Good afternoon, everyone. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler, and before I begin, I am required to point out certain disclosures regarding the relationship between Piper and our next presenting company, OPKO Health, which are posted at the back of the room and also at the registration desk, so OPKO's partner, Pfizer, is selling once-weekly human growth hormone Ngenla around the globe, with OPKO eligible for gross profit share. Recently, ModeX initiated the phase one study of the multispecific MSTAR antibody, MDX-2001, in cancer, and ModeX has also partnered with Merck to develop an Epstein-Barr vaccine, as well as with BARDA for COVID and flu, and recently, the company has actually been very busy on the transaction side, and the BioReference Diagnostic Labs recently sold certain assets to LabCorp for $237.5 million, dramatically strengthening the balance sheet. There are some other things we'll talk on in terms of financial updates. I'm pleased to have with us Vice Chairman and President Elias Zerhouni, Executive Vice President Steve Rubin, and also Chief Financial Officer Adam Logal. Guys, thanks for being with us. Thank you. So after a long and winding road, and Ngenla now approved and really around the globe, Pfizer recently revalued their inventory, which has resulted in somewhat of a lower profit share than we were thinking. I think it came in around $7 million in the third quarter and certainly growing. So I guess my first question has to deal with, how is the daily market transitioning to long-acting HGH? And what are the benefits of having Pfizer as your commercial partner? And I'll kind of come back to sort of the mechanics in terms of the revenue recognition and revenue share. I think. Yeah. So what we've seen to date is about a 15% market share for the long-actings on a global basis. There are certain markets where it's as high as 25% or 26% market share for the long-actings in comparison to the dailies. We expect that transition to continue to pick up. We were seeing most new starts are on the long-acting, and that trend should continue as other patients transition off the dailies and grow the long-actings. Yep, that's really helpful. And then what does Pfizer bring to the table? Obviously, they sell Genotropin. And maybe at a high level, walk us through how the profit share works. Yeah. So Pfizer's global infrastructure gives us a broad reach to effectively every country in which Pfizer's operating, and there's a market for growth hormones. So Pfizer's launched, as you said, in over 25 countries. They're launching in another 20 countries over the next several years, every priority market on the market. And what's important is we share in the gross profit of both their daily growth hormone product, Genotropin, as well as a long-acting Ngenla. As the franchise grows on a global basis, our profit share percentages go up. And as the long-acting takes up the majority of the market share, our gross profit share percentages also increase dramatically. Yep, excellent. And where are we now kind of between U.S. and international revenues? Can you provide any color on that? And where are we in terms of what percentage you're actually receiving, if you can share that too? Yeah. So the gross profit share percentage today represents about a mid-single-digit effective royalty rate on the franchise. Pfizer did last year a little over $400 million in Genotropin and revenue. They don't currently break out the Ngenla revenue, but the majority of the revenue that's being generated by the franchise is still coming from the daily growth hormones. We've seen, again, good uptake on an international basis. They've been in market internationally for quite some time now. They're going into their third year. In the U.S. market, they're just finishing their first year. So the uptake in the U.S. market's been a little bit slower than what we're seeing internationally. Yeah. And clearly, that'll grow with time. How big of an opportunity do you think Ngenla can be for OPKO? Yeah. So Pfizer's the commercial partner, so we'll go with what they've said. And they've guided that they think Ngenla is a $500 million to $1 billion product over the relatively near term. Great. Excellent. So I'm going to just pause there. But transitioning over to ModeX, so this is a really cool part of the story and one that over the last year plus I've really gotten to learn more about and appreciate in terms of the future of OPKO. And you guys are developing multispecific biologics to treat cancer and infectious disease. Elias, perhaps you can start by describing this modular multispecific antibody platform. Right, so when you look at any disease, when I was the NIH director, I was always wondering why we always had to combine drugs to treat cancer or immune disease, and well, the reason you do is because diseases are complex. And if you attack them one target at a time, you don't get the same effect as if you attack all targets at once, so when I was at Sanofi, we created a breakthrough lab with Gary Nabel, and we found a way of building antibodies that are as potent, if you will, as the normal antibodies, but they have four warheads. So that's what a multispecific antibody is. It has more warheads than a regular monoclonal antibody, which has one, but people were saying it's impossible to do, and we worked at it, and we found a technology platform that allows us to do plug and play. So, anytime you want to do something like against COVID, right? COVID, the antibodies stopped working very quickly because they only attack one point. With our quadrispecific, we attack four different points on the virus. The virus cannot escape. And so we found that by doing that, you can really treat the disease, but you can also prevent the disease in patients who are immunosuppressed. I mean, that's the idea. And 15 million people are immunosuppressed, and we still have 400-500 deaths a week in COVID. So that's the idea of the platform. And it can be applied to cancer. It can be applied to infectious disease, immunology, and so on. And you started with COVID. So let's talk about that for a moment. You guys were just awarded an additional $35 million under the BARDA contract to develop more MSTAR antibodies against COVID. And I think you're also doing some work with flu there. Maybe you can describe that collaboration at a high level and what you're working on. Right. So when BARDA came to us, they gave us $168 million saying, "Look, you take 59, show us that the platform works." And that's what we did in the first year. When we finished the first year, they saw what we had. We showed them also early data on flu. So they added $35 million to accelerate the COVID program, and they freed up 16 to start the flu program. So we are both doing COVID and flu multispecific antibodies as both a preventative for people who are immunosuppressed. It's like RSV antibodies or patients who are immuno-impaired, let's say. And that's really something that obviously is of interest to them, but it's of interest to us because that's a market that's recurring. But they also want eventually, if it works, to stockpile because these antibodies, every new variant that came up that we didn't know about, we're still active against. Because of the breadth of the. Because it's the multispecific. I mean, basically, four warheads hitting the virus. The virus can't escape. Yeah. And do you do different binding moieties? Or do you use valency where you're actually doing multiple so that you strengthen the binding? That's a good question. So you can do both, right? So we know that certain parts of the virus don't change as much, class three and class four regions. So you could do a tetravalent against those two, so double targeting. And that works. Or you can do four against the class one, two, three, and four, which are the areas that mutate. But for one virus to come up with four mutations at once, if you look at the numbers, it's in the billions. Yeah, it's not going to fit. Multi-billions, yeah. Yeah. So sticking with infectious disease, you guys entered into a really great partnership with Merck, Epstein-Barr virus. So tell us how you're applying the technology in that case for MDX-2201. And maybe you could tell us when you could go into the clinic. Right. So let's talk about Merck. Merck is a different platform. Merck is another platform based on nanoparticles that can carry multiple antigens. And we developed it for Epstein-Barr virus because Epstein-Barr virus is responsible for 200,000 cancers a year. And so we know that if we can prevent EBV, we can prevent the cancers. But also, it's connected to multiple sclerosis, which is why Merck came to us and said, "We'd like to license this, but you help us continue the development to phase one." And we've done it. Merck gave us $50 million upfront and $870 million in milestones plus royalties, but also continued to pay for the research. So we are now at the point where they're taking it over and entering the clinic as soon as they can. Yeah. That's really exciting. MDX-2001 is a different game. It's a different molecule, which is for cancer, and cancers that have what we call TROP2 or c-MET receptors. There are 10 types of cancers that have that. Yeah. So let's talk about that. So MDX-2001 is your tetraspecific T-cell engager antibody for solid tumors. You guys just started the phase 1. So maybe tell us a little bit more about the construct and then walk us through the design of the phase 1. Right. So it's called a T-cell engager. What does that mean? That means that we build an antibody with two warheads of each, one for the cancer cell and one for the T-cell. T-cells destroy cancer cells. So we bring them together. But the difference is that we have two targets on the cancer cell, which means, again, that the cancer cell will not escape us, will not develop resistance easily. It's the concept of multi-targeting, right? And then the two CD3 and CD28 do two things. The CD3s that we have are short. They don't last long. The T-cell gets activated and eventually gets exhausted. But if you do CD28, which is called the second signal, it proliferates for longer. So think of it as dual targeting with a long-acting TC engager. And the beauty of it is that the targets we pick, TROP2 and c-MET, are very, very common in cancers like lung cancer, breast cancer, gastric cancer, pancreatic cancer. And so that's what we're trying right now. It entered the clinic. FDA gave us our approval day one. I mean, as soon as we applied, they really had no problem for us going forward. And the reason is because these molecules can be very powerful. And so we're looking at the balance between efficacy versus toxicity, and we're still going to the phase one. You have the construct for MDX-2001 with TROP2 and c-MET and CD3 and CD28. Now you're doing dose escalation in the phase one study. That's right. Is that accurate, and is it an all-comers study or in these kinds of cancers? It's in these 10 cancers that are TROP2 and c-MET positive. Positive. Yep. Awesome. That's really exciting. That's for solid tumors, and then we have one for liquid tumors. It's called the CD1920 receptor for cancer cells, leukemias, lymphomas. And then CD3, CD28 on the other. That's for liquid tumors, so the first one is for solid tumors. The second one's for liquid tumors. Yep. And where are you guys in development for? Pre-IND. We're finishing all the work to get to IND in the, I would hope, second or third quarter of 2025. This year, we'll get an IND. This year, yeah. That's great. And not necessarily on your development path because obviously there's a lot to do, especially with the multitargeted agent in lymphoma. But there's obviously been a lot of interest recently in using either bispecifics or CD19 CAR T to deplete B cells and reset the immune system for severe autoimmune diseases. Have you considered that at all? Do you think this agent may be applicable for that? Or do you have more than enough to do on the other? No, I think we did. That was one of the reasons we did. Because when you look at CD19/20, what happens is if you attack a lymphoma or leukemia that has CD19 predominantly, over time, it stops producing CD19 and then goes to CD20. And by attacking both, you prevent the cancer cells from escaping. However, the same idea you can apply to autoimmune diseases. It's the same thing that you would get in terms of CAR T cells acting on CD19 or CD20. And so we think there's a future for autoimmunity as well. Yeah. Very cool. I hadn't even put that together yet, but. Right. People are telling us it may be bigger than the liquid tumor because there's nothing there that works. The key obviously is safety in that setting. So it'll be really interesting to see how that emerges. Whatever you learn in oncology can actually be applied in kinetics and things like that, just with respect to the. Exactly right. So what are your plans more broadly for both of these platforms? For the MSTAR multivalent antibodies, are you going to develop new additional programs? Are you going to do partnerships? And then also on the infectious disease. As you know, we've raised $250 million since we came to do non-dilutive financing of R&D. I think it's a good idea. We still have a lot of incoming interest. We want to explore that into strategic partnerships because I don't think OPKO, if you really look at the development like a vaccine like Merck, there's no way a company our size can do that without a partner. If our oncology portfolio proves that it's valid, because I think a lot of people we talk to say, "Well, four warheads, it's a complicated thing." And SpaceX, that's what we call it. Are you really going to the moon and recovering the rockets? That's the rocket. So we need to get it done. And we are. We got to the clinic. FDA let us go because initially they said, "Oh, FDA will never let you. It's too powerful." So now we're there. Yeah. But we're still looking for strategic partnerships. Yep. Awesome. Just since we're on the topic, when it comes to manufacturing, are these complicated to manufacture? How are you guys doing that right now for the clinical? Right. So everybody would tell you that multispecifics are really, really hard to manufacture. And when we went from bispecific to trispecific to quadri, and then we can do six now, six targets. And people said, "No way. You will not be able to do it." And there is truth to it because if you do more binders, more warheads, you have to have different plasmids, different things going into the manufacturing cell. But the secret to our platform is that we found a way to do it with one long chain. It's called single chain. And then we designed it so that it can self-assemble. And when we did that, we found we have yields, what we call yields. When you produce these things, there's a certain number of grams per liter. People said to me, "Elias, you'll never get more than 100 milligrams," which is not feasible. Not a lot. We're getting 5 grams, 8 grams per liter. So it's not as hard as people thought. It's a real breakthrough. People now believe it. We'll see what happens in the clinic now. Yep. Great. That's really exciting. So one of the other new and I think very interesting angles at OPKO is his partnership with Entera to develop oral oxyntomodulin with their N-Tab technology for obesity. Firstly, if you would tell us about that peptide and what its role is, and then how you're working with what you guys are bringing to the table and what Entera is to. So all of these peptides are derivative of the same molecule for oxyntomodulin. Oxyntomodulin was the molecule that was discovered that had a GLP-1 and a glucagon with it and was active hormonally. And so whether it be the Novo Nordisk molecule, they're all variants of the same peptide with mutations. Ours, we had an oxyntomodulin initially that we even carried to phase 2. And we had 9% weight loss and so on, but the molecule was too big. And so we redesigned the molecule to make it much smaller with what we call fatty acid chains. And now we're testing. We tested it, and it's very competitive, at least in the preclinical area. So that's what oxyntomodulin is. It's a modified form of the natural GLP-1 glucagon peptide, which really could be very important in managing especially liver diseases, liver disease in MASH. So that's what it is. Now, when you look at the market, there are 60 of them out there, and everybody wants to get into this bandwagon. We did the first publication that was in the field was done by my team when I was at Sanofi. So we know something about it. And we had developed actually a coagonist. The problem is obviously the vomiting and which you get when you provide a high dose over a period of time, then the length of time once a week. So then we met these people from Entera. And Entera has a technology which doesn't modify the active, right? It doesn't change the oxyntomodulin, but finds a way to put it so that it can be absorbed orally. And when you look at that, there is merit to that. Not that needles are impossible to take, but you can maintain an equal level day in, day out, and that really changes the safety profile. Not safety, but tolerability. Efficacy, probably, if it's happening out. Right. Because you don't go through that enzyme. You don't have sufficient absorption. Yeah. Yeah. Very cool. Again, remember, this is a little different. People always say, "Oh, it's like Rybelsus." It's like Rybelsus. That's what it is. No, it's not. Because remember, we're doing an oral long-acting. It's different than saying you do an oral with a short-acting peptide, right? Yep. Which was the initial one. And tell us about that partnership. So is this a collaboration? Are you providing the peptide for them to develop? What are the kind of future economics for you guys? No, that is to come. We're probably at that point now. We started off with two peptides, and we provided the peptides that was our only cost. They formulated it with their platform. They did for GLP-2 and oxyntomodulin. We have proof of concept on both of those molecules at this point that will be presented shortly in a scientific conference. We are actually in discussion on how the partnership will work going forward. Really up to date, it's more been kind of a pilot deal or discovery deal to sort of make sure this was going to work together. 100%. Yep. Formulated it. And then, are you guys at a point, and can you comment? Do you have the molecule ready to do official preclinical work? Or do you have a line of sight to? We do. We're actually continuing to develop the subQ version as well. And they have nothing to do with that, of course. So we are producing API now. We should have that in the early part of next year. We expect to go into the clinic really on both with Entera on the oral and on our own with subQ, probably early 2026. Okay, and the first study that you did in phase two, that was the subQ version of oxyntomodulin? It was a pegylated version. Pegylated subQ version. And that's what you'll kind of reinitiate. Will you build on the phase two data and go into registrational trials, or do you have to kind of? No, because it's a different molecule. Okay. But you do have good data. You have good data. Safety. Yeah. So you know what it does safety-wise. It would be nice if we could. We're hoping to have discussions with the FDA that shortcut the toxicity work at least. But we'll see. Yep. Great. So that's awesome. So you guys sold some of the assets of BioReference to LabCorp. Adam, I want to spend the rest of the time that we have left. You also did a $250 million HealthCare Royalty Partners note, new convertible debt, and announced a $100 million share repurchase. So remind us where the cash is. I know this is probably like a moving thing. Ask me at the close today. Where does the debt currently stand? How long does this fund the company? And what's left on the share buyback? Yeah. So on the share buyback, we bought about $40 million in the first nine months of the year under that buyback program. We've continued post the third quarter, but that will continue this year. So you got a sense there. We ended the quarter with a little over $400 million in total cash. We also have some liquid investments that we've been monetizing over time to continue to expand the cash pile. So we'll continue to buy back convertible notes on the open market as well. We've been active there to continue to redeploy capital back from the balance sheet to drive it up. From a total cash runway perspective, we look at it and we're not going to spend all of our cash into R&D or other operations. Elias mentioned the partnerships that we're going to look for non-dilutive financing and to share some of those R&D costs going forward. We look at the balance sheet as fully funded at this point. Yeah. That's awesome. Again, great work because there were a lot of moving pieces, but for all of you guys to really reinvent and start to think about ways to monetize BioReference, it's a lot of work on my part to kind of a lot of hard model work. And I'm not. I'm a biotech analyst. I'm not the greatest modeler out there. So I've been dusting off my finance and accounting skills. I appreciate that. And very much looking forward to some ModeX data next year and potentially some new partnerships to validate that. So guys, thank you very much. I appreciate you being here and looking forward to an exciting 2025. Great. Thank you. Thank you, sir.