Conference Transcript - AMRX 2026-06-09

Matt De La Torre, Analyst — Goldman Sachs

Great. Good morning, everyone, and thank you for joining us. My name is Matt De La Torre. I'm a biopharma analyst here at Goldman Sachs, and we're very pleased to have Amnial Pharmaceuticals with us this morning, where I'm joined by Shirag Patel, co-founder, president, and co-CEO. Shirag, thank you for being here.

Chirag Patel, CEO

Thank you, Matt. It's been a pleasure. It's been a nice Goldman dinner yesterday. Good investment bankers. It was fun.

Matt De La Torre, Analyst — Goldman Sachs

Yeah. Fight the Knicks loss. Yeah, that was tough. Shag, maybe to kick things off, you know, and to level set for anyone the less familiar, maybe, you know, frame for us how Amnual is positioned. You guys just announced, you know, a major acquisition of Kashif Biosciences, which, you know, vertically integrates your biosimilars business. So maybe just kind of, you know, 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. Now we could not be

Chirag Patel, CEO

more excited. This is amazing. This year after seven years we're seeing the growth in our inline products that usually declines 4-5% and now it could be up 10%, 15%, so it's very meaningful growth driven by the hormonal patches, driven by the pain patches. And fortunately, we make them in New Jersey. Quickly, we're able to meet the demand. So 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 warnings lifted, American casual does not cause cancer, so the menopause period women are that from 45 to 65 age of women there now used to, maybe 5% of them used to take the estrogen patches every week, that is forecasted to be 30 40 percent so you can see the multiple folds so we're tripling our capacity maybe quadrupling it but we'll be supplying more from this August the inline is great launches to date are excellent and your main question and we'll go more in deep but biosimilar that entire new pillar of growth 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. So we got a plant in Chicago focusing on E. coli, plant in Scottway focusing on MABS, India, MABS, R&D Center, US, India, just the same playbook we use for MNIL's growth. We are using it for its 100 plus 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. So it's a race to win, and we're completely poised to take the part and be in the U.S. probably in the 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. And we have launches and filing lined up. And already what comes after four years is also being worked. Very exciting growth area.

Matt De La Torre, Analyst — Goldman Sachs

Great. Yeah, maybe let's dive a little bit further into, you know, the bio-cellular market. Clearly, you know, you guys did that deal, and 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 ten years with some of the regulatory changes we've seen with FTA, no phase threes, 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 ten years.

Chirag Patel, CEO

Yes. So what is shifting now is Ravid Label, which is the PBM, same customer we deal with in a small molecule. So we have a relationship over 20 years, and we're one of the trusted suppliers for more than 300 medicines to those channels. So trust in MNEO is there. They know we'll deliver a quality product and on time. So now it is, you look at number of competitors in the pipeline assets, there are less than maybe four, except for Keytruda, Optivo, research and analysis on a bunch of products which could be from a billion dollar to 10 billion, whatever range is, but below five you see less competition. And some of the complex molecules, fusion proteins, that we are able to crack through through Kashiv has two competitors. Like Orencia is only two non-competitors. That's our next products in filing. Dolar, so far, it's only three. And these are the very important molecules for us to go after. So 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. So 70% or so, 7-0, is moving into private label. So 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. And volume matters because that's PBM's job to convert from branded to biosimilar. And that is really important for biosimilar industry to thrive. So that is one, the biggest factor that it wasn't there in all kinds of, well, I'll use it, the games were being played between the rebates, PBMs, the brand companies. You saw that in Humira, biosimilars were pretty much non-existent, and then slowly now they're more than here. So I see future biosimilars getting pretty much 70-80% market share of total volume, and volume is expanding. Private label plus buy and build. So you can do multiple things, as MNIL's commercial engine is set to do multiple. And regulatory, yes, it cut down two years now. at least maybe three if you're really good and almost 50 percent less cost average it would be global development we can get to uh other companies maybe higher used to be 150 million number of players infrastructure they could come in it will take time so it's a race right now the The sooner we get to the more complex biologics, we'll be always leading the pack, as the more in Cateroda you may see. It's amazing. A lot of excess you're creating, so you feel good that patient benefits big time, and global excess as well.

Matt De La Torre, Analyst — Goldman Sachs

And 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 you gain. What you gain in volume is kind of more than offsets.

Chirag Patel, CEO

Yeah, what we gain in the volume as well as we have now less sales and marketing expense. So overall, it's not a bad deal. So similar margins potentially even on... Similar, yes. And it depends, right? If you're two players, then you will have higher margins. Or five less.

Matt De La Torre, Analyst — Goldman Sachs

Maybe, you know, 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, you know, quite strong. But on the call, you guys mentioned that, you know, you were being conservative, which we liked. Maybe walk us through, you know, how you reached that number in terms of, you know, which key products. We know Zolaire and Arendtia are definitely going to be key to that. But just kind of 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. And then maybe frame for us kind of the upside scenario, if that's the base case one.

Chirag Patel, CEO

Yeah, so we have existing products, which then we have launching, so this year launch, approved products. So that should add a good amount of revenue starting from next year. Zoller, absolutely a winner. The market is expanding. We already are in discussion with the private label as we have the whole game plan. So Zoller will do well. And then follow that with Orencia, which would be sometimes late 28, mid 28. and then that's the only two-player market so that should add significant contribution and then we have N plate which is the E.coli based product coming from Chicago that should be in some sometimes in late 28 as well so that should it's only single-player yeah hospital plays quite late count it increases. And then we have one disclosed product, which could be a major one if we break through it, but that is Hashi has worked seven years on it, enzymes. It's a tough one, but you would enter the only single layer. We have advanced, yes, yes, for a long time we could be. We're not talking too much until we hear from FDA and are ready to go. So those products, along with the international revenue added on those products should get us there.

Matt De La Torre, Analyst — Goldman Sachs

Well, maybe shifting to the commercial business, you talked about the affordable medicine segment already a little bit. You all highlighted the ADHD momentum.

Chirag Patel, CEO

Yeah, but affordable medicine just adds our respiratory product portfolio. So we have a cluster of growths within affordable medicine. We're not a tablet-caption company. respiratory. We got a long-acting depose. We just launched Respiridone. We have octetide in a pipeline. These are major driver. We launched 505B2 bags, which are taking the compounded version and turning into the FDA approved products, which FDA loves because it comes from the sterile GMP manufacturing rather than compounded. The hospital love it too. We just launched or will be launching gromidespin which was being compounded and it was a 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. FT approved that product within like six months because of the needed so these guys which is completely unique portfolio and highly diversified the tailwind is behind us in small molecule as well so many LOEs so much diversity we are built on a hospital business respiratory business ophthalmic business batch business so this we're very excited about that segment as well while we grow biosimilars. Continued momentum

Matt De La Torre, Analyst — Goldman Sachs

there, high single digit.

Chirag Patel, CEO

Mid to high single digit.

Matt De La Torre, Analyst — Goldman Sachs

And then layer biosimilars. You guys are also kind of, I mean, this year and next, I think, on the kind of small molecule side are particularly, it's a particularly rich period of launches for you all.

Chirag Patel, CEO

Yeah, I didn't mention the landreotype.

Matt De La Torre, Analyst — Goldman Sachs

Yes, yeah. Maybe, yeah, maybe starting Starting with that one, I think you guys have flagged a Q3 approval.

Chirag Patel, CEO

Yes, yes. So far, everything is looking like Q3 or earlier. And it should be a very good market until somebody else comes in. This is a dedicated facility, our own. We built it for Landry Tide. So it doesn't require a huge footprint, but it requires a dedicated facility, the nature of the product, the viscosity. the device we designed the whole thing

Matt De La Torre, Analyst — Goldman Sachs

Does that end up being

Chirag Patel, CEO

your biggest product? No, no, luckily we have we have other big products as well, but it could be I hope it just becomes so, I don't want to throw the numbers out but it's going to be yeah, so that's we have IO-Hexol other strands are coming which is again, only GE and us supply disruptions. GE alone, this is a much-needed So we have now a couple more strengths coming in. The supply chain is very, very tricky. So we have it somewhat figured out. We're still working more to have a bit of a higher volume. We'll go after certain markets where GE hasn't locked down.

Matt De La Torre, Analyst — Goldman Sachs

So both Landry Tide and IHAC, you'll be the only generic on the market for the foreseeable future.

Chirag Patel, CEO

Yeah, yes, yes, that is true.

Matt De La Torre, Analyst — Goldman Sachs

How are you thinking about the durability of that? Is that, should we think, like, multiple years?

Chirag Patel, CEO

Yeah, I don't know about Landry Tide, how quickly SIPLA can come back. But IOHECSOL, we don't hear anybody coming in. Again, this is, we've been working on supply chain and figuring it out for 10 years. We always work on toughest projects at Emneal, and that is paying off. Sometimes it may take some time, but this is where you need the value. You need more affordable access, and that is where we...

Matt De La Torre, Analyst — Goldman Sachs

You did touch on this a little bit already, but your current biosimilars portfolio, outside of the Kashiva acquisition, I guess, how are you thinking about the Prolia XGiva launches? Obviously, there are other players on the market now, And also, you guys have kind of, 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.

Chirag Patel, CEO

Well, wait until we disclose the creative strategy. You have to find an angle.

Matt De La Torre, Analyst — Goldman Sachs

So that may be tied to that. It will have meaningful contributions. It will have meaningful. And then in terms of the Zolaire 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, you know, in biosimilars. I guess, what do you view as kind of like the critical points of execution for capturing that market? Is there anything that kind of sticks out?

Chirag Patel, CEO

No, FOS3 hurdle is the Scardway plant. FTA is visiting from July 14th, so they will be there a few days. just guiding us through and inspecting. So that's the first hurdle in getting through. And settlement, IP settlement, would be the second hurdle. We don't see issue, but we'll see which month because we do not infringe. Our patent landscape is very... That and after that, it's just supply. And we already have in advance talk with some of the customers ready to go.

Matt De La Torre, Analyst — Goldman Sachs

Maybe me switching gears to the specialty segment, you have two kind of key launches going on right now, Crexon and Breccia, 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, kind of the trajectory as you kind of head towards those long-term targets of, You've highlighted $300 million to $500 million for Crexon, and then $50 million to $100 million for Breccia. What's kind of 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 Crexon?

Chirag Patel, CEO

Fifteen months in Crexon. Fifteen months in Crexon. Yes, and 23,000 patients already on the therapy. It took eight years to get to 42,000 patients for RITERI. So this is moving very fast, and 80% conversions coming from IR. So this is a huge market. There's 700,000 patients to go after, from IR to Lexon. They should not be on IR. So we're running multiple trials to prove that. We already had these four results read out recently. Even on RITER, it's three hours, good on time on top of RITER. And top of IR is what the patient needs, the consistency. They're not the peaks and valleys, peaks and valleys. So all kind of bad things happen for Parkinson's patients. And we're very committed for Parkinson's. The aim is to make corrects on the first line. And that could be hundreds of thousands of patients starting on Clexon. There's no need to start on IR and then working on it right now. Tremendous patient providers. Everybody is. We should be able to achieve our target. Hopefully higher side of the 300 to 500, it looks like. International will start as well. So we're now in India and Europe is coming soon. Europe, they're saying they would be able to run another study in Europe. So Europe never had a long-acting CDLD. This is the first time. Because Ritari is not in there. Ritari is not. It was only in the United States. So the patient for 40 years has been taking IR. We're launching it everywhere through partners. India, we're launching with us and another major Indian player. And demands everywhere. So this should do really well, Crexon. A great molecule.

Matt De La Torre, Analyst — Goldman Sachs

Brachia, I think we're going to double what we said.

Chirag Patel, CEO

It's a 50 to 100. It could be 100. And the reason is it's such a useful innovation. In cluster headaches, severe migraine, you go to, you're banging on the head. Your head is banging on the wall and everywhere. We have a couple of our own employees suffer through it. Actually, our own time to then go to the emergency room. that could be a couple hours wait and then get the same DHE injection administered at the hospital. Now we've made it an auto-injector. They keep the box of four pants. When they have the episode, boom, self-administered. In 15, 20 minutes, they sleep better. They're right there. Emergency room. So very well received by the migraine community. Continue to have more demand than we thought.

Matt De La Torre, Analyst — Goldman Sachs

Maybe just kind of wrapping up the specialty segment, what are your guys' latest expectations for Rattari Generic? Is that still a TBD?

Chirag Patel, CEO

TBD.

Matt De La Torre, Analyst — Goldman Sachs

These are just free quarters.

Chirag Patel, CEO

Yeah, TBD. Specialty, we're very excited, right, because we've got Crexon, huge growth and potential. Brachia, huge growth and potential. We have our unithroid, like Synthroid, it's steady, it keeps growing. Then we have a couple of smaller products which are there. And then we have one undisclosed program, which will probably, once we file it, and that's for men's health, which is also in the news lately. So we got a good product there.

Matt De La Torre, Analyst — Goldman Sachs

And then we have... Do you think of that as in the kind of neuroendocrine bucket, or is it... We'll see soon enough.

Chirag Patel, CEO

Yeah, yeah, yeah.

Matt De La Torre, Analyst — Goldman Sachs

Okay, yeah.

Chirag Patel, CEO

often we don't talk about men's health and then we have a couple of other products which we haven't disclosed because we usually disclose we do invest now almost 30 to 50 million every year which sounds small but with the world of AI and our teams being in US and India that 50 million goes a long way so we would keep investing in it and there's a lot of these niches between, let's call it $300 million to $500 million revenue potential, that big pharma will not be. So it leaves it out for us. And maybe sometimes we hit a big one.

Matt De La Torre, Analyst — Goldman Sachs

And just to touch on that men's health one, you said you'll announce that when you file the NDA. So it'll be going into phase one. No, no, it's going to be filed. Oh, it'll be filed at post-phase.

Chirag Patel, CEO

We're going to file it, probably, and we'll then announce it. It could be launched by the end of 2017, so it's not too far.

Matt De La Torre, Analyst — Goldman Sachs

You mentioned Manjaro a minute ago. So maybe shifting to your obesity program with Pfizer, you've all 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 kind of maybe just level set us where the partnership stands today and how far along you are with the manufacturing facility build out. Great. So Pfizer, we have

Chirag Patel, CEO

been in active discussion. Both teams are working together already. First priority was the execution. They are superbly impressed with the MNILS team because we're not a typical CDMO or CMO. We are the same as them, the manufacturer, which takes everything with passion, how they did it on their vaccine, we're doing it over here, which they never had the infrastructure for GLP except for the fill-and-finish side. So they're working very good. And Metsera, some of the members are there as well, whom we have worked with over the last three years. So manufacturing GLP, the peptide is a key. That facility, there are two facilities. One is at a small scale, which is only dedicated for Pfizer's product, Pfizer Metsera. And then another bigger facility, which is there as well, for API. So these two will, and that API is considered biologics because of 41 amino acids. So over 40 years biologically, you get five more years of, it's 12 years exclusivity for, I think Lilly is fighting on one of their filing. Seven years versus the Pfizer recent data is awesome. And it's believed that this is going to become more of a consumer product. so the more lesser side effect longer lasting without much of other complication like cardiovascular or others would be the winner because it I don't have to sell GLP right everybody knows and what it does it's tremendous in India they just launched it you can't even get it and 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 such a cheap price. So our play was always to partner with branded company, which we did with Metzera. Luckily, Pfizer bought them. So now we are with the 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 markets because Pfizer has a team. Right now, we have the exclusive right in India and other 17 countries, but some of them will co-market. We're always up for what product can do. We can maximize product? Yeah, we'll do it together. It's a very good relationship and moving really well. And the two giant facility, we could use it for other futuristic peptide products as well. it extra capacity okay yeah yeah extra first is dedicated to Pfizer what it was the Pfizer doesn't use we can use it for the peptide is moving as you know yeah

Matt De La Torre, Analyst — Goldman Sachs

yeah even in but you got you guys are not interested in it would be it would

Chirag Patel, CEO

be kind of generics come way 2036 yeah something and by the day and we'll go

Matt De La Torre, Analyst — Goldman Sachs

Maybe, you know, kind of tying the five, it's one of, you know, maybe key, people don't really give you credit for it yet, you know, it's early, but it is one of the key kind of growth levers as we look out.

Chirag Patel, CEO

From 2030 onward. So we do not have it in our guidance. You don't have it in the guidance. No, no. This is all, if we do it earlier, it would be added benefit. We just, we would be always conservative. We like to beat and raise. That's been a public company lesson for us. We like that.

Matt De La Torre, Analyst — Goldman Sachs

In the past, you all have highlighted kind of this nice way to think about it, which is every roughly billion in...

Chirag Patel, CEO

Well, that is, let's wait until how the contract gets updated because we could expand the timeline. The price environment has become challenging. There was back then, I think, calculation when monthly price would be $800 and now I think it's $400 and going down for the treatment in U.S. and Europe. So we'll update, but we have supply. We make money from supplying and we share gross profit royalties as well. And then we make money from our own 18. We share only small royalty back to Pfizer, the rest remains with us. So it's pretty good economics on both sides. And right now we're negotiating, so we'll update as we

Matt De La Torre, Analyst — Goldman Sachs

finish the negotiation. And then as you think about India and some of those other emerging markets, obviously there seems to be a lot of demand now, but they're still relatively small, I guess. How do you, how big do you see those getting? Are you just imagining kind of

Chirag Patel, CEO

So I think, look, for our size, all these 18 countries become our portion. I don't know what Pfizer is going to bring in, but if we do somewhere between $300 million to $500 million annually, the great profitability, not bad. And it depends on what next product Pfizer, MetSera portfolio will produce. We have rights for all that in combination. I'm not sure. Maybe a pro-drug. It's pretty good. It's very good.

Matt De La Torre, Analyst — Goldman Sachs

Yeah. Maybe just to wrap up, you know, kind of post the deal, you know, obviously, you know, you guys are investing heavily in biosimilars. You have the Pfizer partnership we just talked about. How do we have capital allocation strategy, you know, post this deal? Obviously, you

Chirag Patel, CEO

Yeah. So capital allocation is straightforward. We would want to operate under three times leverage. We are at 3.5, maybe temporarily go to 3.6, but we get down to under 3. Once we are under 3, the rest of the free cash flow, which could be significant, be 400 million, 500 million a year as the bidder is rising, all investment, most of it is going to go on. After investing into the, you know, we invest in R&D and biosimilars every year, capex so that will continue but we don't need to buy anything yeah as you

Matt De La Torre, Analyst — Goldman Sachs

highlighted you have a you have a specialty pipeline yes yes and and we'll

Chirag Patel, CEO

do licensing so we're excited about that we have multi-decade strategy so this will continue yeah great thank you thank you very much for being with us today

Matt De La Torre, Analyst — Goldman Sachs

and congrats on all the progress and look forward to monitoring all the update yes please thank you very much