ADMA Biologics, Inc. (ADMA)
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Earnings Call: Q3 2023

Nov 8, 2023

Operator

Good afternoon, and welcome to the ADMA Biologics third quarter 2023 financial results and corporate update conference call on Wednesday, November 8, 2023. At this time, all participants are on 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 Skyler Bloom, Head of Business Development and Corporate Strategy at ADMA Biologics. Please go ahead.

Skyler Bloom
Senior Director Business Development and Corporate Strategy, ADMA Biologics, Inc.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the third quarter of 2023 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer, and Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager of ADMA BioCenters. During today's call, Adam will provide some introductory comments and provide an update on corporate progress, and then Brian will provide an overview of the company's third quarter of 2023 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for your questions. Earlier today, we issued a press release detailing the third quarter of 2023 financial results and summarized certain achievements in recent corporate updates. The release is available on our website at www.admabiologics.com.

Before we begin our formal comments, I'll remind you that we will be making forward-looking assertions during today's call that represent the company's intentions, expectations, or beliefs concerning future events, which constitute forward-looking statements for the purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks, and uncertainties, such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements except as required by 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 2022 Annual Report on Form 10-K for the year ended December 31, 2022, as well as our quarterly report on Form 10-Q for the third quarter ended September 30, 2023, 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. A reconciliation of the non-GAAP financial measures to the nearest comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam?

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thank you, Skyler, and welcome everyone. We are pleased to present a number of firsts today with strong financial results for the third quarter of 2023, which underscore both our unwavering commitment to the continuity of patient care and steady financial execution for our stockholders. Total third-quarter revenues reached $67.3 million, representing an impressive 64% growth rate year-over-year. This rapid growth enabled a 98% quarter-over-quarter increase in Adjusted EBITDA to $12.7 million. Furthermore, it gives me great pleasure to announce that for the first time in ADMA's history, we are profitable, with GAAP net income reaching $2.6 million during the third quarter. We also generated positive free cash flow for the first time in corporate history, totaling $11.6 million during the quarter.

These milestone results are a testament to the efficiency of our organization and our relentless focus on maintaining top-tier revenue growth while judiciously managing expenses. We fully anticipate this positive trajectory will continue to drive earnings growth for the foreseeable future. Building on the momentum we've established this year, we've revised our total revenue guidance higher yet again for fiscal years 2023 through 2025. We now anticipate generating revenues during these periods of more than $250 million, $290 million, and $335 million, respectively. Our company's success in carving a solid niche in the $10 billion immunoglobulin end market is a direct result of our innovative business model, diverse product portfolio, and our targeted medical education, marketing, and market access initiatives.

We remain the fastest-growing provider of immunoglobulin in the U.S. marketplace, with a specialization in treating immune-deficient patients. Specifically, within the later line, at-risk primary immune deficient patient population segment, ASCENIV continues to make significant inroads. In the third quarter, leading ASCENIV demand metrics hit all-time highs across the board. We are seeing record new ASCENIV patient starts and promising persistence and adherence trends as certain patients progress through their third year on therapy. Equally encouraging, ASCENIV's prescriber base is expanding, and we anticipate will further compound the growth among existing prescribers and institutions. The value proposition of our product offerings was highlighted at the annual 2023 IDWeek International Conference, where ADMA sponsored a symposium with two national clinical experts. First among these opinion leaders was Dr.

Alia Baluch, who discussed the heightened severity of respiratory viral infections, or RVIs, in immune-compromised patients, with up to 80% mortality risk in some cases. Dr. Baluch emphasized the lack of a standard RVI management approach, leading to an unmet need, and further touched on emerging therapies. Additionally, Dr. Jolan Walter highlighted the evolving approach to managing infectious diseases in immune-compromised patients, focusing on RVI management. She introduced ASCENIV, a unique intravenous immunoglobulin with increased antibody titer levels against respiratory pathogens. Dr. Walter presented a case where ASCENIV effectively managed recurrent respiratory infections that were unresponsive to standard immunoglobulin therapy and shared her own real-world experience demonstrating the drug's clinical impact in this setting. All told, we are encouraged to see ASCENIV's unique product profile continuing to resonate in clinical practice and the real-world setting.

The therapy's accelerating demand trends and healthy growth attribution continually catalyze us to favorably rethink the ultimate size of the market opportunity, and we reiterate that we believe we are in the early innings here with the product's total potential. Turning to our 2024, 2025 corporate growth initiatives, all activities continue to progress as planned. We have successfully expanded ASCENIV's production to the 4,400-liter manufacturing scale, enhancing the product's margin, yield, and capacity. We expect to realize these profitability benefits beginning late in the fourth quarter and more materially in 2024. Additionally, our post-marketing clinical studies are progressing well and may lead to label expansion with a potential pediatric age group if successful, further strengthening our product portfolio. Our excitement continues to build as we see the potential impact of our manufacturing immunoglobulin yield enhancement initiatives.

During the third quarter, we made significant strides in scaling up our processes and conducting laboratory bench scale runs and analysis. If ultimately successful, we believe enhanced production yields will be transformative in providing increased finished goods output, which would substantially increase ADMA's peak revenues and earnings potential. While it's important to note that these opportunities won't have a potential financial impact until 2025, we cannot overemphasize our enthusiasm for the promising benefits this opportunity offers on both the top and bottom lines. On the plasma supply front, we are confident in our ability to meet the increased production forecast for our immunoglobulin portfolio. Our BioCenters collection network expansion, in addition to our contractually secured third-party supply contracts, provide us with the flexibility needed to meet the growing end market demand for ADMA's immunoglobulin product portfolio.

Currently, all 10 collection centers in our network are operational, with nine already FDA licensed, and we anticipate achieving FDA licensure for our tenth and final collection center by the end of this year, with plasma supply self-sufficiency also expected by year-end. Reflecting on ADMA's journey, it's become evident that our success is a direct result of the unwavering dedication and hard work exhibited by our exceptional staff members. Our remarkable transformation from a virtual clinical stage biotech company to one that is now cGMP compliant, has an end-to-end controlled supply chain now positioned for rapid advancement with a highly profitable commercial trajectory. Thank you for your relentless efforts, which not only drive our accomplishments, but also create a meaningful impact in the lives of those who depend on us. It is the collective spirit and teamwork that truly make our workplace exceptional.

We appreciate the commitment, passion, and diligence that each team member brings to the table. It's this dedication that propels our organization's triumphs and empowers us to maintain complete control of operations in alignment with our core vision. We believe this solid foundation lays the groundwork for even greater success in the future. With this said, I'd now like to turn the call over to Brian for a review of the third quarter financials. Brian?

Brian Lenz
EVP, CFO and General Manager, ADMA Biologics, Inc.

Thank you, Adam. We issued a press release earlier today outlining our third quarter 2023 financial results, and we'll be also issuing our third quarter 10-Q later this afternoon, which we would encourage you to read in conjunction with our comments and discussion points we will make during today's call. I'll now discuss some of the key highlights from the third quarter. As Adam mentioned earlier, total revenues for the three months ended September 30, 2023, were approximately $67.3 million, as compared to $41.1 million during the three months ended September 30, 2022. This represents an increase of $26.2 million or approximately 64%.

The increase is attributed to higher sales of our immunoglobulin products, driven by increased physician, payer, and patient acceptance and utilization, as well as the expansion of our customer base. The growth in product revenues during the quarter was partially offset by a $3.1 million decrease in third-party plasma sales from our BioCenters business segment, which was consistent with our expectations in the context of fulfilling our long-term plasma supply agreement during the first quarter of 2023, while also providing a significant supply of normal source and high titer plasma to our Boca facility for the manufacturing of ASCENIV and BIVIGAM as we migrate toward plasma supply self-sufficiency. Gross profit for the three months ended September 30, 2023, was $24.7 million, as compared to $9.7 million for the same period of a year ago.

This represents an increase of $15 million, which is attributed to selling more of our higher margin product, ASCENIV, during 2023 as compared to 2022. As a result, ADMA achieved a corporate gross margin of 36.6% in the third quarter of 2023, as compared to 23.5% in the third quarter of 2022. We believe the pathway is well-paved to continue to grow gross profits over the coming periods. We are very pleased to report, and as Adam mentioned earlier, that for the first time in corporate history, ADMA has achieved GAAP net income profitability and has generated first-time positive operating cash flow. During the third quarter of 2023, GAAP net income reached $2.6 million, as compared to a GAAP net loss of $14.9 million for the third quarter of 2022.

Our operating cash flow for the three months ended September 30, 2023, totaled $12 million, increasing ADMA's cash on hand to $74.2 million at the end of the third quarter of 2023. ADMA grew Adjusted EBITDA to $12.7 million for the three months ended September 30, 2023, as compared to an Adjusted EBITDA loss of $6.1 million the same period of a year ago. The improvement is driven primarily by increased sales, gross profit, and fiscal operating management of our business segments. Based on ADMA's third quarter Adjusted EBITDA growth and cash generation, the company's current Net Leverage Ratio has organically improved to an impressive 1.6x. We believe. We anticipate the balance sheet will continue to strengthen over the coming periods, enabled by forecasted operating cash flow and growing Adjusted EBITDA.

Lastly, the ADMA BioCenters network now consists of nine FDA licensed plasma collection centers, with our tenth center operational and collecting plasma, which is pending FDA licensure anticipated by year-end 2023. Additionally, in the same period, we forecast raw material plasma supply self-sufficiency from all 10 of our centers. We remain encouraged by the real-time improvements in donor foot traffic and collection volumes, which continue to achieve record all-time highs and remain considerably above our organization's pre-pandemic levels. With that, I will now turn the call back over to Adam for closing remarks.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thank you, Brian. ADMA's business prospects and company morale have never been higher. All systems and teams are working in concert across our organization. We are committed to finishing 2023 on a high note and entering 2024 from a position of strength. 2023, with all of its challenges, is truly proving to be a banner year for the entire organization. With ADMA's cash holdings growing to $74.2 million during the third quarter and Adjusted EBITDA annualizing at more than $50 million, we have established a strong foundation from which we anticipate continuous growth in both revenues and profits. Our ongoing corporate initiatives, particularly those centered on enhancing immunoglobulin manufacturing yields, have the potential to further accelerate ADMA's growth outlook and peak earnings potential. We believe that our financial achievements and growth outlook position ADMA as a distinguished player among standalone biopharma companies.

With substantial barriers to entry in the United States immunoglobulin market and a robust intellectual property estate, in the case of ASCENIV, we are confident in our ability to deliver one of the most durable earnings growth stories in the biopharma industry. Our accomplishments in the third quarter of 2023 reflect our commitment to patient care, financial growth, and market leadership. We are enthusiastic about the opportunities ahead and our dedication to delivering value to our stockholders and patients. Thank you for your continued support and trust in the company. We wholeheartedly appreciate those of you who have supported us through this journey, and we are committed to delivering for you in the periods to come. Your investment in ADMA helps to advance our mission to save lives and make high-quality, safe, and efficacious products that help our friends, family, and neighbors. Please donate plasma and help save lives.

With that, we will now open up the call for your questions. Operator?

Operator

Thank you. As a reminder, to ask a question, please 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. One moment please, as we compile the Q&A roster. One moment please, for our first question. Our first question will come Kristen Kluska - sorry, Cluster of Cantor Fitzgerald. Your line is open.

Kristen Kluska
Equity Research Analyst, Cantor Fitzgerald & Co.

Hi, good afternoon, and congrats on achieving the profitability. This came quite a few quarters ahead of your internal goals, so great job with that.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thank you, Kristen.

Kristen Kluska
Equity Research Analyst, Cantor Fitzgerald & Co.

Yeah. So one question that we've been getting a lot lately, and I think it'd be great to hear your comments on, is just around IP and protection around ASCENIV. It's clearly served as a highly differentiated product, contributing to a lot of success. So can you talk about what you're doing and what you've done to protect that, please?

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Absolutely. Thank you, Kristen. And, it's been a while since I've actually been asked this question. This was a question from back in the days of the IPO, but we have issued patents for ASCENIV, and there's an entire IP estate which covers the composition and the use of the product. The main IP is around the identification and selection of the plasma donors to stimulate the plasma pools in order to ensure that there is some consistency in the anti-RSV antibody levels in the final product. So, this IP has been issued. I believe the patents run into 2035. Yeah. I did not anticipate the question, Kristen, but we do have IP protection here. And, you know, look, we've. This is not a secret.

You know, a number of the things that we do are protected by trade secrets. A number of the things that we do, we do have issued IP for, but, the drug in its form, formerly known as RI-002, you know, was in clinical trials back in, 2012, 2013, 2014. And, you know, here, here we are in, you know, essentially almost 2024, and there is, there is no competitive threat, looking at, a product like ASCENIV with the unique antibody profile that this product has because of the unique donors that we use to make the, the drug. So we feel very good about our positioning. We feel very good about our place in the market.

Again, there are no competitive threats that we're aware of that will be able to make the same compositional claims that we do with ASCENIV.

Kristen Kluska
Equity Research Analyst, Cantor Fitzgerald & Co.

Okay, thanks for that. And, you know, it wasn't that long ago that you were guiding to the street that the peak revenues you think the company could produce would be over $250-$300 million. And now those numbers look small relative to what you're seeing potentially for 2024 and 2025. So, you know, we ask this every earnings call. I recognize that, but I think it'd just be really helpful to truly understand, like, what has really changed over these last few quarters that give you such a high degree of confidence that you can even guide revenues to the street through 2025. Thanks again.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thanks, Kristen. You know, it's—you're asking a different question than you've asked before. I mean, what's changed? Nothing's changed. Everything's working. It's working the same way that it has been for the last couple of years. You know, it's the medical education strategy, it's the marketing campaigns, it's the conversations with payers, it's our sales force, it's everybody that works at the company. It's all the little things that we do come together in such a way that people are responding positively. And, you know, I think that you see this with lots of products. You have early.

You know, going back to my days as a marketing student in college, you know, there are different life cycles that a product goes through, and you have early adopters, and you have these people who, you know, wait online to get the newest and greatest iPhone. They're the first users and they try all the apps, and then the bugs get fixed, and then more people start buying it, and then you have the mass appeal. I guess I would say that we're probably in that stage where the early adopters have worked very closely with our organization, and we've published a lot of articles around the real-world clinical benefits that folks are seeing in these problematic immune-deficient patients.

We've been spending more money on marketing and medical education post-COVID, now that everybody's getting back into the real world. I mean, it's— Yes, people are still getting sick, but I think people are not afraid to travel to these conferences. We're seeing record attendance at the shows that my teams are present at. And, you know, we've invested and built a medical educational speakers bureau that are all throughout the regions of the United States.

And I think, you know, when patients do well and they're advocating, and they're lending their stories to our websites, where you can see new patient advocacy videos that have been posted online, I think it's just, you know, we provide an alternative, and everything that we have said that we're going to do from the beginning, we're doing. So nothing's changing. It's just, I think things are just coming together, and they're coming together a little faster than what we anticipate. And, you know, I'm getting all these nice texts, and I'm getting all these things that people want me to say, all these things, but, you know, I am who I am. We are who we are. Our company, you know, we're regular people just trying to do a good job and make good products that help people.

So that's what we're doing here at ADMA. We're doing our best to provide you with reasonable guidance. Again, I've said it to you probably on the last call, Kristen, or maybe one of the other ones. I remember the second quarter of 2020, and we did not hit our top-line number, and I paid for it. I don't ever want that to happen again. I want my shareholders happy, I want my staff happy, and ultimately, I want my customers and my patients healthy and happy. So, if you don't like the way that we give guidance, there's, you know, 4,000 other stocks you can buy. But for the time being, we think the guidance that we're putting out is fair.

We think that it's certainly attainable guidance. And I think that that's what we want folks to make their investment decisions on, not these pie in the sky numbers that, you know, some folks, you know, backtrack and have to explain why they don't hit them. You know, you're asking me to explain why we are hitting numbers better than what we're saying. You know, I've got a great team. I've got a great team around me. To all of you listening, it doesn't happen without each and every one of you. So don't screw around. Give us an honest day's work and get out there and keep saving lives.

Kristen Kluska
Equity Research Analyst, Cantor Fitzgerald & Co.

Thanks, Adam.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thank you, Kristen. Safe travels.

Operator

Thank you. One moment, please, for our next question. The next question will come from Anthony Petrone of Mizuho Group. Your line is open.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Hey, Anthony.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst, Mizuho Securities Co., Ltd.

How are you, Adam? Thanks, and congratulations, another good quarter. I was on the second quarter 2020 earnings call and turned the page a few years, and it's a huge difference. You have in a press release, Adam, that, you know, your prescriber base and patient base for ASCENIV, you know, continues to grow. You're getting at, you know, net new prescribers as a common statistic out there for therapeutics companies as well as, you know, NRx statistics. You know, can you disclose, I guess, you know, kind of where those are trending, broad strokes? You know, how many new prescribers are coming on board each quarter, I guess, on average? And, you know, maybe what % of this target comorbid primary immunodeficiency market do you think is penetrated, you know, by ASCENIV at this point?

It seems like we're just getting started here, and then I'll have a couple thoughts from Brian.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thanks, Anthony. You know, we are expanding the depth of our product penetration and our medical messaging, and that's really what is translating into this accelerated growth. There are more prescribers, and again, I think it goes back to the answer that I had to Kristen's question around the early adopters and the prescribers that are out there. I mean, look, the best way to convince a physician to use a drug is another physician telling them, "My patients have done well on this drug." Plain and simple.

I mean, I can hire all the reps and all the medical affairs people, and I can put my name in lights all I want, but when a colleague is at a, you know, at a symposium or at a medical conference with another colleague, and they're saying, you know, "Hey, do you use this stuff?" and they say, "You know, I actually do, and I like it," you know, that's the kind of advertising and promotion and benefit that you can't buy. It just happens because it's real world. So you know, it's really that people are getting comfortable with the product. You know, the price is certainly unique for an IG. You know, it's priced on the higher end of the hyperimmune, if you will, specialty IG scale.

But I think that the benefits and the outcomes that they're seeing in the real world, people understand why it is what it is. It's special plasma that the drug is made from, and, you know, it's only made in this way by ADMA. And I think that really it's the grassroots marketing effort that we've taken to our story, to our commercial, you know, throughout the commercial launch of the product, that really is translating into increased number of patients going on the product. We're really only having these conversations in the immune deficient world. That's where we spend our time, that's where we focus, Anthony.

So all the product use is really coming from primary and secondary immune deficient patients that are not doing well on IG, that have comorbidities, that are getting sick. And I think that once a doctor tries the product and sees results in that patient, they're faster to put their second patient on. And really what you're seeing is that because we have a larger number of prescribers, they're getting more comfortable in saying, "You know what? I can advocate for these patients with the payers to get therapy because of these comorbidities." And they're not afraid that they're not gonna get reimbursed anymore. You know, we've been. I think we spent a lot of time over the last year and a half talking about durability, and a lot of the analysts, including yourself, had questions. "Well, Adam, how durable is this?

Is this a one-off quarter? How do you know this is gonna happen every quarter, every quarter?" And I think time is the only thing that I couldn't rush and demonstrate to all of you that, you know, it's. You know, these patients are like an annuity. They, you know, it's the razor blade model. You need a razor blade every month. You need your infusion every 3-4 weeks for the rest of your life. And if you do well on ASCENIV, and if you're thriving on ASCENIV, you know, even though some of my market research suggested that people would come off therapy, they're not. They're staying on in multiple years of therapy. And we're just seeing it compound. So, hopefully, that answers your question.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst, Mizuho Securities Co., Ltd.

Yeah.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

But really, it's the clinicians. It's the clinicians that have you know, said to my team, you know, "Thank you. Thank you for making this product. Thank you for moving the peg forward. You're giving us an option for these patients, and they're doing well." That's what sells drugs.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst, Mizuho Securities Co., Ltd.

Absolutely. And the follow-up should be, Brian, maybe a little bit on gross margin here, you know, well above our estimate in the quarter, drove the EBITDA beat to some extent here, of course. And so a couple questions. One is, you know, you referenced that at least there was some ASCENIV batches that were successfully transitioned to 4,400-liter pool. Are we reading this right, that that product can be fully transitioned to 4,400 by the end of the year, early 2024? And if so, you know, what does that do to gross margin? Does that represent upside to this 40%-50% target in the outer years? Thanks again, and congratulations.

Brian Lenz
EVP, CFO and General Manager, ADMA BioCenters, ADMA Biologics, Inc.

Sure. Thank you, Anthony. Regarding ASCENIV, we've certainly seen more upward mobility or more utilization of ASCENIV than we originally forecasted. With regards to the 2,200 manufacturing batches of ASCENIV transitioning, getting FDA approval not long ago to the 4,400 liter batches, they've pretty much sold out of the 2,200s. The gross margin going from 2,200 to 4,400 is certainly very meaningful. I would say that, you know, historically, we were looking at 80%-85% gross margin for ASCENIV in that 2,200 liter range. Say now we're, you know, higher than 85%, probably closer to the upper 80s, at some point in time, maybe even low 90% range for ASCENIV as we continue to sell only 4,400 liter batches.

Skyler Bloom
Senior Director, Business Development and Corporate Strategy, ADMA Biologics, Inc.

Anthony, it's Skyler. To be clear, though, in the third quarter gross margin print of 36.6%, you're not seeing any monetization of the 4,400-liter ASCENIV product, right? It's on a go-forward basis, and it really materially will not kick in until the beginning of next year, is the way that we think about it.

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst, Mizuho Securities Co., Ltd.

All right. Very helpful. I'll get back in queue. Thanks.

Operator

Thank you. Again, to ask a question, please press star one one on your phone and wait for your name to be announced. One moment, please, for our next question. Our next question will come from Gary Nachman of Raymond James. Your line is open.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Hey, Gary.

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

Hi, guys. Good afternoon, and very nice quarter.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thank you.

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

So first question, how has your contracting been going with the big physician buying groups for both ASCENIV and BIVIGAM? And I wanna get a sense of how much visibility you have on how much product you'll be able to supply them. You know, so I'm curious what you see looking into that funnel when you look out over the next, you know, 9-12 months. And then specifically, what was the mix for ASCENIV and BIVIGAM in the third quarter? And then I have a couple more.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

What was the mix? Do we know what-

Anthony Petrone
Managing Director, Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst, Mizuho Securities Co., Ltd.

The mix. The mix, you know, historically, we said we'd be in that 75/25, 70/30 percent, and then we would start looking at, you know, 65/35, and, you know, we've, we've really migrated to that 65/35, heading more towards 60/40, standard margin BIVIGAM, higher margin ASCENIV, that 60/40 mix right now.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

I'll say, Gary, that that is conservative. Let's see where we go in through 2024, but that's where we're seeing. I know in the past I've said, you know, is there a chance that you get to 50/50? Probably. I do I know when that is? No, I don't. Can I put my finger on it? No. But do we get there? Does ASCENIV, at some point in time, potentially surpass BIVIGAM? Probably. When do we get there? I don't know. But for the time being, for modeling purposes and the guidance that we feel comfortable with, you know, we said 70/30, 65/35 is probably where we are, and 60/40 is where we're gonna go. The first part of your question was regarding contracting and payer reimbursement. I mean, we're very pleased.

I mean, you see the growth. You know, between public and private payers, we're very, very happy. Our patient hub, we leverage the patient hub. It's proved very effective, and it's been very, very important in the, you know, getting new prescribers comfortable and providing patients with some assistance, with their copays and with other expenses as it may relate to their ASCENIV or BIVIGAM infusions. Again, ASCENIV is the drug for the appropriate at-risk population. Again, they're staying on drug. They have these chronic persistent infections that they wind up clearing, but they have underlying bronchiectasis, they have underlying COPD, they have underlying asthma. You know, on the ASCENIV website, we go through a whole battery of all these different risk factors that patients may have.

You know, we're spending a lot of time talking about ASCENIV here, but BIVIGAM, BIVIGAM's a high flyer. I mean, it just as soon as it hits inventory, it's out the door. I mean, we've got so many patients on BIVIGAM right now, and keeping up with demand is certainly a challenge. And I'm sure all my staff listening right now is chuckling, but we really can't keep it in stock. And we think a lot of this has to do with the fact that there's multiple years now of clinical experience. Payers are seeing that they're using less premedication with these patients, and there's less AEs, and there are a lot of, you know, interesting..

Differentiating factors about our IG compared with our competitors, and we think that that's really helping us manage the payer, work with the payer well. From a contracting perspective, again, we feel very, very pleased with our current payer access.

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

Okay, great. And then, I mean, with the consistent positive EBITDA now for a few quarters and now the positive cash flow, at what point would you consider a debt refinancing? You know, is that high on your list when you're looking at the-

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Gary, everything's always high on my list. I know you've been following the company. What is this, your third call, fourth call now?

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

Second call.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

We're always doing everything all the time. Let's just say that. I mean, we're not stupid. We see the markets there. Look at our financials. Look at how they've changed and evolved. I mean, we're having conversations all the time with all types of people. This is the answer that we give to you, and this is the answer we give to all of our, all of our shareholders when we have our one-on-one calls, where we're always having conversations, and I'll just say, stay tuned. We will do the right thing for this business, as I believe that we've done since its founding. And, you know, it can only improve from where we are. And I think that, you know, we finally flipped the pages, right, Brian?

Brian Lenz
EVP, CFO and General Manager, ADMA BioCenters, ADMA Biologics, Inc.

Yeah.

On EBITDA and on net income, and these are the things banks want to see.

Three quarters of positive EBITDA, total assets $350 million, first quarter of net income, positive cash flow. These are things that lenders, banks like to see, certainly, and we're gonna do everything we can, as Adam mentioned, to look at the cost of capital, look at this interest rate that you know has grown over the year. We have refinanced. We refinanced in May, lowered the overall interest rate 100 basis points. We certainly think there's opportunities to do the same or if not more in the future as our financials continue to improve over time.

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

Okay, great. And last question is just on the patients, what are you doing specifically to try and activate patients? One, you know, the first, in terms of the donor supply, just to get more donors, specifically for ASCENIV, are you increasing your incentives now that you see what kind of return you're getting? And then just also in terms of, you know, patients that have been going through the IG treatment, and maybe they could then, you know, make physicians aware as well. I'm curious if that's an important piece of the puzzle. Thanks.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Absolutely. I mean, look, patients, patients advocate for themselves in 2023. If you're a smart patient, and if you're somebody who wants to get better, what we see is that patients are out there advocating for themselves. Gary, if you haven't seen the new additions to the ASCENIV website, there are two patient advocates who tell their story, and they talk about how they... One patient talks about how, you know, their doctor said, "Hey, I learned about this drug at a conference, and I think it might be right for you." The other patient said, "I learned about this drug, went to my doctor, and I said, 'Don't you think this is right for me?'" So I think that certainly is a big part of this. We have...

You know, look, we're a smallish company, but we are spending more time marketing to patients. We are working much more closely and in a much broader capacity with the patient advocacy groups, you know, Immune Deficiency Foundation, Jeffrey Modell Foundation, amongst others. And, you know, we think that that certainly is helping add to the growth for ASCENIV. What was the first part of this question?

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

And donors.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Oh, donors! Yes, yes, yes.

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

Donating and looking-

Adam Grossman
President and CEO, ADMA Biologics, Inc.

I mean, look, do we pay our donors more? I don't know if donors are listening. I don't think we are paying them that much more right now. There is a plethora of plasma donors out there today. Donor fees are coming down across the board. Brian certainly can speak more specifically to that in a moment.

But, I've talked about this, I think, in past calls, and it's funny that you ask the question, Gary, because maybe I had a management team meeting with everybody at the company this week, and we were talking about how we've got testing up and running in-house here for RSV donor screening, and that certainly is going to help expedite the accessioning of these donors, the identification of which donors in our collection center network have the highest levels of neutralizing antibodies to RSV and the panel of respiratory pathogens that we look for. And what I can tell you is that part of our supply chain robustness in owning our own centers is we can choose which donors we're collecting plasma from. So we're not saying that our third-party providers have not been great.

They've been fantastic, and we love you all, and we hope you keep selling us good, high-quality plasma. But, you know, if you work for ADMA, I have more control over what you do, plain and simple. I don't care about sending it to somebody else. I don't care if it has to go into that box. I want it where I want it, and that's what I want. So, we can easily ensure that we get every single RSV high-titer donor that we identify in testing. That is not something that I can say with our third-party vendors. We lose donors. Every unit of plasma that a donor that we've identified, as an appropriate donor for an ASCENIV plasma pool, we have access to. So, you know, this was part of our strategy.

This was part of the philosophy, was that, okay, if the drug does take off, if we do start selling—you know, tens of thousands of grams every month. If this is the way it is and we need all this plasma, how are we going to really control? And it wasn't just the need of the source plasma, it was also because we know folks like you are going to ask us these questions. So, yes, we have full control over our plasma supply chain from a normal source perspective, but we also have full control over our supply chain from an RSV hyperimmune plasma perspective. And, you know, this, coupled with the fact that we are testing in-house the initial screens, we think that that's going to help us identify more donors and faster. We are continuing to work with our third-party laboratory.

We plan to keep that third-party laboratory continuing to test forever, because the one thing I've learned in my seat at ADMA Biologics is redundancy is the key to success. So, even though we can do it better and more efficiently, we're going to continue to keep the assay up and running to ensure the continuity of supply and plasma collection.

Brian Lenz
EVP, CFO and General Manager, ADMA BioCenters, ADMA Biologics, Inc.

Just to add on a bit about the plasma centers. We're very pleased with the exponential growth. It was just a few years ago, back in 2020, when we embarked on a supply chain robustness initiative, where we only had 1 center. Back in 2020, we had 3 centers that were collecting and 1 center that was FDA approved. Fast forward to 2023, we now have 10 centers collecting, with 9 FDA approvals. In the last center, we're hoping to receive FDA approval by the end of the year. So again, we're very pleased with the exponential growth. We'd like to thank our BioCenters employees for the ramp-up and the expansion, as well as our donors who go and donate, because we couldn't do what we do without you.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Absolutely.

Gary Nachman
Managing Director, Senior Research Analyst, Raymond James & Associates, Inc.

Excellent. Thank you for all that detail. That was really helpful.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thanks, Gary.

Operator

Thank you. This will conclude the Q&A portion of the conference. I would now like to turn the conference back to the CEO, Adam Grossman, for closing remarks.

Adam Grossman
President and CEO, ADMA Biologics, Inc.

Thanks, everybody. You know, it's been, it's been a hell of a journey to get here. For those of you who've been here since the beginning, thanks for sticking around. For those of you who are joining us now for the first time, welcome. I really mean it when I say it to all my staff, I'm getting tons of texts here. You all matter. You all make a difference in the lives of all these patients. To all the shareholders, the nice texts and messages that we've received, thank you very much. There's only one time in a company's history that you can say that you're first-time net income positive. So this is the collaborative efforts of many, many people. Thanks for having faith in mine and my father's vision.

It makes me a little bit emotional to think about it, but, look, we're going to keep doing what we say. We're going to keep underpromising and over-delivering, and, donate some plasma, take your vaccines, wash your hands, use Purell, keep the world a safe place, and, thank you for everything that you do. We appreciate your, time and commitment to ADMA Biologics. Have a good evening, everybody.

Operator

This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.

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