ADMA Biologics Inc

NASDAQ:ADMA

Earnings Call Transcript 2023-Q1

[Operator]

Good afternoon. And welcome to the ADMA Biologics First Quarter 2023 Financial Results and Corporate Update Conference Call on Wednesday, May 10, 2023. 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 Web site approximately two hours following the end of the call.

At this time, I would like to introduce Skyler Bloom, Senior Director, Business Development and Corporate Strategy at ADMA Biologics. Please go ahead.

[Skyler Bloom]

Welcome, everyone. And thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the first quarter 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 first quarter 2023 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions. Earlier today, we issued a press release detailing the first quarter 2023 financial results and summarized certain achievements and recent corporate updates. This release is available on our Web site 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 obligation to update any such statements, except as required by the federal securities laws. We refer you to the disclosures notice section in our earnings release we issued today, in the Risk Factor sections of our 2022 annual report on Form 10-K for the year ended December 31, 2022, and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. Please note that today's discussion includes certain non-GAAP financial measures, including adjusted EBITDA. A reconciliation of non-GAAP financial measures to the nearest 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.

[Adam Grossman, President and Chief Executive Officer]

Thank you, Skyler. During the first quarter of 2023, ADMA generated first time adjusted EBITDA profitability, totaling $2.5 million. This milestone achievement was enabled by an impressive 96% year-over-year increase in total revenues, which reached $57 million in the first quarter. The robust revenue growth translated to meaningful operating leverage, which was a result of continued gross profit growth and disciplined management of our operating expenditures. Based on these trends, we have increased our 2023 total revenue guidance now expected to exceed $220 million, and we anticipate continuing to grow adjusted EBITDA from the newly established baseline throughout the remainder of 2023. Although, it's still early for our forecasted revenue growth and profitability cycle, we believe ADMA is now entering a new echelon alongside some of our high quality industry peers. Based on the year-to-date financial results and considering our newly increased financial guidance, ADMA is among only a few standalone biopharma companies in the United States that are expected to generate total revenues of more than $220 million for the full year of 2023, while maintaining a substantial revenue growth rate and also generating continued adjusted EBITDA profitability. We are proud to now be included in this exclusive set of high quality biopharma companies.

Within the $10 billion plasma space specifically, ADMA advanced its position as the fastest growing provider of immune globulin in the United States market, which we attribute to our organization's exclusive focus on the immune deficient patient segment, the immune globulin market's fastest growing cohort. During the first quarter, we treated a record number of patients and gained strong market share among what we anticipate will prove to be sticky books of business. We believe our innovative business model, unique immune globulin portfolio and targeted medical education efforts position us well for future success. We believe the milestones we've achieved to date validate our core mission, to commercialize novel products for immune compromised patients at risk of infection. It is treating this underserved patient population that fuels our organization and drives our company's unified commitment to overachieve and deliver on our operational and financial objectives. Over the past two years, we've communicated an unwavering message about our favorably evolving product mix, and we're happy to confirm that these trends are continuing to strengthen in 2023. ASCENIV growth continues to be driven by its uniqueness amongst immune globulin product offerings and the real world impact and improvements the drug is having on outcomes for problematic immune deficient patients. Furthermore, we're seeing encouraging signs of patient and prescriber persistence among those who have been using the drug for as long as three years in. This dynamic is being compounded by record expansion of new accounts and reorder velocity among existing customers. We believe that the product will continue to account for a greater share of our overall product mix going forward.

We are pleased to announce that during the first quarter and into the second, ADMA made progress advancing it’s recently identified growth opportunities. To reiterate the incremental investment required to pursue these opportunities is not significant and is not expected to compromise ADMA’s robust profitability outlook. First, among these opportunities, ADMA successfully commenced manufacturing of ASCENIV at the 4,400 liter production scale for the first time in our corporate history. We expect the expansion will meaningfully improve the product's margin profile and increase our plant production capacity as fewer batches will be needed to support our revenue goals. The expanded scale provides for uninterrupted production to support our forecasted rapid growth trajectory. We believe these benefits could be realized as early as the second half of 2023. The second growth opportunity we've identified pertains to yield enhancement with our manufacturing and production processes. Recently, the company progressed with development scale and laboratory analysis, advancing ADMA’s initiative to capture additional immunoglobulin production yields. Pending further evaluation, validation of commercial scale production and ultimately regulatory approvals, these yield enhancement initiatives could meaningfully increase both peak revenues as well as margin potential if successful. Finally, our ongoing post-marketing clinical studies progressed as planned during the quarter. And if successful, may provide for label expansion opportunities for both BIVIGAM and ASCENIV to include pediatric aged primary humoral immunodeficiency patients, as well as additional publications supporting the product safety. The potential label expansion we believe would put ADMA’s immune globulin portfolio on a level playing field compared to peer immune globulin offerings. Again, these opportunities represent potential upside to currently provided financial guidance. We look forward to updating the market as developments unfold.

On the plasma supply front, our strong RSV hyperimmune plasma and normal source plasma inventories presently on hand are expected to support all upwardly revised revenue forecasts for our immune globulin portfolio. We believe that the rapid expansion of our internal collection network coupled with our existing contractually secured third party supply contracts provide financial and supply chain flexibility. Currently, all 10 plasma collection centers in our network are operational and of those eight are now FDA licensed. We continue to anticipate achieving complete FDA licensure of our BioCenters’ network as well as plasma supply self-sufficiency prior to year end 2023. In a moment, Brian will describe in more detail the credit agreement we announced last week. But from my perspective, we are pleased to have reduced our interest expense by 1% and we believe the restructuring of the prepayment mechanism provides for additional strategic and financial flexibility. Considered in conjunction with the increased operating forecast we have announced today, we believe an opportunity exists to accelerate net income profitability earlier than previously provided in our timelines. We sincerely appreciate Hayfin’s continued and collaborative support. Our employee's commitment, passion and diligence drive our success. We have prioritize the human connection in all engagements through cooperation and teamwork among staff, leadership and our advisors. Our team's unwavering connectivity has enabled us to assume complete end-to-end control of operations, fulfilling our core vision and providing the foundation for continued success moving forward. We thank our staff for rising to the challenge daily, delivering on our pledge to patients, the medical community, prescribers, advocacy groups and our stockholders. Your efforts make a meaningful difference in the lives of those counting on us. Before turning the call over to Brian, I'd like to confirm that our strategic alternatives process remains ongoing and exploring value creating opportunities remains a top priority for our company. The strategic alternatives process is separate and running in parallel to our pursuit of new growth opportunities. As developments occur, we will keep the market updated.

With that said, I'd now like to turn the call over to Brian for a review of our first quarter 2023 financials.

[Brian Lenz]

Thank you, Adam. We issued a press release earlier today outlining our first quarter 2023 results and we will be issuing our first quarter 10-Q later this evening, 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 quarter. As Adam mentioned earlier, total revenues for the three months ended March 31, 2023 were approximately $56.9 million as compared to $29.1 million dollars during the three months ended March 31, 2022 and this represents an increase of $27.8 million or approximately 96%. The increase is attributed to higher sales of our immune globulin products, driven by increased physician, payer and patient acceptance and utilization, as well as the expansion of our customer base. During the quarter, we also benefited from an increase of $4 million in sales of normal source plasma through our ADMA BioCenters segment, as we fulfilled our long term plasma supply commitment for 2023 with our third party customer. Throughout the remainder of 2023, we anticipate using all of the plasma collected from our BioCenters network to support our IVIG production operations.

Our gross profit for the first quarter of 2023 was $16.5 million. This translates into a 29% gross margin as compared to $3.7 million or a 12% gross margin for the same period of a year ago. This gross profit improvement of approximately $13 million was primarily driven by the revenue increases and the reduction in other manufacturing costs related to an extended otherwise routine plant shutdown in the first quarter of 2022. Partially offsetting the favorably evolving product mix, ADMA sold the substantial majority of the remaining lower margin 2,200 liter scale BIVIGAM product during the first quarter of 2023. As we move forward, production throughput and sales recognition is anticipated to be substantially confined to the higher margin 4,400 liter BIVIGAM product along with ASCENIV. Our consolidated net loss for the quarter ended March 31, 2023 was $6.8 million compared to $25 million for the first quarter of 2022. The $18.2 million decrease in net loss was mainly due to the narrowed operating loss of $14 million period-over-period and the loss on extinguishment of debt of $6.7 million we recorded in the first quarter of 2022, and this is in connection with the refinancing of our senior secured credit facility, partially offset by the increase in interest expense. Our adjusted EBITDA increased by $14.2 million for the three months ended March 31, 2023 as compared to an adjusted EBITDA loss of $11.7 million for the same period over a year ago. The adjusted EBITDA improvement was driven primarily by increased sales, improved gross profit and lower total operating losses.

As Adam indicated, the recent credit amendment with Hayfin provides for multiple favorable changes. First, there's the reduction of 1% in the nominal interest expense on ADMA’s current note. This will result in a lowered borrowing rate of SOFR plus 8.5%. Included in this base rate and consistent with the existing terms of the Hayfin facility, the company may elect to pay up to 2.5% of the interest in kind with the remaining portion of the interest payable in cash. Second, within the first 24 months after the amendment closing date among other provisions, there is a newly structured 50% waiver of the prepayment fee in connection with an acquisition of the company or other certain strategic transactions. Taken together, we believe these changes will reduce ADMA’s cost of capital and provide for added financial flexibility over the near term and on an ongoing basis. In addition to the further enhancements of the capital structure, ADMA's balance sheet remained strong. At March 31, 2023, ADMA had working capital of $227.4 million, primarily consisting of $164 million of inventory, cash and cash equivalent of $69.2 million and $26.5 million of accounts receivable. This was partially offset by current liabilities of $36.7 million while compared to a working capital balance at December 31, 2022 of $231.1 million.

Lastly, our ADMA BioCenters plasma collection network now consists of eight FDA licensed collection centers with two additional centers operational and collecting plasma, which are pending FDA licensure. The company remains on track to have the remaining two BioCenters FDA licensed by the end of 2023, and in the same period forecast raw material plasma supply self-sufficiency from all 10 centers. Now well into 2023, we are encouraged by the real time improvements in donor foot traffic and collection volumes, which are now considerably exceeding our organization's prepandemic levels. With that, I'll now turn the call back over to Adam for closing remarks.

[Adam Grossman, President and Chief Executive Officer]

Thank you, Brian. As demonstrated over the last two years, we take a conservative approach to guidance construction, contemplating a range of both macro and company specific variables. That being said, today, we are pleased to be increasing total revenue guidance, which is now expected to exceed $220 million. Further, we anticipate continued adjusted EBITDA growth from the newly established first quarter base. Growth in business trends are strengthening and the forward-looking visibility required to meet or exceed our financial targets is as clear as ever. We believe our investments in the supply chain and commercial infrastructure in recent years have created a solid foundation for maintaining best in class revenue growth and potentially achieving an ultimate margin profile at the upper bound among plasma product manufacturing peers. Additionally, we've taken a thoughtful approach to pursuing new growth opportunities. We continue to progress with these projects, which we believe had the potential to yield further upside to what we already anticipate will be a highly profitable growth cycle over the near and longer term. We look forward to building on the momentum of early 2023 to drive further success. In closing, I'd like to thank you, our stockholders, for your continued support as your investment 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'll now open up the call for your questions. Thanks everyone. Thank you, operator.

[Operator]

[Operator Instructions] Our first question comes from the line of Elliot Wilbur of Raymond James.

[Elliot Wilbur, Raymond James]

Just wanted to extend my congratulations to management and the entire organization on all year accomplishments of the past couple of years. It's been a terrific journey and certainly have enjoyed being able to observe it from my analyst seat. And obviously, congratulations on the achievement of first time positive EBITDA. I know there's been a lot of blood sweat, maybe even a few tears invested behind that over the years, but obviously a significant milestone for the company. First question, it has to do with the revenue trends over the balance of the year and just looking at the over-performance in the first quarter and then sort of taking literally the low end of your guidance, which would be $220 million, that would imply the possibility of a sequential step down at some point over the next three quarters. Markets obviously have become accustomed to sequential positive top line growth over the past couple of years. But just wanted to get your thoughts around the likelihood or whether or not there's something more definitive that would, in fact, we'd actually see revenue step down over one of the next three quarters before resuming growth?

[Adam Grossman, President and Chief Executive Officer]

Elliot, we're always conservative in our guidance, but we continued to reiterate that we anticipate quarter over quarter growth. Certainly, in the first quarter of this year, we had outsized plasma revenues from our plasma collection business. These plasma revenues will not recur going forward, but I'll tell you that the demand that we're seeing for ASCENIV and BIVIGAM, the demand that we're seeing for our intermediate fractions and even NABI, we are very, very bullish on the continued top line growth, as well as trends for continued EBITDA and potentially even bringing profitability a little bit earlier than anticipated. So we really are confident here. In the prepared remarks, you heard me say a couple of times that it's still early in the growth trajectory for ASCENIV and we do feel that the way that the product is being perceived, the way that we are seeing patients getting added to the program, we think that the growth is only going to continue. So we feel very strong about our prospects financially going forward. The first quarter had some headwind still. The revenues consist of some of the lower margin BIVIGAM that we have been talking about over the last few quarters. We have exhausted most of that inventory. So we really feel very good about the forward-looking prospects of enhancing EBITDA, getting to net income profitability possibly a little bit earlier, but ultimately top line. Are the beats going to be as big as they have been? I don't know. Is the quarter-over-quarter growth going to be as big? I don't know. But we are committing to quarter over quarter revenue growth, and my hope is that it continues. I mean, the staff is working. Our company has never been more unified. The staff is working extremely well from what we do here in Boca, from making the product all the way through to our commercial folks, plasma collection trends look great. I mean, everything really falling into place right now and we feel really strongly that this is only the beginning and it's going to continue.

[Elliot Wilbur, Raymond James]

And then I have a follow-up question for Brian as well, and his touches on an issue we discussed at length last quarter, and that's with respect to the reduction in plasma center operating expenses, fairly significant sequential step down. I assume that's not an actual reduction in cost, but just an allocation to -- or capitalizing of those expenses versus running them through the P&L. But is the number this quarter indicative of a new floor and will cost basically remain at these levels going forward? Just trying to get a better sense of the trend in that number. And as a corollary to that, one of the larger fractionators that reported results yesterday highlight multiple times in its conference call significant reduction in its COGS specifically tied to rather sharp reductions in the cost of collection. They talked about 25% to 30% decline in the cost of collections as being a key factor, resulting in their improved margins. And I'm wondering if you are seeing a similar trend in terms of the actual collection cost.

[Brian Lenz]

Very good observation regarding the plasma center costs. And as they continue to progress throughout the year, as we continue to progress throughout the year, we think these costs as you see in the first quarter are going to remain very stable. The step down that we saw from first quarter '22 to first quarter '23 really is predominantly made up of the -- we have more centers in production now, more centers are now have entered into maturity phase of collections. For instance, this time last year in first quarter '22, we had seven centers collecting and open and now we have 10, all 10 of our centers are open and collecting plasma. We had five centers in the first quarter of '22 that were FDA approved and now we have eight. So again, the majority of our centers are now more in that maturity phase. They're collecting plasma in greater numbers than they certainly were in the first quarter of 2022. So we would expect that the number for the first quarter ‘23, the $1.8 million to, I would say, remain fairly constant throughout the rest of the year, because we are able to capitalize more of those cost to inventory and then being charged the cost of sales against revenues.

Regarding some of the commentary on plasma collection fees and overall costs, we don't comment on other competitors and what they say in the market. What we do see is we do see some donor fees in certain areas decreasing, we see certain programs that were in place a year or two years ago as we've exited the COVID pandemic that have wound down, that's because of certain special government programs, stimulus programs and so forth. So some of those incentives to donors have sunset, if you will. And we certainly want to remain competitive as a collector, but it's not just about the donor fees, we're really proud of our centers. We get very good comments back from our donors that our centers are very professional, they're clean, they're welcoming and it's about also the experience. So, again, as Adam said, we're very proud of the organization as a whole, especially our plasma collection centers and how well maintained and how professional we treat -- and treat our donors.

[Elliot Wilbur, Raymond James]

And final question for Adam. Just thinking about the incremental opportunity in the pediatric population, my assumptions are that pediatric population is about 10% to 15% of the total. And I'm wondering if that's consistent with the company's thinking. And then just looking at some of the timelines associated with the ongoing studies, it looks like the BIVIGAM study may have been completed already. And I'm wondering if that information's been submitted to FDA as of yet. And I'm assuming that ASCENIV would still be on track to have the actual data submitted to FDA by the end of the year, I want to confirm that. And then wondering, is there a case to be made for higher relative utilization of ASCENIV in the pediatric population than what you're currently seeing across the current patient base, either just based on higher comorbidities, such as asthma and ear infections or because there's just a naturally higher rate of IVIG non-responders in the pediatric population?

[Adam Grossman, President and Chief Executive Officer]

So I don't think the 10-Q has been filed yet, but I remember us editing the section. Yes, the BIVIGAM study is fully enrolled and is completed. I believe that we're working through the data sets and that'll be submitted imminently to the FDA. ASCENIV study is ongoing and enrolling and we're going to be asking for an extension to keep that study open for a period of time and we'll update the market and in the queue as that progresses. Regarding the pediatric indication, I've talked about this before on calls. I know people out there are going to go back and look at what I said historically, so I don't want to misspeak. But we don't view the pediatric indication as something that we absolutely need in order to grow this product. It'll put us on a level playing field with other immune globulin offerings in the United States, both from a subcu and an IV standpoint. It's a legal requirement that the FDA has that manufacturers complete pediatric obligations and pediatric studies ASCENIV. I don't want to misspeak but I think we have age 12 up to 65 BIVIGAM. We didn't run that study, we inherited that product and we acquired the assets back in June of ‘17, that product, I want to say, is 18 and up. But we're not looking at it as it's really going to expand the market. I mean, for ASCENIV specifically, as you were asking, it's for problematic primary immune deficient patients, full stop. For patients that are not driving on their existing IG, it's for patients that have chronic and persistent infections, be it young or old.

Problems don't discriminate whether you're a child or whether you're an adult with VI. I don't have the data in front of me on the spread, but I'm going to go out there and say that the majority of utilization with ASCENIV is currently on label, it's in patients that have had VI for a while that have experienced multiple IGs over the course of their treatment journey. They've changed brands, they've had dose escalations, they've been on antibiotics for multiple months and years at a time, they've been on [AMIFLU] multiple months years at a time. And it's a product that really the real world evidence is demonstrating that it's doing something unique and different out there. So we feel good about the product, we feel good about how it's differentiated in the market and that the only product that's manufactured by blending RSV plasma and normal course plasma. And just to circle back to your question, the pediatric indication is something that we believe that we should obtained, but it should not impact our ability to grow revenue for BIVIGAM or ASCENIV into the future. Hopefully that answers your question.

[Operator]

Our next question comes from the line of Anthony Petrone of Mizuho Securities, USA.

[Anthony Petrone, Mizuho Securities]

Thanks, and congratulations again here on another strong quarter, strong start to the year 2023. Maybe Adam to start, we can talk a little bit just about hyperimmune globulin specifically. Certainly, there's momentum in ASCENIV here, your prepared remarks point towards stickiness but also continued new patient volumes for ASCENIV. And then your competitor and supplier Grifols also reported a very strong hyperimmune globulin number for their quarter and 1Q of ‘23. So maybe just to level set us a little bit here on the state of hyperimmune globulins and then specific to ADMA just the tailwinds we're seeing in ASCENIV, how sustainable is the momentum in new patient starts, and over time how sticky can this prove to be on those patients as we continue to move ahead here? And then I'll have a couple of follow-ups.

[Adam Grossman, President and Chief Executive Officer]

You know, what I'll say is that, you mentioned Grifols, we are in completely different spaces. I mean, I think the majority of their hyperimmunes are derived from their rabies product. We don't compete in that space. They also have tetanus and Rho(D) immune globulin, they compete more with CSL and some other companies there. So it's a completely different space. But I think to your point, the utilization of hyperimmune globulin is something that is very sticky in general and it is very standardized. With ASCENIV, I mean, look, we have been saying it for well over a year. We have been saying that the patients who are leaving their normal IGs, their standard IGs and being placed on ASCENIV, we continue to see persistence in the ordering and utilization trends. I mean, I think that that's recognized by the quarter-over-quarter growth. And the fact that we are a couple of calendar quarters earlier than we anticipated from an EBITDA perspective. I think it speaks volumes to the fact that the utilization of ASCENIV is growing and the demand is growing. So we have got good -- we know what our distributors are buying, I always find it and I always make this comment too and some of my staff and my kids at home always say, I have tomorrow's newspaper today. I know what I'm selling already in the second quarter. And I would not be reiterating like I did with Elliott's question that, I feel confident about quarter-over-quarter growth, if I didn't feel that that utilization was sticky.

The patients are doing well on drug, Anthony. I think that we have all learned a lot. I think, again, I haven't said this in a while and I don't really want to bring up COVID, but I really think that in patient mind and in physician minds that we all understand that more antibody is better than less when trying to treat or prevent an infection. I think the only way that immune compromised patients get antibody is through immune globulin replacement therapy and we are the only product that screens their donors. And again, not an RSV drug, we just use RSV as a marker to identify who the hyperimmune donors are. And then as we have published these donors have high titers to panel of different respiratory viral pathogens. And the scientific thought process is that these donors could theoretically have higher titers to other viral and bacterial pathogens. So that's why the patients are doing well. And the doctors keep the ordering, the payers keep paying and our distributors keep reordering, paying their invoices and stocking products. So the product is pulling through faster than ever. I always get a little nervous, and I think I mentioned this last quarter. I always get a little nervous as the calendar flip, when people are changing insurance or insurance plans are changing, CMS rules changing all the time. But we really have had very little attrition. And I think that whoever the payers are and the doctors are, they are seeing that these patients are doing well. They're not being hospital, they don't have the same opportunistic infections and the continued persistent infections. They are thriving.

And we have got some marketing campaigns that we have been routing through our promotional review committee here internally, and maybe this is a little granular for folks. But we are going to be rolling out some patient testimonial, and we are working on expanding that because of the product. It's still a new product but it's not that new and we have got patients who've been on therapy for multiple years now who are willing to put their name on the line and say, hey, I want to tell my story. So I don't know what is better -- what's a better reward than that. And we have people who have said that, I was not doing well and doctors thought that this was a good product, or I did my research and I learned about it, I asked my doctor and I've been feeling great on this. So I feel it's sticky. Our commercial team tells me, Adam, don't worry, we got this. I'm committing to quarter-over-quarter growth. I feel good about this, Anthony. I really, really do.

[Anthony Petrone, Mizuho Securities]

No, it's that's great and obviously, evident in the results here. Maybe Adam, a couple quarters now you're talking about newly identified growth initiatives the company's pursuing, and don't want to zone in on the yield enhancement initiative. Maybe just if you can to give us a little bit behind the scenes there, maybe where is the Boca facility today in terms of yield when we think of grams per liter and where can that go over time, and maybe what's the path forward? I mean, how much testing has to be done and what type of regulatory pathway do you need to pursue?

[Adam Grossman, President and Chief Executive Officer]

We truly are excited. These new growth opportunities I feel are just transformative for the business. You didn't mention it, but I'm super happy about it, because ASCENIV at the 4,400 liter scale, it's something I said I would never do. But I'm eating my hat and we're doing it and we've successfully made a couple of batches so far. And really excited about that because what it does, it allows us to put more plasma through the plant, it allows us to absorb more of the, unabsorbed manufacturing overhead. We think margins for ASCENIV could creep. We've always said it's 80%-ish gross margin product, maybe it creeps into the upper 80s, maybe low 90s, we still have yet to see. But it's really exciting and it's going to allow us to put more product through the plant ultimately lowering cogs and absorbing some of that manufacturing overhead. With respect to the yield enhancement. I mean, this is truly transformative. And I don't want to get ahead of myself, I don't want to get over my skis. The data that has been shared with me has looked very favorable. For those who understand plasma fractionation, there is loss inherent in the cone ethanol alcohol fractionation process that we employ here at ADMA. Our yields, I've always said historically, roughly 3.8 to 4.1 grams per liter or so in that range historically. Some of our competitors who use [indiscernible] get a little more yield. I like using our centrifuges. I feel that there is something to be said with respect to treating the protein very gently, but that's a scientific conversation for another day.

But what I could say, Anthony, is that we anticipate yields, meaningful improvements. I'm not yet prepared to completely quantify it, but let's just say that it would transform our business. I don't think it's unreasonable to expect that the profitability targets that we're laying out there, which currently do not contemplate the yield enhancement or really 4,400 ASCENIV product in there should continue to expand going forward. You asked a question about regulatory process, you asked a question about timelines. First, I'll comment that the actual spend to do this work, it's I don't want to say it's not material, but it's not material. I was looking at the numbers today with Brian, he was preparing me for this, and we've got a lot of assets. So I think it's over $300 million worth of asset value here. The $2 million, $3 million we're going to spend on this, it's really not that much considering where we've come from and where we're going. Timelines, I mean, again, a lot of it comes down to what happened with the bench scale. But what I can tell you is that the team is very excited about this. We've got our small scale model working 24 hours a day around the clock. We're pushing this forward. We're having conversations about the regulatory path and the regulatory strategy. But quite frankly, it's a comparability protocol, it's something that ADMA's been successful with.

Anthony, I know you followed the company for a while. Elliot, you've been following the company for a while. Kristen, you've been following the company, not as long. But I'll just say that when we took this facility over and we optimized, I think that was the term we used, the manufacturing process, it was a very similar process to what we think we're going to have to employ here. We're going to have to make some conformance batches, we're going to have to put them on stability, we're going to submit to the FDA and the FDA's going to have a PIS to review. I don't think this is anything that's scary. Certainly, doesn't scare me at this stage. I mean, we've been successful doing this multiple times. So I think as we progress, I don't want to scare my process development team who's probably listening to this call, because a lot of the staff listens to the call. But let's just say that they are truly dedicated to this. Our hope is to get this done as rapidly as possible, because look, the company is transforming, in general. We're selling more ASCENIV, we're selling all the BIVIGAM we can make. We're finding cost efficiencies across the organization. I reiterate that the company is totally unified behind this. We are motivated by the benefits that we're providing out there to immune compromised patients. And we truly, truly see -- I mean, we're actually at the end of the tunnel where we're maybe not positive now. And we think that that's going to continue and we want to get there as fast as possible. But I'm not really totally prepared to give guidance on the timelines, but we're working as fast as we can.

And I think our investors and I think our analysts know us by now that we are truly dedicated, we are conservative in our guidance, both financially and as well as our regulatory timeline. So give us a little bit more time, but we assure you it will be exciting and I believe we'll be successful. And I think that it's only going to reap more benefits for us as we grow into the future. So for those long term holders, I mean, that forward-looking guidance that we continue to reiterate roughly 250 top-line next year, 300, 2025, we think it only grows. And ultimately, when you're making more product from the same -- to use Skyler’s term, when you're getting more juice for the same squeeze, sorry to do that to you, but do say that, our margins are going to improve. And I think this is ultimately what everyone's been saying to us is, Adam, you got to get the margins better, Adam, you got to get this better. And I think this all plays well. Just to tie it in as we're moving forward, I think people start to pay attention. You know, Anthony, we're moving into a different echelon of company. I said it in prepared remarks, I mean, there's very few companies out there that are under a few billion margin cap that are doing over $220 million a year in revenue that are positive EBITDA, that are forecasting continued top line and EBITDA growth. That's ADMA Biologics. I mean, we are no longer -- I mean, I don't think we're a sleepy company anymore. I think we are a company that's here to play, we are moving into a different category. Hopefully, the market cap reflects that as the trading day starts tomorrow. But I can tell you that the yield enhancement strategy is only going to make us stronger.

[Anthony Petrone, Mizuho Securities]

Well, with that, I'll hop back in queue as they say, you guys have arrived again. Congratulations on the quarter and we’ll talk soon…

[Adam Grossman, President and Chief Executive Officer]

We have a lot more to do, Anthony. We're not there yet. The team knows it. We are not stopping here. We have got a lot more growth. And I want that net income. When we hit net income, I told Skyler, I wouldn't say this, but I'm upset that the Rangers lost. But only then will I be able to die in peace when we have net income profitability. So I want to get there fast, but thank you. Thanks for the kind words.

[Operator]

Our next question comes from the line of Kristen Kluska of Cantor Fitzgerald.

[Kristen Kluska, Cantor Fitzgerald]

Let me also add my congratulations to you on another great quarter and the pattern that we've really seen emerge over the last couple of quarters here. So I wanted to ask you a bit more on ASCENIV utilization. If I look at some of your publications, posters, et cetera, it really seems that the benefits are quite broad. I mean, the age of the patients, the underlying comorbidities, the time to treatment, it seems pretty diverse amongst the patients yet the benefits are all there. So curious if real time you are seeing that the effects represent a broad patient population or if there is a specific type that you’ve seen? And then can you talk about some of your plans maybe the next 12 months to collect and report on more of these case studies?

[Adam Grossman, President and Chief Executive Officer]

I don't want to sound like a broken record, but you kind of answered your own question with the question. I mean, it is a diverse population. I mean look, PIDD comes in all shapes and sizes. Immune deficient patients primary and secondary, look, that's where we are focusing our marketing efforts. We focus exclusively on that patient population and we are targeting infection disease conferences, we are targeting immunology, clinical immunology conferences. And these patients come in all shapes and sizes and they all have a different. Now it sounds corny, but this is the way that the marketing team has ingrained it in my head. Everyone has their own treatment journey. So these patients are -- they are all unique, they are all special, they all have their own problems that they have to deal with. So I can't pinpoint for you that where it says, it's a patient that’s 30 to 50 years old, that has had two bouts of pneumonia, bronchiectasis, has asthma, has COPD, has this, has that, I mean, sure. I mean, if you go to the ASCENIV Web site and you click around, you can get a general sense of the types of comorbidities and the types of problems that we believe make up the subset of the broader PIDD population that ASCENIV targets. But it really is for -- if doctors could know offhand which patient was not going to do well on a standard IG, we would know that much more about the disease and the genetic defects that these people have, but unfortunately they don't.

So most patients typically start out -- I can't speak that I know a very many patients who are being newly diagnosed with primary immune deficiency and ASCENIV is their first product. The majority of the patients have been on IG for a year or longer and they just haven't done well. That's the one underlying factor that I can say that I hear from our commercial and our medical affairs team that unifies these patients together. If we were going to have a ASCENIV support group, everyone would say, I imagine I was on another IG, I wasn't doing well, and my doctor suggested that I switched to this or I wasn't doing well, I did some research, I found this drug, I presented it to my doctor and my doctor said what, it's worth a shot, let's try it. So hopefully that answers your question. But what I will say is that the subset is quite large and we certainly have not penetrated all of the problematic patients who are currently receiving IG. So I still think that there's more room to grow.

[Kristen Kluska, Cantor Fitzgerald]

And I know one avenue for the quarter-over-quarter revenue growth has been due to the product mix and the associated margins. But you did point out specifically for this quarter that you're seeing a record number of patients as well. So wanted to ask what's been the key factors, if you can dig into this trend, is it greater awareness, is it just a continuous unmet need? What are you seeing to kind of get to these record number of patients now?

[Adam Grossman, President and Chief Executive Officer]

No, I appreciate the question. And not to use my Shark Tank analogies, but I think we've really locked in on how to acquire customers and we are spending only on programs that really target our patient population. Our MSL team, our medical affairs team is doing a great job and I think that they really understand the drug. And I think that our sales force is pounding the pavement, they love traveling and I've never seen a group of people that are more dedicated. But they're out there and we're hitting all the right meetings, we're hitting all the regional meetings, we're hitting all the right outpatient infusion companies, and we're talking to docs. We're sponsoring medical education programs, we sponsor the Clinical Immunology Society Summer school. I mean, we're doing things that are really meaningful and I think are impacting. And look, again, it's still a new product and we're still -- we still have a lot of room to grow, as I've said a couple times today. But what I'll say is that the awareness is there. I believe that in our small subset of clinical immunology, physicians and infectious disease consults to the clinical immunology programs, this is not something that they haven't heard, they've seen it at IV week, they've seen it at CIS, at Quad AI for multiple years. And I think people have asked that question. I'll tell you that our commercial force, MSL, market access, reimbursement, national accounts and ultimately, sales and marketing, when they're at these shows, no one's saying, it was a dead show, we didn't get a lot of leads. People are continuing to come up and ask us questions, explain to me how this is made, explain to me why this is different. Explain, explain, explain. I mean, we wouldn't be investing in these programs if we didn't see that we were gaining penetration from it. So what I can say is that I'm really excited about the patient testimonial campaign that's going to be rolling out there. I think it's meaningful to the nurses that attend these meetings. They spend a lot more time with the patients and the docs. And I think that the doctors are really seeing that they've got something in their armamentarium that is not an end all be all but it certainly is something different that helps move to take forward, and we think the trends are going to continue.

[Operator]

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

[Adam Grossman, President and Chief Executive Officer]

I just want to say thank you to our staff. I mean, honestly, it's been a long road for all of us. Some of you have been here a long time, some of you have been here a short time, but we can't do it without each and every one of you. To our shareholders, we appreciate putting up with this, but we're finally, showing you EBITDA, profitability. And we're going to continue to under promise and overdeliver. So stick with us. Thank you again for your confidence and support everybody. It truly is -- this is a very exciting day for us at ADMA Biologics, and I hope everyone listening is very proud. I'm proud of all of you and I'm proud to lead this organization where we're really making an impact on patients' lives who may not have a voice. So with that, have a good evening. Donate plasma out there, you're going to help save a life. And that's all I got to say. Have a great evening.

[Operator]

Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation, and you may now disconnect.