Hey everyone, I'm Gary Nachman, a biopharma biotech analyst at Raymond James, and we're very excited to have ADMA Management with us. We have Adam Grossman, CEO and a founder of the company, and he was kind enough to make the trip up from Boca, so not too far of a trip. ADMA is a company focused on specialty plasma-derived products with two key immunoglobulin or IVIg products, ASCENIV and BIVIGAM. This is a really great story, with numbers that just keep getting better. They had another really nice beat-and-raise quarter last week, and that seems to be more of the trend these days for them. You're officially profitable and cash flow positive, so congrats on that. It's great to have you here to talk through the ADMA story and thank you so much for coming.
Well, thank you very much, Gary.
And thank you everyone for sticking around for the last track of the conference. We really appreciate it. It's a nice crowd here. Adam, so, you know, since this is a generalist audience and people may not be as familiar with this area, you know, first spend a few minutes describing what you guys do, the process of collecting the plasma, what goes into the manufacturing of the IVIG products, and for what types of patients both ASCENIV and BIVIGAM are currently being used, to treat their immunodeficiencies.
Sure. Thank you, Gary. Thank you to Raymond James for hosting this great conference. It's a great question. You know, we are in the plasma-derived specialty biologics space, so everything that we do, and all of our commercial products, are made from human plasma. We like to think of it as a vein-to-vein model. So, it starts with people altruistically donating plasma. We have 10 plasma collection centers that we own. We also have supply contracts with some other third-party collectors to source this scarce raw material that we use to make our products. We own our own manufacturing facility, as Gary said, down in Boca Raton, Florida, where we do all the drug substance and drug product manufacturing.
So, the short version of this 7-12-month production cycle time is we take that plasma, we do all this testing, and that plasma can be used after 60-90 days. Then we pool that plasma together. We use 4,400 liters of plasma in each production batch that we make. And this plasma is sourced from a minimum of at least 1,000 individual unique plasma donors. This is according to the FDA Code of Federal Regulations. Upstream and downstream to get that plasma separated into the antibody portion of this plasma, which is our therapeutic product, our basically pooled human antibodies. We like to call it a healthy immune system in a bottle. That takes about 8 days to do that process. And then we would then move that bulk drug substance into filling into vials and then label packaging and final release testing.
But the whole process with release testing, with the FDA review, takes about 7 months at least to produce a batch of this drug. Once the drug is then released and cleared by the FDA for commercial distribution, it is then shipped, and the majority of our patient population is in the outpatient setting. These are patients that have a disorder called primary immune deficiency, PIDD. This is a class of over 400 different genetic defects that renders a human's immune system to be deficient in some way. There are about 300,000 of these people diagnosed in the United States, and roughly about half, a little bit more than half, receive immunoglobulin, these pooled human antibody products, every 3-4 weeks for the rest of their life.
If you've heard of the bubble boy, essentially this is the drug that allows the bubble boy to live outside of the bubble. What we do with our products and if you want me to.
Yeah, yeah, go into BIVIGAM and ASCENIV and how each of those are used a little bit differently.
Maybe I'll start by saying the U.S. immunoglobulin market, there are six players in this market, so it's a semi-oligopoly, if you will. We are one of the smaller players in this market. There are, it's a $10 billion top-line revenue opportunity in the U.S., roughly about 100 million grams of IG are produced and utilized every year in the U.S. Our product BIVIGAM is a standard immunoglobulin. It's essentially a me-too product. Now, there are no generics in plasma-derived biologics. Each product is unique. It has its own J-code. It has its own FDA BLA license number. And they are not, in theory, interchangeable. But what I can say is that BIVIGAM is a standard IG product, and that's targeted to immunocompromised patients. ASCENIV, ASCENIV is a really unique and exciting drug. It's the reason why we founded ADMA Biologics.
So, ASCENIV has IP, around, testing assays on how we individually handpick and screen which plasma donors have high levels of neutralizing titers to Respiratory Syncytial Virus, or RSV. RSV is a marker, if you will, for us to identify who are high responders, who are people within the plasma donor population that have high levels of antibodies, not only to RSV, but to this panel of other respiratory pathogens. So, we use that plasma and blend it with normal source plasma, creating a unique immunoglobulin with a unique antibody profile in the resulting end product. That product is targeted at a subset of these 300,000 PI patients that are receiving immunoglobulin. Not all patients thrive when they're on regular IG. People will survive, but they don't thrive necessarily. They may have chronic and persistent bronchitis, chronic otitis, chronic sinusitis. They're on antibiotic therapy for years at a time.
They're on antiviral therapy like Tamiflu. And that's not the way you're supposed to use these drugs, and that's not the way we all live. Why should an immunocompromised patient? So, ASCENIV, we look at, we're targeting roughly about a 10% segment of the overall PI population. So, there's about 30,000 patients that we believe have certain comorbidities and other risk factors that would render a clinician to make the choice to use a product that is formulated and enriched the way ASCENIV is. This 10% of the PI population has a disorder called bronchiectasis, or they have some sort of chronic lung condition like COPD or asthma that would render them, say, more susceptible or have, a harder time clearing a respiratory tract infection. So, we're very excited about the product that we're offering.
It really is the first innovation immunoglobulin in over 30 years, and it's being received very, very well. And I like to take credit, and I like to say that our company is doing a great job, and we've got great marketing, great medical education, and great sales force. But at the end of the day, when you see the results of what's occurring with our business, and it really is sort of snowballing from a revenue generation standpoint, the drug is good. The drug works, and the real-world outcomes are proving sustainable. And when the clinicians see that a patient that has had problems and hospitalized, that just doesn't feel well and calls up and complains, when they put them on ASCENIV, they seem to do better, and people are staying on therapy for years at a time. And we're very proud of it.
Yep. No, that was a great overview. And we'll get more into your product specifically, but in terms of the market, if people think about competitive threats or competitive dynamics, does the sub-Q matter that much? You have an IV, there's a sub-Q out there, there's some shift. And then also talk about, because some people may have heard about argenx and, you know, that sort of mechanism going after certain aspects of the IG market, if you think that's a competitive threat at all. So, in terms of how the market is segmented and where you fall.
So, I'm smiling here because, you know, my father and I founded the company 15, 17 years ago, and we were strictly focusing on immunocompromised patients. That's where we focused. Now, IVIg, you asked about sub-Q, you asked about a number of things. I'm going to try and tick them all down.
Yeah, argenx.
I forgot my pad. I should write that down, but.
I'll remind you. Don't worry.
What I'll say is that the IG market, this $10 billion market, probably about a third of IG, $3-$4 billion, is sold into primary and secondary immunodeficiency. So, the other, call it, you know, 60%-70% are in neurological, neuropathy, autoimmune, other indications. So, IG is not.
Like myasthenia gravis , for example, fall into that.
Myasthenia gravis is an unlabeled use.
CIDP.
There are 6 labeled uses for IG. There are 60 evidence-based uses that public and private payers will reimburse for. We focus only on the immunocompromised patient segment. So, first and foremost, I want to say that. You asked about sub-Q. Now, I am advocating for the immunocompromised. I'm not a physician. I'm not an immunologist, but I make decisions based on common sense. I was taught years ago when I was carrying a bag as a sales rep by leading immunologists that immediate bioavailability of antibody into the bloodstream in an immunocompromised patient is the right way to treat an immunocompromised patient. About 80% of IG in the U.S. is IV, 20% is sub-Q, and that's basically been stable for the last decade or so. We don't have a sub-Q formulation.
Again, I am a believer that the right way to provide immunoglobulin to the immune-compromised is through the intravenous route. There is some data published where you can, where people have used anecdotally our product subcutaneously, but that's really more of a convenience factor. And I'm not going to get into all the science as to why I think sub-Q works well in other indications, but from my perspective, it's not the right way to treat an immune-compromised patient. So, I tick that one. The other one is argenx, FcRn. So, FcRn, again, I'm not an expert in this, but this is a monoclonal antibody targeting the neonatal Fc receptor, which is where IVIg has shown benefits in certain clinical indications, myasthenia gravis, CIDP, other autoimmune and neurological disorders. Argenx is doing a great job with their drug.
There was a thought process that, you know, prior to argenx getting approval, that they were going to erode market share from the U.S. IG market with their great new monoclonal antibody. And all I can say is that in 2023, immunoglobulin utilization grew at the fastest rate, that it has, in the last decade. IG typically grows anywhere from, call it, 5%-7% year-over-year, and that has been without any competition from things like the FcRn. So, the fact that IG continued to grow with the competitive threat from argenx's FcRn product, I think that that speaks to the utilization and to the pent-up demand that's out there for immunoglobulins.
Really, the identification of a primary immune-deficient patient is on the rise and also the increase in secondary immune deficiency, based on novel drugs, you know, like Keytruda and CAR T-cell therapy products, things that suppress your immune system to treat your autoimmune disease or your cancer. Clinicians use IG to support the immune system of these patients, and that population is growing at a rapid pace.
Okay, that's great.
Hopefully I answered the question.
Yeah, no, that's excellent. All right, so let's get more into your business.
Okay.
And like I said, you just reported really good Q4 results, took up your guidance for 2024 and 2025 again, and it's been several times now over the last few quarters. So, talk about the key drivers behind that accelerating revenue, the mix shift that's happening between BIVIGAM and ASCENIV. Obviously, ASCENIV is a higher margin product. And yeah, I mean, just in terms of the margin profiles and why you've been able to take up the guidance the way you have in terms of, I guess, the demand that you're seeing for ASCENIV.
Sure. So, I think that our business has a uniqueness to it. Because of that 7-12-month production cycle time, the drug that we're selling today, we made last year. Well, I know how much drug I made last year. In fact, I know how much drug is physically in inventory. I know what the demand is because we know how many patients there are, and these patients receive this therapy every 3-4 weeks. So, these are easy predictors. Our ability to forecast and plan is certainly different than that of other companies that don't have this kind of visibility. I see where the demand indicators are looking as we proceed throughout this year and into next year and even beyond. And we work well with our specialty pharmacy partners, our distribution partners, our infusion clinic partners.
And, you know, we understand that these patients are already receiving IG, and we're now working with our customers to understand, well, how many of these patients do you think you're going to transfer onto this therapy? Doc, how many patients are you seeing in your practice that are not doing well that you want to add onto this therapy? And we can adjust accordingly our production of our products. What's really nice about our business is the plant doesn't care what it's making. It makes the same stuff every day. Whether we're making BIVIGAM or ASCENIV, it's the same manufacturing process. The real science of what we do comes into the selection and the type of plasma that's in there. So, if we're making our Hepatitis B product, which we haven't spoken about, we're using high-titer Hepatitis B plasma.
If we're making ASCENIV, we're using that mixture of high-titer RSV plasma with normal source plasma. If we're making BIVIGAM, it's just normal plasma. But the process is essentially identical. So, we have the ability to plug and play as we see demand increasing for ASCENIV, which we did last year. We added more batches of ASCENIV into the production mix so that it's available now. We see this growth and this snowballing pull-through effect. You know, I've had all these payer consultants, and all these reimbursement consultants talk to me about calendar flip and, oh, we're going to lose patients, we're going to lose patients. For some reason, we're not losing patients. The patients are doing really well on therapy with ASCENIV, and they continue to stay on therapy. I mean, we have some patients that are on therapy now, entering their fourth year of therapy.
There's no seasonality with that, with the product. And I do think that just, you know, in this post-COVID world that we're all in, you know, is there anybody in this room that didn't consider themselves an immunologist at one point in time over the last couple of years? I think that the medical education for the entire population that nobody could have ever paid for, you know, not even Pfizer or Moderna could have paid for. So, I think that, you know, people are hyper-focused, especially if you're immunocompromised. And really what drove us to start the business and why I think we're being successful is that more antibody is better than less than trying to treat or prevent an infection. That's what we learn in our immunology textbooks. That's what we learned through COVID. And I think that doctors, some doctors who know everything maybe learn something also.
I think that patients are more attuned to what's going on. And if you're an immunocompromised patient and you're on IVIg, you know, you're typically hyper-focused on novel things that are in the market. And I think all of these factors together are driving interest, adoption, and acceptance for our products in the marketplace.
Yeah, just on that, maybe talk a little bit more specifically about your commercial efforts and what you're able to do as a small company in the space. So, starting with getting the right plasma donors to come into the facilities, especially if you want more of the ASCENIV plasma coming in. What you could do with the physicians, the immunologists, to help educate infusion clinics, you know, the types of relationships that you have, because you're a pretty lean company. So, we are lean.
I like it that way. Hire the best people that you possibly can. They're going to work harder than more people. But what I'll say is, you know, we ask questions. We're not trying to jam anything down anyone's throat. We're asking clinicians and having a conversation that none of the other producers of IG, I won't necessarily call them competitors, because are they really competitors? They're selling billions of dollars and hundreds of millions of grams of IG. We've got the ability to produce 2 million, 2.5 million grams of IG. So, from a unit perspective, we're a 2%-2.5% player. But what I'll say is that we're engaging with the clinicians on a different level. We're not there selling them products. We're there asking them questions about their patients.
We're asking them questions and we're funding medical education symposia at a number of immunology meetings, Infectious Diseases Week, ID Week every year. We have a symposium. We're challenging these doctors and saying, look, you know, this is not good enough. You know, just the fact that they're alive is not good enough. We can do better. If your patients are on, you know, how many patients do you have, Doc, that are on antibiotics for longer than 3 months, longer than 6 months, longer than 12 months? How many patients do you have, Doctor, that call you, you know, after every infusion and tell you that they just feel crappy? How many patients are you rounding and visiting in the hospital every week, month, quarter?
I think that it's gotten really, you know, the lead nurses in these practices are doing the heavy lifting, but it's gotten the practice, if you will, to look at their patient population and stratify the risk that each patient has. There are socioeconomic factors in play, as I mentioned, some of the other comorbidities earlier. Do they have chronic persistent infections? Do they have a chronic lung condition? If you go to the Asceniv.com website and you poke around, you can see that if you're a clinician, there are certain things that we are asking clinicians to think about from a risk perspective.
And if you click on the patient side, there are a number of questions that we say, hey, answer this survey and then take this to your doctor and use it as a guide to challenge your doctor to see, do you need to change something about your treatment paradigm? So, this is a different way of marketing. You know, I talk about this in the one-on-ones. It kind of fits right here. My background, I've grown up in the IG business. If there's anything I know how to do, it's how to sell immunoglobulin. And my family started a drug wholesaling business back in 1980 focused on plasma-derived drugs. So, I was born in 1976. So, for as long as I could talk and walk, I'd been in this industry. And I think that we're just taking a different approach and engaging the immunologists.
And again, we're offering them something new in the armamentarium. There has been no evolution, no change. You know, Gary, you asked me about Sub-Q. Sub-Q is great. It offers convenience. The patient can sit at home and put on their Netflix and, you know, stick themselves with a little needle and take their IG. Great. But that's not changing outcomes. It's convenience. And we're really the first company that's offering something novel. And one of our KOLs says, Adam, look, it's not the end all be all. We can still do better. And that's why we're continuing to develop new products with our pipeline. But what I'll say is that we're moving the peg forward and we're giving the market something that they can use now for these problematic patients to help improve outcomes.
Okay, that's great. Let's hit the payer question because you get it all the time, I get it all the time. It's important to address. So, ASCENIV, obviously a much higher priced product. How are you able to manage the reimbursement with that product? Let's just start with that. And, you know, if payers, if you've seen any pushback, basically as this product has been ramping up.
I didn't answer it, so, I'll answer it now. I've blended, you know, we say our gross margins are going to be in that 50% range, bringing, you know, you know, 20%-30% down to the bottom line. ASCENIV is roughly an 80%-85% gross margin product. BIVIGAM, along with the intermediate fractions that we sell, these are the byproducts from the manufacturing process, is roughly a 25%-30% margin product. And this doesn't include any of the yield enhancement initiatives that we're working on, which are going to transform our margin profile. And we don't have to get into all that now, but you can read about it. Your question with the payer mix. You know, so, probably about 30%-40% of our utilization for all of our products go through Medicare. So that's government pay. The government probably spends $2 billion on IG.
So, you know, with our, you know, I'm very proud of our revenues, but in the scheme of things, they're tiny. And especially from an IG perspective. With respect to ASCENIV, you know, it's not a product for everyone. And it's not priced like a product for everyone. It's a product for the really, really sick. It's a product for the comorbid. It's a product for the patients who are not doing well, who are costing these payers tens of thousands, if not hundreds of thousands, if not millions of dollars a year managing their opportunistic infections. So, ASCENIV is a drug that you may fail one or two different IVIGs. Some payers have put these step edits in where you have to fail at least two IGs in the last 12 months in order to be considered for a product that's not one of their preferred products.
We love that. In a way, that's our marketing strategy. We can't make enough supply to satisfy the demand that we have today. Imagine if everybody could just get access to this product, we would never be able to supply enough drug. So, the payers are looking at this and as long as it's in the right patient where the doctor is saying, look, this patient has tried IVIg, you know, X, Y, and Z. They still have this chronic sinusitis. They still have chronic bronchitis. They've been hospitalized. They don't feel well. They're white, you know, they just have problems. We're seeing very limited pushback. 70% of immunoglobulin, whether it's on label or off label, whether it's a preferred brand or a non-preferred brand through a private payer, 70% require prior authorization anyway.
So, the doctors are used to having to write letters of medical necessity to justify why they're putting a patient on IG. So, this is not something new that they're doing. We're not asking doctors to do any more work than what they're normally used to doing. But we're providing an alternative. And I really think, look, it seems new, right? It seems like a new product, but we launched it in the back half of 2019. COVID sucked. It was hard to engage with docs, and we didn't sell a lot of drugs during COVID. But if you see the revenue ramp post-COVID and you look at 2022 and 2023, I mean, it's just going gangbusters.
Just to put it in better context, what is the current penetration for ASCENIV? So if it's 10,000 or so addressable patients, and that's part of it also, we're talking small numbers of patients on a relative basis.
Correct. So, you know, I look at it as you have the 300,000 PI patients that I spoke about. Probably 10% of those are our target market. So, there's 30,000 patients. You know, we don't typically quantify it, but it's, you know, somewhere between 500 and 1,000 patients we have on therapy. So, the reason why I'm so boisterous on our conference calls and I say, you know, we think that there's a lot of space and a lot of room. The population is there. The population is there. We have to collect more plasma and make more drug.
Where could the penetration go, do you think? If they're between 500 and 1,000.
I mean, look.
It's whatever you could make.
So, it's whatever I can make. And, you know, look, if you look at my plant, if you look at the plant, if we fill the entire plant with just plasma to make ASCENIV, which I don't think is reasonable, it could be a $2+ billion revenue opportunity. Again, at these 80+% gross margins. Do I think that's likely to happen? No. You know, look, we're very conservative. If you look at our guidance from 2023 and 2024, we really got close to 2024's guidance in 2023. I like to under promise and overdeliver. It makes me feel good. Keeps the investors happy and keeps my analysts happy. But, you know, look, I think that there's room. I do.
I think that this product is making a difference in the outcomes of patients. And quite frankly, I mean, that's the philosophy. That's why Dad gave me the money to start the company. And that's my family's motto. If you make good products that help people, everything else falls into place. And the product is working. It's helping people. So, I do think that we do have a lot of headroom there with respect to the addressable market for ASCENIV.
Okay, great. Also, you mentioned it very briefly, but spend a couple of minutes on the manufacturing efficiencies. High level, what you're able to do and just to clarify for people that that's not in the current guidance. So that could be upside to the extent that you can generate more finished product.
Sure. So, on our website, the corporate presentation, I don't remember what slide number it is. Maybe it's 12 or 15. We talk about this pie chart. So, in everybody's plasma, it's roughly 90% water. It's about 7% protein. Those different proteins are what ADMA and other manufacturers harvest in order to make therapeutic products to give back to patients. Again, we harvest the II+III paste, which is where all the antibodies live. So, the question was about the.
Efficiencies. What you're able to do.
When we're doing this manufacturing process, I don't care about anything other than the IG. That's it. Our process is optimized to yield as much IG as we possibly can. Now, in this process, inherently, there are byproducts. There are waste streams. The things that we just throw away. Some things we monetize, some we just throw away. We have some brilliant people in our process development group. They came to me and they said, hey, there's this new resin from Thermo Fisher that's available, commercially available. I think if we take this resin and we take some of our waste stream, which is where we lose the majority of the finished goods that we want in our manufacturing process, we can get that back. Basically, we're taking something that we throw into biohazard garbage.
And we're going to put it through a chromatography column using this fancy, expensive resin from Thermo Fisher. And we're going to, you know, we haven't given guidance on what percentage recovery we can get, but we think that it is transformative. So, we're going to take something that's garbage today. We're going to elute out over this column and take the antibodies, put them back together with the main downstream process. And we think that that can add, you know, upwards of 10% or more to the finished goods output for the same input. Again, as Brad has been making the point throughout this conference, headcount is right-sized. CapEx is minimal. I mean, we've already spent it. You know, the effect is really going to go straight to the bottom line here. So, it's an exciting time. Plus, we also do fill-finish in-house now.
So, we do have a third-party vendor who we love very much and we're going to continue to work with, but the more product that we fill in-house, we're seeing improvements just because of the efficiency of our fill-finish machine. It's a different process. And we're seeing a couple of percentage point improvement in finished goods yields just based on our own internal filling. So, these are all strategies that we have. And then, you know, I talked about it briefly and we had a press release about ADMAlytics.
Yeah, I wanted you to touch on. I was actually at a dinner last night and someone said, "Where do we see AI in healthcare?" And here this is one example of it.
You know, I'm good at one thing. I'm good at making and selling IVIg. I'm definitely not an AI person, but I am now. I'm a true convert, and it's taken my information technology team a little bit of time to teach me about this, but in all seriousness, we are using AI today to build these pools, if you will, for ASCENIV. So, if you can imagine, there are, you know, as I said, there's greater than 1,000 donors and there's 4,400 units that go into a plasma pool. We've had human beings using Excel spreadsheets with some, you know, fancy, you know, pivot tables, I guess, in it that they can make our batches. It may take somebody a week to produce one or two lots the old way.
Well, ADMAlytics is now programmed not only to look at the RSV titer, not only to look at the number of donors, but also to look at the historical data on protein content from which geographical region the plasma comes from. To sort of make us plasma pools that are very consistent and will produce the highest yield output. So, we're using the system today for that. I believe, and based on what they're telling me, and maybe I'm getting it wrong, but I believe that the system can learn from every batch that we produce, looking at pump pressures, looking at mixing speeds, looking at, you know, the time it took to break down centrifuges or to rebuild something, or the temperature was 0.2 degrees higher or 2 degrees lower, whatever it may be, it's still in spec.
But the computer system is going to learn about what are all the factors that go into producing a batch. And if we can find ways to standardize this, and if the computer can predict when something's going to break a piece of equipment, or when, you know, we're just able to keep the plant operating with more uptime, I think it's only going to help us to improve margins, improve efficiencies, and make us into a better company. So, this is, you know, I'm surrounded by a great team of people who are very forward-thinking and because we're lean, as you mentioned, you know, we're a lean organization. We don't have all the red tape and the BS that bigger companies would have in order to implement this.
Plus, when you look at, you know, some of our larger plasma fractionating brethren, you know, they're talking about yield enhancement in the back half of this decade. Like that's, I get it. They've got three plants, four plants around the world. They've got 60 countries that they've got regulatory approvals in. It's a lot of work for them. But because we have one plant, we're only focused on the U.S., which is the best market in the world for these products. We're able to implement a lot of these changes more rapidly. And I think that's what's also driving the success of our business.
Okay. In the last couple of minutes here, touch briefly on the new pipeline opportunity. So, a hyperimmune product for pneumonia that you talked about recently. And we just covered a lot of stuff that's going to help the business in the next few years. This is something that's farther out, but I don't think people appreciate the different branches that you might have down the road, potentially with multiple hyperimmune products and if that's the ultimate strategy long term.
Sure. So, I'll just touch on, so, we have IP issued through 2037 on manufacturing a hyperimmune globulin with high titers to Strep pneumoniae. Strep is the leading infectious problem and the immunocompromised. It's one of the top 10 leading causes of death in the U.S. and globally. Resistance is prevalent. Antibiotic resistance is prevalent with strep. And, you know, we just look at this as it's a problematic pathogen for the PI population. What I can say is, again, it goes back to my feeling of common-sense medicine. I'm assuming everyone in this room, you are all immunocompetent and you can go to CVS or Walgreens or whatever your favorite pharmacy or doctor's offices and get any vaccine you want. We're very lucky. An immunocompromised patient either will not generate protective antibodies or will have no response at all to a vaccine.
So, we look at this market as we make vaccines for the un-vaccinatable. That's what an immunoglobulin is. It's the ability to confer protective immunity to a patient through human-derived antibodies. Again, very, very simple. Invented in the 1940s, I mean, the ability to harvest this. So, the Strep pneumoniae product, you know, we did some work a couple of years ago and then we put the project on hold as we were fixing our business and ramping up production and commercializing our products, but we've dusted off our notes and we've got an established and validated method for immunizing plasma donors with commercially available vaccine to Strep pneumoniae. Collecting that plasma and we're going to produce a bench-scale batch of this drug and run some animal models and really use the way that we develop ASCENIV.
Use that as a proxy for what we're going to do with the Strep pneumoniae product. You asked about the follow-on pipeline. Our IP covers manufacturing specialty hyperimmune through testing for naturally occurring antibodies, which we apply to ASCENIV through vaccination of donors, which is what we're applying to the Strep pneumoniae. But we also have another component where we can make a normal immunoglobulin pool, if you will, and then spike it with a monoclonal antibody to enrich it. So, we've got this very interesting and novel IP, and I think over the next decade or so, you'll start to see us as we begin to really produce cash flow, which is the stage of the business that we're in. Look, I'm hyper-focused on creating shareholder value. Gary, this is an investor conference and.
Okay, that's great. We're up on time. We'll end on that note. Thank you, Adam. That was a great overview. Good luck with all the continued progress and thanks everyone.