Good afternoon, and thank you for joining us here for a session on ANI Pharmaceuticals. These are our standard disclaimers regarding forward-looking statements and of the financial information that we're presenting. So I'm proud to tell you here about ANI Pharmaceuticals, a profitable, high-growth biopharmaceutical organization that we're transforming into a leading rare disease company. As we go through the presentation, I'll tell you about how we're accelerating this transformation into a leading rare disease company. In 2026, we're projecting over $1 billion of revenue, which represents 26% growth year on year versus 2025. 2026 will be delivered greater than 39% year-over-year growth. The rare disease business is our primary focus and will account for approximately 60% of total revenues, with our lead asset, Purified Cortrophin Gel, providing substantial, durable multi-year growth opportunities.
Our generics business delivers strong cash flows driven by superior R&D capabilities, operational execution, and U.S. manufacturing. And what you see on the right-hand side is this creates a virtuous cycle of growth where our EBITDA and cash flows from generics and brands allow us to invest in rare disease and expanding the scope and scale of our rare disease business and are accelerating the transformation into becoming a leading rare disease company. We have a proven track record of delivering top and bottom-line growth. Since 2022, we've more than tripled our revenues and more than quadrupled our adjusted non-GAAP EBITDA. To speak a little bit about our 2025 accomplishments, where we had robust expansion across the business. Our net revenues grew by more than 39% to $854 million-$873 million in revenues, and our adjusted non-GAAP EBITDA grew more than 42% to $221 million-$228 million.
This was driven primarily by the rare disease business, which generated greater than 84% year-over-year top-line growth, and our generics business, which outperformed with greater than 20% year-over-year top-line growth. As we begin 2026, our priorities to drive long-term growth and value creation are threefold. Number one, to accelerate ANI's transformation into a leading rare disease company. Purified Cortrophin Gel, our lead asset. For that asset, we will maximize the multi-year growth opportunity by addressing significant unmet need across indications. We'll build on the momentum in the under-penetrated specialty indications of nephrology, neurology, rheumatology, and pulmonology, and in addition to that, we're building and deploying this year a 90-person organization dedicated to acute gouty arthritis flares by the middle of the year. We're also advancing a phase four trial to establish further evidence supporting the use of Purified Cortrophin Gel in acute gouty arthritis flares.
And we will continue to evaluate opportunities to enhance patient convenience. For our second rare disease asset, Iluvien, in 2026, we will return Iluvien to growth by leveraging the commercial and patient access initiatives that we began in 2025. Priority number two, continued execution in our generics business, leveraging our superior R&D execution, our operational excellence, and our U.S.-based manufacturing footprint and business development expertise to continue expanding cash generation and delivering and/or maintaining a current cadence of 10-15 launches annually. Coming to our capital allocation, which is our third priority, we will continue to be disciplined in our capital allocation. From a balance sheet perspective, we will explore opportunities to expand the scope and scale of our rare disease business.
From a P&L or OpEx perspective, we will invest in the dedicated organization for Cortrophin Gel and gout, and we will invest a high single-digit % of generics revenues to support the growth in generics. When we look at our 2026 guidance, it reflects strong top-line and bottom-line growth. Our net revenue guidance is $1,055-$1,115 million, representing 24%-28% growth. Our adjusted non-GAAP EBITDA guidance is $275-$290 million, which represents 24%-27% growth. Importantly, Cortrophin Gel net revenues of $540-$575 million represent 55%-65% growth, and this is in year five of our launch, right, and after delivering 76% growth between 2024 and 2025. To tell you a little bit more about our rare disease business. The rare disease business is the primary driver of growth.
It's expanded from 0% of our sales in 2021 to almost 60% of our sales in our 2026 guidance. Even between, you see the strong growth from 2024 to 2025, but even from 2025 to 2026, we're estimating a 51% growth across both Cortrophin and Iluvien. Cortrophin gel is our lead rare disease asset. It's a purified corticotropin, a late-line treatment option for patients that are struggling with certain chronic autoimmune disorders. Cortrophin is approved for multiple indications in neurology, nephrology, rheumatology, ophthalmology, and pulmonology, with a strong potential for multi-year growth as the key indications are significantly under-penetrated and therefore have significant unmet need. The ACTH market is a fast-growing market with two players, and it grew 45% year-over-year in 2025 to about $992 million. We have long-term sustainability in Cortrophin driven by significant barriers to genericization, both regulatory and IP.
And lastly, we have multiple presentations for patient convenience. We have vials as well as a prefill syringe. To take a step back, the ACTH market returned to growth following the launch of Purified Cortrophin Gel in 2021, and as you can, or sorry, in 2022. And what you'll see is that it has been accelerating since we, over the past two years, we had 27% growth in 2024, and you're seeing 45% growth in 2025. We believe in the strong future multi-year growth potential, and because across indications, they're significantly under-penetrated, and we have a proven ability to reach new HCPs and patients. Over 50% of our clinicians that have prescribed Purified Cortrophin Gel were naive to ACTH and had never prescribed an ACTH drug before. So to dimensionalize the under-penetration across indications, and what this shows, this shows across five different therapeutic areas, but I'll start with the four on the right.
Those are our foundational therapeutic areas: multiple sclerosis, RA, sarcoidosis, and nephrotic syndrome, and you see that the number of patients that we believe are in our addressable market are significantly larger than anything that we're treating, than the number of patients we're treating today, and then I'll double-click on acute gouty arthritis flares and walk you through how we arrive at the, as an example, at the addressable patient population, so there are roughly 10 million patients in the U.S. with gout. About 36% receive treatment annually, and they have one and a half to two flares on average per year, but only 8% of those patients receive an injectable flare treatment, and that's the group that we consider with severe acute gouty arthritis flares as our addressable patient population, and that's 285,000 patients.
As I said before, a very small portion of that is being penetrated today and creates a significant opportunity, multi-year growth opportunity for ANI. So what are we doing? I said the word strong multi-year growth opportunity multiple times, but what is ANI doing to invest in and capture this growth opportunity? Number one, we're investing in high ROI commercial initiatives. We're building a new 90-person dedicated organization to expand our reach to patients with severe acute gouty arthritis flares, and we expect to deploy this 90-person organization in the middle of 2026. We're generating scientific and clinical evidence. As an example, we're advancing a phase 4 clinical trial for Cortrophin and gout, and we're enhancing convenience. We launched a prefilled syringe in 2025, and we continue to explore opportunities to further enhance patient convenience. With this, with these investments, we're continuing to see very strong growth.
In 2026, we'll see 55%-65% growth, with Purified Cortrophin Gel growing to $540 million-$575 million. What's important to emphasize is there's a significant growth runway beyond this in the overall ACTH market by growing the market, right? This is all of our initiatives are aimed at growing the ACTH market and capturing the under-penetrated addressable market that we had highlighted before. Let me tell you about the gout expansion. As I had mentioned before, there are about 285,000 patients that we believe are in our addressable market, and we are expanding and creating a 90-person commercial organization to go service these patients and meet and address this unmet need. Why gout, right? Number one, as I said, there's a large addressable patient population. The most severe patients, 285,000. Number two, we are the only approved ACTH therapy for acute gouty arthritis flares.
Our competitor does not have this indication. We have a proven track record. The gout indication generated approximately 15% of our usage in 2025 from nephrologists and rheumatologists. In 2025, we also ran 10 successful pilots across 10 territories to explore the opportunity for expansion in primary care and podiatry, and we've had them be very successful. And that gave us further confidence to deploy this new 90-person commercial organization. We're also investing in evidence generation through the phase four trial to expand the use over time. We're really looking forward to this opportunity, and we'll update you as we build the team and deploy the 90-person organization by the middle of the year. Let me move to our second asset, Iluvien. It's a long-acting therapy, ocular therapy approved for DME and chronic NIU-PS.
It's an intravitreal implant that provides continuous microdosing of fluocinolone acetonide in patients with retinal disease, two indications, diabetic macular edema. Again, greater than 50,000 patients in the U.S. that are not well served by anti-VEGF therapy, and we have less than 5,000 patients starts annually for DME in the U.S. with Iluvien, so representing a long or large growth opportunity. It's also true in chronic NIU-PS, where that's non-infectious uveitis affecting the posterior segment of the eye, where there are greater than 75,000 patients in the U.S. that are candidates for this treatment and less than 5,000 that receive Iluvien annually, again, giving a long runway for growth. In 2026, we'll focus on returning Iluvien to growth by leveraging our established commercial and patient access initiatives.
We're making new strategic investments in marketing and medical affairs to support increased awareness of the New Day clinical study data that a clinical study read out in the middle of 2025, and we're making investments to support the increased awareness of this study for Iluvien in DME. We're also strengthening the commercial team and further enhanced promotional efforts with a ramped-up peer-to-peer education program, new promotional materials, and a strengthened commercial team. And we're growing the use of alternative access channels to navigate the market access challenges that Medicare patients faced in 2025. Next, we move to our generics business. Our generics business drives strong cash flow generation. It's a high-performing business with superior R&D capabilities, three U.S.-based manufacturing facilities, and operational excellence. We have a robust pipeline in place to deliver 10 to 15 new product launches annually.
We invest high single-digit % of generic sales in R&D for generics, and we have a strong operational backbone. We manufacture and supply over two and a half billion doses of therapeutics. That's what we did in the last 12 months, two plants in the U.S. And as you can see, we've consistently delivered very strong growth, and in 2025, we delivered low 20% growth. Our growth was in the low 20s. Over 90% of ANI's revenues comes from finished goods that are manufactured in the U.S., with only 5%, approximately 5% of revenues having a direct reliance on China. And as I mentioned before, we have three manufacturing facilities in the U.S., all with a strong GMP track record, two in Baudette, Minnesota, and one in East Windsor, New Jersey. So in summary, ANI is well positioned to deliver strong long-term growth and value creation.
Our 2026 strategic priorities are to accelerate the transformation into making ANI a leading rare disease company, continued excellence in generics, R&D, and operations, and executing a disciplined capital allocation strategy. We have a virtuous cycle of growth that drives the transformation of ANI, with rare disease business expected to represent approximately 60% of total revenues in 2026, with our lead asset Purified Cortrophin Gel growing 60% year-over-year in 2026, with substantial multi-year growth opportunity ahead, and a strong generics business that's generating cash flows that we're reinvesting to expand ANI's rare disease business. And from a financial strength perspective, we're over $1 billion in revenues, $275 million-$290 million in adjusted non-GAAP EBITDA. We'll have approximately $285 million in cash on the balance sheet as of 12/31 and less than 1.7 times net leverage. So that's ANI in summary, and with that, I'll ask Ekaterina to ask any questions.
Yeah, sure. And I guess let me start with the 2026 outlook you provided. Just talk about some of the pushes and pulls as you think about the business.
Yeah. So thank you, Ekaterina, for that question. In 2026, we will exceed $1 billion in revenue for the first time, with rare disease accounting for more than 60% of the revenues. Our lead asset, Purified Cortrophin Gel, will see strong growth, delivering 55%-65% growth. And that growth will come from the existing indications or core indications that we're in: rheumatology, nephrology, neurology, pulmonology, and ophthalmology, as well as the expansion into gout, where we're launching a go-to-market team to drive the growth in launch, sorry, to drive the growth in gout, specifically within primary care and podiatry.
And then, as we think of profitability, you will see that we maintain profitability in 2026 from at an EBITDA margin level, despite investing over $50 million in this expansion for gout with incremental OpEx. Yeah.
And then on Cortrophin Gel specifically, I mean, 60% is a very nice number, and I think more than I think most people were expecting. Just main drivers of this and how should we think about maybe quarterly gating or just anything else to keep in mind for that product for sure?
Yeah, we'll address the quarterly cadence when we get to the full-year earnings, but in terms of where will this growth come from, we did an expansion of our commercial team in 2025, and we saw some impact from that in 2025 itself, but the majority of the, or we will get the full year impact and additional impact from that expansion in 2026. So a good portion of the growth from 2025 to 2026 will come from the expansion that was done in 2025. And then additional growth will come from the setting up of the team to pursue acute gouty arthritis flares in primary care and podiatry, but that team will deploy mid-year. So it will start delivering towards the back half of the year, and we'll have a full-scale impact in 2027 and in 2028.
So we will get operati ng leverage on the investments in this expansion as we move forward. Yeah.
Yeah. No, that makes sense. And then just looking back, earlier question, but looking back to 2025, if you think about both Cortrophin gel and Acthar, I mean, growth really stepped up. Just looking back, how much of that was the introduction of the prefilled and the pen? How much of that was maybe some kind of more reps representing both products and some of the Part D changes? Just talk about the mix of what do you think caused the entire market to step up.
Sure. Yeah, look, it's really the patient populations. There is a real unmet need here. ACTH is used as a late-line treatment for patients for whom other therapeutics are not working, who are refractory or have high side effects with other therapeutics.
It's a late-line treatment option. Really, what's driven the growth is the unmet medical need and the patient populations, as we've shown across indications that can benefit from ACTH therapy. That's the primary driver of the growth. It's really, again, from our perspective, this is really about market growth and with both companies creating increased awareness of the ACTH category, both with clinicians and patients are benefiting from the efforts of both companies. You asked about the prefilled syringe. I think the prefilled syringe has taken on a much more widespread adoption than we had originally planned. Initially, we thought that the prefilled syringe was intended for patients with dexterity issues or visual impairment, but we've seen more widespread adoption. We've talked about 70% of our enrollments in Q3 were for the prefilled syringe, and that momentum continues. But that's a presentation choice.
The underlying growth is driven by the patient need, and then you talked about IRA. We've seen a moderate positive impact from IRA. I believe the competitor has seen a tailwind from IRA. So I think those are the drivers of growth, but again, main driver for Cortrophin for ACTH market and Cortrophin growth in 2025 was the underlying unmet need and patient demand, and that will persist, and that's what gives the runway for growth for the ACTH market and for Cortrophin.
And would you say there's any two to three indications that are kind of driving most of it, or is it broad-based kind of across indications?
Yeah. Really, it's broad-based across indications. We saw growth in 2025 across the core indications. When we launched in 2022, we focused on neurology, nephrology, and rheumatology, and then over time, we've expanded into ophthalmology and pulmonology.
We really, if you call these our foundational indications, we see growth across all of these indications. We see growth in existing prescribers and new prescribers. We've talked about 50% of our prescribers are folks that were naive to ACTH, so that's enabled us to reach newer patient populations. And gout, right, has grown to be, it's an indication that only we have, about 15% of our volume. A lot of that volume in 2025 came from specialists such as rheumatologists and nephrologists. And then we had the pilots that we did in 10 territories, which drove some growth, but again, at small level. Now we're really going after that opportunity with the team expansion. Yeah.
And going back to kind of the broader class, obviously we've seen a lot of growth. I think we're actually approaching the previous $1.2 billion peak.
Just how big do you think this class can become over time? $2 billion, $2.5 billion, $3 billion? Yeah.
Yeah. We're not giving multi-year guidance today. I think what I can say is we do not see. We see significant growth opportunity for the category driven by the patient demand and the unmet need. Getting to $2-$2.5 billion or double of where the previous peak was, we don't see significant barriers to the market growing there. Really, the conversations internally are just about expanding the patient pools that we're reaching, as seen by our investment and growing the market. So this is all about market growth for us. Yeah.
And then talk a little bit about the data generation angle, just as you think about Cortrophin gel. I know you're doing a study in acute gout.
Are there any other indications where you think doing some phase fours might make sense?
Yeah. So since we've launched, we've actually been generating data of two types. First is preclinical data, which supports the differentiated mechanism of action, the non-steroidal mechanism of action of Cortrophin, and that's been helping. And we're doing this across indications and supporting the clinicians and their decisions on where to use Cortrophin. And then more recently, we launched the phase four study for acute gouty arthritis flares with Dr. Hyon Choi and Mass General. And we believe that that will generate additional data to support the use of Cortrophin in acute gouty arthritis and potentially adopted into the ACR treatment guidelines.
And then your decision to kind of invest in a dedicated gel sales force, you talked about this, but maybe you can just elaborate what type of physicians you're going to be targeting and how will this fit into your existing infrastructure?
Sure. So as I said, there was about 15% of our volume that came in 2025 from acute gouty arthritis, but that really came from specialists, really rheumatologists and nephrologists. And as we were exploring how do we serve more patients, capture more of these 285,000 patients that are in our addressable market, what we realized is there is this trend of patients going more to internal medicine and podiatrists because it's tough to get to specialists or it's increasingly harder to get appointments with specialists. And so we ran this pilot in 10 territories where we asked our teams to pursue these two: internal medicine and podiatrists.
And we found that there is a subset of internal medicine or primary care and podiatrists that serve more patients with severe acute gouty arthritis. And so we've identified about 7,000 targets, physicians that treat more patients that suffer from severe flares. And our team is aimed at—that we're building is to aim at reaching these prescribers and therefore accessing the broader patient population.
And then just one last question, if I may, on Cortrophin gel. Just competition, anything on the horizon out there that you're kind of watching, or is there some sort of kind of generics pathway or just anything you're kind of thinking about there?
Yeah. We believe this category and both the ACTH category, both products are very tough to genericize. They're naturally made. It's a complex formulation. There have been efforts made to genericize. So there are both regulatory as well as IP challenges.
Both companies have IP that go into the 2040s, multiple Orange Book-listed patents. And we're also continuing to monitor alternate pathways that companies may be pursuing. Obviously, as the category keeps getting bigger and more people become informed about the unmet need, there may be more interest into the category. Yeah. But we do not see anything on the horizon. Yeah.
And switching gears to the ophthalmology business, obviously, if you think about YUTIQ and Iluvien, 2025 was a bit of a challenging year, not just for those products, for I think a few others. But just elaborate a bit on what you're expecting 2026 specifically, what you're kind of factoring in for the foundation-level funding and just anything else to kind of keep in mind as we think about the recovery of that franchise.
Sure.
Our initiatives for Iluvien really started in 2025 as we call that a reset year for Iluvien. Those initiatives have taken shape. We have a stronger commercial team in place. We have a ramped-up peer-to-peer education program with new promotional materials that will start rolling out in 2026. We are spending additional time in bringing the strategic investments to bring the results of the New Day clinical study in DME for Iluvien to a broader set of clinicians. All of these initiatives, along with the alternate access pathways for patients that have the copay challenges in Medicare, will help us return Iluvien to growth. It is a key priority of us in 2026 to return Iluvien to growth. As you can see in the Q4 results, and we're starting to see that traction, and we'll look to build on that as we move forward in 2026.
As far as our guidance for 2026 goes, it assumes no return to funding for foundations that support copay for Medicare.
And I just feel that that funding issue, I mean, it's having such a big impact on the market. Is there anything you can do to kind of address it, or there's some ways to kind of go around it? Just anything, because I know that piece of it is outside of your control, but is there anything you can do to kind of avoid the issue, I guess?
Sure. So we are exploring alternate access pathways. So there are patients. The patients that are impacted here are patients with Medicare Part B, but some of those patients also have Medicare Part D. So they have the drug benefit.
And when they have the drug benefit, we work with the physician offices, and we've been doing this since early 2025 when the foundation funding issue initiated. And what we found is that there are offices that are willing to explore this alternate pathway. There is additional workflow needed for this pathway, but there are offices that are willing to explore that, and we see an increasing use of that. In terms of getting the foundation funding at the levels that are needed to support the patients, I think that that is probably. There are probably more zeros required there than anything ANI Pharmaceuticals can help with. Yeah.
No, fair enough, fair enough. And then just as you think about taking a step back, has your peak sales kind of potential for this franchise changed at all?
Is this kind of more just like near-term kind of issues, or has your thinking kind of changed about the longer-term opportunity here?
No, absolutely not. I think that both in DME and NIU-PS, there are patients that can benefit from this treatment. In non-infectious uveitis, steroids are the standard of care, and there's less than 5,000 patients being treated. And we believe there's about 75,000 patients that could be in the addressable market. And then in DME, there are 53,000 patients, roughly, that show suboptimal response to anti-VEGFs and show positive response to steroid trial. That's the addressable market. And again, we're scratching the surface with less than 5,000 patients being treated. So no change in our opinion on the larger opportunity. Yeah.
And then switching gears again to generics, you're obviously lapping some major launches in 2025.
What should we expect on 2026, and do you think you have enough in the pipeline to kind of offset, I think, Motegrity and also the partnered launch that you had at Q3?
Sure. Yeah. So generics has been a strong cash flow generator for us. We invest a high single-digit % of generic sales into R&D, and we will continue doing that. And it will give us to maintain the current cadence of about 10-15 launches annually. When you come to 2026 guidance, we believe with the very strong year that we had in 2025, we would deliver low 20% growth. And over the long term, as investors will know, we talk about delivering high single-digit, low double-digit % growth in generics. So in 2025, we really delivered a two-year growth, right?
And so in 2026, the numbers will, and we'll speak more about this as we get to the Q4 earnings, the generics will largely be flattish versus the 2025 number. Yeah. But our current cadence of launches will continue. We believe that in high confidence in the superior R&D capabilities and the same R&D capabilities that got us prucalopride, we'll continue delivering for us in our generics business.
And actually, that was going to be my next question. Is this kind of, how sustainable is this kind of cadence of launches? Is this kind of like a pocket of a lot of launches and then it kind of tapers off, or do you think that you can kind of keep doing the 10-15 kind of?
No, I think it's, in generics and for ANI, the cadence of new product launches is critical.
We will continue to invest high single-digit % of sales in generics R&D to maintain this cadence of launches and to continue supporting the growth. And, beyond 2026, we continue to see the high single-digit, low double-digit growth. And I mean, just for reference point, we've doubled our generics business in the last four years. So we've delivered, even though we orient to high single-digit, low double-digit growth, we've actually delivered much higher growth rate compared to that. Yeah.
And in the last few minutes, I did want to talk about margins for a little bit. How do you see margins evolving beyond 2026? Cortrophin gel is obviously growing, coming in at higher gross margins. Just how much of the upside do you think flows through versus kind of gets reinvested in the business?
Sure. So ANI is very committed to driving growth and balancing that with profitability.
So when you look at 2026 as an example, right, at the gross margin level, our gross margins are down a little bit from 2025. Our guidance was 61%-62% versus that in 2026. Our guidance is 59.3%-60.3%. But if you look at the bottom line, right, even in a year where we're investing in this, investing about $50 million for this expansion of the Purified Cortrophin Gel gout organization, we're still maintaining an EBITDA percentage of 26%. And so managing the bottom line and bottom line percentage is really important. And as you look forward from 2026, remember I said that this organization that we're investing in, the real impact is going to come in 2027. So we're making the investment and we'll get the operating leverage that will drive EBITDA margin expansion in the subsequent years. So that's really important.
And this coming back to the gross margin, just to make sure I address that, the year-over-year change is really driven by three things. Number one is we had the prucalopride launch, which was a 180-day exclusivity, a generics launch that really had brand-type gross margins to it. Second was we had brands upside in 2025 that will at least are not factored in the current guidance. And then third, for Cortrophin, the royalty that is due to Merck on that is increasing in 2026 from low 20s in 2025 to high 20s in 2026. And so if you take those three things into account, that's what's driving the shift. But again, very importantly, the EBITDA percentage, which is what drops to the bottom line, we've maintained that in an investment year. That's not to be lost.
In an investment year where we're putting $50 million, we're maintaining the bottom line percentage. When you look at EBITDA growth, right, the top line growth is 24%-28%. The EBITDA growth is 24%-27%. We're ensuring that as we grow, we're balancing profitability.
Then just business development, current appetite, what kind of assets are you interested in just in terms of development risk, if you're willing to take on any of that and just scale, just talk about priorities there?
Sure. From a capital allocation perspective, balance sheet investments will go towards rare disease to expand scope and scale of our rare disease business. We believe that the next acquisition will likely be a commercial asset or one that does not have clinical risk to it. We may adopt some regulatory risk, but unlikely we'll adopt something with clinical risk.
And look, we have the benefit of two sets of opportunities. One with call points into different indications that gives us a broader aperture, but also a very strong backbone, rare disease backbone across medical affairs, patient support, market access that can also be leveraged even if there's not call point synergy. But that's the types of assets that we'll be looking to. Yeah.
Yeah. And just as you think about capital allocation going forward, you're generating a lot of cash flow. Just priorities, as you think about the mix between BD, maybe Share Repo or anything else you're kind of considering?
Steve.
Yeah. We're quite pleased with the cash flow generation in 2025. We generated $140 million of net cash, bringing our cash balance to $285 million at year-end.
We were net levered 1.7 times as of September, and you'll expect that we'll be delevering a touch off that point when we report full results in February. We expect to allocate our cash and capital to expanding the rare disease business, and we expect very healthy cash flows in 2026. And at this point, continue to accrue that cash to the balance sheet to support the future BD and M&A aspirations on the rare disease side of the business.
Perfect. And I think we're right about time. So thank you so much.
Thank you. Thank you, everybody.