All right, well, let's get started. David Amsellem for the Piper Sandler Biopharma team, and day two at the Piper Sandler Healthcare Conference, 37th Annual Piper Sandler Healthcare Conference. We have Amneal with us. We have Tasos Konidaris, CFO. Thanks so much for joining us. It's been quite a year. A lot going on with the brand business, biosimilars, injectables, a lot of growth in the generics business. Lots to talk about at a high level. Given the evolution of the business, particularly away from oral solid generics, talk about generally how you see the generics business evolving over the next several years, particularly as you've de-emphasized the oral solids piece of the business.
Yeah, good morning and thank you for having us. Good morning, everybody. I hope everyone had a nice Thanksgiving and hope everyone survives the remaining of the holidays, so it's been an extraordinary, what I would say, the last six years. We have executed the people that are following the company. I think a fantastic financial turnaround. We have diversified the business over the course of time, reduced debt, and I think we are in just kind of the best shape. The business is in the best shape that it has been over the last six years. When you look at it over the diversification story, right, so we've built our affordable medicines business. We acquired AvKARE about six years ago. That has been a phenomenal success, and we have expanded our specialty business, our biosimilars, and our injectables, so for us, it has been a journey of diversification.
Now, within the affordable medicines, this is the space, the essence of your question, David. That's a big business for us. About $1.5 billion. It's growing mid- to high-single digits. And every part of that business is growing. The oral, which is essentially the retail part of the business, is growing nicely. The injectables and biosimilars have been growing. One of the things we have done within that segment is try to de-emphasize a bit the oral solid part of the portfolio. And that is because historically, that has been a segment that has been a lot more price erosion. And we've done this successfully. So we go back a few years ago. Within the affordable medicines business, about 53% of the revenue was coming from oral solids. Last year, that was about 25%.
Over the next few years, that's going to decrease farther into the 10%-15% range. And that was a conscious choice. That was a conscious choice. And what is happening is, as a result, we are not as exposed to price erosion. We're playing in part of the business that are not as competitive. This is why our focus around complex generics has been so successful in growing both the top line and the bottom line. And that's what you see. About 65% of our ANDAs pending at the FDA are in the complex generics. 90% of our pipeline, of our R&D pipeline, is focused on complex generics. So over the course of time, our affordable medicines business will continue to grow mid- to high-single digits. Profitability will continue to increase because we're not just as exposed to price erosion.
I think we provide additional value to patients and payers.
So let's talk about generic injectables. So that's a growing footprint. Help us understand how big of a sales footprint you expect for generic injectables in the next two to three years. And just give us a sense of just how many generic injectables are currently in the portfolio and how we should think about cadence of approvals as we move through the next 12 months.
Great. Yeah. There is nothing about our company that's revolutionary. So everything is kind of evolutionary. And that is our journey around injectables. So rewind the clock about a few years ago, injectables was called about $130 million of annual revenue. This year, we'll do closer to $200 million. Okay? Next year, my gut feel is we'll do $240-$250 million and continue to grow. We have about 40 products into that space. And every year, we add another, call it 10 new products. Because a lot of our pipeline is focused into that area. So that will continue to grow over the course of time. We have a number of exciting product launches coming up in that space, like risperidone, the contract solution, IXO, and lanreotide later on. So real value products as opposed to commodity products.
Yeah. And I actually wanted to ask you about Omnipaque. That was a recent approval. And then that's been a product that's been off patent for a long time. You're the first generic. I believe you're the only generic. So maybe talk about that opportunity and also the potential barriers to competition on that down the road.
That was an exciting achievement for our team. Because as you know, there is a reason why that product, I think it's been made by GE HealthCare, has been without competition for a long time. It's kind of hard to manufacture, high cost of API. And we got approved with the only generic approval for the 300 milligram dosage. Okay? So we don't have the full spectrum of our schedules. But over the course of time, our intent is to have the full line of products. So it's a meaningful opportunity for us. It's going to start making a difference to the top line and the bottom line throughout 2026 and beyond. And for us, it was kind of much more about kind of R&D and supply chain success that's going to pave the road for more and more complex products and expanding that opportunity over the course of time.
Is it reasonable to think that you could be the only generic for an extended period?
We should be. Because beyond the, as I mentioned, the high cost of API, the regulatory complexities only grow larger as you're trying to get through the different strengths. And then you obviously have to deal with the specifics of commercial penetration. You have to go through the hospitals. You've got to go through the GPOs. So you've got to have that commercial infrastructure that there are not many companies in the U.S. in the injectable market space that have it.
Got it. Let's switch gears to biosimilars. So a similar question that I asked on the generic injectables. What's your current sales footprint for biosimilars? And where do you see this part of the business growing next year?
So great. So the people don't know us. Biosimilars is a relatively new area for us. So rewind the clock three years ago, we had zero products, zero revenues. This year, we have three products: Alymsys, Releuko, and Fylnetra, most of them in the oncology market space. This year, we should do about $100 million worth of revenue and we'll continue to grow. More importantly, we have a pipeline that should be launching probably an additional five new biosimilars throughout 2026, 2027, 2028. So some of them is the Fylnetra, OBI, and the auto injector. We have the denosumab coming up. We expect approval hopefully in December, which means it's a potential launch in 2026 and for us, the biggest opportunity is generic XOLAIR. So we'll see. So we filed with the FDA. We'll hear over the next few months about acceptance and potential.
For us, it's much more of a 2027 opportunity. XOLAIR, it's just a big market, right? It's a $4 billion product, growing 30% per year. We probably will be the second generic in the marketplace after Celltrion, which allows us to capture a big part of that opportunity at good prices.
Yeah. I want to come back to denosumab. That is somewhat crowded, but a big market nonetheless. So how are you thinking about that opportunity as a '26 driver?
Yeah. So I said kind of good news and bad news for our company. The bad news is there is not one product, but we're counting on delivering top line and bottom line. The good news is there is not one product. That makes a big difference. So denosumab is going to be the same thing. As you mentioned, because this is a new area for us, it's a crowded market already. I'm sure we will make meaningful contributions. It's not going to make or break the year next year. It's just going to be another driver of growth. And we'll continue to grow 2027. The biggest by far biosimilar opportunity for us will be XOLAIR.
Yeah. I mean, as you think about that for 2027, to the extent that you're the second to market $4 billion brand, I mean, that's something that can really.
That can be hundreds of millions of dollars.
Yeah. Yeah.
That can be just flat out.
So just taking a step back on biosimilars, I know Chintu and Chirag have talked about more vertical integration here. And I guess my question here is just if you can provide specifics on how you're thinking about that, what kind of long-term investment that entails?
Yeah. So for us, kind of stepping back, we're not a big M&A shop, just number one. So our uses of cost typically have been growing the business organically, right? Pay down debt, and then do kind of selective M&A. So I think that's going to stay with us. As we look at the next, call it 10 years, because we're building a company here for the next 10 to 20 years, right? The big areas of growth is small molecules, right? We have a tremendous amount of opportunity for all players because there is a tremendous amount of molecules going generics. But then also you have a tremendous amount of market in the biosimilars, right? So far, we have built our biosimilar business with minimal cost outlays, right? Both CapEx. And we've done them through licensing. But what that means is we have split the margin into two, right?
As we think about the next 10 years, this is what we think. We don't think there is room for two margin companies over the course of time. This is what we have said is. We continue to spend time assessing potential acquisition targets, right? There is not a ton out there, number one. Number two, we tend to be pretty cheap. That doesn't necessarily help us to kind of overpay for deals. When we have something to announce, we'll announce it. You can assume it's going to be done the right deal. It will be financed the right way. It's not going to take away from our long-term objective of reducing debt over time.
So right now, your biosimilars are shared economics, and you're the distribution partner. Can you talk to what those margins look like relative to your corporate margins?
Yeah. So if we look at the overall gross margin of our company, right, it's about 44%. So within that, you have an oral portfolio that's probably in the 30s. You have an injectable that's in about 50s. A product like a crowded marketplace, right? Like Alymsys, Releuko, and so forth, it can be the gross margins can be in the 30%. But the product that doesn't have as much competition will be in the 50%-80%. Like XOLAIR will be probably an 80% margin product, even though you may have 60%-70% net price declines from the brand.
But as you think about your shared economics and your EBITDA contribution.
When you look at the shared economics, our overall, let's get it down to EBITDA. Our overall EBITDA as a company is about 22%, right? So right now, our shared economics will be around that level. Okay? If we're able to capture the whole margin, you should be in the 30 plus.
Okay. That's helpful. All right. So let's turn to specialty and want to talk about CREXONT. So as a starting point, just talk to how the product's being used in practice and more to the point, how is CREXONT being used differently from how RYTARY has been used historically?
Yeah. So, tremendous amount of excitement. So, CREXONT, as far as we're concerned, is the first major innovation for Parkinson's patients. So, we have a population that's about 700 to a million patients, and it's growing every year as all of us are getting older. And the gold standard for the last 50 years has been a combination of CD/LD, carbidopa/levodopa, right? So, the key major innovation was Rytary. We launched it about 10 years. It's going off patent. Second major innovation was CREXONT. Okay? So, it's an oral. What we are seeing out there is tremendous receptivity. So, this year, we expected about $50 million worth of revenue. My gut feel is we'll do about 60. If you extrapolate that into next year, we're probably talking about 120. And to us, our trajectory is in line with our goal of doing $300-$500 million of annual revenue.
So we feel really good about it. And this translates probably to about 15%-20% patient market share for people. So what we are seeing is about 80% of the patients that are coming into CREXONT are just conversions from CD/LD into CREXONT, which was exactly the strategy. Our strategy was not a conversion strategy from Rytary to CREXONT. So we're seeing great receptivity there. Pricing, it is extremely well priced and affordable. And what we're more excited, so when we got the label, the label speaks to an improvement on time, right? This is when Parkinson's patients are at their best, right? Faculties. And we invested probably about $15 million in a new phase four study. The results of the first 55 patients, it's a 200-patient study.
It's an open label, which means we'll be able to share the results with the physicians and investors over the course of time. Our first results on the 55 patients are going to be presented this Friday at the Parkinson's Symposium out in San Diego. We're incredibly excited because what you are going to be able to report is a substantial increase on time, even versus the label. Okay? So I think there is going to be, over the course of the next, what I would say, 18 months, substantial positive results way beyond the initial label that I think will establish CREXONT as the gold standard and is going to give us even more certainty about those peak year revenues of 300-500.
I wanted to ask you about competitive dynamics. We've got the continuous infusion pumps, AbbVie's VYALEV , and Supernus' APOKYN . How do you think about their role and the potential that they could pose any sort of competitive threat to CREXONT over time?
Yeah. We don't think of them as competitive threats. So we think of them as kind of tackling two very different segments of the market where the pump, let's pick the AbbVie pump. I don't know the exact cost, right? My gut feel is it's over $80,000 a year. I don't know what it is.
Probably more than that.
Maybe seven, most likely a hundred. So I don't want to speak for them. The annual cost of therapy for CREXONT is probably between $3,000 and $5,000, right? So these are two segments of the market.
$3,000-$5,000, that's net?
Annually. Yeah. When we think about the pump, it's probably more for the much more severe Parkinson's patients that have fell throughout the course of time. So we don't think of them as direct competitors, number one. Our gut feel is once the phase four study results start coming out, we will have better on time than anybody out there. So from our perspective, you'll be able to have a much better product at a fraction of the cost.
Yeah. What's your take on why we haven't seen a generic for Rytary yet? And what are your expectations for Rytary generic competition?
Yeah. So the people don't know. So RYTARY went out of patent in July of 2025. The first filer was Teva. Teva has still not launched. Our gut feel is Teva is a pretty competent organization. They'll come out at some point in time next year. As to why Teva hasn't been there yet, my gut feel is it's not an easy formulation, number one. My gut feel is they have their own kind of portfolio optimization issues in manufacturing. But at some point in time, they'll be generics. But I think it's probably their prioritization within their own portfolio. And number two, it's not an easy product to make.
Sure. Coming back to CREXONT, what does payer access look like, particularly in terms of Medicare Part D? And how should we think about the gross to net?
Yeah. So gross to net is probably around kind of 45%. Gross to net for Rytary was probably more about 55%. This is a little less discounted product because it is a better product, number one. Number two, payer access has been great. So we finished last year, 2024, I think 30-40%. Q1 of 2025, we were about 50%. I think we'll finish this year at about 60%. And so our expectation is next year, just because Medicaid, Medicare Part D takes a little longer, my gut feel is next year we'll be at about 70%. Okay? And as a point of reference, Rytary after 10 years was at 80%, just as a point of reference. So we're never going to get 100%.
Yep. Got it. Wanted to spend a little bit of time on your DHE auto-injector. So that's a new launch. I think it became available commercially very recently. So that's a crowded space, I mean. So I'm not going to gloss over that. But DHE is a well-known, well-established, and effective molecule in migraines. So with all that in mind, how do you think about the role of the product commercially, and what do you think payer access is going to look like here?
It's amazing. I've been in this business for almost 25 years now. I've never seen a new product that has resonated and has so much brand awareness as DHE and within the investment community. So you guys must have a lot of suicide headaches because that's the other way that this thing is described for and so forth. So great innovation, great job by our manufacturing and our R&D teams about making this product available to patients. And to your point, it's a we have a crowded space, but at the end of the day, nothing works at the end of the day when you have those cluster headaches as effective as DHE. And people end up kind of wasting their whole day going to the emergency room to get essentially what now will be almost like an EpiPen available. So we launched it, right?
We're in the middle of the launch right now. My gut feel is 2026, probably we'll do $10-$15 million worth of revenue. Over the course of time, we think this product will do $50-$100 million, right? Not billions or hundreds of millions of dollars. That's what our plan is. I think it's a great innovation to our patients.
Okay. Wanted to spend a little time on Metsera. So you announced your partnership with them. And of course, now Pfizer owns the asset. But I guess my question here, and it's a hard one to answer, admittedly, but how do you envision the partnership evolving? And my thinking is, wouldn't Pfizer want to just leverage its own manufacturing capacity for the obesity management products that come out of the Metsera pipeline? But how are you thinking about it? Is this something you think you can monetize, just given the change in control?
I mean, so a couple of things. We're excited about now the new partnership with Pfizer, and it's going to play out. It's going to play out. They'll have to look at the contract that we have with Metsera, and then they'll have to figure out how they want to move forward, right? I'll say a couple of things. Number one is when we did the original contract with Metsera, we anticipated that this will be the likelihood of them being bought out by someone who is incredibly high, and we reflected that in the contractual obligations that we have. Kind of point number one. Point number two is we think we add a lot of value to Pfizer and to Metsera. So we're building two brand new manufacturing sites in India, right? That's well on their way.
One is for API, a number of a few different tons of 5-7 million tons of API, and the other auto-injector facility that can do 100 million auto-injectors per year, right? So I agree with you, Pfizer has a tremendous amount of capacity. We just don't know what their exact capacity is when it comes down to auto-injectors, right? What their exact capabilities are around peptides and the complexity, and frankly, we think we bring to Pfizer and what we brought to Metsera is really thoughtful skills around development of both the oral and the injectable. And if I'm Pfizer at this point in time for less than $100 million worth of investment, right, I have access and speed to market, that's going to be fantastic for them. So we're looking forward to working with them.
My gut feel is we'll be a win-win situation if they're going to reconsider some type of a change in the existing contract.
Okay, so in other words, yeah, when you say win-win, you mean either they cut you a check or you continue the partnership.
Exactly.
Okay. So I wanted to ask about GLP-1s. And this is something that you've talked about on and off, but wanted to get your thoughts on your capabilities regarding your own generics and thinking longer term. I guess do you expect to be in the dulaglutide market when that goes off patent? That's not that far away. And even generic semaglutide in ex-US markets, there's LOEs outside of the United States that's not that far away. So how are you thinking about that and your ability to participate in those markets?
Yeah. So we have invested a substantial amount of both R&D and manufacturing capabilities around GLP-1s, complex peptides because over the course of time, right, that's going to be a big market for us. We don't have any immediate steps, right, any immediate plans to launch semaglutide or any of those generics this year or next year. But over the course of time, between our internal capabilities and peptides and our manufacturing capabilities, the two manufacturing facilities we've built, we're going to play into those markets. We're going to play into those markets, whether or not it is ex-US, primarily in India, which is a big diabetes market for us, as well as in the U.S.
All right. Terrific. Well, we're out of time. Thanks, Tasos, so much. And thanks to everyone in the audience.
Thank you so much, everybody. Thank you.