ADMA BIOLOGICS, INC.(ADMA)Q2 2026 法說會逐字稿

Good afternoon, and welcome to the ADMA Biologics Second Quarter 2026 Financial Results and Business Update Conference Call on Wednesday, August 5, 2026. 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 second quarter of 2026 and recent corporate updates. I'm 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 the corporate progress, and Terry will provide an overview of the company's second quarter 2026 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 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'll 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 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 quarterly report on Form 10-Q for the quarter ended June 30, 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. With that, I would like to now turn the call over to Adam Grossman. Adam?

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, and 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 large 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 health care 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 health care 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 health care 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 provide 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 health care 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, and 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 streptococcus pneumoniae prevention recommendations. Immunocompromised patients remain at a disproportionately high risk for severe pneumococcal disease. Underlying impairments in functional immunity limit vaccine-mediated protection, leading to 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 to $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. Overall, we believe ADMA enters the second half of 2026 from a position of increasing strength. ASCENIV demand is accelerating and its differentiated value proposition is becoming increasingly well supported. BIVIGAM demand is stabilizing in the face of increased competitive pressures, and 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, and 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 remains central to our performance and positions the company for sustained long-term success.

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, while 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 0.5 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 30, 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 to $560 million, adjusted EBITDA of $265 million to $300 million and adjusted net income of $170 million to $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.

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 health care 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 specialty plasma-derived biologics in an area of medicine where significant unmet medical needs persist. To sum up, commercial momentum continues to build. Our differentiated evidence base continues to expand, and 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 health care 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.

Our first question will be from Ryan Deschner with Raymond James.

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 do you think there will be? And if you could give us an idea of how payment terms compare between McKesson and your other customers?

Thanks, Ryan. 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 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 partner. We are seeing very good utilization and are having productive conversations with many decision-makers at several parties that buy exclusively through McKesson under these GPO contracts, and 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.

Next, our question will be from Kristen Kluska with Cantor Fitzgerald.

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?

Thanks, Kristen. With respect to reimbursement dynamics, ASCENIV and BIVIGAM 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. We think that is mostly driven by the body of real-world data and evidence that we published to date, and we expect that trend to continue, especially in light of the new data that we discussed in the prepared remarks and which is included in the press release. With respect to some of the market dislocation challenges, we still see large amounts of standard IG throughout the U.S. marketplace. We play in the outpatient setting; almost 100% of the product that ADMA sells is in the ambulatory infusion or home infusion setting. We are still seeing 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. BIVIGAM recovered a bit and is seeing stronger utilization, but 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, and June represented the largest month-over-month growth in end user utilization that we've seen since the first half of 2024. Payer access continues to be open and broad. This is all predicated on the fact that the product is being used in refractory, comorbid immunocompromised patients who are not doing well on standard IG products.

And then—sorry, may I ask one more?

Sure. Go ahead.

Yes. 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.

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, in Q4 as we start to manufacture conformance lots.

Next, we have Anthony Petrone with Mizuho Financial Group.

Maybe, Adam, going back to the traditional IG market, BIVIGAM. Some of the PPTA data out there is still showing an erratic pattern with distributor stocking and you referred to some competitors 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? I have a couple of follow-ups.

Thanks, Anthony. We're seeing some stability with BIVIGAM in our market arena. Certainly, the competitive dynamics we touched on continue to persist, but we are seeing stabilization there. Guidance is unchanged. I noted during the last quarter call that we've taken a conservative approach to the new guidance framework. We still anticipate BIVIGAM being down roughly 40% to 50% from 2025, and ASCENIV should be in the upper 20s to low 30% range year-over-year growth. We feel very good about ASCENIV go-forward utilization growth. It's plugging a hole from the BIVIGAM downturn as well as some of the other intermediate fractions and normal source plasma that we no longer generate revenue from. Could there be some upside from BIVIGAM? There's always a chance, but that's not currently something we are contemplating. We've been working with BIVIGAM, with some of our distribution partners and new GPOs. BIVIGAM has been awarded some preferred status across some programs, and we're optimistic the drug will continue to be used. It's a safe, efficacious product made by us. We think it has stabilized and that this is a run rate that could be anticipated going forward. Any upside would only benefit the business.

And the follow-up would be your comment that commercial payer access could potentially further strengthen here. I know that CVS Caremark has a dedicated policy in place for ASCENIV, and 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 commercial payer access can potentially expand? Are there milestones we should be looking for?

To the best of my understanding from our market access team, ASCENIV and BIVIGAM are largely on par with a number of other IG brands. We are starting to see additional access and increases across different geographic regions and various commercial payers. Our team has been engaged in robust discussions with a number of payers to secure improved access for ASCENIV as we continue to publish data. In the appropriate-use patient population, we are continuing to see more patients get approved through the prior authorization process. That is not unique to us; it is across the entire IG landscape—roughly 70% or more of IG prescriptions require prior authorization. We feel good about payer access and are well positioned for continued growth; we are seeing the commercial payer book of business increase quarter-over-quarter.

Our next and final individual with a question is Gary Nachman with Canaccord Genuity.

Adam, on the increasing demand for ASCENIV, you previously talked about growth of 2% to 4% month-on-month. Do you expect it to continue at that rate? Or could it possibly be even better than that? It sounded like it accelerated nicely in June. Was it actually above that range? And maybe just some more on what drove that acceleration? Then I have a follow-up.

Sure. June certainly month-over-month was outsized. As we contemplate guidance for the full year, Gary, we are forecasting 2% to 4% month-over-month growth if you smooth it out throughout the year. But we are seeing acceleration with respect to ASCENIV end-user utilization and end-user pull-through from our distribution partners. This is data they report to us, so it is only as good as the data reported, but we feel very good about the utilization. What I really think is happening is that our continued presence at medical conferences, medical education, grassroots medical education efforts, regional speaker programs and presentations at regional and national meetings are building awareness. When you publish enough papers, people start to believe. Multiple institutions across different geographies are publishing data that shows improved outcomes and reduction in health care resource utilization. We think all of this is changing clinician mindset and bolstering the confidence of clinicians who previously had one or two patients on ASCENIV and are now willing to put more patients on it. It's a combination of the expanded evidence base and increased education. Since launch in the back half of 2019, it's been a journey, and we believe we're at a turning point where real-world data supports ASCENIV as a differentiated product with a unique antibody profile demonstrating benefits for patients not thriving on standard IG therapy. We expect continued growth and are doing everything we can to grow the business as fast as possible, with field reimbursement, medical affairs, national accounts and sales all working together.

Okay. Great. Just a follow-up, if I can. You mentioned the 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? And how important do you think that will be for the overall growth of ASCENIV moving forward?

I previously mentioned that we have investigator-initiated studies ongoing in certain organ transplant patients, mainly lung; that work is still ongoing and I expect hopefully sometime this year we'll see results. There are a couple of other investigator-initiated studies that are either kicking off or will kick off in the oncology setting. 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 who are refractory to standard IG and who continue to experience chronic persistent infections and the comorbidities I have described. There is a lot of white space for us to grow within the labeled primary immunodeficiency market. Over time, as we progress into 2027 and beyond, IG is widely used in secondary immunodeficient patient populations—oncology, organ transplant and autoimmune disease settings—which is the fastest-growing area of IG growth in the United States. While it may not be our primary focus today, over the next several years we aim to penetrate those markets as well. We are starting to see utilization in those segments, through McKesson specialty relationships and some community oncology practices. But today, utilization is driven mainly by primary immunodeficiency patients who are not thriving on standard IG therapy. When those patients try ASCENIV and do better, positive outcomes lead to continued growth for ASCENIV and for ADMA.

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 your time this afternoon. We appreciate it. Donate plasma; help save a life, and we look forward to speaking with you soon. Thanks for your support.

Thank you, Adam. This concludes the conference call for today. We appreciate your participation, and you may now disconnect.