There we go. Cut the music. All right. Good morning, everyone. Thank you for joining us. For our next presentation, we're excited to be hosting Amneal Pharmaceuticals. Chirag Patel, to my left, is the Co-Chief Executive Officer and President of the company. In the front row, we got Joe Todisco who does all things finance. To his left, my right, would be Tony DiMeo, who heads the investor relations function that I think many of you know. We're excited to have you here. Thank you for joining us. You know, why don't we just jump right into it? You know, I probably should have mentioned, I'm Glen Santangelo, I'm the analyst at Barclays that covers the stock. We launched in December with an outperform rating.
You know, Amneal is new coverage for us here at Barclays, so we're pretty excited about it. Thank you for joining us. You know, maybe a good place to start is we're a week and a half off your fiscal year results. I mean, you wrapped up a very successful 2025. Maybe that's a good place to start and just give people just a quick recap of 2025 and those, you know, fiscal year results and set the table for 2026 with your guidance. I don't know if there was anything that surprised you. I mean, there was a lot that maybe surprised you the upside, anything to the downside that might surprise you coming out of fiscal 2025.
Great. Thank you, Glen. Thank you for hosting Amneal here and inviting me here. The journey for 2025 actually started in 2019. We call it Amneal 2.0. When my brother and I, we successfully ran a private company from founding of Amneal in 2002 to 2018 when it went public. We came back August 2019, and we started strategizing, what do we do for Amneal 2.0? It obviously takes time. First, we had to make sure our base business keeps growing. We did that. We introduced new products and then invested in different R&D, more complex R&D, which paid off. Diversified the company as well.
We bought a distribution company, especially for VA and DoD, which is doing fantastic. AvKARE in 2020. With all that diversification, what you saw and continue to invest in specialties. Got CREXONT approved, Brekiya launch, couple of biosimilars launch. All these activities over the last six years, the platform is now even more set from where it goes from 2026 to 2032. I mean, we have a whole roadmap to 2035, but 2032, we're very excited. 2025, amazing year on all aspects. We obviously meet and raise our guidance, which we like.
Yep.
To be conservative and go forward. The Affordable Medicines Group, which we call it instead of calling generics, it's generics, injectable, and biosimilars. We call that Affordable Medicines Group, which is growing. It has grown 5% over the last five years. Now we expect to grow in high single digit or even more when we have successful biosimilar launches. Which we'll talk more about it. Specialty segment is growing despite of LOE, authorized generics of RYTARY. CREXONT has been a superb launch. The product is outperforming everybody's expectation because what it delivered, the absorption it delivered, the crossing over blood-brain barrier. The patient are taking it twice a day instead of four, five, six, eight capsules a day, and it provides them a stable good on time.
It's been an awesome year, and we also won the Best Company to Work For Award last year from BioSpace, which was always given to big pharma. First time they chose a leading affordable medicines company. We're very, very proud of that as well.
Okay. Maybe just before we dive into the different segments, you know, on that conference call, you also announced some changes to AvKARE, you know, in that portion of your business. You know, you touched on Affordable Medicines, you touched on specialty, you didn't really touch on that segment. Maybe just to round out the conversation for people.
Sure.
You know, why you made that decision, and then we'll dive in.
Right. When we acquired AvKARE, the 50% revenue came from VA/DoW channel, which is the most profitable channel we have. That is where we are growing. It's value-added generics and injectables, will soon be biosimilars and branded products. 20 million lives at VA/DoW and the veterans are aging, so we have two benefits there. Most of the profit comes from that channel. There was a second part of the channel which we did not really care, which competes with traditional wholesalers at 2%, 3% margin. That's a low margin business, pure distribution. They take Gilead's product and distribute. That's not the business we are in. That is the one we are de-emphasizing. It's only nothing like $350 million in top line. Bottom line is not even $10 million-$15 million.
We're not going to invest behind distribution.
Yeah. Okay.
That's where you're seeing this, but remarkable growth on all the core areas of the business, including AvKARE government distribution.
Okay. All right. Let's dive right into Affordable Medicines. You know, you talked about there's three different businesses, and they're generics, injectables, and biosimilars. When we look in 2025, you know, a little bit of a mix of things going on, right? The trends in biosimilars and injectables were down, but you know, in the traditional generics business, that was pretty strong. Maybe if you can, you know, unpack the different segments within that.
Sure.
Affordable Medicines business to help us, to help the investors think about all the different
Yeah.
The underlying trends and what's impacting that business.
Right. All three are essential medicines, which 92% of prescriptions are filled using generics product, right? Let's take the small molecule retail channel, where we lead. We're number three in the nation, soon to be number two, which is the business we do with CVS, Walmart, Walgreens.
All the channels, and Express Scripts, and Optum. That segment is continuing to grow because we're launching ophthalmics products. We have an entire line of transdermal. Right now, recently, DOTTI, the Astellas patch is in shortage. We are one of the largest supplier because FDA removed the block, black box warning. The demand went up by quadruple, and then transdermal is not easy to just increase the production. But we're working day and night to supply more DOTTI. The ophthalmics launches are coming up as well. We already launched 15 or so. There are more coming. We have two inhalation products that are approved, PROAIR and QVAR. That entire inhalation portfolio now you'll see over the next five years, which will provide growth to this retail channel.
We pretty much do everything in retail channel. About 260 products, includes topicals, liquids, transdermal patches, inhalation products, respiratory products. We have the ophthalmics, as I said, tablets, capsules. We got the full line that the retailers need, and one of the best pipeline in the industry. A lot of first to market products in that category. Second category is injectable, which it's timing of launches, we are focused on, very complex injectables like long-acting depot, iohexol, right? This is the first time anybody introduced it.
Yep.
Competing with GE HealthCare. Lanreotide is going to be approved hopefully very soon here. These are the. We have the whole pipeline. We also took certain products in a bag manufacturing, the ready-to-use bags, so they were being compounded. We made them FDA-approved. Entire pipeline in injectables is set for growth. Third, the biosimilars, which will provide the highest growth, but we would need to do certain M&A.
Yep.
To have our own development, manufacturing, and obviously, U.S. will market directly, and the rest of the world would be marketed by partners. Very exciting in Affordable Medicines category.
Okay.
Huge growth.
Can we talk about biosimilars for a second? You know, you have a couple launches on the way with denosumab and the XOLAIR approval later this year. How do we think about the growth in 2026? I mean, I think probably is, maybe not expected to be as big as XOLAIR, and XOLAIR will probably more benefit 2027. How do we think about, you know, what we saw in some deceleration in 2025 with maybe stabilization in 2026 and re-acceleration in 2027? Is that the right way to think about it or no?
Yes, yes, because we had these ASP-driven products, which always come under pressure, so we did well with those.
Yep.
They're a little bit under pressure, Avastin, Neupogen, Neulasta. Now denosumab is being launched second half of this year. That would accelerate the revenue growth.
Yep.
XOLAIR in 2027-
Yep.
Would accelerate further growth. If we are successful in announcing the M&A transaction, you'll see the more and more launches in 2028, 2029, 2030.
Right.
Every year, new launches, and every year, new filing. The pipeline is so large, opportunities are, it's total 110 products. But we at Amneal, along with our potential partner, is about 27 products in pipeline would be, could be announced. That builds the entire portfolio, and we now become vertically integrated, top five companies in biosimilars.
For a long time to stay.
Yeah. When you think about the guidance, right? I mean, 7%-8% growth this year, but high single digits sort of longer term.
Yes.
Which is maybe reflective of that pipeline.
Yes, yes. It could be more. If we are successful in executing on biosimilars, this is the golden time. It's not just me. My friend Richard Saynor says the same thing.
Yeah.
It's who executes how fast will win.
Yeah.
You need to have R&D.
Yep.
Manufacturing, because it's a very complex manufacturing. Multiple bioreactors, huge science team, the analytical team. Now FDA has made it easier. You saw yesterday's announcement. That is the second announcement.
Yep.
They took out pretty much the need for phase III, now took out unnecessarily the bridging studies between different RLDs.
Can you talk about the margin tailwind that this will potentially create in this segment?
Yeah, glad-
How should we think about that?
It is, so it's increasing the margin. We already saw our margins going up this 2025. 2026, we expect another 100 basis points to go up, and we will keep ahead in margin as long as we have our own manufacturing and distribution and R&D for biosimilars in the United States.
Okay. Can we talk about, let's maybe transition over to specialty and let's talk about RYTARY, right? We're expecting some generic competition this year. Could you maybe talk about the timing of how you think that sort of plays out and how you sort of layer that into the guidance for this segment for 2026?
We have layered in as April first potential launch. Anything delayed, we would obviously benefit. Most exciting thing is CREXONT, which is outperforming in year one. It converted 80% of ER patients out of 25,000 patients that are on CREXONT already in one year. It took RYTARY about six, seven years to get to 25,000 patients. The demand is so much because what product is doing, and we made it very affordable access for the product. We learned that from RYTARY that 38% scripts were being rejected. This time our goal was less than 10% rejection or nothing.
Yeah.
We want to become America's leading affordable medicines company. We believe that innovations must reach the patient.
Yeah.
Because there are potentially 700,000 patients, and CREXONT has a potential becoming a first-line therapy because how it's performing and how it's formulated and what we are seeing the real-life examples, real life. It's so very exciting. We have guidance is $300 million-$500 million.
Yeah.
For now.
Well, yeah, that's maybe where I wanted to go next. Maybe we can talk about CREXONT, maybe, 'cause it's clearly, you know, filling in a big hole left by RYTARY, right?
Yes.
It's giving you some significant growth. I just to put some numbers around it, for those that may be familiar, I think it was $63 million in revenues this year, but doubling next year.
More than doubling.
You talked about peak sales number of $300 million-$500 million.
Correct.
Right? Which maybe could prove conservative over time. You know, who knows? Can you talk about this product and maybe what you think differentiates it, you know, versus compared to some of the other immediate release and extended release products on the market, and why you feel like it's, you know, you're seeing such huge demand, maybe even above your own expectation?
Yes. We kind of own the Parkinson's field. We probably spend the most time over the last 14, 15 years, which I'm counting the Impax years. The scientists learn, obviously they first came up with RYTARY and then what were the pitfalls of RYTARY. They designed the new formulation with different polymers, the different bilayer that came up with it. Also they increased the IR in initial dosing. It's IR/ER combination. Patient gets the kick just like IR, but then it's stable for 8, 9 years. The absorption at an exact proper place in the small intestine as well as the blood-brain barrier, it's crossing much effectively. Even we thought the patient would take 3 x a day are taking 2 x a day.
Yeah.
Starting early, which is we just launched another trial, because the product is approved for naive patient as well. We are studying, first of all, our phase IV data came, which is 3.13 hours of good on time. It's like every pump with a capsule. It's amazing what we are seeing on the field as well as the data is showing. The second trial would take the naive patient and then study them over two years, three years, four years and compare that with the IR.
There's data available for IR, how the disease progresses if they just use IR versus using CREXONT.
We also have outlicensed this product in Europe. They'll be launching it soon. In India, we're launching it by ourselves and then Middle East, everywhere in the world, Canada, South America, we have licensed it out, so it will add additional revenue for CREXONT.
Okay. In your prepared remarks, you touched on Brekiya a little bit. I mean, this is, you know, meaningful, not as big as CREXONT, but still meaningful.
Yeah.
Obviously, you've also talked about peak sales of, I think, $50 million-$100 million. You know, could you maybe touch on this product at all and you know?
Yes.
You know, the outlook for 2026?
This is another useful innovation Amneal came up with because there are about 200,000 cluster headache patients, and there are many more severe migraine patients. They would go to the emergency rooms and clinics to get DHE through the injections. We made it auto-injector.
Yeah.
Brought it home for them. They're saving, you know, this is a 10 out of 10 pain. The horror story, they're banging on the wall and their heads, and they just go crazy. In that, you have to go to emergency, wait there. Nobody wants to do that. Now there is a psychological safety product sitting in the refrigerator. They can. It's auto-injector like Mounjaro. You just boom, take it home or take it at home. The uptake is amazing. It surprised us.
It's three times more than we thought.
Because it's the useful nature of the product, and there are so many patients suffer through these.
Does that make you rethink your peak sales number potentially?
Not yet. Not yet.
Okay.
We're gonna be modest in our way.
Okay.
We're so happy that the patients are benefiting. Our own employees stood up in a town hall and said she had the episode and she took Brekiya. In 30 minutes, she never felt better like that.
Oh, great. Awesome. All right, well, maybe just in the interest of time, let's move on to AvKARE, and we don't need to spend much time here. You already sort of talked about it. I thought it was kind of interesting, right? In that, you know, you're getting out of some of the less profitable businesses.
Yeah.
It had an impact on your revenues, but a positive impact on your profitability. We'll segue to guidance in a second, right? When you look at your revenues are coming in 2026, maybe a little bit lower than what everybody thought, but the EBITDA is much better, right, on the profitability of what's remaining. You can just maybe talk through that transition and how people should be thinking about AvKARE in 2026, given the change.
Right. The core business, which is obviously the Affordable Medicines growing 7%-8%.
Yeah.
Depending on the timing of launches, we could do better. The second one is the specialty which already grew from 2024 to 2025, from $440 million to $529 million. We're saying it would be steady this year because we'll lose LOE for we're-
Yeah
We're assuming on April first. Still is staying steady. These are the high margins businesses. Then, AvKARE, the government business is doing well.
Yeah.
They have a little bit flattish year because they had a big launch in CREXONT last year, which now the competition is there, but they're launching new products.
Yeah.
We expect that to continue to grow over many years, and that's very core to us. We love that direct distribution. Many of Amneal's products, because VA and DoW require TAA compliant, made in USA is a big advantage for us. We can provide many products from our U.S. plants to VA directly without the wholesaler margins.
Yep
...to VA, DoD or VA and DoD or W.
Okay, can we maybe segue to the Metsera deal? I don't know to what extent you maybe-
It's Pfizer now.
Well, I was gonna get to that. I was gonna say there was already some interest in it, and the spotlight has intensified now, you know, with the Pfizer transaction.
Yeah.
I don't know if you've started to think about, you know, quantifying the opportunity and, you know, maybe what attracted you to the deal to begin with, and are you more excited now because of the Pfizer transaction, or is it still the same? Like, how should we be thinking about, you know, how impactful this can be?
Yeah, it's very impactful. It's an interesting question you ask. We wanted to go in GLP-1, and we did not want to just be a generics GLP-1 player. We have a lot of talent in the company.
Yeah
Lots of scientists, peptide experts. We approached our friends at Metsera back then, and I know Clyde really well for years. I have all these capabilities and talent, CMC, clinical support, oral solid formulations, device selection and drug device combination, peptide manufacturing, and we can make it cost-effective because we could bring this from India rather than making it in the United States, which will be very expensive and long time. We partnered with Metsera, and it was such a comprehensive partnership. As you know, Pfizer now acquired, Pfizer is continuing to work with our team, and we're very excited to be a very helpful partner for Pfizer. I know they're big guys, they have a lot of capabilities, but there are things we can provide, and right now the partnership's going in a great spirit on both sides.
This is obviously future down the road as we think about, you know, contributing to that growth algorithm.
It's huge, right? Because just Zepbound was launched in India, so the total deal is in the two phases we have. We have a right to market in 18 countries, including India. We have exclusive rights for Pfizer products now. Used to be Metsera.
Yeah.
Which is very lucrative for us in India and other emerging markets. In India, Zepbound is running out of products.
It's that much in demand.
Globally, it will be in demand. The prices, as you know, the price points are going to come down. At that point, having a technology which produces the cost-effective peptides and have these highly automated fill and finish total from start to end packaging lines, which we have three of them being installed right now, two cartridge line, one auto-injector line. It is really needed for the global supply. We with Pfizer and us, we're very excited. Well, we're more excited than I guess they are, but they're very excited as well.
Just two more quick ones as we're starting to run out of time. Let's talk about the balance sheet, over $300 million in cash. I mean, manageable leverage. How should we think about sort of capital allocation in 2026 and beyond? I mean, anything that sticks out to you opportunistically or what you'd like to do?
Well, we continue to invest in the company, right? We have our own R&D, which about $180 million-$200 million we invest. Capital expenditures, we'll continue to invest. Outside, as we have said, this year priority is vertical integration for biosimilars, and which hopefully we'll be announcing that shortly.
Okay. Well, we're out of time. What I wanna do is I just wanna give you the last word to sort of close us out. It feels like we've come off a very successful 2025. We got a lot of momentum, you know, in affordable medicines.
Yep.
You know, within specialty, you know, we're overcoming the LOE of RYTARY. We got CREXONT and Brekiya that are sort of picking up the slack. You've made some changes on the profitability side of AvKARE. I mean, what else have we not talked about that you wanna mention to investors, and what's the final word you wanna leave with the investors here today?
Well, thank you, Glenn. Well, we're very zoomed in, focusing on the execution of
Yeah
massive portfolio that we have and looking forward to successfully integrate biosimilars and become a top five players for the United States. So that's a huge opportunity for us. We do have a couple of candidates on specialty assets sides of R&D, which how it moves forward, we'll be announcing towards the end of the year or beginning of next year. All segments are doing really well. There is some growth in international markets.
Yep
India being direct market and then through partnership in Europe and rest of the world. That would become meaningful maybe after three, four, five years.
Okay. All right. Perfect.
Thanks.
Chirag Patel, Co-CEO of Amneal Pharmaceuticals. We'll leave it there. Thank you very much.