ADMA - NASDAQ

Good afternoon and welcome to the ADMA Biologics Fourth Quarter and Full Year 2024 Financial Results and Business Update Conference Call on Monday, March 3rd, 2025. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately two 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 fourth quarter and full year 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 fourth quarter and full year 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the fourth quarter and full year 2024 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 SEC filings, which may cause actual results to differ materially from the results expressed or implied by any 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 in the Risk Factors section of our previously issued SEC filings and our Annual Report on Form 10-K for the year ended December 31st, 2024 once filed on or before March 18th, 2025, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. Please note that the discussion on today's call includes certain non-GAAP financial measures, including adjusted EBITDA and adjusted net income. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that said, I would now like to turn the call over to Adam Grossman. Adam, go ahead.

Thank you, Skyler, and welcome everyone to today's call. 2024 was a year of exceptional performance for ADMA, marked by significant financial growth and operational achievements. Total revenues reached $426.5 million reflecting an increase of 65% year-over-year. Adjusted EBITDA grew to $164.6 million representing a growth rate of 309% from the previous year. These results are a testament to the real-world benefits our biologic therapies continue to deliver to immune compromised patients throughout the United States as well as the dedication and expertise of our leadership team and exceptional staff. Our commitment to financial and operational excellence continues to drive strong performance, allowing us to once again revise our financial guidance upwards. We now expect total revenue to exceed $490 million in 2025 and $605 million in 2026, with adjusted EBITDA projected to surpass $225 million and $305 million respectively in 2025 and 2026. Adjusted net income guidance for 2025 and 2026 is now raised to more than $175 million and $235 million respectively. We anticipate continued margin expansion as our revenue mix shift towards ASCENIV's, which we believe represents a potential $1 billion or more opportunity with lasting growth and brand durability through at least 2035 and likely beyond. In anticipation of a potential mid-year regulatory approval for our enhanced yield production process, we increased medical education and marketing efforts at key scientific conferences in the fourth quarter, while preparing for an increase in high-titer plasma supply, work-in-process and finished ASCENIV inventories. Throughout commercialization, we have strategically managed new patient start to ensure continuity of patient care and maintain an uninterrupted drug supply. And we have accordingly taken a conservative and thoughtful approach to onboarding new ASCENIV patients. ASCENIV's forward-looking demand metrics are making new all-time highs into 2025, which has resulted in a queue of identified new patients waiting to initiate ASCENIV treatment. Having currently penetrated what we believe is just over 3% of ASCENIV's targeted, complex and refractive PI market, we have strong visibility into scaling new patient starts in the coming periods and we believe we can address the significant unmet needs within this PI patient population. We believe our recently executed third-party high-titer plasma supply contracts mark a transformative milestone, paving the way for what should be long-term top tier growth for ADMA. These long-term agreements allow the company to source high-titer plasma from approximately 250 US-based third-party plasma collection centers, representing approximately a fivefold increase in total collection capacity. While we continue to ramp up these third-party high-titer procurement contracts at a rapid pace, we've also grown internal high-titer collections to record levels. These third-party supply contracts combined with the robust internal plasma collection trends are expected to sustain ASCENIV's revenue growth and position us to potentially exceed $1 billion in total annual revenue prior to 2030 with anticipated growth headroom thereafter. We deeply appreciate the commitment of our plasma supply partners to our company and to the immunodeficient patients we all collectively serve. We believe the anticipated approval of our enhanced yield production process represents a transformative opportunity for the company. This innovative process has demonstrated an ability to increase production output by approximately 20% from the same starting plasma volume, potentially driving meaningful increases to financial guidance if approved. Our scientific, technical operations and regulatory teams have been instrumental in advancing this novel process and our ongoing regulatory dialogue reinforces the confidence in timely potential approval by mid-year 2025. Upon approval, we are well prepared to swiftly implement the new process enhancements, which would drive commercial sales and financial upside beginning potentially in the second half of 2025. Consistent with our conservative guidance approach, any revenue generated from immunoglobulin produced using this enhanced production process would represent potential upside to our current 2025 and 2026 financial projections. We believe the anticipated increase in available high-titer plasma supply will enable us to meet ASCENIV's growing demand in the coming quarters, accelerate revenue and earnings growth and further build on ASCENIV's still developing growth curve. ASCENIV's robust intellectual property estate covering proprietary screening assays, plasma pooling formulas, methods of immunoglobulin use, secures brand protection through at least 2035 with potential extensions extending beyond. Regulatory barriers and proprietary know-how further safeguard our franchise. Our comprehensive IP portfolio encompassing immunoglobulin treatment for all virally induced respiratory infections supports our expectations that ASCENIV alone could surpass $1 billion in total annual revenue. With strong intellectual property and regulatory protections ensuring a long runway of profitable growth, we are building what we believe will be among the most durable earning streams in the biotech and pharmaceutical sector. We continue to advance our lead R&D pipeline program SG-001 targeting strep pneumonia, representing an additional upside lever to currently provided $1 billion total annual revenue guidance expected to be realized prior to 2030. If approved SG-001 could contribute $300 million to $500 million or more in high margin annual revenue. Issued IP protecting SG-001 ensures branded protection through at least 2037 with the potential for extensions. We are confident in our ability to advance this program through development and potential regulatory approval in a highly capital efficient manner. We believe the strength of our balance sheet and our increasing net cash position provide a solid foundation to execute from a position of strength with the flexibility to act opportunistically should market conditions shift. At year-end 2024, total cash holdings exceeded $103 million representing a net cash surplus relative to the $75 million of total debt currently outstanding with Ares Capital. This strong financial position should enable us to continue executing our strategic initiatives, while maintaining disciplined capital allocation. With our fully US domiciled operations and supply chain, coupled with our growing portfolio of life changing medicines, which continue to address clinical unmet needs for the immune compromised, we believe that we're well positioned to continue to execute on our business plan in the current political and economic backdrop. We take great pride in the impact our work has on patients, plasma donors and public health. The achievements outlined here are a direct result of our team's dedication and commitment to excellence. We extend our sincere appreciation to our employees for their hard work and determination, qualities that define our company and we believe set us apart in the industry. Finally, prior to turning the call over to Brad, who will speak to the matter in additional detail, I'd like to address the ongoing KPMG audit process. The successful consolidation of reporting ADMA's financial results is an important milestone for the company as ADMA's financial profile continues to rapidly grow and improve. Management and our audit committee have met with KPMG prior to releasing the financial results today and we feel confident that our reported financials are accurate and we do not anticipate any changes to these financials once the 10-K is filed on or before March 18th, 2025. As previously disclosed, KPMG was engaged by ADMA as the company's new independent registered public accounting firm in the fourth quarter of 2024. The company graduating to a big four independent accounting firm and releasing our reported financials today should instill confidence in the accuracy and quality of our financial statements for our stockholders. With that said, I'd now like to turn the call over to Brad for a review of the fourth quarter and full year 2024 financials.

Thank you, Adam. We issued a press release earlier today outlining our fourth quarter and full year 2024 financial results. And as Adam mentioned, we expect to be filing our full year 10-K on or before March 18th, 2025, which we would encourage you to read when filed. I'll now discuss some of the key financial highlights from our fourth quarter and full year. Total revenue was $117.5 million for the quarter ended December 31, 2024, as compared to $73.9 million for the quarter ended December 31, 2023, an increase of $43.6 million or 59%. Total revenue for the year ended December 31, 2024, was $426.5 million as compared to $258.2 million for the year ended December 31, 2023, an increase of $168.2 million or 65%. This increase is primarily related to increased sales of ASCENIV as we continue to experience increased acceptance and utilization by physicians, payers and patients for this product. Gross profit was $219.6 million for the year ended December 31, 2024, as compared to $88.9 million for the prior year, which represents a gross margin for fiscal year 2024 of 51.5% as compared to 34.4% for fiscal year 2023. The improvement in gross margin is primarily driven by a significantly more favorable mix of higher margin IG sales in 2024 as compared to 2023. Along with operating efficiencies achieved resulting in a reduction in manufacturing costs, adjusted EBITDA was $48.3 million for the quarter ended December 31, 2024, as compared to adjusted EBITDA of $18.6 million for the quarter ended December 31, 2023. Adjusted EBITDA for the quarter includes all non-GAAP reconciliation items, including stock-based compensation, depreciation, amortization, interest expense and loss on debt extinguishment. Adjusted EBITDA was $164.6 million for the year ended December 31, 2024, as compared to $40.2 million for the year ended December 31, 2023, an improvement of $124.4 million. The increase was primarily due to the substantial increase in operating income. GAAP net income was $111.9 million for the quarter ended December 31, 2024, compared to a net loss of $17.6 million for the quarter ended December 31, 2023. The increase was primarily due to higher operating income, lower interest expense, a reduced loss on the extinguishment of debt and an income tax benefit. GAAP net income was $197.7 million for the year ended December 31, 2024, as compared to a net loss of $28.2 million for the year ended December 31, 2023, an increase of $225.9 million. The increase was primarily due to an increase in operating income, lower interest expense, a reduced loss on the extinguishment of debt and an income tax benefit as compared to fiscal year 2023. Adjusted net income was $33.4 million for the quarter ended December 31, 2024, as compared to an adjusted net income of $8.5 million for the quarter ended December 31, 2023. Adjusted net income was $119.2 million for the year ended December 31, 2024, as compared to adjusted net income of $0.7 million for the year ended December 31, 2023, an increase of $118.5 million. As Adam mentioned, we opportunistically and strategically increased medical education and promotion activities during the fourth quarter in advance of anticipated increases in high-titer plasma supply. Accordingly, we would expect the normalized OpEx run rate to be lower than spend reported in the fourth quarter. 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 $48 million of operating cash flow generated during the fourth quarter and significant adjusted EBITDA growth, the company has currently reached a net cash surplus position relative to the $75 million in total debt outstanding with Ares Capital. Over the course of 2025 and beyond, we anticipate significant growth in our cash balance, which lends optionality to continue to reduce ADMA's weighted average cost of capital and advance all growth initiatives from a position of strength. Expounding on Adam's earlier comments regarding the auditor transition, we are pleased to have engaged and onboarded a new big four independent audit firm, KPMG. Given the relatively accelerated window for the audit process following KPMG's onboarding in the fourth quarter of 2024, the delay in the filing of the Form 10-K is due to a combination of factors relating to the company's need for additional time to test and document the company's controls associated with its use of and reliance upon certain third-party service providers and to complete its assessment of the effectiveness of internal controls over financial reporting as of December 31, 2024. As a result of the foregoing, KPMG has not yet completed its audit procedures. We look forward to our next chapter with KPMG and we thank the KPMG audit team for their efforts to date and for their dedication to their review of our financials, which we reported today. With that, I will now turn the call back over to Adam for closing remarks.

Thank you, Brad. Our unwavering commitment to patient care, innovation and operational excellence should continue to drive meaningful growth and long-term value creation. Positioned for anticipated both near and long-term success, we are focused on sustaining revenue growth, expanding margins and accelerating earnings throughout 2025 and beyond. We believe our strong balance sheet, growing net cash position and robust intellectual property estate provide the financial strength and flexibility to support this trajectory, while ensuring reliable access to our lifesaving biologic therapies. Looking at the current political and corporate borrowing backdrop and ADMA's net cash surplus compared to our gross debt, coupled with our top tier revenue and earnings growth outlook, we believe the company is reasonably insulated and well-positioned to continue to outperform and execute on its robust strategies focused on delivering innovative and lifesaving therapies for patients, ultimately delivering stockholder value. We believe we have established a durable and diversified raw material plasma supply, anchored by long-term agreements and record internal collections. This critical plasma supply footprint underpins our commercial expansion and strengthens our growth outlook. The potential mid-year regulatory approval of our enhanced yield IG manufacturing process could further amplify efficiencies and deliver additional increases to our currently reported financial guidance. Increased availability of high-titer plasma should position us to broaden patient access, accelerate the pace of new patient starts among the growing prospective ASCENIV patient queue, deepen market penetration as well as advance our capital efficient R&D pipeline with the utmost confidence. Looking ahead, we aim to leverage our innovative US-based business model, agile production platform and in-house R&D to unlock new growth opportunities and maximize long-term stockholder value. Our strategic focus on donor retention, third-party plasma procurement partnerships and scalable production capabilities support our expected path toward a $1 billion plus revenue milestone as rapidly as possible, positioning us to meet growing demand while creating lasting value for patients, providers and stockholders. Thank you all for your continued support and dedication. Together, we will continue to build on ADMA's success. Operator, we'd now like to open up the call for questions.

Thank you. Today's question-and-answer session will be conducted electronically. [Operator Instructions] And your first question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please go ahead.

Hi, Kristen.

Hi. Good afternoon, everybody. Hey, Adam. So thanks for taking the questions. I have a few. I guess first of the third-party supply contracts you have, can you give us a sense of how many are currently up and running today and the cadence we should expect in 2025?

So we are advancing very rapidly, Kristen. We are certainly more than 50% of the way there. We're beating internal estimates. Our testing throughput is increasing rapidly. We've really done a great job. My scientific and technical ops team is burning the midnight oil. We've onboarded some more staff, running more shifts to turnaround testing faster. The more testing we can handle, the faster we can onboard these collection centers. So as to the number, I don't have the exact number handy, but it's certainly well more than 50% of the centers that we were looking to add. It's conservative in our guidance estimates. We are -- I saw some data today. We are collecting more plasma at this stage of the year. It's actually quite remarkable what the team and our third-party suppliers have been able to do. So if these trends hold, I think that there could be upsides to guidance certainly for 2026. With more plasma, we can make more drug and we believe that the demand trends are continuing into the first quarter of this year and we're really seeing great uptake in ASCENIV utilization so far.

Thank you. Appreciate that. And then maybe just help us to understand. I know in the press release, you've made a comment you expect new patients to start on ASCENIV in line with this. So can you characterize, is there a waiting list of patients that we know are qualified for the treatment just waiting because I know in the past, all the supply on hand was essentially making sure the patients on drug would continue to receive it. So how might that change now that you have more supply potentially?

So the queue is growing. I mean plain and simple. I said it, Brad said it in the prepared remarks. The queue of prospective patients is growing. And we are onboarding more of these patients than we were previously and you're going to see that start to accelerate over the coming months. As we're collecting more plasma putting more pools into the tanks for ASCENIV, you're going to see us rapidly increasing this. The demand KPIs are growing at accelerated rates. We feel really, really good about this. I mean, look, we make a good drug that help people and it's continuing to help people. Payer coverage still is robust. And everything looks positive, Kristen. We feel really, really good about new patients being identified, new patient starts and the ability to ensure the continuity of supply for the duration of their treatment.

Thanks. And last question from me, if I may. Just do you have a sense of when a new doctor to treats a patient with ASCENIV, how many more on average under their care, do they end up recommending the therapy to once they see the benefits firsthand themselves? Thanks again.

So great question. And again, it's practice dependent, but the majority of the docs who -- our sales force and our medical affairs team calls upon, roughly about 10% of their patient population has the criteria and the comorbidities and other risk factors that could trend that ASCENIV could provide benefits to them. We feel that many docs now who have experience with one or two patients are queuing up patients three, four, five plus. Depth and breadth is going to continue to grow at the same institutions at the same clinics. And we really do believe that there's a lot of white space in front of us. I mean we see the demand out there. We still have the engagement at the scientific and medical conferences. This is coming from a data-driven place. The data is being analyzed through our ADMAlytic system and we feel really, really good about forward-looking opportunities here. I mean we wouldn't be increasing guidance if we didn't think we could collect the plasma or have the patients in queue waiting for therapy. So everything looks good. If demand trends continue, I think that you could expect the same cadence from us. And we're taking the same conservative approach to guidance as we always have and we feel really, really good about our positioning to exceed the numbers that we're putting in front of stockholders today.

Thanks and congrats on a great year.

Thank you, Kristen, very much. We appreciate your support.

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

How are you, Anthony?

Doing well, Adam. Thank you very much. Good afternoon, everyone, on the call, and I echo that. Congratulations on a great 2024. Maybe, Adam, I'll start with the long-term guidance, what's in there and what's not in there. My understanding is the $605 million for '26, $495 million plus this year and the $1 billion target is at least somewhat inclusive of the extended supply agreements, but does not include yield enhancement. So maybe I'll start there and I'll have a couple of follow-ups.

That is certainly fair, Anthony. We're conservative on the third-party supply. As I mentioned earlier, we are seeing accelerated collections at the present time. This may ebb and flow, there may be some seasonality, but at the end of the day, the numbers for '25 certainly do exclude yield enhancement. If at all, we've said back half of the year, we could see some accretion assuming a midyear approval, there are some levers to pull where that could potentially be earlier. 2026 yield enhancement is heavily risk-adjusted. So we do think that for 2026, if you factor in yield enhancement with the collection volume at its current pace, there could be some significant upside.

Yes. That would be my -- the follow-up there on yield enhancement. Maybe just explore that opportunity a little bit. My understanding is the effort here is in and around three quarters of a gram per liter. Is that number right? And when you run that math on current BIVIGAM and ASCENIV pricing on an annualized basis, not saying this is what the upside is, but the math sort of points to something in the $100 million to $300 million range, depending on what that mix between ASCENIV and BIVIGAM is. So is three quarters of a gram the right way to think about it? And if that is the case, how do you think that new yield coming out will be split between ASCENIV and BIVIGAM and NABI?

Well, the first thing I'll say is it's excluded from NABI, NABI's process isn't changing. We're not utilizing yield enhancement for NABI. It is a 20% effective incremental bulk product yield. So on the back of envelope, I know you're using a number of about 3.8 is how I'm backing into your math. So in theory, yes, it's close. That would be a fair estimate from a bulk drug increase. Again, no incremental FTEs required. The infrastructure is in place. We spent a large portion of our shutdown time period over the Christmas holidays, New Year's holidays upgrading the facility. And we feel in a great position for regulatory approval midyear and the ability to hit the switch on day one when we're ready to produce these yield-enhanced batches. The FDA dialogue has been constructive. We feel good about timing for approval. But again for your question concerning guidance for this year, it's certainly conservative. You asked about mix. I mean, look, BIVIGAM continues to be the majority of the planned throughput. But as we collect more high-titer plasma, we are seeing additional ASCENIV batches being added to the production schedule all the time. I know I probably sound like a broken record when I'm saying that, but that's how it's working right now. When we get enough plasma that meets a pool, we're putting another batch of ASCENIV into the tank. So we're borrowing from BIVIGAM slots to make more ASCENIV as we collect more plasma. But the mix is continuing to shift from a production throughput standpoint. Certainly, the top line mix ASCENIV continues to outpace BIVIGAM dramatically.

Excellent. And I'll hop back into this shift to Brad. And Brad, just your high level views as you get yield enhancement to come in new supply coming in. How do you think about working capital? How much of that gets caught in the inventory process and just your latest thoughts on the cap structure, particularly you have high yield debt. Just thinking about your thoughts there on potentially when you could see a refinance? Thanks again, guys. Congrats.

Sure. Thanks, Anthony. I mean going -- talking about yield enhancement first, right? I mean what Adam is saying is we're going to get 20% more IG from the same starting point. So we will carry a little higher inventory as we continue to produce when we start producing yield-enhanced materials. So that -- it's not going to put a lot of pressure, but it will put slight pressure upwards on our inventory levels. In terms of the cap structure, right, we have always said we are going to generate cash this year. We feel very confident in our ability to continue to generate significant cash, especially coming into 2025. And we are going to be opportunistic with that cash and we are going to look for -- continue to look for ways, as we've always said, to maximize shareholder value, whether that's paying down debt or doing other things. But again we will -- we are going to be very opportunistic with the cash that we're generating and our goal is to continue to generate shareholder value.

Thanks again.

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

Hi, Gary.

Hey, guys.

Look forward to seeing you.

Yes, definitely. So thank you. My congrats as well on the progress. So Adam, first, just I'm curious, how big is that queue for new patients waiting to get treated with ASCENIV. So how much has it been growing relative to the current patients that are getting treated? And what do they do in the meantime? While they're waiting. Any risk that you lose then if that queue builds too long?

So all great questions. I can say that the queue is robust. And there are more patients that I'm able to supply today. What are these patients doing? I mean they are on their standard IG therapy. They continue to maintain on the same drug that they've been receiving. And that's the way that has been going. These patients are on regular immunoglobulin, which currently is pretty well supplied right now in the marketplace. So there's no risk that these patients are going to switch off to something else. I mean there is no other alternative for these patients besides IVIG replacement therapy. So they typically stay on the immunoglobulin that they're currently on. And when we have product supply availability, coupled with reimbursement approval, we're switching them to ASCENIV's. So these patients are at various stages. I mean we have doctors who identify these patients and we work back and forth with the payer to iron out any letter of medical necessity and debate and argue there with some of the commercial payers. But at the end of the day, if the patients meet the criteria that we've been talking about have significant comorbidities, have chronic persistent infections, are in and out of the hospital. We're seeing these patients added without too much pushback. So we're really super pleased with access right now. We're super pleased with the reimbursement profile throughout 2024 and into 2025. The calendar flip has not thrown up any flags for us at this point. And we continue to make progress. I mean, look, we're pretty bullish. I mean, increasing guidance again. We just gave guidance at JPMorgan. Now we're increasing guidance again a couple of weeks later. And I think that, that has to do with the confidence of, number one, we're getting more plasma than we anticipated. Number two, demand trends continue to increase and improve. And I mean every Monday, I get my distribution data, and I've been a happy guy every Monday, which is very rare for me having to come back to the office. So hopefully that answers your question.

Yes. In addition to the two points that Adam just called out in his level of confidence. I mean, the other key point is we are extremely confident in the ADMA's team's ability to continue to execute and continue to execute at a high level. And when that happens, and it will, we will continue to drive year-over-year revenue growth and expanded margins. So the confidence not only in collecting plasma and the payer situation, but we are extremely confident in our team's ability to execute at a high level.

Okay. Great. And then as the mix is obviously shifting a lot more to ASCENIV, where do you expect gross margins to be for this year? And I mean if you could give us some high-level guidance for next year as well? And how much do the supply agreements impact that? And how will those, I guess, be staggered over the course of the next one to two years? Within your guidance?

I mean, ASCENIV's gross margins, Gary, are 80%, 85% plus this side of yield enhancement. The impact of the supply agreements, it's not tremendous at all. I mean, it's really, we're paying market prices for what we've been paying for this plasma all along. I mean there is not much added from a cost perspective. Brad can correct me if I'm wrong there. But we feel really, really good about this. You're going to see ASCENIV continue to drive to become substantial overwhelming majority. It is the overwhelming majority. It's going to continue to grow. It's going to continue to grow because, number one, we're not producing as much BIVIGAM and we're producing ASCENIV. And we believe that all demand indicators that it's going to pull through at a rapid pace. Number two, when you bolt on yield enhancement, which we anticipate should occur. I mean the FDA dialogue has been pretty good. We feel very, very confident about the likelihood of approval, albeit people still stay employed at FDA. But we really are looking at gross margins from the standpoint of they're only going to expand. There is nothing that we see in the foreseeable near-term, that's going to impact our ability to deliver these 80% plus gross margins on ASCENIV as we continue to go forward.

And just furthermore, I mean the 20% additional yield going with yield enhancement, significantly outpaces any investments that we make in RSV, any investments that we make in the yield enhancement process itself. So that 20% extra IG from yield enhancement is going to be very favorable and accretive to margins going forward.

Okay. Great. And then just two more quick ones. Just on the FDA review here for the enhanced yield process, do they have to do any sort of inspection, I mean you're very confident with this major time line, so just want to make sure of that. And then just on 001, when do you think you're going to have that animal data? And how soon could it potentially enter the clinic? Thanks.

All great questions. So we're not aware of a requirement for a preapproval inspection for this submission. We haven't been notified at all from FDA yet that they're going to do a PAI, and we're well into the review cycle here. So we feel pretty good about our positioning. And I don't think that they're going to come, but you never know, maybe they're going to listen to this and they're going to show up. But we feel good about the ability to pass any FDA inspections, Gary. And we wouldn't be this confident and my compliance team and regulatory team wouldn't let me say the things that I'm saying today if we didn't feel like we were having a robust, active positive dialogue with the agency. So they've got all the data. They've been reviewing data. We've been fielding information requests in the normal course back and forth all year so far. And we feel very confident for an approval on time. With respect to SG-001, I had a meeting last week that made me very excited. We are moving very, very rapidly. We produced some bench scale lots of product at different potencies and I've seen some preliminary testing data with those batches. We hope to have the animal data later this year. We haven't guided to the development timelines, but we do think that the contribution to revenue, which is the $1 billion revenue target prior to 2030. We certainly do think that it's reasonably likely that SG-001 could enter the clinics substantially before then and potentially be contributing revenue. And that's excluded from that $1 billion plus revenue target. So again, it's an additional upside lever. I have not been this excited about this opportunity. I've had blinders on for a while. I think our stockholders and staff knows that I've been pounding the desk saying more plasma, more high-titer plasma, more ASCENIV. This is the first time that I'm really super excited about the potential opportunity we have with our in-house R&D engine here. I really think that it's capital efficient. I think that there's a substantial unmet medical need. And if everything that the team is hypothesizing, if half of what the team is hypothesizing comes to fruition. We've got another winner on our hands here. So I'm really positive about the product. Let me get the animal data done. Let me get the donors vaccinated. Let me get plasma collected and I promise to you later this year, we will update you with respect to the development timeline.

Great. Thanks for all that color. Appreciate it.

Thanks, Gary. Look forward to talking on Wednesday.

And ladies and gentlemen, this will conclude our question-and-answer portion of the call. I'd like to turn it back to Adam for additional closing remarks.

I just want to thank the ADMA Biologics team 2024 was a year that will go down in our history as we're writing our book. It's one hell of a chapter and I appreciate you all for showing up and giving your best every day. To our stockholders. Thanks for trusting us. And we appreciate your investment in ADMA, because it allows us to keep doing what we're doing. So thank you everybody. Have a great evening.