reasonable level of 90 to 105 days from where it is currently. How do you expect to get there and in what timeframe? What initiatives are you putting in place with your current customers? How important is McKesson to help you get there, and how much will that play into continued increases in cash flow generation that you talked about?

Terry Kohler: Sure. As I said, DSOs in the quarter were 107 days. We want to target between 90 and 105 days. We believe that in the back half of this year, we are going to be able to drive improvement in our DSOs. McKesson, as you pointed out, is going to be important. As that business continues to grow as a percentage of our overall distribution partners, they are favorable to our overall DSO performance, and we believe that will push us down into a range within our target. We also believe that while competition will continue for the rest of the year, ordering patterns will normalize, which is baked into that as well.

Some of the concessions that we provided in the normal course to distribution partners over the first part of this year, we will look to tailor back in the back half of this year. All those things should help us with our DSOs. On cash generation, in the quarter we generated $58 million in cash from operations, which is greater than all of 2025. We believe our cash generation will continue to be strong over the course of this year.

Adam Grossman: Gary, if I could touch on one thing—thinking about McKesson and the opportunity from the new book of business we are able to target now that we have that distribution partner in place. Secondary immune deficiency is the largest driver of growth of IG. This is the first time the market is in a period of consistent supply—or maybe oversupply—versus the long-standing supply/demand imbalance. For the last decade-plus, IG has been growing at low double digits year-over-year. Now we see some industry expert analyst reports forecasting low single-digit growth, about 2% to 4% year-over-year.

I do not think this is something our brethren IG companies are talking about publicly, but it is factored into our guidance and why we are targeting the secondary immune deficient population and going after that book of business. IG is still growing and highly durable; usage is not going away. Growth has slowed near term—we think it is transitory—but it is important that investors are aware.

Gary Nachman: Two quick ones to close. Do you expect spillover of discounts and rebates from the standard IG space over to ASCENIV, or will pricing hold up? And on SG-01, how long do you think it would take to run the clinicals you might start this year, and when could it realistically reach the market?

Adam Grossman: We take a disciplined pricing approach across all products. ASCENIV has been largely insulated. You see the broken-out product level revenues—ASCENIV remains a strong product for us, generating substantial margin. That speaks to the durability of the drug, our business model, and our resilience during competitive pressures. I do not anticipate heavy discounting for ASCENIV anytime soon. The product speaks for itself. The data we have published, and that others have published independently, demonstrates the utility of this drug in refractory, highly complex immunodeficient patients who suffer from persistent infections. It is differentiated—no one has anything like it on the market. Our government/commercial payer split leans a little more toward commercial.

We have been contracting through 2025 and 2026 with commercial payers—there are a couple of points depending on utilization—but we are very proud of the positioning for both our products, including our status with Florida Cancer Group, which works exclusively through McKesson Specialty. On SG-01 timing, we have not given timelines yet. Assuming our animal work, preclinical testing, assay testing, and pilot-scale lot production pan out, there are multiple shots on goal for clinical development, from a PIDD pathway like we did with ASCENIV to a potential treatment indication for hospitalized patients.

Hypothetically, for a PIDD pathway, FDA guidance calls for taking about 50 well-controlled patients off their commercial IG and replacing with the investigational product for 12 months, with a primary endpoint of less than one serious bacterial infection per patient per year. Every IG I am aware of that has run an AIDP/PIDD study has met that primary endpoint. A 12-month study typically takes about 18 months to complete. We have not yet provided timing on when that trial will start. We plan to meet with FDA this year for a pre-IND meeting so that as we enter 2027 we will be in a position to provide guidance on trial design, timing, and cost.

We will present encouraging preclinical data at an upcoming conference, and we will update our website accordingly.

Operator: Our next question comes from Kristen Kluska at Cantor.

Kristen Kluska: Hi, everyone. Thank you for taking the questions. On prior revenue guidance, the underlying assumption seemed to be that the vast majority would be driven by ASCENIV. You provided helpful color today on BIVIGAM. Are you looking for any specific market dynamics over the next few months that would get you comfortable providing guidance, especially as ASCENIV is going to have a lot more of the revenue share in the future? And the other question is on understanding real-world benefits—CIS is this week. There have been third-party publications. How do you plan to utilize these data sets not just for physician conversations but for payer and reimbursement as well?

Adam Grossman: Thanks for the questions, Kristen. On the second question, the data we have been publishing—and that third parties have published on their own—has been very helpful in our payer conversations throughout the back half of 2025 and into 2026. Payers are seeing this real-world evidence in their own patient populations: patients staying out of the hospital, fewer ER and doctor visits, and less concomitant medications in patients who switch from standard IG to ASCENIV due to chronic persistent infections. This real-world data is adding value for us with commercial payers. On guidance and ASCENIV’s contribution, the real-world data is helping convert clinicians who have been on the fence, especially in the buy-and-bill IVIG setting.

Feedback from our commercial team has been robust and very positive. Clinicians concerned about reimbursement risk are becoming converts and have started patients this year in 2026. As noted in the prepared remarks, we are seeing increasing new prescribers and new patient adds. ASCENIV is gaining traction and momentum in the ambulatory infusion setting. The McKesson specialty agreement and the secondary immune deficient population represent a great opportunity. With the pediatric indication, we are also having good conversations with pediatric teaching hospitals, and some are discussing putting ASCENIV on formulary for hospitalized immunocompromised children. The outlook remains positive.

ASCENIV will continue to drive growth and profitability, fund our capital deployment initiatives such as share buybacks, fund our R&D, and potentially any future clinical trials from our capital-efficient R&D engine. The core message: BIVIGAM got hit; ASCENIV is largely insulated; and our growth outlook for ASCENIV is unwavering. There are challenges in the market that affect the pace, but we believe ASCENIV will grow.

Operator: Our last question comes from Anthony Petrone at Mizuho Financial Group.

Anthony Petrone: Thanks—just hopping across some calls here. You mentioned excess plasma supply as well. It sounds like there is elevated finished IG on the shelf and maybe some elevated plasma. Considering that, how long does it take the supply chain to straighten out—two quarters, a year? And on McKesson, when you think about new sites of care, how quickly can the McKesson addition result in net-new prescribers for ASCENIV?

Adam Grossman: Thanks, Anthony. On IG inventories, the Plasma Protein Therapeutics Association publishes data on IG sales from reporting manufacturers into the U.S. market. If you look at 2025 data published around March, it appears there was an enormous amount of push-in from the overall industry. The monthly trend was roughly about 12 million grams of IG being sold, and in December it was about 16 million grams. Utilization did not grow 20% from October/November to December, so my read is there is some excess standard IG inventory in the channel that needs to work through. How long that takes, I do not know. IG utilization is robust.

Encouragingly, BIVIGAM returned to what I would call normal levels in April from a utilization standpoint—on the lower bound of normal, but back to a place I feel better about. I do not know how much inventory competitors have or how long they will continue aggressive discounts and rebates and erode their ASPs. On raw material, I think there is an oversupply of normal source plasma. We have seen announcements of center closures by some plasma collection organizations. ADMA Biologics, Inc. monetized our centers in the quarter and signed a new third-party agreement; others chose to close some centers.

The spot market has attractive pricing at the lowest levels we have seen in a while, and that may persist longer than the finished IG oversupply. For us, we are largely self-sufficient for normal source plasma from our seven centers and are in a good position with high-titer procurement from third parties and internal collections for ASCENIV. On McKesson and net-new prescribers and sites of care, we are already seeing increased utilization—April was a good month and in line with expectations. The McKesson book of business is starting, we had a strong April, and we anticipate continued compounding growth as we progress.

Operator: This concludes the question-and-answer session. I would now like to turn it back to Adam for closing remarks.

Adam Grossman: I just want to thank everybody for taking the time today to dial into today's call. We appreciate your continued support. And again, donate plasma—you can help save many lives with just one donation. Thank you again to the ADMA Biologics, Inc. staff and team.

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