ADMA Biologics Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 7, 2024

There are 8 speakers on the call.

Operator

Thank you for standing by. My name is Celine, and I will be your conference operator today. At this time, I would like to welcome everyone to the ADMA Biologics Financial Results Third Quarter 2024.

Operator

All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. Session. Thank you. I would now like to turn the call over to Skyler Bloom.

Operator

Please go

Speaker 1

ahead. Welcome, everyone, and thank you for joining us this afternoon to discuss Avren Biologics' financial results for the Q3 of 2024 and recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer and Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments and provide an update on corporate progress and then Brad will provide an overview of the company's Q3 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions.

Speaker 1

Earlier today, we issued a press release detailing the Q3 2024 financial results and summarize certain achievements and recent corporate updates. The release is available on our website at www.admabiologics.com. Before we begin our formal comments, I'll remind you that we will be making forward looking assertions during today's call that represent the company's intentions, expectations or beliefs concerning future events, which constitute forward looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our SEC filings, 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.

Speaker 1

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 in the Risk Factors section of our quarterly report on Form 10 Q for the quarter ended September 30, 2024 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 these non GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman.

Speaker 1

Adam, go ahead.

Speaker 2

Thank you, Skyler, and welcome everyone to today's call. The Q3 has been another period of exceptional performance for ADMA. Total revenues reached $119,800,000 reflecting an increase of 78% year over year. Adjusted EBITDA rose to $45,400,000 representing a growth rate of 2 56 percent from the previous year, while net income increased by 1300% year over year to $35,900,000 We successfully achieved sequential growth from our 2nd quarter financial baseline, both in revenue and earnings, further solidifying our position as one of the fastest growing and profitable companies in the biotech sector. These achievements are a testament to the dedication and hard work of our teams as well as the real world benefits that immunocompromised patients are experiencing on our therapies.

Speaker 2

We believe the future of asthma has never been brighter and we are exceedingly optimistic about the opportunities that lie ahead. We believe our commitment to financial and operational excellence is reflected in these results. In turn, we are yet again revising our financial guidance upward for both 2024 2025. Based on current market trends, we now expect total revenues to exceed $415,000,000 in 20.24 $465,000,000 in 2025, with adjusted EBITDA projected to surpass $160,000,000 $215,000,000 respectively in 2024 2025. We are also raising GAAP net income guidance for 2024 and 2025 to more than $120,000,000 $165,000,000 respectively.

Speaker 2

As we expect to close out 2024 on a strong note and look forward to next year, we anticipate significant margin expansion driven by an ongoing revenue shift towards Ascentive. We see Ascentive emerging as a potential $1,000,000,000 revenue opportunity with substantial growth headroom and branded durability potentially extending thereafter through the 2030s and beyond. Demand for Ascentiv is strengthening with forward looking metrics broadly supporting sustained growth momentum. In response, we have strategically adjusted our production schedule, providing for greater ascent of production throughput. And as a result, we anticipate an accelerating pace of earnings growth.

Speaker 2

To further bolster our supply availability, we've implemented plasma donor retention programs aimed at increasing high titer plasma collections within our network, which are already showing positive results. Additionally, we are actively partnering with 3rd party plasma collectors to secure even more high tighter plasma. These combined efforts reinforce our confidence in advancing Ascena's rapid growth trajectory. We believe we are well prepared to meet the growing end user demand and deliver increasing units of eSENIV to immunocompromised patients in need. This quarter, we also made significant progress with our yield enhancement production project as well as our strep pneumonia hyperimmune globulin pipeline program, which we refer to as SG-one.

Speaker 2

We are pleased to announce that we successfully completed production of a pilot scale batch of SG001. Additionally, we've identified a prospective laboratory partner and we are engaged in discussions for their services in order to initiate animal model studies. Like with ATHENNEV's preclinical development, we believe the data obtained from animal model studies will provide an understanding of the potential for SG-one and aid in identifying the appropriate development pathway for potential future human clinical evaluations. We remain confident that this program can be developed and brought to market in a highly capital efficient manner. And if approved, SG-one could potentially generate $300,000,000 to $500,000,000 or more in high margin annual revenue.

Speaker 2

Also on the R and D front, I'm pleased to announce that all patients in Acentiv's post marketing pediatric study have now successfully completed their treatment schedule and that the clinical trial database is on track to be locked during the Q4 of 2024. The successful enrollment and execution by our team further illustrates the strength of ADMA's internal R and D engine and speaks to our highly capital efficient and nimble approach to the development of specialty biologics for patients in need. Aetna now anticipates filing its efficacy supplement to Ascentiv's biologic license application over the coming quarters with potential label expanding approval during the first half of twenty twenty six. Ascentiv's pediatric label expansion, if approved, may further strengthen the product's positioning and utilization in the immune compromised patient setting. Our immunoglobulin production yield enhancement initiative is also progressing planned.

Speaker 2

We anticipate regulatory approval and the commencement of commercial sales of immunoglobulin produced from our innovative process during the second half of twenty twenty five, which could lead to a substantial increase in revenue and earnings growth beginning in the second half of twenty twenty five with further acceleration projected into 2026 and beyond. In the Q3, we continued the implementation of Admelytics, our artificial intelligence and machine learning platform across the commercial operations of the business. Since its staggered rollout began in February of 2024, Admelytics has delivered impressive outcomes, including increased production efficiency, enhanced manufacturing visibility, optimized commercial planning, streamlined plasma pooling and reduced variability in FTE hours. We expect further optimization of our commercial growth strategy as Admelytics reaches full deployment, strengthening our rapidly growing earnings projections and aiding with the identification of organizational efficiencies. Our balance sheet continues to strengthen and we are confident in achieving net leverage neutrality during the Q4, driven by increasing organic cash flows and growing adjusted EBITDA.

Speaker 2

This strong financial position should provide us with substantial flexibility moving forward. In terms of capital allocation, we are unwaveringly committed to deploying resources in a way that maximizes stockholder value and lowers ADEMO's cost of capital. Our commercial portfolio of life changing medicines continues to provide significant benefits to patients, addressing unmet medical needs for the immunocompromised. We take immense pride in the impact we make on patients, donors and public health. These accomplishments are a direct result of our team's unwavering dedication and we extend our sincere appreciation for their goal oriented hard work.

Speaker 2

It is this collaborative spirit that sets our workplace apart. Finally, prior to turning the call over to Brad who will speak to this matter in additional detail, I would like to address the recent auditor transition. Although we received notice of Kone Reznik's transition sooner than we anticipated, we are pleased to announce that we have now engaged KPMG as our new independent audit firm. We thank Kone Resnick for the 17 years of being our audit partner, during which we had no disagreements at any point during our working tenure or any manner of accounting principles or practices, financial statements disclosure or auditing scope or procedure. We appreciate Kone Refnig's continued support and commitment to ADMA in ensuring a smooth transition to KPMG.

Speaker 2

With this said, I'd now like to turn the call over to Brad for a review of the Q3 2024 financials.

Speaker 3

Thank you, Adam. We issued a press release earlier today outlining our Q3 2024 financial results. We will also be issuing our Q3 10 Q report 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 financial highlights from the Q3. As Adam mentioned, total revenues were $119,800,000 for the quarter ended September 30, 2024, as compared to $67,300,000 for the quarter ended September 30, 2023, an increase of $52,600,000 or approximately 78%.

Speaker 3

Gross profits were $59,700,000 for the quarter ended September 30, 2024 as compared to $24,700,000 for the quarter ended September 30, 2023, an increase of $35,000,000 As a result, Avnet achieved a corporate gross margin of 50% in the Q3 of 2024 as compared to 37% in the Q3 of 2023. Q3 2024 corporate gross margins were adversely impacted due to an outsized spot sale of low margin normal source plasma. This normal source plasma available for sale is due to our designed shift of production throughput toward Azenis. Adjusting for this impact, corporate gross margins would have been in the mid-50s on a normalized basis for the Q3. During the Q3, adjusted EBITDA was $45,400,000 as compared to adjusted EBITDA of $12,700,000 for the quarter ended September 30, 2023, an increase of $32,600,000 or approximately 256 percent.

Speaker 3

GAAP net income was $35,900,000 for the quarter ended September 30, 2024 compared to a GAAP net income of $2,600,000 for the quarter ended September 30, 2023, an increase of 1300%. As we expect to finish 2024 from a position of strength, we believe we are just beginning to generate financial results that demonstrate the distinct operating leverage that our business can realize if our revenue continues to grow as planned and fixed expenses are tightly managed. Based on the robust $25,000,000 of operating cash flow generated during the Q3 and the significant adjusted EBITDA growth, the company's current net leverage ratio has organically improved to approximately 0.1x annualizing the Q3 results. We anticipate the balance sheet will continue to strengthen over the coming periods, augmented by forecasted free cash flow and growing adjusted EBITDA. Expounding on Adam's earlier comments regarding the auditor transition, we are pleased to have engaged and onboarded a new big four independent auditor, KPMG.

Speaker 3

This transition to a big four accounting firm is an important milestone as our organization matures and if earnings continue to rapidly expand as expected. We look forward to the next chapter with KPMG and we thank them for the timely and efficient completion of their new client onboarding process. With that, I will now turn the call back over to Adam for closing remarks.

Speaker 2

Thank you, Brad. Our commitment to innovation and performance continues to drive substantial growth and value creation, which we believe positions ADMA for both near term and long term success. We expect to finish 2024 on a high note and embark on 2025 from a position of significant strength. In the periods ahead, we anticipate delivering sustained revenue growth and continuing to drive a favorable shift in our revenue mix and production schedule towards incentives. We believe this would result in significant margin expansion and earnings growth.

Speaker 2

We are confident our strong balance sheet allows us to be capable stewards of stockholder capital and maximize equity value while supporting our rapid growth trajectory. Looking beyond 2025, we aim to leverage our innovative commercial model, agile specialty biologics production platform and in house R and D engine to unlock revenue and earnings opportunities that could significantly exceed our current projections. The collective impact of our internal donor retention programs and 3rd party high titer plasma supply initiatives positions us to potentially reach a $1,000,000,000 annual revenue milestone as rapidly as possible with further growth opportunities extending thereafter. We are confident that these strategies will enable us to meet the rapidly growing demand for Ascentives across both short term and peak periods. Thank you all for your continued support and dedication.

Speaker 2

Together, we will continue to build on ADMA's successes. And with that, we'd now like to open up the call for questions. Operator?

Operator

Thank you. We will now open the line for questions. Your first question comes from the line of Kristin Kalska with Cantor Fitzgerald. Please go ahead.

Speaker 4

Hi, everyone. Thanks for taking the questions and congrats again on a great quarter. I'm not sure if I'm familiar with any company raising guidance 5 times in a year. So you may have the record on that one. So I saw in the press release, this might be one of the first times I think you've put it in writing about the potential for this to be $1,000,000,000 revenue opportunity.

Speaker 4

So I was hoping you can maybe give us a little bit more color around some of the work that you've been doing to get more hyperimmune plasma as that's likely going to be the driver to get you to those numbers.

Operator

Hello? Oh,

Speaker 2

sorry. Can you hear us? At the KRN conference, we were talking about the potential opportunity. And we just have a lot of great visibility into what we think is a very compelling operating leverage trajectory. And as we look at the demand indicators, they continue to remain strong.

Speaker 2

So I don't have to reiterate the same thing I've been saying for the last couple of quarters. I mean, the patients are there and we've defined appropriate use, all that stuff still holds true. But we've been implementing a VIP donor program. We've been implementing methods with Admelytics to identify where we can optimize plasma collections and how we can build our pools. And when we just look at all of the factors that are going into this, we're able to accelerate the identification of these donors and collect more plasma.

Speaker 2

The real hampering to a ceniv's growth is really around the raw material supply. We've got production capacity. We've got the ability to switch from BIVVIGAN to a ceniv again. The plant doesn't care what we make. It's the same process for ASCENIB and BIVVIGAN.

Speaker 2

We've invested in some additional testing machines and equipment, even more were delivered in the last couple of weeks that have been validated and turned on. And we're working with our 3rd party collectors and we're currently negotiating with them on ways to potentially add some more centers and we'll provide updates to that in the future. But as we look at this right now, we believe that we're going to identify high titer RSP plasma donors faster. We believe that we're implementing strategies to retain these donors for longer periods of time, maximize the number of collections that we can get out of these donors. As I'm sure you recall, I've said it a bunch of times, plasma donors can donate twice a week up to 8 times per month.

Speaker 2

And we are implementing strategies to attract these donors and retain them for longer. So when you put all of this together, we believe that the demand is there. And if we find the plasma, we're going to make more incentive. And you heard in the prepared remarks that I said that we've strategically shifted more production from BIVVIGAN to incentive all throughout this year and we're going to continue to do that. So as we look forward, I don't know when it's going to happen, Kristen, but I know that we're all working very, very rapidly here.

Speaker 2

Is it 25? No. Is it 26? No. Could it be 27, 28, 29?

Speaker 2

Sure. We really are very optimistic about the forward looking outlook. And I think when you couple this with yield enhancements, which also in the prepared remarks, we put some brackets around timelines here. Certainly in the back half of twenty twenty five, we expect to see accelerating revenue and certainly margin accretion. But it's going to expand rapidly in 2026.

Speaker 2

When you really look at what the opportunity that we have with the ability to gain 20% more finished goods from the same starting material, 100% of what we're going to sell in 2026 will be made from what we believe will be the then approved yield enhanced process. You're going to see margins expand substantially 2026 forward. So we will give additional guidance like we always do in the beginning of the year around the JPMorgan conference. But working to identify donors faster, retain these donors, keep them engaged at our plasma centers and incentivize our 3rd party collectors, you put all those things together and we're really encouraged by the durability of what we're building here and we think it's truly unique.

Speaker 5

And just to add to Adam's point. We're going to accelerate towards that $1,000,000,000 threshold as soon as possible to Adam's earlier comments. But the key point is, it's not over there. There's growth headroom thereafter and we're going to continue to chase it.

Speaker 4

Thank you for that. Can you give a little bit more specific metrics behind this VIP donor program? Is this implemented in all kind of your collection facilities? And just in general, can you speak to what you're seeing once you initiated that in terms of footprint traffic? Is it the same donors coming in one more time a month?

Speaker 4

Like what can you give us in terms of that? And recognize it's still early days for this program?

Speaker 2

It's a program that we've kicked off earlier this year. I believe at this stage it is in all of our centers, all of our 10 centers. I mean, it's a pretty simple formula, Kristen, but I'm not going to give all the details so my competitors know. But I can tell you that we treat our donors well. We've always believed that the donors are the it's a pun, but the lifeblood of our ability to impact and improve the lives of patients in need.

Speaker 2

We build nice centers. We keep clean centers. We are working on donor retention strategies and programs that certainly include compensation. But we are seeing donors donating more frequently. We are seeing donors donating longer.

Speaker 2

And I think that from the data that I've seen and we have one of our RSV Plaza meetings today, the trend is we are collecting more plasma than we ever have before, not only from our internal centers, but also from our 3rd party collector. So you're going to see look, maybe I'll just touch on this. We had a one off in the quarter where we sold some normal source plasma. We don't really want to be in a very, very low margin, negative margin source plasma selling business anymore. But what we're doing is we're looking at our inventory.

Speaker 2

We're taking a very, very hard look at all of this. And we only want to keep inventory and plasma that we can use to make the products that we want to make and that's mainly offensive. So these are all things that I think that investors and our analysts can look at to understand that. We're positioning this business appropriately to Brad's point not only to do $1,000,000,000 but we do believe that there is room. And like I've said before that if we could fill the whole plant, which again I'm not guiding to, I don't know if it can happen, but we certainly want to try.

Speaker 2

But if we were to build the entire plant all 500000, 600000 liters a year that we can process, you could be generating somewhere in the range of $2,000,000,000 annually. So we're going to keep pushing hard. We're going to keep treating our donors timely. We're going to keep paying them to come back. We're going to keep explaining to them why the plasma that's inside them is

Speaker 4

Thank you for your support, Kristen. Thank you, Kristen.

Speaker 2

Thank you for your support, Kristen. Thank you, Kristen.

Operator

And your next question comes from the line of Anthony Petrone with Mizuho Group. Please go ahead.

Speaker 6

Thanks and congratulations. Doing very well, Adam. Thanks again and congratulations on another strong quarter here. Maybe I'll stick on the supply end of the equation, just a couple of high level ones. When you think of just churn, is churn a big issue?

Speaker 6

Adam, are you actually losing any of these donors? It sounds like retention is actually quite high, so just a little bit on the churn. And then when you think of just how you're managing that inventory, are you fully at a level where you have enough safety stock that you're able to sort of supply these longer term contracts, so that would be the first high level one? And then I'll have a follow-up. Thanks.

Speaker 2

So we're always losing donors, Anthony. Unfortunately, naturally occurring antibody doesn't stay around forever. Some donors it does, but the majority of donors stay on the program for a period of time, as I've always said, and then they fall off. We're constantly testing these donors. We're constantly adding new donors.

Speaker 2

Donors move, they have lives just like everybody else, but we're absolutely everything that we possibly can to ensure that the donors who we do identify that have high titers to RSV antibodies come back as frequently as possible. I'd be lying to you Anthony, if I said to you, yes, sure, we've got all the safety stock we need from a plasma supply standpoint, because we don't. If we did, then I'd be making much more incentive and I think you'd see revenues growing even faster. But we've got plenty of work in process material. We've got plenty of plasma in inventory to continue to producing a drug to continue to drive that revenue mix shift towards Ascentive, which we're seeing every single quarter, every single period for the last couple of quarters here.

Speaker 2

Ascentive is the majority of our revenue. It continues to grow and we're doing everything we can Anthony to build that safety stock. I think if some of our negotiations proved successful and if some of our activities with some of our 3rd party suppliers proved to be successful, hopefully we'll have something to announce around JP Morgan. But our goal is to find as many centers around the country who are willing to sell us plasma and collect that plasma. So we'll keep you posted there.

Speaker 2

But we certainly feel very, very optimistic. Or also our attorneys wouldn't let me say some of the things that I've said today.

Speaker 6

Fair enough. And then maybe

Speaker 7

just Go ahead, Brian.

Speaker 5

Hey, just real quick. Just going back to the spot sale. I mean, you know, Adam, you know, Adma, we're opportunistic. If we need to do a spot buy, we will do a spot buy. If we need to do a spot sale, we're going to do a spot sale.

Speaker 5

And of course, we do that to align our plasma inventory with our production needs. And in this case, we made a spot sale, as we continue our designated or designed shift of production to a center. And we will continue to be opportunistic when it comes to plasma, whether it's doing spot sales or spot buys.

Speaker 6

Very helpful. And then a quick follow-up, just again high level, more of a macro question there. Obviously, big events this week. There's a change in administration coming, change at the Senate level. There'll be new personnel at FDA here.

Speaker 6

So maybe just your thoughts on how administration influences FDA and what that potentially means just for the plasma space in general and atma specifically? Thanks again.

Speaker 2

Thank you, Anthony. I mean, it's that's quite a question. If you could see the smile on my face here. I mean, I don't know how to answer that because I really don't really have visibility yet into who's going to be where and I know that there's a lot of conjecture out there. But what I think I can speak to are the facts and the facts are that since Obama, Trump, Biden now going back to Trump, there's been bipartisan agreement across the board that plasma derived therapies have been excluded from price negotiations.

Speaker 2

They recovered under Obamacare. I anticipate that with another Trump administration, I wouldn't anticipate that there would be a lot of changes there. What I can speak to is, I think you know this for those who don't, I am the current Chairman of the Plasma Protein Therapeutics Association North American Board. The Plasma Protein Therapeutics Association is the industry association that advocates for access and availability of plasma derived therapies for all patients that receive these therapies as well as for industry. And the association working with representatives from all the member companies, we formed a plasma caucus.

Speaker 2

So I believe, I think I'm right, there are about 38 sitting Congress people who are on the plasma caucus. I think Capitol Hill is pretty well versed in the scarcity of plasma that you can only use plasma collected from U. S. Citizens in the United States in order to make these products for the U. S.

Speaker 2

Population. And I really feel that we all of us in the plasma derivatives industry are in a good position here with the change of administration. Specifically regarding ADMA, I mean, something that I've been championing about our company for a long, long time. And I was shouting it from the rooftops a little bit during the last Trump administration is, we are the last of the Mohegans. We are the last 100 percent U.

Speaker 2

S. Domicile plasma derived therapeutics producing company. 100% of our manufacturing supply chain is in the United States. So we make our drug here in Boca Raton, Florida. We fill a Senv and Bibigam here in Boca Raton.

Speaker 2

We also have a 3rd party fill finished facility in Virginia. All of our finished goods distribution is out of Tennessee, I believe. We only sell our products in the United States. So we feel really good about some of the noise out there, but I think it would be premature, Anthony, to really comment specifically. But I can tell you that if there is legislation passed that, hey, if you make your goods in the good old U.

Speaker 2

S. Of A, we would meet that criteria. So it's been a mission of ours. It was one of our founding principles. I always felt it very, very important that the United States also control some of their manufacturing capabilities and that the U.

Speaker 2

S. Company has some of this control. And here we are. We're making good products. We're putting more product into the market every single quarter and we feel real good about it.

Speaker 2

But I don't think the change in administration will provide any negative impacts whatsoever to ADMA or other plasma derived drugs on the market. I know that you cover some other companies there. But from a business perspective, we feel very good about the opportunities that lie ahead.

Speaker 6

Very good. Thank you so much. Congrats on that again.

Speaker 2

Thank you.

Speaker 3

Thanks, Anthony.

Operator

And your next question comes from the line of Gary Nachman with Raymond James. Please go ahead.

Speaker 7

Good afternoon, guys. My congrats as well on the strong quarter. So just back to the incentive supply availability, obviously the topic du jour. Adam, do you think you need any more plasma donor facilities of your own to have more plasma supply? Can those 10 facilities and then the 3rd parties get you to the $1,000,000,000 target?

Speaker 7

And is there any risk to you sharing the methods of screening for high RSV titers with 3rd parties?

Speaker 2

Great questions. Thank you, Anthony. To your part of that question, do we need more centers? No. Do we want more centers?

Speaker 2

No. 10 centers gives us a great base for which we can collect and have control over some of our internal collection for the high titer plasma. As I've said to you in the past, in our private conversations and also as I say publicly, we certainly care very much about what we do and our staff is certainly trained to maximize the number of collections that we're getting from any specific donor that we identify as being high titer. Our 10 centers collect more on average than any of our 3rd party collectors. And I really think that's because they're arcs and we control who's donating in the chair and we control what we compensate those donors with.

Speaker 2

So our 10 centers from my perspective collect more than say one of our 3rd party centers can collect and we're going to continue to do that. So no, we're not investing in any more centers. We're not going to build centers at this time. We're not buying any additional centers. 10 is enough and that's where it's going to stay.

Speaker 2

With respect to the methods of screening, I think that's a great question and I want to make sure that you and others understand this. We don't give away our secret sauce to anybody. First of all, it's patented. 2nd of all, all the testing, all the science is done by ADMA. So what one of our third party collectors will do is we get a sample tube, of every new donor that walks into their center in any given week.

Speaker 2

So typically new centers have between 20, 50, 100 donors depending upon the size of the center per week, some centers have more. So right now we're collecting from, I want to say about 70, 80 centers, maybe a few more. But we're getting, call it, 100 to 1000 of samples every week that we do testing on in either our laboratory here in Boca Raton or we have a laboratory who we partnered with for many, many years that does screening and tighter testing for us as well. So all the science is controlled by us. All the 3rd party collector will know is that we say we want donor number 14,603.

Speaker 2

We want donor 14,609. That's all they know. They don't know what the donors' titers are. They don't know whether their titers are super high or in the middle range or in the lower high range. All they know is that we're going to pay them more money for that liter of plasma that they collect from that donor.

Speaker 2

So all of the scientists kept in house. Again, all of our testing methodologies are patent protected as well as we have certain know how and other trade secrets that we employ around the testing and the screening. But our 3rd party collectors love us because essentially they're collecting the same thing that they're always collecting, which is just regular plasma, but we're going to pay them more money for it. So the only thing that one of our 3rd party collectors does differently is they collect an extra sample tube and they send us I think it's 5 ml of plasma per donor and we test it in our screening assay.

Speaker 7

All right, great. Now that color is very helpful and comforting. So I mean you had a really strong quarter, but I'm curious, why didn't you take full year guidance up more than you did, just when you look at what 4Q might be? Could it be a sequentially down quarter, in the 4th quarter and what might cause that? And I also want to confirm that the yield enhancement benefit in the second half of next year is not in the current 2025 guidance?

Speaker 2

So let me take the second part of your question first. The yield enhancement benefit is not yet contemplated in our guidance number. Again, we don't have FDA approval yet and we do take a conservative approach to guidance. We're going to continue to take the same conservative approach that we've employed since the beginning. And maybe I'll just start off and Brad certainly add some more color.

Speaker 2

But yes, Gary, we're talking already about that there was a one time opportunistic plasma sale in the quarter. I think it was what $6,000,000 $7,000,000 So we're not going to have that next quarter. We are seeing growth of Ascendant. We are seeing growth of BIVVIGAN. But again, being conservative, we are not going to have $6,000,000 worth of revenue generation from plasma sales in the quarter.

Speaker 2

Additionally, and maybe I'll make mention of this here, we've also voluntarily stopped producing 1 ml NaVI HV from the market. We only now produce the 5 ml product. The margins were not great on the 1 ml and candidly with the PDUFA fees where they were just didn't make sense. So we're not going to be selling any 1 ML Navi in the Q4. We do hope that we pick up that business as 5 ML revenue, but that's yet to be determined.

Speaker 2

But it would be a down corner on the top line, but I think that when you look at guidance, we've increased EBITDA and net income guidance for the quarter because we do believe that the revenue mix is going to continue to shift towards Ascentive and higher margin products. So we feel very good about where we are ending the year. We feel really good about where next year is going to be. And again, to your question about yield enhancement, 2026 is going to be gangbusters. I mean, we're just so excited about what the future holds for us there.

Speaker 2

But Brad, if you want. Yes.

Speaker 5

Gary, we're focusing on BIVVIGAM and the Ascentiv mix shift. We're focusing on yield enhancement. We're focusing on our high margin products. And when you think about it, ADMA's next chapter will be defined by margin expansion and earnings growth. We are going to continue to leverage our operating structure.

Speaker 5

We're going to continue to drive top line. We're going to continue to focus on high margin products and make those margins even better with yield enhancement. And again, by doing that, by leveraging our operating structure, we're going to continue to drive margin expansion. We're going to continue to drive net income. We're going to continue to drive EBITDA.

Speaker 5

And that's our plan.

Speaker 2

Margin expansion and earnings growth. I'm going to get a T shirt.

Speaker 7

Okay. That's the mantra. Okay, awesome. Just a couple more quick ones. Just on the S.

Speaker 7

Pneumonia program, when could we see some animal data on it now that you it looks like you've identified a lab to do that study? And then congrats on getting KPMG. You've contracted with them for 2024, the year end audit. Just when do you think you'll finalize 2025 with them? We've been getting some questions on that.

Speaker 7

Thank you.

Speaker 2

Wait. So, okay. SG-one, I wrote down. Your last part of the question about KPMG is when will we finalize engaging them for 2025?

Speaker 7

Yes, correct. People obviously are excited to see that you engage them for this year just when we get

Speaker 2

here Yes, we're asking for the question. Okay. I just wanted to make sure it was the same crazy question that I'm getting from investors as well. Okay. So let's start with SG-one.

Speaker 2

So we successfully produced a pilot scale batch product. So excited our scientific team here, our scientific technical ops team, with doing everything that they're doing for yield enhancement, Caitlin and I said, hey, let's push them even harder and we're very excited to be here. We're evaluating labs. We're currently writing and drafting testing protocols. I don't really have a timeline, but I want everything done immediately.

Speaker 2

I would hope in the Q3 of next year. I'm probably going to get yelled at when I walk out of this conference room, but my hope is sometime in the back half of next year or early back half we should have some data. But please don't hold me to it. And if it comes earlier, great. But I want to answer your question.

Speaker 2

I want to be straight with you. We're very excited about this opportunity. But obviously, the priority for us is yield enhancement. The priority for us is expanding our production capabilities here to ramp up to be in a position that as soon as rapidly possible, we can be producing from the yield enhanced process next year. And the goal is to sell as much yield enhanced product as we can in the second half of twenty twenty four excuse me second half of twenty twenty five And certainly all of 2026 will be from yield enhanced produced drug.

Speaker 2

With respect to KPMG, I mean, there are new auditor. And it's so funny to me when people ask these questions. But no one ever asked me, well, is Cohn Resnick going to continue to be your auditor after they finish your year end audit here. They are our new audit firm. They are new independent registered accounting firm that we are going to be working with from now for the foreseeable future.

Speaker 2

So they're currently actively working with Brad and his team. We are going to continue to work with them and we believe that we're going to be filing our 202410 on or before the filing deadline, which I believe is March 3, 2025. We're working rapidly to meet or exceed that deadline. But I don't think there's any reason why anyone should doubt that KPMG is not going to be our auditor for 2025 and 2026 and 2027, 2028 all the way into the future. We spent 17 years with Cohen Resnick.

Speaker 2

I tell the partners at KPMG, I don't know if I'm working another 17 years, because I'm not as young as I used to be, but if I am, we're very loyal here. I don't know, Brad, if you want to add anything to that? No, I completely agree. Completely agree.

Speaker 7

Okay, fair enough. And thank you for clarifying that. Congrats again.

Speaker 2

No problem. No, thank you. Look, we're very proud of transitioning to a big four audit firm. And I think it just really represents the growth of the business and the maturation of our processes and our operations. So we're excited to be working with them.

Speaker 5

Absolutely. I mean, it's an important milestone in our organization and we don't expect any go forward impact on the numbers and or the filing timelines as Adam had said and we are happy to have engaged KPMG and have their service.

Speaker 7

Great. Thank you.

Operator

That concludes our question and answer session. I will now turn the conference back over to Adam Grossman for closing remarks.

Speaker 2

Thank you very much everybody. We really appreciate your continued support and partnership. We thank our donors. We certainly thank our staff. And we're here to make good products that help people.

Speaker 2

To our stockholders, we appreciate you putting up with some of the pain last quarter, but it's behind us now. And I think the forward looking outlook is nothing but right for us. So thank you very much. Donate plasma, help save lives and stay healthy and safe and have a happy Thanksgiving.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. Please wait. The conference will begin shortly.

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Earnings Conference Call
ADMA Biologics Q3 2024
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