Great. Good morning, everyone, thank you for joining us. My name is Matt Dellatorre, I'm a Biopharma Analyst here at Goldman Sachs. We're very pleased to have Amneal Pharmaceuticals with us this morning, where I'm joined by Chirag Patel, Co-Founder, President, and Co-Chief Executive Officer. Chirag, thank you for being here. Thank you, Matt. It's been a pleasure. A nice Goldman dinner yesterday. Mingling around with the Chief Executive Officers. The investment bankers. It was fun. Thank you. Fight the next loss. Yeah. That was tough. Chirag, maybe to kick things off, and to level set for anyone less familiar, maybe frame for us how Amneal is positioned. You guys just announced a major acquisition of Kashiv BioSciences, which vertically integrates your biosimilars business. Maybe just kind of frame for us what you're most excited about broadly, your key priorities, and what you view as the most meaningful growth drivers as we head into the second half of the year and beyond. Great. We could not be more excited. This is amazing. This year, after seven years, we're seeing the growth in our in-line products that usually declines 4%-5%. Now it could be up 10%-15%, so it's very meaningful growth driven by the hormonal patches, driven by the pain patches. Fortunately, we make them in Yardley, New Jersey. Very quickly, we're able to meet the demand. We're not all of it. We're building our capacity as fast as we can. We get the calls from pretty much all news channels, "When are you going to supply more?" They say, "You know the story behind it." Black box warning lifted. American Cancer Society say estrogen does not cause cancer. From 45 to 65 age of women there now, maybe 5% of them used to take the estrogen patches every week. That is forecasted to be 30%-40%. You can see the multiple folds. We're tripling our capacity, maybe quadrupling it in months. We'll be supplying more from this August. The in-line is great. Our launches to date are excellent. Your main question, and we'll go more in deep, but biosimilar, that entire new pillar of growth, along with our small molecule, where we lead, is amazing. All we have to do is execute. We got the pipeline of 20 biosimilars. Our own R&D, our own manufacturing. Multiple plants. We got a plant in Chicago focusing on E. coli, a plant in Scotway focusing on mAbs. India, mAbs. R&D center, U.S., India. Just the same playbook we use for Amneal's growth, we're using it for Kashiv's growth. Massive market. It's 100+ products you could launch over the next seven, eight years. That only 20 or so are being worked on because not many players are in the industry now left to focus on biosimilar. It's a race to win, and we're completely poised to take the part and be a U.S., probably top three. Globally, we have a partner model, so we don't know where we'll end up, but significant revenues will come from global markets as well. We have launches and filing lined up over the next four years, and already what comes after four years is also being worked on. Very exciting growth area. Great. Yeah. Let's dive a little bit further into the biosimilars market. Clearly, you guys did that deal so you're positive on not only your portfolio but also the space more broadly. I guess, how do you kind of see the market evolving now over the next five to 10 years with some of the regulatory changes we've seen with FDA? No phase III, and kind of more alignment on the payer side, which you guys have highlighted in the past. For instance, private labels. I guess just kind of high level frame for us maybe how you see the market evolving over the next five to 10 years. Yes. What is shifting now is private label, which is the PBM, same customer we deal with in a small molecule. We have a relationship over 20 years, and we're one of the trusted supplier for more than 300 medicines to those channels. Trust in Amneal is there. They know we'll deliver a quality product and on time. Now it is, you look at number of competitors in the pipeline assets, they're less than three, maybe four, except for KEYTRUDA, Opdivo. All if you do a research and analysis on bunch of products, which could be from a $1 billion to $10 billion, whatever range is, but below five, you see less competition. Some of the complex molecule fusion protein that we are able to crack through Kashiv, has two competitors. Like Orencia has only two known competitors. That's our next products in filing. XOLAIR, so far it's only three. These are the very important molecule for us to go after. 75% of our portfolio is going to be niche, where we define niche as less than four competitors. Less than three would be ideal because three major customers. 70% or so, 70, is moving into private label. What happens is now when you launch and when you have patent settlement, you already have a market. You're not waiting for one, two years to create a kind of quasi-branded market. We don't need to do that anymore. Volume matters because that's PBM's job to convert from branded to biosimilar. That is really important for biosimilar industry to thrive. That is the biggest factor that it wasn't there in all kinds of, I don't want to use the word, well, I'll use it. The games were being played between the rebates, CMS, the PBMs, the brand companies. You saw that in HUMIRA. Biosimilars were pretty much non-existent for first year of launch. Slowly now they're more than 50%-60% market share. I see future biosimilar as getting pretty much 70%-80% market share of total volume. Volume is expanding. Private label plus buy and build. You can do multiple things as Amneal's commercial engine is set to do multiple things. Regulatory, yes, it cut down two years now, at least, maybe three if you're really good, and almost 50% less cost. On average, it would be global development, our average is about $75 million, maybe $60 million we can get to. Other companies may be higher. Used to be $150 million. Number of players. A lot of infrastructure. They could come in. It will take time. It's a race right now. The sooner we get to the more complex biologics, we'll be always leading the pack. As the more, in KEYTRUDA, you may see 14 players. Right. It's amazing. A lot of access you're creating, so you feel good that patient benefits big time. Global access as well. Just to touch on the private labels, you guys still view that as an attractive segment of the market, because maybe you give up a little bit of price, but what you gain in volume is more than offsets that? Yeah. What do we gain in the volume as well as we have now less sales and marketing expense. Overall, it's not a bad deal. Similar margins potentially even. Similar, yes. It depends, right? If you're two players, you will have higher margins. Four or five, less margins. Interesting. Maybe, with the deal, you guys also gave long-term guidance, which included projected biosimilar revenues of about $1.2 billion by 2030, which I think everyone viewed as quite strong. On the call, you guys mentioned that you were being conservative, which we like. Maybe walk us through how you reach that number in terms of which key products. We know XOLAIR and Orencia are definitely going to be key to that. Just which products are going into that and how you're thinking about, I guess, potential share and pricing, which you touched on, I guess, a few minutes ago. Then maybe frame for us the upside scenario, if that's the base case one. Yeah. We have existing products which do about $100 million. We have. We are launching those, hope settlement agreement with. This year, we launch approved products. That should add good amount of revenue starting from next year. XOLAIR, absolutely a winner. Market is expanding. We already are in discussion with the private label as well as have the whole game plan for buy and build as well. XOLAIR will do well. Follow that with Orencia, which would be sometimes late 2028, mid 2028, and then that's only two-player market. That should add significant contribution. We have Nplate, which is E. coli-based product coming from Chicago. That should be in sometimes in late 2028 as well. It's only single player. There's nobody in Nplate. Hospital plays, platelet count increases. Amgen's product. Right. We have one disclosed product, which could be a major one if we break through. We're waiting for the FDA's comment back. That is a big winner. Kashiv has worked seven years on it, characterizing probably more than 70 enzymes. It's a tough one, but. You would potentially be only single player. We have advanced. Yes. For a long time, we could be single player if we crack through this. We're not talking too much until we hear from FDA and are ready to go. Those products, along with international revenue added on those products, should get us there. Great. That's really helpful. Maybe shifting to the commercial business. You talked about affordable medicine segments already a little bit. You all highlighted the ADHD momentum and- Affordable medicines, I just want to add our respiratory product portfolio. We have cluster of growths within affordable medicines. We're not a tablet capsule company. We're more of a respiratory. We got long-acting depots. We just launched risperidone. We have octreotide in the pipeline. These are major driver. We launch 505(b)(2) bags, which are taking the compounded version and turning into the FDA-approved products, which FDA allows because it comes from the sterile GMP manufacturing rather than compounded. The hospital allow it too. We just launched, or will be launching romidepsin, depsipeptide, which was being compounded, and it was cytotoxic product. Teva was there with RTU. Since 2017, they had to pull out for some stability reasons. We cracked the stability. It took us a couple of years. We have a great science team, and now we are in the market. FDA approved that product within six months because of the need in the hospitals. These guys, which is completely unique portfolio, and highly diversified. The tailwind is behind us in small molecule as well. Many LOEs, so much diversity we have built on a hospital business, respiratory business, ophthalmic business, batch business. We're very excited about that segment as well while we grow biosimilars. Continued momentum there, high single digit type, mid to high single digit. Could be more than that. Layer biosimilars on top of that. Yep. You guys are also kind of, this year and next, I think on the small molecule side, it's a particularly rich period of launches for you all. Yeah, I didn't mention the lanreotide. Yes. Maybe starting with that one, I think you guys have flagged a Q3 approval. Yes. So far everything is looking like Q3 or earlier, and it should be a very good market until somebody else comes in. For a couple of years, we already have so much demand. I have spoken to customers. Ready to go. This is a dedicated facility, our own. Yeah. Right. We built it for lanreotide. It doesn't require a huge footprint, but it requires a dedicated facility. Wow. The nature of the product, the viscosity, the device. We designed the whole thing over the past seven years. Could that end up being your biggest product within? No. It won't be. Luckily, we have- Okay we have other big products as well, but it could be. People think it's going to be very big. It could be. I hope it just becomes so I don't want to throw the numbers out. Yeah, right. It's going to be very significant. Yeah, that's lanreotide. We have iohexol. Other strengths are coming, which is again, only GE and us. If there are any supply disruptions, right, it's GE alone, and this is a much needed product. We have now a couple more strengths coming in, and supply chain is very tricky. We have it somewhat figured out. We're still working more to have a bit of a higher volume. We'll go after certain market where GE hasn't locked down customers. Okay. Both lanreotide and- Iohexol You'll be the only generic on the market- Yes For the foreseeable future. Yeah. Yes, that is true. How are you thinking about the durability of that? Should we think multiple years? Yeah, I don't know about lanreotide, how quickly Cipla can come back. But Iohexol, we don't hear anybody coming in. Again, we've been working on supply chain and figuring it out for 10 years. We always work on toughest projects. At Amneal, that is paying off. Sometimes it may take some time. This is where you need the value. You need more affordable access, and that is what we bring in. Great. You did touch on this a little bit already, your current biosimilars portfolio, outside of the Kashiv acquisition, how are you thinking about the Prolia and XGEVA launches? Obviously, there are other players on the market now. You guys have, I think, set expectations a little bit lower for those in the sense that they're not going to probably take huge share, but please correct me if I'm wrong. Well, wait until we disclose the creative strategy. Okay. You have to find an angle, right? Okay. Maybe, tied to that. It will have meaningful contribution for Amneal. It will have meaning-- Okay. Yes. Okay. In terms of the XOLAIR launch, obviously, there's a lot of excitement about that. You guys will be one of the first two players, could be one of your biggest products probably through 2030 in biosimilars. I guess, what do you view as the critical points of execution for capturing that market? Is there anything that sticks out? No. First hurdle is the Cashel plant. FDA is visiting from July 14th, they will be there a few days. FDA Guiding us through. Okay. Inspecting. That's the first hurdle in getting through, IP settlement would be the second hurdle. We don't see issue, we'll see which month, because we do not infringe patent. Our patent landscape is very strong. That, after that, it's just supply, we already have an advance talk with some of the customers ready to go. Great. Maybe switching gears to the specialty segment. You have two key launches going on right now, CREXONT and Brekiya, which I think on the 1Q call, you guys highlighted continued momentum. I guess, as we think about those launches over maybe the coming quarters, the trajectory as you head towards those long-term targets of, I think you've highlighted $3 million-$500 million for CREXONT, and then $50 million-$100 million for Brekiya. What's the most critical aspects of the commercial strategy, is it evolving now that we're a year or a couple of years, I guess, into the CREXONT? 15 months in CREXONT. 15 months in CREXONT. Yes, 23,000 patient already on the therapy. It took eight years to get to 42,000 patient for RYTARY. This is moving very fast, 80% conversions coming from IR. There's a huge market. There's 700,000 patient to go after and from IR to CREXONT. They should not be on IR, so we're running multiple trials to prove that. We already had phase IV results read out recently. Even on RYTARY, it's three hours good on time on top of RYTARY. Top of IR is even longer. Right. That's what the patient needs, is the consistency. Not the peaks and valleys, peaks and valleys. All kind of bad things happen for Parkinson's patients, and we're very committed for Parkinson's. The dream is to make CREXONT a first-line therapy. That could be hundreds of thousand patient starting on CREXONT. There's no need to start on IR and then move to CREXONT. We're working on it right now. Tremendous patient providers, everybody is talking about CREXONT. We should be able to achieve our target. Hopefully higher side of the three to 500 looks like. International will start as well. We have approval now in India and Europe is coming soon. Europe, they're saying they would be able to do a whole lot as well. They ran another study in Europe. Europe never had a long-acting CD/LD. This is the first time. Oh, really? Oh, really? Oh, because RYTARY is not- It was only in the U.S. The patient for 40 years been taking IR. We're launching it everywhere through partners. India, we're launching with us and another major Indian player, and demands everywhere. This should do really well, CREXONT. A great molecule. It's amazing technology we use. Brekiya, I think we're going to double what we said. Is a 50-100, it could be 100-200. Wow. The reason is, it's such a useful innovation. In cluster headaches, severe migraine, you go to the clinics, the pain level is almost 10 out of 10. You're banging on the head. I mean, your head is banging on the wall and everywhere. We have a couple of our own employees suffer through it. Actually, our own head of marketing has severe migraine issue on Brekiya. Them to then go to the emergency room, that could be a couple hours wait, and then get same DHE injection administered at the hospital. Now we made it a auto-injector. They keep the box of four pens. When they have the episode, boom, self-administered like Mounjaro. In 15, 20 minutes, relief is provided. They sleep better. They know the treatment is right there. Don't need to go to emergency rooms. Very well received by the entire, the migraine community and cluster headache community. We'll continue to have more demand than we thought. Maybe just wrapping up the specialty segment. What are your guys' latest expectations for RYTARY generic? Is that still just TBD? TBD. These are just three quarters. Yeah. TBD. Specialty, we're very excited, right? Because we got CREXONT, huge growth and potential. Brekiya, huge growth and potential. We have our Unithroid, like SYNTHROID. It's steady Eddie. It keeps growing. We have couple of smaller products which are there. We have one undisclosed program, which we'll disclose it by probably once we file it. Okay. That's for men's health, which is also in the news lately too. Yeah. We got a good product there. We have, what. Do we think of that as in the kind of neuroendocrine bucket, or is it. Yeah. We'll see soon enough. Yeah. Okay. Yeah. Often, we don't talk about men's health much. Right. Then we have a couple of other products which we haven't disclosed, because we usually disclose ones probably after phase II. We do invest now almost $30 million-$50 million every year, which sounds small, but with the world of AI and our teams being in U.S. and India, that $50 million goes a long way. We would keep investing in R&D every year. We love that data. There's a lot of these niches between, let's call it a three to $500 million revenue potential that big pharma will not be in. Right. It leaves it out for us. Maybe sometimes we hit a big one. Just to touch on that men's health one, you said you'll announce that when you file the- Yeah, we'll file the NDA. NDA. it'll be going into phase- No, it's going to be- it'll- filed. Oh, it'll be filed at post-phase. Filed. Yeah. Okay. We're going to file it probably end of this year. Wow. We'll then announce it. It could be launched by end of 2027. Not too far. You mentioned Mounjaro a minute ago. Maybe shifting to your obesity program with Pfizer. You all have been very enthusiastic about this. I think when we spoke post the quarter, you all kind of highlighted that the partnership could be potentially even expanded in terms of longer term. I guess maybe just level set us where the partnership stands today and how far along you are with the manufacturing facility build-out. Great. Pfizer, we have been in active discussion. Both teams are working together already. First priority was the execution. They are superbly impressed with Amneal's team, because we're not a typical CDMO or CMO. We are same as them. The manufacturer, which takes everything with passion, how they did it on their vaccine, we're doing it over here. They never had the infrastructure for GLP-1 except for the fill and finish side. They're working. Metsera, some of the members are there as well, whom we have worked over the last three years. Manufacturing GLP-1, the peptide is a key. That facility, there are two facilities. One is at a small scale, which is coming online very soon, and only dedicated for Pfizer's product, Pfizer Metsera. Another bigger facility, which should be done by end of next year as well for API. These two will. That API is considered biologics because of 41 amino acids. Over 40 is biologics designation, under 40 is small molecule. You get five more years of exclusivity, right? It's 12 years exclusivity for I think Lilly is fighting on one of their filing. Yeah. Seven years versus 12. The Pfizer recent data is awesome, we always believe that this is going to become more of a consumer product. The more lesser side effect, longer lasting, without much of other complication like cardiovascular or others, would be the winner because I don't have to sell GLP-1, right? Everybody knows and what it does, it's tremendous. In India, they just launched it. You can't even get it. People are paying for it, for the branded products. Generics becomes a dime a dozen because it's just so many players will make it. Sell it at a such cheap price. Our play was always to partner with branded company, which we did with Metsera. Luckily, Pfizer bought them, so now we are with a big guy, and we have a great relationship with them, and we'll announce probably in a couple of months the updates on the agreement. We may co-market in some of the big market because Pfizer has a team. Right now, we have the exclusive right in India and other 17 countries. Some of them will co-market. We're always up for what product can do. We can maximize. Ye ah, we'll do it together. Yeah. It's a very good relationship and moving really well. The two giant facility, we could use it for other futuristic peptide products as well. Extra capacity. Okay. Yeah. Extra. First is dedicated to Pfizer. Whatever Pfizer doesn't use, we can use it for others. Peptide is moving, as you know, huge field. Even in- You guys are not interested in kind of focusing on generic. Oh, no. It would be kind of Generics come way Right. Mounjaro generics will be 2036 something. By then, Wegovy. Wegovy Who's going to use it? It's old with a lot of side effects. Mm-hmm. Maybe, kind of tying the Pfizer. It's one of your maybe key People don't really give you credit for it yet, it's early, but it is one of the key growth levers as we look out. From 2030 onwards. We do not have it in our guidance. You don't have it in the guidance. No. No. If we do it earlier, it'd be added benefit. We would be always conservative, b eat and raise. That's been a public company lesson for us. We like that. In the past, you all have highlighted this nice way to think about it, which is every roughly billion. Well, let's wait until how the contract gets updated. I think we'll see. we could expand the timeline. The price environment has become challenging. There was back then, I think, calculation when monthly price would be $800. Now I think it's $400 and going down for the treatment in U.S. and Europe. We'll update, but we have supply. We make money from supplying, and we share gross profit royalties as well. We make money from our own 18 markets. Right. Yeah. We share only small royalty back to Pfizer. The rest remains with us. It's pretty good economics on both sides. Right now we're negotiating, we'll update as we finish the negotiation. I see. As you think about India and some of those other emerging markets. Obviously, there seems to be a lot of demand now, they're still relatively small. I guess, how big do you see those getting? Are you just imagining kind of- I think, look, for our size, all these 18 countries become our portion. I don't know what Pfizer is going to bring in, if we do somewhere between $3 million-$500 million annually, a great profitability. Not bad. Depends on what next product Pfizer, Metsera portfolio will produce. We have rights for all that portfolio. Maybe amylin combination, I'm not sure. Maybe a prodrug on oral. That is still R&D. It's pretty good. It's very good. Maybe just to wrap up, kind of post the deal, obviously, you guys are investing heavily in biosimilars. You have the Pfizer partnership we just talked about. How does the capital allocation strategy post this deal obviously You guys- Capital is straightforward. We would want to operate under three times leverage. We're at 3.5, maybe temporarily go to 3.6, but very soon we get down to under three. Once we are under three, the rest of the free cash flow, which could be significant, $300 million, $400 million, $500 million a year as EBITDA is rising. All investment, most of it's going to go on specialties. This- Specialty We invest in R&D, in biosimilars every year, CapEx. That will continue. We don't need to buy anything in. As you highlighted, you have a specialty pipeline. Yes. We'll do some M&A as well, spreading in licensing. We're excited about that. We're a multi-decade strategy, this will continue. Yeah. Great. Thank you. Well, Chirag, thank you very much, for being with us today, congrats on all the progress, and we look forward to monitoring all the updates. Yes, please. Thank you very much. Thank you.