Good afternoon, everybody. I'm Katerina Peshkova at JP Morgan, and it is my pleasure to be introducing the Amneal team today. From the company, we have Co-CEO Chirag Patel, who'll be doing a presentation, and then we'll jump into Q&A. Chirag, Happy New Year. Thank you for joining us, and look forward to your remarks. Thank you, Katerina. Very nice to be here. Is this yours? Okay. Good afternoon, everybody, wishing you excellent 2023. We can all use that. Many good years to come by. I know it's a monsoon kind of season outside. I don't know if you saw it around one clock. It was pouring down. My name is Chirag Patel. I'm a co-founder and co-CEO of Amneal. It's been a fascinating journey. It started 20 years ago, I'm gonna walk you through the history a little bit before we jump into where we stand today. It was a very humble beginning. In 2002, in Paterson, New Jersey, we started, my brother and I, along with our father's help, Amneal Pharmaceuticals. Not any big goals or big dreams at that time, we always believed in making affordable medicine for American patient with the highest quality, we continue to do that. We grew remarkably from 2002 to 2007. We set the infrastructure. 2007, we launched our first generics product. Revenue starts from 2007, we took it up to $1.1 billion in 2017. That was Amneal 1.0. We built the fourth-largest generics company, in volume, value, we are third largest. We're one of the companies, very few can boast all capabilities in transdermal, injection, inhalation, ophthalmics, liquids, topicals, obviously oral solids. Very much set the generics business really well. As you know, the generics industry is here to stay, the LOEs, the patents are expiring in a big clip. Over the next 10 years, almost $300 billion in small molecule and same number in biosimilars. We'll talk about biosimilars a whole lot. Where do we stand today? One note as I chair the industry in America is that we, our industry is the only industry probably can say this, saving $350 billion annually for American healthcare system, patient providers, companies, everybody. Over 10 years, $3 trillion. It's a really remarkable, essential industry for America and for the globe in that matter. Very proud to be a part of that industry and leading the industry. More savings, as you know, next 10 years, 15 years are coming from biosimilars. We do not know exactly how it will stack up in savings, but it could be as high as $100 billion a year, biosimilar savings just in United States once industry is mature. We'll cover all that exciting thing. Today, we got 12 manufacturing sites, and they're located in United States, four of them, one in Ireland, and the rest are in India. Pretty, a very nice, robust manufacturing network of what we need. We do not have excess capacity. We do have capacity to add on our new product launches, so we do not need to waste our time in shutting down plants or reorganizing. We are focused on growth. Very, the employee base has been superb. 7,000+ employees, about 2,300 are in the United States. Big chunk is in India, 4,500. Because of our employees, Amneal has done what Amneal has done, is we kept building great team after great teams and continue to do so as we advance into the more difficult to make products. Very proud of what we have built today, and I'll walk you through now where Amneal 2.0 is going. These are the areas, the growth strategy that we have, and we've been implementing for the last three years. It's a five-year journey, that's the first phase, the next five years journey. We are entrepreneurs. We're still majority owner of the company, we have a long-term vision, we do not make any decisions which are just quarterly or annually driven. Let's walk through each of these. In retail segment, which is our foundation business that Amneal 1.0 rebuilt it, that is stabilized. That's the good news. Finally, after five years, we're seeing lesser price pressure, which is first time change after five years. It's moderating because there's nowhere to go for matured old generics products. There's no further price reduction we can give. We're still growing 2%-3% every year while our competitors are degrowing this category. Retail generics means the products we sell to CVS, Walmart, Walgreens, Rite Aid, and it's prescribed over the retail channels. Injectables, we started building this business six years ago. Now it's almost running around $200 million annually, and we expect that to go to $300 million-plus. Just in the United States, we also have more opportunities outside of the United States market. Excellent growth area. Now we have 19 production lines and four plants. Three of them are FDA-approved plant, one is being inspected in March, so we expect that to come online as well. Not only just the capacity, but capabilities. We have excellent R&D capabilities, peptides manufacturing, long-acting depot, large volume parenteral bags, so long-acting injections. All these capabilities we have built over the last seven years, and very proud to bring those to the market globally. Biosimilars, my favorite category. The reason is very simple. Next 10 years, almost $560 billion LOE, half of them are biologics. Biologics, where you have 10-12 active competitors. Commodity generics, 150. Complex generics, about 15 players. We're moving up the value chain to complex GX, injectables, biosimilars, and we have worked last seven years to build this. We have three approved products. Two are launched, one we are launching. Excellent commercial capabilities are being built. They're mostly built. Just like on a generic side, we led the marketing, we will lead this side as well. We're very good at customer service. We know what customer wants. We always look at the long-term view for our customers, and customers are many in biologics. They're not just two, three buyers. You have to take care of the, obviously, patient first, but then the providers, then you have insurance companies, within that you have PBM, then you got retail chains, you have wholesalers. It is a complicated situation, and interchangeability is coming shortly as well. We will, we'll talk more about biosimilars, but very exciting growth area. It's not an overnight. Lot of investment over seven years. Now, FDA's learning is there too. They're asking for less and less clinical trials, which makes the product development around the cost around $50 million compared to used to be $150 million. It's a huge difference, this is why I believe biosimilar is a business for companies like us, Teva, Sandoz, obviously Amgen has an arm focus there. Celltrion is there. You need to be vertically integrated for biosimilars in the long run to be successful. You can't just keep in-licensing product and be successful. It will become competitive and declining revenue business over years. You have to have pipeline, you have to have proper cost of goods sold. Production, manufacturing is everything. Everything is made in the process, from the clone development all the way to the finished products you have to control. And it's very complicated and high degree of difficulties in manufacturing. Very excited in biosimilar. AvKARE is growing excellently. We actually had a high single-digit growth this year, and we expect same next year. This is the business where we distribute products to federal government, unit dose to the hospitals and certain 340B clinics. The reason we acquired this business is we wanted to be one of the leading players in, since being a U.S. company, for the federal government. And we are. We're supplying more and more products, working with U.S. government to even further secure the supply chain for essential medicines, which are antibiotics, antivirals. Hopefully, we can come up with that solution, working with government in the United States and maybe partner country as well, to not run out on amoxicillin and Tamiflu and other essential medicine, which is really a problem. Now we do not need to wait for the excuses, right? The pandemic happened, war happened, natural disaster happens. Anything could happen. We must secure these 80 products' production in, within United States, at least at the certain capacity, maybe 50% capacity, then we can have surge capacity. We're actively working with U.S. Department of Commerce and other related parties to bring that. Specialty, we acquired this business from Impax when we bought the company in 2018. We have a leading Parkinson's drug. Very excited about this growth as well. We're about $400 million in sales in this business. We have a new IPX203 being launched very shortly, which I'll walk you through. In the international, we just started with a Europe partnership. We filed products in China with our partner, Fosun. We're looking at out-licensing products to certain companies in Middle East and North Africa, Southeast Asia. Pretty soon, we'll enter into agreement in South America. Same assets, it's American manufacturing, some of them, but American R&D and all U.S. FDA-approved products, has great values overseas, and we are capitalizing on that now. This is all incremental for us. This is just the innovation. We keep innovating ourselves. As you know, the first few years were commodity generics, which now has 150 players. Since 2010, we've been moving to the complex GX, where we see 10-15 key players. Into injectables, we're also limited number of players, now moving into biosimilars, then specialty 505 technology-driven products, which is again $100 million-$500 million range branded products using technology to really change the molecule for delivering clinically meaningful differentiator. We have to do that, otherwise the me-too crowd will catch up. Our Amneal fame is being really good in R&D, and we keep moving upward in upstream. Exciting. We will not stop that, right? Within biologics, there's biosimilar, there's simple MAbs, there is bispecific, there's ADC, there's one day cell and gene therapy. All of these technologies and biologics will need affordable solution. Who would provide that? The people who have invested in biologics manufacturing, understanding would provide that. Within generics, as again, reiterating, we have shifted the oral solid mix to now 88% of our pipeline is non-oral solid. I think we are the only company that shows growth in generics from 2019. Other companies have erosions. That tells you the quality of our pipeline, quality of our execution, consistency. Our customer service, you call any of our large customers, they would rank Amneal in top two in pipeline service quality and in the innovation that we do. We will continue to grow this business because of that. We are number one in first to market products. I'm not gonna walk you through all of them, but you see that it very diverse into various therapeutic area, various categories on a dosage form, ophthalmics, injection, oral solids, liquids, nasal sprays. Big pipeline, 106 pending with FDA. Any given time, 100 products are being worked on it. We are set for this innovation engine. It's been set for a while now, our focus is more onto more complex GX as well as the similar side. The injectable, I mentioned that we are focusing on more technology-driven. The cartridges, the LVB bags, liposomal microspheres. These are the technology we have been developing for last seven years. It's a very exciting area. We are already on our way in a growth. We grew 30% last year. We'll publicly have stated that we will be over $300 million in this category in 2025. Excellent growth and diversification for us. The exciting biosimilars. We have a team already buzzing out there, setting an entire commercial infrastructure and already getting the Q codes, getting the payer coverages, talking to customers, using all our relationship and trust that we have built with the large wholesalers, with the large oncology practices. We are utilizing all of it, and we are very determined to take our fair share. I know we are late in these ones. Our future products hopefully will be in a first wave and some of them in a second wave. We believe that biosimilar would remain a limited competition market. Yes, some of the molecule you will see seven, eight players, but it's still much better markets than the even complex generics and injectable. Over time, we have to be vertically integrated. This is our specialty business, almost around $375 million, and we're both... Branded products are growing. UNITHROID is growing at double digit, more than 13%, RYTARY is growing around 7%. The pipeline, IPX203, we have a PDUFA date June 30th. That will be very exciting to launch in July, two years before the RYTARY expiry, patent expiry. We are ready to launch because RYTARY, we focused on only movement disorder specialists and have gained 5% market share. There are about 700,000 Parkinson's patient in the United States, and we have 35,000 on RYTARY. Our goal would be to go much higher. This is much needed therapy because 30 years old technology on CDLD, which is a gold standard, and I'll go to the next page here. That has a lot of fluctuation. For Parkinson's patient and the caretaker to every two, three hours have fluctuations and then off time and then on time, then off time, First is the health issues. Second is you have the regular chores of the day-to-day activities you are unable to do. This is. If we speak with KOLs and SABs, it should be used in first line, and that is where we will be trying to focus there. We have Medicare with the new 50% patients are on Medicare, and then a new law is much lower in the co-pay compared to what it used to be. On the commercial side, we have excellent coverage. On RYTARY, we expect the coverage to continue or get better for IPX203. Very exciting, and we have a roadmap to get to a $300 million-$500 million peak sell as soon as we can. This is not a new molecule. It shouldn't take that long to get there. Our experience of last seven years is very helpful. International market, very exciting news. We just announced partnership with Orion. It's a Finland company. Why we chose Orion? Because first of all, there's very minimum overlap. Excellent culturally fit. They're a 100-year-old company. We're only a 20-year-old company. They $1.3 billion in sales, about 750 sales people throughout Europe, so they can pretty much cover entire Europe. They've selected key complex GX. We have no interest in commercializing the me-too commodity generics. This is all about complex GX, complex injectables and biosimilars to come. We expect this partnership to grow to more and more products and all sales are incremental for Amneal. China, we have filed 10 products, keep filing a few products every year, and we expect approval this year and commercialization this year. India, we see that as one of the fastest-growing market. The entire economy is growing in the double digit. The pharma industry is growing double digit. We launch our label. We set our commercial infrastructure in Mumbai. We started with hospital sales, emergency meds, and now going into different therapeutic categories. Very excited about growth in India. It's a again, incremental market for us. We grew up in India. We have 5,000 employees and still have a lot of connections with India, so we feel comfortable operating as a direct market in India. From U.S. is obviously top market for us. India is the second direct market. The rest of the world we will be partnering at this point. Growth has been remarkable. It hasn't been noticed, but we grew 11% even in difficult times in revenue and 15% bottom line, and we expect our growth to be robust over 2023, 2024, 2025, 2026 as injectable growth comes in, specialty growth comes in, distribution is keep growing, complex generics, international brings tremendous growth. Highly diversified company, we're not reliant on one products, two products, huge concentration. Very excited what we have built in last few years and even more excited for next three to five years. Capital allocation, very keen to reduce debt, increase EBITDA, get the leverage down to 4x, and get the refinancing completed as soon as possible this year. The debt maturity is two and a half years away. Here are some of the catalysts you can watch for this year. There are a lot in each area. You can tell we are so busy. We work 24 by 7. It's a nimble company. The changes what are happening in the market is actually favorable to us, such as Sandoz going public by itself. Teva having a new leadership. Viatris focusing on other areas, leaves a very wide for mid-size company like us to grow. That's what we're going to capitalize over the next five years in the areas I mentioned. This is the takeaways from today. That we keep execution. Execution is the key to watch. We're good at it. We're gonna keep doing it, keep working on those and the key catalysts that I shared. It sets up very well for us, the growth acceleration this year, more next year and more in 25. Then 26, 27 is built with biosimilars and more specialty products as well. Thank you very much. We have a Q&A session now. I guess to start, 10 years from now, what does Amneal look like? Big. What do you kinda need to do to kinda get there besides getting big? Hello, can you hear me? Yes. Oh, great. biologics, excellent infrastructure and set business. complex generics and injectable will continue. They're not going anywhere. key specialty products. Commodity GX is hard to compete. It's almost 150 players. That place requires consolidation, hopefully someday consolidations are allowed there, because as you know, the buying side has become so powerful. There are three buyers and 150 suppliers, guess what happens? The government has weakened the manufacturing base so much that sustainability is at stake, which fills 90% of prescription commodity generics. We hope consolidation happens at that time on Commodity GX. As you think about, you know, 2023, you're obviously not giving official guidance, but what are some of the kind of pushes and pulls that you're thinking about or some of the swing factors that you would highlight to us? I'll pass it to Tas. The swing factors like IPX203, uptake on biosimilars, how well we do on a commercialization, getting the refinancing done, putting the opioids behind us, which is not a big issue for us, fortunately. And keep succeeding in R&D. Like we work on many projects, so hopefully we have a 70% or so success in R&D. On biosimilars, just as you think about the U.S. market. On one hand, obviously we've seen some great launches, good uptake. I feel like, you know, price erosion has been quite steep in some of the markets. I guess just in general, what are your thoughts on biosimilars, and how has it evolved kind of as you expected? It's still evolving. If somebody called it's in early innings, maybe inning number two, but it's a high-scoring game. It will keep evolving from obviously the regulatory side, the advancement in manufacturing, continuous manufacturing. On the market uptake, it's almost 70% now is biosimilars evolution. Not as 95% or 97% like GX, but it's already 70%. Interchangeability will play a key role. The more launches coming up in the next five years, so the market will be well set within next five years. As you think about your portfolio, you obviously have ALYMSYS and FYLNETRA, Bunelesta. Out of those three, which is the most exciting for you? ALYMSYS bevacizumab and Neulasta, B Neulasta. The big market, we are third to enter in bevacizumab, so it's still place for us, and we are penetrating already. We got our Q codes in place, products in the market, and insurance coverage is getting there. Very exciting. It's always nice to go against Pfizer and Amgen. You're proving yourself from the beginning. Neulasta we're fifth, but there is a dynamic that we could get our, let's say, 10% market share. Just as you think about, you know, the company's strategy in biosimilars longer term, is the plan kind of build upon the three assets that you have, kind of like in the hospital kind of oncology setting? Or do you think, you know, kind of a broader, you know, prescription, et cetera, kinda broader portfolio? Yes. Oncology we are in already, so we'll keep building onco on a commercial side. We are working on in-licensing product and also looking at, hopefully by year-end or early next year, vertically integrate to have pipeline as well as manufacturing capabilities in the United States, R&D capabilities on our own. We are. At that time, it could be autoimmune product, it could be in other categories. Once the basic, which we have set up the biosimilar infrastructure for us to add ophthalmology, marketing or the allergist, it's not going to take a long time. Plus, remember, we have the already branded business, so a team of 180 in the branded sales and marketing. Those are the, I think, easier part. The harder part is to get the product through IP and launch. Unfortunately, we can do well on that side as well as. We truly believe it has to be vertically integrated because as you said, the prices are going to be declining when you have two partners to share margin, it then may not be attractive. Plus, you do not control all your destiny from quality, manufacturing, consistency. If you are vertically integrated, you can also market it globally. Right now, when we go for in-licensing, we only get U.S. rights. Internationally would have at least 30% if U.S. is 70%. Quite a bit, market out there. Switching gears, I guess, a little bit, you know, to just like, you know, regular generics, I guess. The industry has obviously seen a lot of challenges. Some companies have pivoted away from the U.S. generics market. What are your thoughts on this? I think more importantly, do you think that where we are right now when it comes to kind of, you know, oral solids, you know, traditional quote-unquote, "generics," do you think like, that's a stable situation or do you think eventually consolidation is gonna have to happen or like something's gonna have to give? Kinda, kinda? Yeah. On a generics, you break it down into two categories. Mature generics, which are the mostly oral solids and older products. We're seeing moderation there, because after five years, first time, customers are more concerned on consistent supply. Then now fighting for lowering, for example, penny a pill. How do you do the math? Like half a penny? Quarter penny? Environment is better, that doesn't mean we do not need consolidation. We do need consolidation because the top three buyers have 90% market power, we top 20 has 55% market share. That's just uneven. Plus on top of that, there are 100 more suppliers. If you don't allow consolidations in our industry, the government is just going to weaken our industry, which is by the way, we do everything from the R&D, IP, manufacturing, API, take the returns, sell the product. The wholesalers and retailers just hand the products out or PBMs, they have no value on generics. I think government should be very keen to have the industry and see what's going on. We have put a lot of comments with FTC in this matter. Like people talk about these shortages, right? Just happen and give you example on Tamiflu. We've been asking our customers to give us a proper forecast since April, since we saw what is going on in Australia flu season. That's where it starts every year, and it was pretty bad. We said, "And everybody's out, nobody's wearing mask." They did not place enough orders on time, and last minute, they want all the inventory. The products is sold very cheap, and we work 24 by 7 to produce as much as we can. When there was no COVID, I mean, no flu season two years ago, they had same orders, they didn't change much. They returned all those inventory at full charges to us. We are responsible for all the cost, all the inventory. How are we gonna do that? The margins where they're taking the prices to penny a pill. This is not sustainable. As you kinda think about the more attractive, you know, part of the generic industry complex, injectables, things like that, you know, over time, do you think there's a risk that that Goes kind of like the same route that like orals went in terms of, you know, as more people kind of enter, do you think, you know, price competition is gonna get as bad as we're kinda seeing in the oral market? Or do you think there's like technological barriers that are gonna prevent? Yes. 20, 30 people kind of eventually competing in that space? Totally two different space. You cannot start making device-based product, not 150 of them. It requires a lot of investment, a lot of science, a lot of engineering, lot of time. This is why like product like Iluirin, you see two, three suppliers, even when competition come. Yuvafem, we were first to launch three competitors after seven years. Sucralfate, three years we were alone, two more competitors. I do not see at all commodity generics like play in complex injectable or complex generics. There will be competition as people come up with the technology. Inhalation, same thing, it'll be two, three. Switching gears again. IPX203, I think you're launching that, mid-2023 or later this year. Can you talk about a bit the plans of how you're gonna convert, I guess, like the people who are on RYTARY right now, like the speed of that conversion, how that's gonna go? How do you see the market evolving once we're gonna have, you know, RYTARY go off patent and we're gonna have generic competition? Yeah. Nice thing about IPX203 is. seven years of being in the market for RYTARY and Parkinson's space, there are 700,000 patient, and we so far have penetrated to 35,000 patient. We went after maybe only 100,000 patient, which is movement disorder specialty. Now we're going to general neurology. Our the dosing regimen is much simpler than RYTARY. It's better product than RYTARY, much better than IR. Using all the new social media campaigns to go to patient, 700,000 in different district, different areas, to penetrate big time. It is a much needed product, so it would have a lot of following. When we will be positioning as much as we can as a first line therapy rather than step at it and jumping. There is no need for I.R. It should be, because IPX203 has IR component and then CR component. You're getting the immediate impact that you need to get onto good on, good on time, and then the extended release prolongs it well, and the blood-brain barriers are much better achieved in IPX203 than the IR, which is 30 years old technology. Just as you broadly think about your specialty pipeline, anything else you would kind of highlight that you're most excited about? K-127, K-114, both are advancing. LYVISPAH, we have launched, and DHE auto-injector, as soon as we figure out the CMO manufacturing issue, we'll be launching that as well. Looking at other additions, which we'll announce shortly. Switching gears a little bit. On margins, as you think about 2023, you have, you know, the biosimilar launches, you have IPX203. Should we be thinking about operating costs kinda step up a little bit in 2023? Or do you think you can kinda handle most of that via kinda existing infrastructure in place? Yeah. I think given all the launches that we're having, IPX203 as an example, LYVISPAH, full year, support of that, those will expect operating expenses to grow. Not at the same amount as this year that we had. I think after that, we're leveling off. Now also you have an incremental revenues that you can offset some of that increase in operating expenses. Gotcha. Gotcha. On leverage, I think I saw you guys say that the target is four times. What's the timeline to get there? How long do you think it'll take you to get to four times? Yeah. I think it's gonna take three years or so to kinda get there. Our first priority, number one is kinda rewind the clock a couple years ago, that ratio was seven times, right? I think the company who created, we grew EBITDA substantially, number one. We diversified the portfolio, it becomes a lot easier to kinda manage any specific products having competitors. The last couple years, we grew it from seven to five, right? I think now our priority for this year is a solid refinancing of the debt. It turns, you know, even though it doesn't come due until May 2025, we're just actively looking at the market this year. Wanna get it done, sooner the better, to provide clarity for everyone. After that, it's really kinda continue to focus organic revenue growth and any tack in acquisitions. The remaining cash, I think, just kinda go down to reduce that level of debt. Yeah. I think we're just out of time, so thank you so much. Yeah, you're welcome. Thank you. Thank you.