Hey, good morning. This is David Amsellem from the Piper Sandler Biopharma team, and welcome again to the 36th Annual Piper Sandler Healthcare Conference. Delighted to have Amneal here and Chirag Patel, Co-CEO. We don't have your brother here, but you know we have you. Yeah. But we have you. We're fine to go ahead with both of us. Yeah, but delighted to have you here, and certainly lots to talk about. We'll just dive right in. Sure. Let's start with Crexont, which was approved earlier this year and is launched, and it's a pretty important brand product for the company. So I wanted to pick your brain on just your overall commercial strategy for the product in Parkinson's, and how differently is it being positioned relative to Rytary? David, before I go there, let me just share great news, and we are blown away with what we are hearing. We were at Movement Disorder Specialists Conference in Philadelphia. Not one MDS, but almost 20 of them approached me. I spent a whole day there, actually a day and a half. What they're hearing from their patient is just outstanding. They were telling us stories that they only need two per day instead of five Rytary or four Rytary. This is all Rytary comparison. On IR, we are absolutely even much better than that. That's first great news. We thought we would exit this year in two months, or it'll be three months in December, end of December, at 0.25% of market share. We're exiting at 1%. We're seeing a lot of momentum, great momentum in coverage. We already got some coverage. It took Rytary a whole year to get 11% coverage. We got in the first two months 22% coverage. We expect more than 50% coverage next year, and it looks like we'll have more coverage than Rytary. And the scripts growth, right, it's coming from not only the MDS, but the new prescribers. You mean general? Just early days. You mean general neurologists? General neurologists, which are 12,000 in the nation. Sure. We have a team of 100 people, just dedicated MSLs, salespeople. We know this market for 10 years, great relationship with KOLs. So we're very excited about Crexont. Okay. So a few follow-up questions about the product. So we all know Rytary is losing exclusivity next year. So I think one of the big questions is, okay, Crexont is growing, but you do have the loss of exclusivity of Rytary. What does your Parkinson's franchise footprint, sales footprint look like in 2025 versus this year? The footprint is more solid. Yep. We have Ongentys, right? Yep. We got Rytary continues, but we stopped marketing now. All focus is on Crexont and Ongentys. With that, we don't see much of a fallout in terms of net revenue for the year because Crexont is picking up. Ongentys is picking up. Then from 2026, we should go on a plus side. Then 2027, 2028, we should reach our peak sales that we have forecasted, $300-$500 million. Okay. Okay. That's helpful. So you mentioned good payer access. Yeah. So far. I guess looking ahead, though, and I realize Crexont is a different product than Rytary, but. Much better. When there is a generic for Rytary, how do you see the payer landscape changing, if at all? If they were going to change, they would change now, right? Yeah. But they're seeing Rytary and Crexont totally two different products. So they're independently covering Crexont. We haven't gotten pushback on that because Rytary is going GX. And Rytary is very, it's 28,000 patients out of 500,000 potential patients could be using this product. Sure. They should not be on a 30-year-old IR. So we're trying to change everybody's mind. And we have a label which includes naive patient. Rytary did not have that. Sure, so let's. We're running a phase four. We'll have more data as well. Yeah. That's a good point. Okay. So let's talk more broadly about brand assets, and I know you get this question a lot, but I have to ask it. No, that's fine. Just how much of a priority is in licensing and acquisitions of a brand asset here and there? And what's your capacity in terms of how big you can go? Capital allocation. Yep. Our first priority is to pay off $150-$200 million debt. We're down to 4.2 times leverage. We'll be at four times by year-end, which is a year earlier than our promise, and now we're going for three times leverage. That doesn't stop us from the investments, so we have organic investments, which is about almost around $200 million in R&D. Obviously, the CapEx we spend is an additional investment, and then in licensing, we look for Ongentys kind of opportunity. So we'll keep doing it because our operating cash flow is still great, and the interest rate hopefully starts going down. We may reprice it so that further reduces our interest costs, increases our operating cash flow. With that, our priorities for the M&A is only on the branded side. Yep. Some biosimilar. So pretty much think about outside of the R&D and within, even in organic, we are balancing between, we have reduced our GX spend to almost 40%. 40% is biosimilars and 20% is specialty. So when I see that GX going down to probably 30%, biosimilar would stay around 40% and 30% specialty. Are most of the brand assets you're looking at in neurology, or are you thinking about? Onco as well. Okay. Because now we have a team selling three biosimilars. Right, so your biosimilars. Yes. And we're excited to find the niche opportunity within oncology. We're excited. That's larger than neurology. Yep. Okay. So in terms of biz dev, neuro and oncology are areas that. Yes, and we'll quietly add some pipeline asset because we have excellent R&D capabilities, U.S., India, thousand scientists, just all the clinical setup, so when we have it, you will know. Okay. You did have some recent developments on the DHE auto injector. Yeah. And so maybe you just walk us through that product and that opportunity. I mean, DHE is a, it's a good drug for migraines. So help us understand how you're thinking about it. So this drug-device combination and auto injector, which helps patients, is so big, right? So cluster headache is the pain. Everybody knows it's really, really at the level of a gunshot pain level. So for them to go to clinic, wait for an hour, two hours, three hours versus have auto injector, which allows them to administer at home. So we're very excited from the patient perspective. And we see this product. We're right now publicly saying $50-$75 million. We're most likely launching the late first half next year. We have filed it with FDA. And so we expect we had to change the manufacturing facility because the CMO we were using had FDA issues. So we moved it to our own facility. Do you have commercial infrastructure in place? Do you need to add headcount to support that product? So. Migraine specialists? We would add some. Okay. But we will also use our Unithroid sales team. Your Unithroid sales team. Okay. And. Just reallocate those reps. Yes. Yes. To—understood. And some of the sales is through that channel as well. Okay, and speaking of Unithroid, I mean, that's grown fairly significantly. Yeah. Help us understand why that has been a growth product for you, given that levothyroxine is, there are generics in that market. It's a unique market. What's been the driver of continued volume growth there? David, you know that 20% of patients suffer through the fluctuations in hypothyroidism treatment. They used to be either on Synthroid or Mylan generics or Unithroid. Then five generics approved. So now the patients are like ping-pong balls. They can change. The pharmacists would change this NTI product, narrow therapeutic index. And these 20% patients, which we're talking about 20 million prescriptions, this is huge, right? So they do not like the fluctuations. They have the side effects with fluctuations. They want to stick with their brand. There's the depression issues, placebo issues, right? So Synthroid, as you know, has a following. We have created a following for Unithroid. It's a made-in-USA product. Excellent. The results are the patients love Unithroid. So we're just marketing that and making it accessible for them. We haven't even scratched the surface. It's generic, so we don't expect that to go too high, but we're going to approach 1% of market share. Even 2% can double this product. So we'll keep marketing it. It has to be also affordable because it's GX. So we're walking a fine line and growing the product. Okay. Let's move on. But it's kind of a permanent brand. There's no IP or any issues there. Right. Right, and even though there are generics, I mean, to your point, because the dosing is so individualized and so carefully calibrated. The pharmacy changes the generic manufacturers. That's right. So the patient may get company A, company B, company C, and they don't work the same way because of the NTI, and FDA did not approve levothyroxine for a reason for years. Right. And then they loosen up the guidance. Five approvals happen. Yeah. Let's move on to injectables. So that's obviously a growing part of the business. Remind us what the current top-line contribution is for generic injectables this year. And just in general, what's your aspirational goal in terms of number of launches of injectables annually? It's about $175 million. Yep. We said we would grow to $300 million, but it will grow higher than that. We will reach our goal to $50, $300 next year. Then it will keep growing. It's a diversified strategy we have. It's not just the volume. We're never a volume player, right? Sure. So we came up with, as you see here, three 505(b)(2)s for Focinvez, Pemrydi, and we just launched potassium phosphate bag, which was a compounded product. Now RX and ANDA available in the hospitals. 90% hospitals switched within one month to our product because sterility is guaranteed versus compounded. Sure. Plus, the shelf life is two years versus compounded, which is 60 days to 90 days. So we have 15 of such products, which is 503, changing 503 into the ANDAs and coming up with a ready-to-use, whether we take the excipient out, which is causing side effects. So it's all highly improved formulations, reducing the medicines, the errors in the hospital. So that's one category growing. Three launched, 15 in the pipeline. Then we have the microspheres, liposomal, all the technology we filed, Risperdal Consta. We just got Byetta approved. So we got our first GLP-1 approved. It's fantastic. So that sets up well for Metsera and other GX to come because this took time to have that technology and capabilities. And then we have shortage products. So we have 13 shortage products we are providing. We'll provide more. So this is a very diverse portfolio. Our capacity is 20 million to 60 million, and we're also now putting up a sterile infrastructure in Long Island at our plant, which is a 700,000 sq ft plant. The 200,000 sq ft, we're making it sterile. So you've talked about shortage products and also you're focused on complex injectables as well. I guess my question here is, as you look over the next sort of one to two years, is more of the growth going to be coming from more complex products, or is it going to be coming from shortage products? Complex. It's going to be mostly complex. Shortage, it's more of a public service as well. Right. It's complex products, these 505(b)(2) products, 505(b)(2) drives tremendous growth. Okay. And in terms of capacity, are you right-sized? How much more capacity? We have excess capacity now because of this pipeline that needs capacity. We had to build it. So we probably still have 50% capacity left. So we're utilizing 30 million. 30 million is left. So we don't need to add new CapEx. We have it already. Okay. In terms of the generics pipeline, broadly speaking, can you talk to your evolution away from oral solids and talk through your pipeline right now in terms of how much of the pending ANDAs are not oral solids? Obviously, that's been a big change in Amneal over the last few years, but maybe help us better understand where you are right now. So Tony is good. He keeps me up to date. It's 24% is oral solids and 76% is non-oral solids. These are filed products. Filed products pending in works is 90% non-oral solid, 10%. Okay. Current revenue mix is also 24% value is just OSD, 76% non-OSD. So look, I know the generic industry people are saying the investors specifically had like it fell out of favor. It's an essential industry. Sure. LOEs double than what it was in the last seven years. We're just entering the golden times of the generics industry again. Redefine as affordable medicines industry, including injectables, including these 505(b)(2) bags. So we're changing how it's delivered, drug-device combination, biosimilars, and complex GX inhalation ophthalmics. So that is us. We should not be compared with companies like Aurobindo, which plays in a massive volume, right? Right. I think the investors will warm up now because it's better bets than having one or two biotech, and we don't know what phase three is going to show up. Here we know that these products are coming. The world needs it. There's international growth. There is a huge biosimilar market. There's $200 billion of brand LOEs in the next seven years. The $30 billion market is being built on biosimilar, net sales of manufacturers out to market. IQVIA will show you $60 billion. Sure. And actually, that's a good way to segue into your biosimilars business. So you have three. Can you talk to the current top-line contribution from the three biosims you have on the market and how you see the aggregate opportunities for the three, the Avastin, Neulasta, and Neupogen? Neupogen. Yeah. So we are at $125 million this year, growing to $200 million range. Then OBI comes. It will even go higher. We expect OBI to be launched by the end of next year. So that would be a great franchise. One of the Indian companies bought Coherus franchise for $500 million. Yeah. I saw it. Yes. OBI and PFS, then we have Denosumab following up, and that's a good product for us as well, then Xolair is the biggest in the current pipeline, and then we have undisclosed products and integration, about eight to 10 biosimilars that we'll be disclosing over the next year or two years. Is it eight to 10 that are currently partnered with you? It's not partner. As we have said before, this business in biosimilars, the companies would be successful who are vertically integrated. So we plan to integrate, have the manufacturing and R&D capabilities, and much bigger pipeline that we are making biosimilars for the international market because there's 40% value outside, 60% in the United States because we want to be a serious competitor in biosimilars. So we would compete with great companies like Sandoz or Celltrion, Biocon. And because to do the PBM negotiation early, to have the proper setup for sales marketing for all these products and then managing when ASP goes down, you must have your own manufacturing. True margins would be difficult for biosimilar business. What does that mean for you guys in terms of CapEx and deployment of cash resources to get to vertical integration in biosims? It was just shifting it from the GX, which we're done. We have enough CapEx into biosimilars. Okay. Not much of an addition except for the Metsera project, which is our GLP-1 portfolio. Yep. We'll have a partner is contributing $100 million, and we're putting up about net $150 million over the next three years. So that would add CapEx. But it's not gigantic CapEx that goes out of like $400-$500. We're talking about $60 million going to $100 million, maybe $120 million for a year, a couple of years. Okay. Because we are not spending any more on GX. Okay. That's helpful. That's helpful in understanding the CapEx. But massive values it's creating, right? Having an integrated portfolio because there are not many players left. Where do I in-license because they're unable to continue on? Sure. And biosimilars, broadly speaking, are just not going to have the kind of commoditization that you'd see with oral generics. No. Different markets. That's the high value, right? Yes. Because the products are priced very high to start with, branded products. So let's talk about Metsera and GLP-1s. But maybe first, just talk about the collaboration. And I think there's one product here, MET-097. Yep. So maybe talk about that, the collaboration and that product. So MET-097, I'll share with you whatever is public. Sure. It's an ultra-long GLP-1 going into phase two and soon to be in phase three. It's a great team at Metsera, and they have multiple other products, so we're partnered with all of them, so we work with them on oral peptides as well as injectables. It's a great partnership, known them for 15 years, and the engine we are providing is our CMC engine, our manufacturing engine, engineering engine, so they can go and focus on more clinical trials and keep advancing the science and do the marketing. We got some marketing rights for India and other 20 countries, which is good for us, and we are building two state-of-the-art plants, one to make peptides, which is key capabilities because nobody has a large scale except for Lilly and Novo, large scale peptide manufacturing capacity. And then we have the injectables, the devices, which was about $100 million capacity we're building gradually. In terms of your overall GLP-1 strategy. Yeah. I realize this is probably not a ton you can talk about here, but you've got liraglutide. There's. Exenatide we start with. Or sorry, exenatide. Extenatide. There's. So we're launching that, launch already. Liraglutide is a. In the pipeline, let's say. In the pipeline. But then we got Trulicity is another one. Yeah. So that's another one. Huge. That's another one, I'm assuming. It's a diabetes patient. Yeah, yeah. Okay. But we're not disclosed, but these are the assets, right? Yep. And then Metsera 097 plus the other three, they have Amneal combination. So they got a big pipeline. So we keep working. Metsera is one. We would do the generics, then biosimilars, and then we will add on the other CDMO offering because it's state-of-the-art two plants. So even Lilly, we'll approach them. Novo, we can do work for them. So there's additional stream of revenues. And eventually, we'll have the GX for Mounjaro and. And semaglutide. Simaglutide, yeah. So to be clear, all of the usual suspects. Yeah. So it's a long-term, 10-15 years. We want to be really leading players who have capacity, not just file the product. Because you need capacity to make your own peptides and have the fill and finish. Looking at, I know Trulicity is one that's interesting because I think it's a 2027. Yeah. Trulicity. But so that's one that you're, I know you're not disclosing where you are, but let's assume that. Is it safe to assume you're going to be a market participant? Those kind of products we would, as it fits our strategy. Okay. And then just lastly, very quick question. I know we started late, so I'm going to. Give me one more question. Give me one more, but just the AvKARE business. Oh, that's a great business. Which I guess it's a little bit of a different business. So is it a core part of Amneal? David, I love that you cover all the bases. So it is now we say it is core because we are loving the business. It allows us to, you hear all these middleman stories, right? And the government is getting stricter and stricter on middlemen. Middlemen are taking a lot of profits from generics distribution. So we rather control as much as we can. It's not a big thing that our customers who are also the middlemen would notice, but it's enough to have a profitable business keep growing. I mean, it's doing great. It's a double-digit growth every year, as you know. And next year's even looking better. So that's why we like to keep the distribution capabilities. If we can reach our customer directly, we'd like to do that. All right. And that's the differentiation from the other, if you call it GX company or. The red light is blinking, so. All right. I'm going to leave it.