Amneal Pharmaceuticals, Inc. (AMRX) Earnings Call Transcript & Summary

January 14, 2026

US Health Care Pharmaceuticals Company Conference Presentations 39 min

Earnings Call Speaker Segments

Christopher Schott

Analysts
#1

Good afternoon, everybody. I'm Chris Schott at JPMorgan, and it's my pleasure to be introducing Amneal today. From the company, we have the company's Co-CEO, Chirag Patel, who's going to be doing a presentation, and they're going to jump into a Q&A session from there. But Chirag, happy New Year.

Chirag Patel

Executives
#2

Thank you for having me here, Chris. Thank you very much for joining us at 4:30 today. But great to see you. I'm very excited to be here. And thank you again to JPMorgan for a wonderful conference here. So we're going to jump right into it. We have a lot to share, and I'm going to start just a little history about the founding of Amneal, very humble beginning. My brother is here as well. This time, he comes -- we're co-CEOs, co-founders. Our father helped us with his knowledge, and he's also pharmaceutical scientists. And that's -- our humble beginning started in 2002 in Paterson, New Jersey. So we're a U.S. company dedicated to America, and we have a huge mission, which we will get there. And obviously, it's much needed in the society as well. In 23 years, we have delivered so much savings. 175 million prescriptions are filled with Amneal's products today. Number one in quality, we -- that's our highest priority all the time. All complex dosage forms we have. So we make products from transdermals to in-house injectable to respiratory to topicals, liquid, obviously, oral solids, less and less; and biosimilars now, which we partner in. So it's excellent opportunity, great founding, and we won the best company to work for from BioSpace, which usually won by the Lilly's and [indiscernible] and big pharma. Amneal won it first time. So it's a fantastic company to -- it's the people make it happen, and we're so proud to win that award. So our mission is we've been very public. We're focused on, we call it, Affordable Medicines segment, which consists of retail generics, injectables and biosimilars. And we'll talk more about each segment as we go forward. We're probably ranked #3 or 4 today, and we should be #1 by 2030 and remain there. And that -- this is for America. So we're 98% revenue, so all of it is United States. So we're zoomed in focus in the United States, but we are slowly expanding through partnership in Europe and other parts of the world. This is the evolution, this is what we have done. As you know, retail generics got very competitive from companies from China, India, hundred of competitors, 3 buyers. It really became highly competitive in 2017, '18 when FDA started approving so many ANDAs. So each one product could have 15 approval, 20 approval, and it's race to the bottom. So that we have moved out of it. Only 25% of our revenue is on retail oral solid. We're more into complex Gx where you see less competition. And those products are very complicated drug device combination, long-acting depots, respiratory injectables, complex injectables portfolio, ready-to-use bags that avoids the hospital errors. So that is -- it's not only affordability we are providing, we're also providing solution for our customers. So that is exciting. And then biosimilars, we launched 3, about to launch 2 denosumab presentation, [ GY ] Prolia. So that would be 5 biosimilars, and I'll speak about biosimilars as we go forward. AvKARE has been a great distribution company, value-added distribution to VA/DoD, the second largest. And VA/DoD is almost 18 million now recipients in VA/DoD. They're aging. So a number of prescriptions are also going up for them. And we bring affordable products for government as well. And it's direct distribution. Specialty branded, there we have CREXONT. We just published Phase IV data. We've been hearing from the physicians and patients that how well that product is doing. So we're very excited about proving that in Phase IV, and it's the best oral medicines in Parkinson's, maintaining Parkinson's disease in the world. We have a partner in Europe as well running a further trial, and they'll be launching in Europe. We launched in South America, Canada, all over the world. So this is excellent innovation. And we're very, very proud of what we have done for the Parkinson's patient. And we get a lot of letters, we get a lot of phone calls from the patient that they couldn't walk. Now they're walking, going to the grocery store and playing with grandchildren. So it's been an amazing discovery. We'll continue -- not a discovery. It's -- our formulation is so well that it absorbs at the right places and crosses the blood-brain barrier to produce more levodopa for the patient. So that has been amazing, and we will share more specialty branded products story as we go forward. And GLP-1 peptide that our partnership with Metsera is working out really well. Now it's with Pfizer, and we look forward to work with Pfizer. We already started speaking with them. It's a fantastic 2 plants we are building dedicated for Pfizer in India, one for manufacturing peptide. It could manufacture up to 3 to 5 tons using hybrid processes. And second is auto-injector and -- which could be cartridges, could be PFS, capacity up to 100 million. So global supply, it's additional supply for Pfizer, and we are there to assist Pfizer in all our capacity to make the product very successful. With that, let's just -- a reminder how we have progressed over the last 6 years. We doubled the revenue, doubled the EBITDA. Net leverage is down from 7.4 to 3.7 now, but it will even further go down. EBITDA is crossing at a high end of 685 plus. So it's tremendous progress. Pipeline is really focused on high value. It's not a number of products, it's what each product is doing, and you'll see more and more biosimilars as well. Very excited about the next 5 years as well. Every year is a growth year. And why? Because of all these areas, it's so essential to have generics medicine, affordable medicines, biosimilar. You look at the retail generics, it's competitive, so not growing in dollars as much. Injectable is still growing, huge growth in biosimilars, we'll talk about it separately. The branded side, we could come up with new products, niche products that big pharma doesn't focus on it and keep growing that entity and GLP-1 from '29, '30, 2029, '30 starts adding top and bottom line revenue for us. So excellent areas we are in, multiple growth drivers. And we expect all of them to grow high single digits or more. And all about execution, affordable medicines category, we could double the business over the next few years with biosimilars, new complex injectables. It's a really good business. And so much LOEs, are double than last 5 years. So over $234 billion product -- worth of branded products going off patent. So it's a huge opportunity. And in biosimilars, there are 130 candidates. Only 20 people talk about it. They are smaller ones, $500 million, $1 billion, $1.5 billion. But if you can develop it cost effectively, execute it properly, have right COGS, launch it globally, U.S. being the main market; it's huge growth in that segment as well. So it's -- and it's needed for the country, it's needed for the patients. As you know, 92% of prescriptions are filled with generics products or biosimilar products. Specialty also, we expect higher growth. Branded products, we'll see what happens to our pipeline assets, but they could just keep adding. We do about $540 million in 2025. For specialty, it will keep growing. AvKARE is such a niche business, we value add it for government, keep growing. And total company is growing. So it's excellent. So let's talk about CREXONT. The first year of launching, we already have 22,000 patients on CREXONT. It took 6, 7 years to get to 22,000 patients for Rytary. And it already achieved 3.2% market share. It took Rytary 6, 7 years. And eventually, Rytary achieved 6% market share. We will be 6% most likely this year in 26. It's patient feedback, doctors' feedback, how -- what products doing, the "good on" time with the Phase IV. You can see on the right side, it's the best in the industry. You can compare any product, and it's oral. So 3.13 "good on" time over IR, which is about 80% of prescriptions are IR. About 10% could be IR in combination with COMT inhibitor. We beat that as well by 2.31 hours. And this -- think about the Parkinson's patient and caregiver, huge difference. As I said, it's -- we get a lot of thank you letters. And we beat our own product Rytary by 1.8 hours. So then this is showing. We've been getting calls. Certain doctors have set up a CREXONT clinic. So it's amazing, and we are very confident about our projections of peak sales, $300 million to $500 million. And it's a great product, and we'll continue to research more in Parkinson's category. Another branded product that we have just launched, very useful innovations. Obviously, these are done by companies that our size, Affordable Medicines and who have science as well. So this is when there's cluster headache, there's severe migraine, patients go to the emergencies. They could drive for whatever, 30 minutes, 1 hour, then wait an emergency and it's such a massive headache, and then they get DHE auto-injector. We're delivering that at home auto-injector just like Mounjaro, Zepbound, you just take it at home. And only FDA-approved auto-injector. So we -- it's in just 2 months, the feedback from the cluster headache centers, severe migraine centers, it's very positive what we have done for the patient, saving the emergency visit. It's a cost effective as well for the insurance company. So they're authorizing these use. Then come to our original business foundation. We've been filing a certain number of products, getting approval, growing it. Now we see high single digit. It was a low 3%, 4% growth. Now we see 8%, 9% growth in complex Gx because of respiratory approvals, because of more ophthalmics products being approved, drug device combination, complex injectables. So with -- and this doesn't count biosimilars, that's a separate within Affordable Medicines. So we're launching 20, 30 key products, high quality. The customers are -- where you can call customers, they'll tell you who is their #1 favorite company. It will be Amneal in complex Gx or any Gx products. So we're proud to serve our customers. Here's -- we're not going to go through all of these, we were so excited, we put it out this, products that have been approved lately and what are going to be approved in the next few quarters. It's the most exciting pipeline in complex Gx. It took us a little time to get back and get restarted as we came back in 2019. And now we're very confident, very happy where it's going, and it's going to keep growing with the new products. Every year, you should expect list like this. And they are higher values. In generics, when you make $20 million, $40 million, that is a good product. This is just the United States, we don't even sell outside of the United States. Some of them we may sell in Europe, we have a partner, or in India. So excellent, I mean, you see -- I mean, I'm not going to go through the well-known brands, huge opportunity. Very excited about the -- even biosimilar as well. Denosumab, as we talked about, Prolia, XGEVA, romidepsin. We are the first company came up with a radiopharmaceutical approval, iohexol. So only GE is the biggest supplier. Now Amneal, it will take time to build it up as the API is expensive. We don't have volume yet. We will -- and we'll get more strength approved. FDA is approving our ready-to-use products very fast as well because they are compounded products, we're turning them to be approved product. Like sodium bicarbonate just got approved today. We brought sodium phosphate. So there's a lot of protection phosphate we brought. So a lot of products we're bringing, which are compounded typically, in an approved route. And hospitals are very appreciative of that. Moving to the biosimilars. I know everybody is shocked with what happened in first inning of biosimilar or first 2, 3 innings, if you use the baseball terms, because it was a new thing. It was -- FDA just published guidelines, it was a gold rush, the branded companies jumped in. They thought the pricing would stay very high. A lot of people invested a lot of money like HUMIRA, you saw 12 approvals, is STELARA. So the old development, you saw multiple approvals. They spent $200 million, $250 million per product to get -- in 7 years to get to the finish line. Now it is less than 5 years you can develop the products from start to launch. It could be $50 million to $75 million if you're really smart about it, which Amneal does a very cost-efficient job. And it's a global product. Adoption is 80% plus. It used to be 5%, 10%, 20%. Private label, all 3 big insurance company PBMs are doing private label. So they can move the volume just like generics immediately. So for example, Xolair, we are very excited about that in early '27 launch, and we're speaking with private label side as well. They can move the volume immediately. So you do not need to detail the product like a quasi-brand. So it's a huge opportunity, but it requires -- complexities are higher as well. So only 7, 8 serious player for the United States remain. Sandoz is a leader. We will be there in a few years. We would -- we look forward to vertically integrate, have our own R&D and manufacturing. So that's the key target for us in 2026 and then have a much broader pipeline, a global pipeline. And we will partner as well. So it's -- if you think about it, if you have 3 to 5 competitors only, those products are going to do commercially really well. And now the channels for conversion is controlled by the payers. So everything is going positive. And many players, unfortunately, have dropped out. They couldn't sustain -- stay in the business for 10 years, the smaller companies. So there's only a few large companies left to Corient, right, Celltrion, Samsung. You got Biocon from India, Sandoz, you got [ mbScience ], Kabi, Amneal. Obviously, Amgen will stay in. Pfizer looks like it's not interested in biosimilar, obviously, Biogen has given up. So you will see very few players, and it takes years to develop this platform, develop the product. It's -- you're making your drug substance and drug product, and you need infrastructure and a lot of science. So not hypercompetitive. It may become -- not hypercompetitive right now, less than 10 competitors. In the future, it could be probably 15 to 20 competitors, but that's 5, 7 years ahead. So we're trying to take advantage now to be a very key player in biosimilar. This is our pipeline. It's been disclosed. This presentation is also posted on our website, but excellent progress, and we'll keep making it. So -- and commercially, we're well set for the United States to market these products. I talked about Metsera-Pfizer collaboration. We look forward to expanding this and very excited, obviously, with Pfizer name, their capabilities, capacity, the volume is going to be much larger than we had anticipated with Metsera. So excellent opportunity for us going forward. Just pointing out this chart, is so interesting because every year, I used to hear 2019, '20, the leaky bucket, the generics revenue will go away. We used to do, if you see this blue, $1.2 billion, 2019. Those generics products still doing $1 billion today because they're needed product, essential medicines, so players come in, go out, you have some quality supply. It's over 6 years, we have lost 20%. So that's not bad. You have 4%, 5% price erosion, but you keep launching new products. And now we have moved up the value chain. So it's excellent progress. Expect us to keep performing this way and more. Just summing it up, a bold company, clear mission, long time. We're co-CEOs. We are here to stay and make this bigger and bigger, and we do want to be America's #1 affordable medicines company. And we are well our way. We're committed as well. And it's obviously, financial growth is going to be there, too. So very proud of what we are doing. Q&A, I think, up, sorry, 1 minute.

Christopher Schott

Analysts
#3

Excellent. Well, thank you very much for the guidance here. Yes. Maybe just to kick off, bigger-picture question. How do you think about the evolution of the Amneal portfolio over the past few years? So how far along are we in this kind of transformation process with what you're trying to do with the business?

Chirag Patel

Executives
#4

Sure. The transformation process is -- I think it's 70%, 75% there already for the complex Gx. Biosimilar, we would have to integrate and start. And so that would be the focus next 5 years. And specialty is as we make progress, we will share that.

Christopher Schott

Analysts
#5

Okay. Great. And I guess on that same front, as the company scales, should we think about the balance of investment across the businesses staying kind of where it is now? Or would you see Amneal, for example, leaning more into an area like branded specialty where there could be some very large products, really attractive margins, et cetera?

Chirag Patel

Executives
#6

Yes. So the first goal this year is to vertically integrate in biosimilars, move the R&D investment more from complex Gx to more biosimilar as well. And then we do about $50 million or so internal R&D on branded side, which we expect will go up. And then from '27 and onwards, it is mostly going to be the specialty assets because that is where it's unlimited growth. And the new ways of developing products with AI, and we've been at it for the last few years, and my brother can add more to it, he's on to this. He's more R&D manufacturing quality, I do the rest. But thank you for coming this time. He's a younger brother, so I gave them a little time. But I think you can come up with a branded product, not discovery from the beginning with all the tools available and where regulatory has moved up, maybe in $100 million, $150 million. I don't think you need $3 billion for many of these products. We can do that. We have 1,000 scientists, we have worked on 400 products. We have a lot of knowledge, and we have added now branded R&D people as well more and more. You want to add something?

Chintu Patel

Executives
#7

So our main focus is going forward on how we pivot more towards even more complex -- besides complex Gx, as Chirag mentioned, biosimilar in specialty. And we have a division in specialty where we are focused on affordable innovation because that's the key. How do we use the AI and other technological tools and efficiency where even the branded product -- because we believe that any innovations we do should be accessible to everyone. That's our purpose, and that's the mission of our organization. So yes, you will see a shift more towards complex areas. We will reduce our Gx spend below 50% in our R&D. The 50% or plus will go towards more specialty and biosimilar.

Christopher Schott

Analysts
#8

Great. CREXONT has been a great launch. Maybe just share just some of your learnings from the ramp so far, kind of what's working, kind of directionally, where do you see us going...

Chirag Patel

Executives
#9

So we were very fortunate to get a label with naive patient because we showed the data, and now it's showing up more and more, but we still have to convince doctors on naive patient to start with CREXONT. Our goal and mission is to replace IR. I think IR should just go away. It's 50 years old technology. Why use it on and off all the time? Crexont should become standard of care. That's what we are working towards. It will take us a few years to get there. Our partner in Europe will go on a similar way. And then it's a much larger opportunity. And then the new innovations will come after that. But this is a gold standard. But so far, so good. And this AI is really helpful. We're able to do the marketing and reach the provider more efficiently with even lower budgets. I mean we're still spending properly, but we can reach -- and AI is so good to identify what's connected TV, whether they watch Hulu or HBO Max. And here you go, CREXONT shows up. And what we have seen is when they see CREXONT message, it's 6.7x more likely to prescribe CREXONT. Then we're talking about general neuro, which we never marketed for Rytary. So 80% of the patients are coming from general neuro. IR patient to CREXONT, which is fantastic. That's a huge market, right, like 600,000 patients.

Chintu Patel

Executives
#10

Yes. And just to add that we continue to provide a lot more data in coming years on CREXONT and how beneficial for the naive patient. So we'll have a lot more Phase IV data in this year in 2026. We are also will be starting another Phase IV to show the true benefit because we believe that it's a game changer for the Parkinson's treatment, especially for the naive patient, and it will be hugely benefit. So you'll see a lot more data over the next 2, 3 years, continue to provide the proof what we've been telling.

Christopher Schott

Analysts
#11

That's great. I know you just recently shared some of the initial Phase IV data. What's the feedback you've been getting from that from physicians?

Chirag Patel

Executives
#12

The physicians already were calling us, thanking us and said, "This is what we are seeing, this is amazing," all the stories. And now it's there. And we'll continue to do another 100 patients have been enrolled as well. So it's a 200-patient trial, so it's sizable. And we're -- as my brother said, we're launching a naive patient trial, also Phase IV. So we'll continue to produce more data. And it's affordably priced. So about like $6,000 a year for a patient that's very attractive. We have very great commercial coverage. And that's why we are talking about affordable innovation, affordable access.

Christopher Schott

Analysts
#13

When we think about uptake in 2026, just any rough expectations we should be keeping in mind of the revenue or market share?

Chirag Patel

Executives
#14

We're doubling it. We did about $60 million, $65 million last year. This year, $120 million plus. And market share about 5%, 6%, already Rytary level. We already exited at 3.2%.

Christopher Schott

Analysts
#15

And then just on the peak sales, $300 million to $500 million, is that still that the right peak sales? Or is that...

Chirag Patel

Executives
#16

Right now, we're keeping it. Let us go through the -- this year evolution, next year, and then we may adjust.

Christopher Schott

Analysts
#17

But a few years ago, we were pushing the low end of the range. Now it seems like...

Chirag Patel

Executives
#18

It will be higher, will be higher.

Christopher Schott

Analysts
#19

Well, that seems going well. Last one on this, on Rytary. Generic timing there, any updates?

Chirag Patel

Executives
#20

Don't know. I mean, so far, they haven't launched. So we do expect sometime this year.

Christopher Schott

Analysts
#21

Okay. Moving over to the generic business, you've had a number of approvals in the last few months. I know you're expecting a few more in 1Q. Just of those opportunities, what are you most excited about?

Chintu Patel

Executives
#22

So as you can see, like we are most excited about ophthalmic portfolio. We have many good ophthalmic [ OT ] products that's going to drive a lot of value. We have an entire franchise of epinephrine, so all single dose, multi-dose. We are a leader on adrenal. So we have the entire now franchise of the epinephrine. And we are very excited about the inhalation, the 2 inhalation approval, which creates the pathway for many more. We have publicly disclosed. We also have the Respimat technology platform. So I think the launches of QR and albuterol along with ophthalmic product launches, which is coming up and [ OT ] and our risperidone depot because we are excited about the launches, but what it does for the future? Because it's always the tough to get the first one. So now you crack the code, now the next code would be much more easier. So I think the entire inhalation, our long-acting depot pipeline, our drug device combinations in a especially complex injectable, so these are the some of the products. Sodium oxybate is a meaningful opportunity for us in 2026 also, which is -- we already launched that product this month. So these are some of the highlights.

Christopher Schott

Analysts
#23

Great. And just any initial thoughts on what growth can look like for the generic business in 2026?

Chintu Patel

Executives
#24

High single digits. High single...

Christopher Schott

Analysts
#25

Yes. So that's...

Chirag Patel

Executives
#26

Affordable Medicines. If you can use that term, would be great.

Christopher Schott

Analysts
#27

I'd get used to that. Maybe just shifting to biosimilars a little bit. On -- first, maybe Prolia and XGEVA, just thoughts on how those markets are shaping up and how attractive those are going to be for Amneal?

Chirag Patel

Executives
#28

There's only a couple of launched already. That's it. And there -- we know how the channel is working. So we're working on -- we are very excited. We have 2 different BLA, one for Prolia, XGEVA. I think we're the only company has 2 separate BLA. So we can manage the products properly in the channel. And we're excited. It's a sizable product for us. It's a huge product, but combined revenue.

Christopher Schott

Analysts
#29

Yes. And of those two, how are you thinking about the differences, I guess, between the...

Chirag Patel

Executives
#30

The onco will do better than bone health.

Christopher Schott

Analysts
#31

And maybe just similarly on Xolair biosimilars...

Chirag Patel

Executives
#32

Yes. That's first quarter '27. We're very excited that is just -- Celltrion has approval. I think they're launching in fourth quarter '26. Right after them, we're already speaking with private label. That's a huge opportunity. And it's a growing market. Xolair as a product is growing.

Christopher Schott

Analysts
#33

You mentioned this integration of the biosimilar business. Can you talk a little bit what does your biosimilar business if we're looking out 5 or 10 years, what is this looking like for [ MDL ]?

Chirag Patel

Executives
#34

We'll be in top 3, probably 30 or so products already launched, multiple in pipeline, great manufacturing capabilities and capacity in the United States and India. We follow that model all the time, dual filing. So global supply. Key player in -- for the U.S. And then we partner geographically like Europe, we're not going to put boots on the ground. That's not the model we have. We'd rather focus on product, science, manufacturing. There's plenty of things to do rather than having a sales marketing in 80 countries, not our cup of tea. And plus, those are great partners. And if you go with Brazilian champion, you got European champions, Sandoz, our good friends, and then you find Southeast Asia, somebody, Middle East; so it's -- you'll see substantial revenue increase within the segment of biosimilar and Affordable Medicines is why I'm saying we would more than double the whole revenue. There's huge opportunities, right?

Christopher Schott

Analysts
#35

Just the cost of vertically integrating. How should we think about what that's going to mean for you?

Chirag Patel

Executives
#36

So we're very, very disciplined, right? We -- the hard work to get to 3.6. We're going to stay disciplined at the leverage, the net leverage could go up to 3.8 temporarily, fine. But it will be a smart deal and more accretive right away from '27.

Christopher Schott

Analysts
#37

Excellent. A couple -- maybe just moving to Natera collaboration. First, just any color you can provide in terms of conversations you've had with Pfizer and how you're thinking about that relationship?

Chirag Patel

Executives
#38

Albert, I know him since 2012. We changed the -- he's already like "look forward to working with you, Chirag." And we're here to -- I told him we're here to make you successful and product successful this capacity. So it's going well. We have several meetings already and more coming up. Chintu and I will go see Albert as well in nearby New York.

Christopher Schott

Analysts
#39

If Pfizer decided to do their own manufacturing, what does that mean for Amneal?

Chirag Patel

Executives
#40

It's giant. They will do their own fill and finish. Peptide, they don't have manufacturing of peptides, they need a partnership, and they need additional volume as well. As I said, we've got cost-efficient global supply. And plus, we have rights to 18 countries, marketing rights. So we're marketing in India, Indonesia, Malaysia. So we got good countries in emerging markets.

Christopher Schott

Analysts
#41

Yes, but a pretty exciting opportunity for you.

Chirag Patel

Executives
#42

It is. It is. I think it's working out well. It was right back...

Christopher Schott

Analysts
#43

Absolutely. Absolutely. Just kind of continuing on. AVKARE, just maybe stepping back to 2025, can you just talk about dynamics we saw over the course of the year? And kind of how -- as you think about the growth going forward, just how are you thinking about that business?

Chirag Patel

Executives
#44

Now they're entering into biosimilars, it will take a couple of years for them to ramp it up specialty products. The generics products that keep coming. So they're focused more on government channel, higher margins because it's value-added, they're developing products, investing versus pure distribution, which is like 3%, 4% margin and the unit dose in hospitals. So it will keep growing, but it won't grow double digit all the time. It's now we are saying high single digit, yes.

Christopher Schott

Analysts
#45

And thoughts on that business more broadly, how that fits into the portfolio? It's been a great investment. It's done well for you. Is this one -- I think in the past, you said that maybe that the right buyer, there'd be an opportunity to monetize it. Is that still the thought? Or is it thought...

Chirag Patel

Executives
#46

Not immediately, but down the road, if somebody is consolidating the areas, then we are open for it, right? We've got multiple growth vectors. But we love the business. It's run by the team that owns still [ 35% ] of the business. So they're the expert. We just provide more products from our U.S. clients.

Christopher Schott

Analysts
#47

Excellent. As we report to 2026, can you talk through pushes and pulls? It seems more pushes than pulls, but just...

Chirag Patel

Executives
#48

Yes. I mean I have Tasos ahead of late flight, so I was covering your questions. Go ahead.

Anastasios Konidaris

Executives
#49

I was minding my own business. As you can imagine, every year, there are multiple things that are happening. But this year, we're entering -- I feel having been here 6 years, we're entering a new year more so in a position of strength than any other year in the last 6 years. And that is driven by substantial amount of new products approvals we have had the last 3, 4 months. So that dramatically reduces the risk level of the forward year revenue and EBITDA. So I feel good about it. You have the typical price erosion, which we have had the last few years of 4% to 5%. So that is nothing new for us and it has been stable. So that's always there, and we always account for that. Then you have new product approvals that are coming in. So we talked about it, really excited about the new inhalation products that are coming in after 10 years of work by our R&D colleagues. So that's going to be an upside. That's going to be definitely a growth driver, not only for 2026 and beyond. A number of 505(b)(2)s, biosimilars that we talked about it, so new product approvals is definitely -- with the win in our box more so than any other prior year. From a gross margin perspective, we should see 50, 60 basis points improvement, and that's a combination of the higher-margin products and the operating efficiencies we're getting. Operating we will continue to invest $180-or-so million in R&D. So year-over-year, that should be neutral. Our operating expenses and the investments in sales and marketing, the level of growth should not be as in prior years because we have built the commercial teams now for the neurology and the other products, and G&A will continue to go up 5%, 6%. So at the end of the day, EBITDA for 2026 should grow faster than the revenue. We should continue to generate a tremendous amount of cash that should continue to improve our balance sheet. And EPS will grow double digit, no question about it because our interest expense after the latest refinancing that we did a few months ago and the repricing that we did last week should allow for 20, 25-plus EPS growth rate next year -- this year.

Christopher Schott

Analysts
#50

Great. Maybe last question for me. Just as leverage comes down, I know you touched on a little bit of this, what are you most focused on, on capital deployment on the business development front?

Chirag Patel

Executives
#51

So biosimilar is the first priority. And then we would be looking at either branded assets mainly and within Parkinson's or within oncology. And it could be Phase III, it could be approved. So multiple choices is huge opportunity in our wheelhouse, right? And then keep growing that business. It's a fantastic business. We got the grew. We've been doing it for almost [ 8 ] years now.

Christopher Schott

Analysts
#52

So I think on the branded specialty piece, that's probably more '27 is that?

Chirag Patel

Executives
#53

'27, '28 onwards because we have enough of our in-house development in biosimilars, complex Gx. So that's enough pipeline. We may do some partnership with a trusted partner, but mostly the deals are going to be -- and we will have good -- I mean EBITDA is going up. We'll operate the company just below 3x levered. The rates are awesome, 300 basis points plus LIBOR or SOFR. So that's a disciplined approach. And so still, if we have higher EBITDA, the cash flow is there. As equity grows, right, the equity price, we can use shares as well at some point. So very excited about the next few years.

Christopher Schott

Analysts
#54

Excellent. We're just about out of time here. Thank you so much for all the comments.

Chirag Patel

Executives
#55

Thank you. Really appreciate it.

This call discussed

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