Okay, great. Thank you, everyone, for joining us today. My name is Matt Dellatorre, and I'm the Generics Pharma Analyst here at GS. We're very pleased to have Amneal Pharmaceuticals with us for this session with Chirag Patel, Co-Founder and Co-CEO, and Tasos Konidaris, the Chief Financial Officer. Great. Maybe just to get started, how about just level set us on where Amneal is headed from kind of a long-term perspective? Talk about your vision for the company over the next five years and what you all are most focused on from an execution perspective over the next, say, 12 to 18 months. Great. First of all, thank you, Goldman, for starting covering the essential industry. It was like we were neglected. Now it seems like more investment banks are covering us. As you know, 92% of prescriptions are filled by generic drugs, which we call it now Affordable Medicines Group because it includes biosimilars and certain hospital injectables, which are 505(b)(2)s. It is Affordable Medicines, extremely important for any nation. For our country, 92% prescriptions, that's where all the heavy load happens. Without the Affordable Medicines industry, the costs would be so high, the shortages. It is an extremely important industry for the national security, for the country, for the patients. We're glad to be one of the leaders. The five-year vision, 10-year vision, as you know, we have a very core business that is very strong. Where we are focusing is on expanding biosimilars, which we see a huge opportunity. There are about 100 molecules, only probably 20 molecules are actively being worked on. 80 are not being worked on. Those could be somewhere between $500 million annual revenue to $4 billion. For some odd reasons, they're not being worked on. I tell you why, because a lot of investment is required. Seven years, only big companies can sustain it. Amneal has entered very smartly in biosimilars. You expect us to be the top five players globally in the next five to seven years. This is multibillion dollars in making for us. At the right time, we'll disclose the right pipeline. We would have to, at some point, do our own manufacturing, our own R&D on top of what we license. To be top five, we will need to have a pipeline, which is 15 assets, 20 assets, 25. Every year, we're adding three, four. That is one category of growth over the next five to 10 years, huge category. It is a very complicated manufacturing. You will see when we are able to announce how long the investments have been and what the R&D, just like what we did in Complex GX, how we can lead the R&D. The second growth is in our GLP-1, the Metsera announcement, which is very—we do have a generics approval, which is a Biotech. On top of that, we have a Metsera transaction, which we can talk more about. They are making very good progress in their pipeline. Not only do we supply, we are the majority supplier for them globally, but we also got marketing rights for 20 countries. If you just look at India, which we have marketing rights, India has almost 134 million people who could be using the next-generation diabetes and weight management therapy. Even, let's say, and we did further survey that how many people can afford $600, $700 per year, not per month, about 55 million. There is a huge market just for GLP-1s. Let's see the filing timing. When can we file in India with global filing the same product? Oral will also increase the utilization of the product. Huge growth in GLP. We could do work for Lilly's and Novo's as well. Generics, we're not too excited on GLP. That is another big business being built. You're not excited? No. It's so much innovation going on. The pricing is going to come down. Then generics, Emma, they price it at wherever they'll price it versus the—even Mounjaro will be priced competitively. There'll be third entrants. It'll be more consumer products. They would want the latest and greatest, like Metsera has a monthly injector, right? Monthly injection is better than the weekly. The side effect profile could be better. Maintenance dose could be just once-a-day pill. The specialty side that we have successfully launched Crexont, and now we're launching Brekiya. At the right time, we'll add one or two more products or disclose what we work within our R&D. We may license some assets. Those are high probability of success assets, so they're more 505(b)(2)s. This is the vision for the next 5 to 10 years. Completely be focused on core business, build a solid biosimilar business, expand in the GLP-1 space, and this both are global, and work on the pipeline optionality with the specialty drugs. Because we only have a budget of $200 million per year on R&D, we have to do affordable innovations. Somehow, we have to figure it out. These are the assets which could do $100 million-$500 million in revenue, which are meaningful to us, not for Big Pharma. Great. Maybe just kind of staying high level here, you all have operated as a key player in the U.S. generics market for more than 20 years now. Maybe just help us put the current market environment in perspective and just kind of how you think about how it evolves over the next five to 10 years. Yeah. So the current market is back to the—I would call it the way it was running in 2010, 2012, 2013, 2014, 2015, all those years, that you will have typical 4%-6% price erosion. You can offset that by volume increase in existing products once you have a large portfolio like we do, 280 medicines. And then the LOEs are double next five years than the last five years, even in small molecules. So there is a double in size. So there are more opportunities to go after. So the business is going to keep expanding. The government is keeping incentivizing the affordable medicines industry to do more and directing FDA to approve the products faster, interchangeability. So I see a huge growth in even small molecule, the large molecule biosimilars, both would be tremendous. And the leading companies will have both, like us and Teva and Sandoz. Some of the Indian companies will enter biosimilars. Right. Right. Right. Maybe kind of just shifting to policy macro perspective, I realize it's a little bit difficult to handicap at this point, but maybe kind of what is your base case assumption at this point on likelihood, timing, and scope of potential pharma tariffs? Oh, boy. Look, we've been very active lobbying against. We have submitted so much and had many calls with the White House. There are smart people there. Hopefully, they get it that putting tariffs on generic industry will not bring the manufacturing back to the United States. We have given them the mathematics behind it, that 25% tariff, the cost of producing here, it's more than that. Because products are already cheap, right? It's already very affordable in the United States. MFN doesn't apply to us. I hope they put MFN for generics. We'll have to increase the price. That will not happen. We hope tariffs don't come. We have given you can't win your argument if you just say, "Don't do it." The government, you have to understand why they're insisting on this. We, as a country, are in a clear present danger. In case something happens globally, we make zero antibiotics here. Zero. No KSM, no API, no finished products. What happens in a war scenario? What happens in the pandemic scenarios? Can we put our security of our nations, the health security and patient at risk at all, even if that risk is only 1%, to not have antibiotics here? It is not rocket science to make these. It is not as complex as chip manufacturing, right? We will need lots of water, electricity, corn to start making the 6-APA for the Penicillin G. For cephalosporin, you make that 7-ACA. It all used to be done here. We need to bring that back. We have put a certain other essential medicine. The government is the biggest buyer of the medicines, about 40%-50% on a molecule. Why can't Congress pass a bill for essential medicines for whatever number, 70 to 100 molecules, the government would buy American-made products? Other countries do that to have local manufacturing and supply security. Because executive orders will not—I mean, those would be temporary. Tariffs would be also temporary or not effective. This way, you create the whole market. So we gave them an alternate solution, which is being thought about. Your views that they're sympathetic or have an understanding of the risk here. Yes. Correct. I'm only speaking for the generics industry, Affordable Medicines. Maybe, let's say, for whatever reason, that's not fully appreciated, tariffs are implemented. How do you feel like Amneal's position to kind of handle the potential impact? Amneal wins, right? Because we still have 2/3, almost 70% of our production value is the United States. We're the only last warriors keeping the manufacturing here, large plants in the United States, and somehow still competing. We did put up multiple plants in India. We'll have some impact, but we would offset that by working with our three big buyers, saying, "Hey, you've got to take some cost." They already are open to it. We would bring, if it makes sense, we have one big idle plant. We could bring some commodity tablet manufacturing and capsule manufacturing to that plant. It has a capacity of 7 billion units in Long Island. We can restart it. We have multiple choices. As an industry, I don't hope and wish that tariffs will come. They shouldn't because it could create an interruption in the supply chain. Already, we have like 270 products in shortages. Mostly, it's economics. Great. Great. So we kind of talked about your strategy in biosimilars and the GLP space as kind of like the key growth levers. I guess, would you want to talk further about how you kind of see the biosimilars market evolving over the next decade? I think you all have mentioned that you're really targeting kind of that smaller $1 billion-$5 billion in the medical benefit segment. You're probably going to stay away from the large PBM molecules. Look at Zoladex. Zoladex's 50% is PBM-driven, 50% is buy and bill. We'll do both because we need to expand the portfolio. PBMs, we've already been working with them, these big buyers, for 20 years. We sell 280 products to them. Huge relationship, mutually trusted over the years. We sit in an even better position than, let's say, Sandoz or Celltrion because they do not have those 280 products to offer like we do. We have a pipeline every year. We're offering 30 more products. We are U.S. focused, obviously. Today, it's all 100% United States. How it will evolve, Matt, it's going to be, you can follow, right, that some companies, the branded side, would be aggressive in defending their market share. Maybe for a year or two years, you saw that in HUMIRA, and now it's going away. Buy and bill, you can start building the market share, but it takes a couple of years to get to the 20%, 30% market share or 40%. In PBM, you can get it day one, just like generics, because CVS would move all their patient to your product on biosimilars. The acceptance of biosimilars is there already. FDA with Congress is working on a bill so all products will be interchangeable, just like ANDA. That way all government knows to save $100 million a year in savings from the biosimilars, you need to really support the industry. The brand companies cannot keep playing games, right, unless they want to become a biosimilar company. They have to focus on innovation, the next generation therapy. Why would they keep defending? Because our cost of entering this is now it's going to be $60 million-$80 million a molecule. If they want to keep playing the pricing game, we will win, just like in generics. Initially, in the 1990s, they were defending, and then they gave up in 2005, 2010. By 2015, the GX got 90%, pretty much 92%, sometimes 95% of total market. Biosimilars, same thing. Maybe this one 80% will go to biosimilar player. Brand will hang on to 20%. Markets are opening. People always forget there are 100 molecules to go after. It's so complicated manufacturing and R&D. You will not see 150 players from India, China, Europe, everywhere jumping in like small molecules. You'll see currently there are about 10, probably, or even less. Used to be 15, 20, but they disappeared or consolidated. It'll be a small amount of players and plenty of products to choose from. If you smartly choose, you'll have two competitors, two competitors to begin with. There's another product called Orencia, two people working on it. The multiple products, only one or two companies or there are many, zero companies are working on. People are underestimating biosimilars. Okay. So you'll. You have to stay put for 10 years. You'll see the big revenue pickup from 2027, 2028, 2029, 2030, 2031. Huge, all the way to 2032, 2035. I mean, we have analyzed all 10 years. Okay. So it sounds like you guys are kind of agnostic then to the channel. Agnostic. The size you'll pursue kind of all over the product. Yeah. We're more focused on less competitive products. Less competitive. So probably. Now, we may have to offer Keytruda, Opdivo globally because everybody needs it. Because remember, the main reason, the fun part in biosimilars is you're creating more access. That's good work, right? More patients are taking products. Any thoughts on the private label? Is private label a necessity now in the PBM market, or yeah? Yeah. They want private label. Whatever way they want to do it. We have worked with them for 20 years very closely. We'll keep working with them. Okay. Okay. Maybe switching to GLP-1 space and the Metsera partnership. So obviously, you have that manufacturing and commercialization partnership. It's a phase II GLP-1 asset. I know they recently had some data this past week. They have good data. Which looked very good. Yeah. With Amneal. With Amneal. Yeah. Maybe kind of just remind us, walk us through the opportunity set within this partnership. Then maybe we can talk about kind of the strategy within GLP more broadly. Great. This is the first time in the industry this kind of partnership was formed. It's a more trusted relationship. I know the founders of Metsera for more than 15 years. They know Amneal. They've been to our plants. They see, wow, this is better than brand companies' plants. Visit the Long Island plant, and all of our plants are awesome. We told them what we can do. We have 1,000 scientists. We have a lot of CMC expertise. We have worked on 300 molecules, more than the CMO will work on or brand companies would work on. We have a lot of various expertise on device side, drug-device combination, peptide synthesis, right? We're working with them on enhancing their oral formulation for more bioavailability. It looks promising. We're working on getting higher yield on peptide manufacturing. We also have API manufacturing expertise because we have 70, 80 DMFs and two big API plants. We're building an API plant for peptides, building the 100 million units, the injectable, whether PFS or auto injectors plant, right, in one campus. We'll have some manufacturing in the United States as well. These two plants are going in India. Then we'll have it in the U.S. as well. Oral solids, we have enough capacity in the U.S. Most likely, we'll do it here. We do not need to build anything new. For the oral peptides. For oral peptides. So we're well set there. The tricky part, the key part is can we get the higher yield because of oral manufacturing, we're going to need lots of peptides in tons. In injectables, you can get by with kilos. Kilos, you can make it in solid phase chemistry. And for the oral, the five, 10 tons, Lilly successfully just did it. They have higher yield API now. You're going to need five tons, 10 tons. To make that, you need to use the liquid phase as well, solid phase, liquid phase, molecular, high wind, next generation technology to have right yield and lower carbon footprint as well. Yeah. So it's a very unique partnership. And we got 20 countries marketing, right? So that would be substantial revenue for Amneal. Yeah. It sounds like India is kind of maybe the most mature of the. That's the biggest. Of the biggest. How big do you think that could be kind of from an Amneal perspective? I mean, as I said, it's about 50 million patients can take it at a $600-$700 per year. That's the total market. Obviously, the big guys, Lilly and Novo, would be taking a big market share. Then generics, semaglutide will take some market share. We'll do our best. We'll partner with a local big company as well because they have already 1,500 sales reps. Oh, distribution company. Yeah, yeah. Oh, interesting. Yeah. We'll try to maximize, but it could be really significant revenue driver. We purposely, Matt, have not said a lot about the economic opportunity that we see as Amneal as it relates to Metsera, right? Because we did not know enough about what data they are going to show. Now that we are beginning to have a little bit more clarity from Metsera's product in terms of their data, their timelines, and so forth, as we think about Q3 and into next year, that gives us an opportunity to frame the economic opportunity for our investors, right? There are multiple ways we see the economics, either both on the gross margin, in terms of the gross margins we will be making by producing the product, as well as the economic opportunity in India, as well as any royalties and so forth. We will be able to provide our investors the same way we said about our new product, right? DHC auto injector, the same way we framed that opportunity as $50-$100 million peak year revenue, the same way we framed the Crexont opportunity as $300-$500 million peak year revenues. We'll be able to provide our investors with our thoughts and the specifics behind the Metsera opportunity over the next few years. Will that be an investor event or on earnings probably? We'll see. In order to kind of have a big investor event, you need multiple things to talk to. As we're having the DHC and the Crexont and the Metsera thing as a company, we're having more and more things to talk to investors. Think of it as an investor day or an R&D day. That's an option. The other way is through our normal communications in terms of the earnings goals and so forth. We just need a few more months to see a little bit more of their data. Yeah. As we think about. As you just said, our EBITDA margins right now are at about 22%, right? We expect that to grow over the course of time. The EBITDA margin will be accretive even on the CDMO business. Because as you said, there are just not enough incremental CapEx. Great. You talked on this a little bit just a few minutes ago, but is it fair to say that peptide manufacturing is still quite difficult for the industry? It's not. Yeah. Nobody's making in tons today. No one's making in tons. No. They're all kilos. 100 kilos, 200 kilos. Capacity is locked out by Lilly's taking as much as they find. Novo tries to do it on their own. Then there's Metsera kind of companies. They would need Vikings, and others will need capacity. Generics will need capacity. It's going to be a supply constrained market as far as you're concerned. Yeah. Because you'll see 10 generics filer in semaglutide. How many have their own API? They're all buying from one or two sources. And injectable, it's fine because it's in kilos, right? Because it's lower. Injectable is easier. Better yield than orals. You're using a very small amount of API versus tablets because of bioavailability. An injectable would be 100% here. If we get to 10%-12%, you're using 10x more API. And it's daily tablets. Great. Great. Maybe switching over to the branded portfolio. Crexont, obviously, off to a strong start. It is ahead of expectations in terms of, I think, both share and coverage at this point for the year. I guess, how should we think about the trajectory over the next couple of years? How confident are you guys in hitting that peak guidance of $300 million-$500 million? Very confident. With what we have seen last six months, it's just amazing patient testimonials. The MDS, they come visit us, and they have set up, some of them have set up, Crexont clinics. They are that excited. The biggest name, Dr. Hauser, called it a miracle formulation. It's a superb absorption. Obviously, this is the best product. As you know, Matt, this is the course of their disease, they are to take this until there is some revolution on some cure. That is far away. This maintains their daily lives really well. We meet so many patients. Our coverage is awesome. It's almost commercial side. We pretty much covered 90%. Medicare side, we're working through it now. Medicare is about 60% usages in Medicare. Medicaid, 40% is commercial. We are in its pricing. We priced it appropriately because we saw the right 35% patient were unable to get the medicine because of the copay. We priced it properly. Copay became lower. We're getting favorable coverage. We went after now general neuro. We never did that with Rytary. We expanded the market. We're going direct to patient. We're going to general neuro. It's creating a lot of buzz out there. We comfortably will achieve over 300 to 500 and obviously shoot for higher. We have a European partner who will be launching it in a few months as well. Our Canada and Latin America partner will be launching it soon. We have India we're launching on our own. We just licensed Southeast Asia. Only two big countries left are China and Japan. We'll license that out. The 300 to 500, is that purely U.S? And then the. We've been kind of very conservative, so we don't say that until we are very. Right? Because we want to set the right expectations. So right now, consider overall. There's plenty of opportunity in Crexont. Yeah. The Crexont highlights what a lot of people, I guess more and more people appreciate our story, which is there is no lack of growth drivers. The only conversation we're having about our business, it is just the pace of growth. Whether or not it is AvKARE growing double digits, right? Whether or not it's the launch of Crexont, whether or not it does 300 to 500, it's a big range. I get that. The more important point is we're able to more than offset the LOE of Rytary, one of our largest products, without tanking the earnings, right? A lot of our competitors, a lot of other companies, when they lose the LOE, they lose exclusivity for one of their key products, the company catches a cold, right? Our ability, we're even able to grow in spite of that. It's the same thing for the affordable medicines. That business is growing as well. I think it just highlights our ability to have multiple growth drivers. Because in any business, not everything hits on all cylinders all the time, right? Our ability to overcome different challenges, whether or not it's startups or not, with just an incredible amount of confidence, our ability to overcome those and continue to drive value creation from the patient perspective with innovations like Crexont, innovations like DHC for the patients. And the payers, frankly, right? We talked about biosimilars, right? Being able to kind of serve all of those customer segments. You mentioned DHC. You guys have guided to 50 to 100 there. Is it fair to assume that that kind of ramps over the next three to four years? And you could be at that. Yeah. Yeah. That's exciting. The commercial team is psyched. They're part of their planning, the launch planning right now. It's a great pink device. Yeah. I mean, those are packets of four, right? It is exciting. We like products. We like brands. Looking to launch probably September timeline. Yeah. It's approved. And it's a useful innovation, I call it. It was much needed for the severe migraine or migraine patient overall and the cluster headache patients. They have to go drive to clinic, hospitals. It could take two, three, four hours to administer the same drug. Now they can do it at home. Boom. And it's the GLP-looking pen, beautiful device, easy administration on a thigh, just like EpiPen. So you could think of it as EpiPen of migraine. Very nice. Maybe moving to capital allocation. You all have made it very clear that you want to vertically integrate your biosimilars business. I believe that the plan is to acquire Kashiv BioSciences. We haven't been public about it, but that's most likely target. That's most likely target. Yeah. I guess how much of a priority is this? Could you tell us more about just why you want to vertically integrate here? Right. The in-licensing deals are far and few in between because everybody like Teva has its own. Teva wants from Alvotech, and they could pay higher, and they get global rights. We're not set up for globally. We're only negotiating U.S. rights. If we don't control our R&D and manufacturing, I think in the long term, two margins will be difficult for a biosimilar business to keep it healthy, making sure you survive on ups and downs of the markets, ASP adjustments, 340B pricing. Having one margin, those companies will be the top 10 or top five that they control most, especially the biggest market like United States. We're doing our own marketing, our own R&D, our own manufacturing. Globally, we can license out, receive the R&D fees back also from the international partners and the royalties and supply price. It becomes a global business for us. We add multiple pipeline assets at once. Kashiv has been working on it for the last nine years. The reason we set up Kashiv as a separate company, we were Amneal and Kashiv were both private companies. Also co-founded by us, Kashiv, me and my brother. We put our personal investment there because it was going to take too long. We knew that. We can't just keep hitting Amneal with all this risk, CapEx, everything. We invested separately and matured the business. It's the right time to now integrate it. I see. So the plan would be bring in R&D and discovery. Manufacturing. Manufacturing. There are three manufacturing plants. Commercialize it in the U.S. and out-license it to European players. Perfect. European, Asian, South America, everywhere. Great. How should we think about the value of this deal? And kind of what's the base case in terms of how you would finance this? We haven't commented any of those, but we'll be discussing. All of this is kind of speculation, right? What I would say is a couple of things. Incredibly focused on driving both top line and bottom line and cost generation, right? That does not change. Nothing adds shareholder value than organic revenue growth. That is a key priority for us, number one. Number two also is I think we have been incredibly also deleveraging continues to be a key priority over the course of time. We have brought leverage down, and you can expect that to continue. The third thing we do, I think we have been very disciplined. Think about the biosimilars business we have built so far, right? We have built that business by not allocating a lot of capital, doing smart deals that even though we are splitting the margin, right? Got. We have not spent hundreds of millions of dollars like others building that business. Think of it, the Metsera deal, right? We got access to a huge market. The way we structure that deal, right? It is a, call it $300 million investment, which for us, it is probably at the end of the day when you think about Metsera contributing 100, getting another $80+ million from the Indian government dramatically reduced our own costs over the course of time. I think every deal we will do will be done in a way, right, that does not impede our ability to deliver, right? It is in a place that we can feel we can execute and gives us access to big markets that we can grow over the course of time. That is why I would say. Be disciplined. We have to be creative. We will have to be creative and disciplined. That's no different than what we have done all the other deals. Interesting. It could include some kind of milestones or royalties or some sort of. Everybody has control over both companies. Yeah. We will have to. You also have. We want to keep reducing our leverage. Obviously, this is highly accretive with the EBITDA growth, the pipeline. It is huge. We do not want to add on the leverage. Right. Right. Maybe just lastly, you guys have also flagged branded specialty drugs in neuroendocrinology and oncology as a focus. Coming up. Coming up. We're working on certain device-based products like DHC. And then we have a couple of value-added onco products now because we know how to sell in Oncology now. So why not add a few specialty assets? The same call points. Right. Great. With that, I think we're out of time. Thank you, Chirag and Tasos, very much. Thank you so much. Appreciate you being here. Thank you, Matt. Thanks for having us.