All right, I think we're ready to get going. Yep. Okay, great. So thanks, everyone, for joining us again at our Guggenheim Securities Biotech Conference. I'm Vamil Divan, one of the biopharma analysts here, joined by Daniel Krizay, one of the associates on the team here. And next up here in this room, we have ANI Pharmaceuticals, Nikhil Lalwani, the CEO of the company, joining us. We'll do a fireside chat format to go through the story. But maybe, Nikhil, if you can just sort of start for people maybe less familiar with the story, just an overview on ANI Pharma, the kind of the recent updates over the last couple of years, a lot of changes, a lot of progress, and then we'll go deeper into the questions.
Sounds good. Thank you for having us, Vamil, and good afternoon, everybody, and thank you for joining us. ANI Pharmaceuticals operates in three business segments: Rare Disease, Generics, and Established Brands. Our key focus area and primary driver of growth is our Rare Disease business. In our Rare Disease business, we have three durable, commercial, and growing assets: Cortrophin Gel, which is in year three since launch, and we'll do about $200 million in sales, or delivered almost $200 million of sales last year in 2024, and then two new assets that we added last year through the acquisition of Alimera, which are ILUVIEN and YUTIQ. These are intravitreal implants that are used to treat uveitis and diabetic macular edema, and then so that's our Rare Disease business, and it's the key focus area and primary driver of growth.
We also have a Generics business that we believe is a high single-digit to low double-digit grower, on the back of superior R&D capability that delivers new product launches, operational excellence, and a U.S.-based manufacturing footprint with a strong GMP track record. And then third, we have an Established Brands business, which is high margin, generates strong cash flows, which we can redeploy to drive growth in our primary two growth drivers, which are Rare Disease and Generics. Yep.
Yep. And then you touched on this a little bit, but in terms of your expected drivers of growth, it definitely sounds Rare Disease, obviously, the focus, but maybe just your sense of how you see the growth from here over the next year.
No, absolutely. I think that Rare Disease will be the key focus area for capital allocation and the primary driver of growth going forward. And our Generics business, through investment in OpEx and R&D, will drive high single-digit, low double-digit growth. So those will be the primary growth drivers going forward.
Okay, so maybe why don't we dive deeper on the Rare Disease side, and we'll start, obviously, with Cortrophin, which you mentioned had a strong performance in 2024, so maybe you just talk about, it's been a couple of years now in the market, sort of the progress you made with the launch, where you've seen the traction, and then we can talk about sort of where you go from here.
Sure. So we launched Cortrophin Gel. It's indicated for the treatment of multiple autoimmune indications, largely for patients that are steroid resistant or they're refractory to steroids or they have a high side effect profile to steroids. And what we've seen since we've launched, and it's year three of launch, last year we did $198 million, almost $200 million in sales. And we've seen growth across the therapeutic areas we focused at launch, which is neurology, nephrology, and rheumatology, as well as the newer therapeutic areas of ophthalmology, pulmonology, and gout. When you think of our momentum, even in Q4, we had the highest across all these therapeutic areas, especially in the ones that we launched with, we saw the highest number of new patient starts as well as new cases initiated, right? So in Q4.
And then if I talk more specifically about the newer areas, ophthalmology, obviously we've expanded our ophthalmology commercial presence with the acquisition of Alimera and the addition of ILUVIEN and YUTIQ, and we're focused on that area with a 46-person sales force out promoting all three products. That, in, as far as Cortrophin goes, Cortrophin saw 2x the number of new patient starts in Q4 versus the prior quarter. So that talks about traction in ophthalmology. And for the first time, we started giving more details on gout, which is an indication that we have and the competitor does not. 15% of our volumes comes from the acute gouty arthritis flares indication. And equally interesting, 15% of prescribers that write for acute gouty arthritis are naïve to ACTH. They haven't written ACTH before.
And so again, as you think about the growth of Cortrophin to date, it's come across indications and from existing prescribers and new prescribers. Yeah.
So we saw last year was the first year where we saw year-over-year growth for the class overall. So maybe can you talk about that? You mentioned there's one other competitor, just how the market has evolved in the time since you entered.
Yeah. So for those that are new to the story, Cortrophin Gel operates in the ACTH market. The ACTH market was $1.2 billion in 2017 with one player, and that market steadily declined until 2021 for a number of different factors, but we entered in 2022, and since we've entered, the decline has first reduced in 2022 and 2023. Then in 2024, for the first time, the market has grown again. If you add our results with their guidance, what guidance that they gave at the end of Q3, the market will grow 23%-24%, and will still only be at roughly $650 million versus the $1.2 billion that it was in the past.
More importantly, when you look at the underlying patient population, what you'll see is that the number of patients on therapy today is significantly lower than the number of patients that were on therapy back in 2017, and even from an epidemiological perspective, even the number of patients being treated in 2017 was a small subset of the total addressable market, which is basically the number of patients that suffer from these autoimmune indications and are either refractory to steroids or have a high side effect profile, so our overall point being that as a result of that, the category has a long trajectory, and specifically Cortrophin has a strong multi-year growth trajectory possible. Last point to add is acute gouty arthritis flares, which we spoke about, and it accounts for about 15% of our volumes. That indication was never part of the competitor does not have that indication.
So, we see that the ACTH market is back to growth, delivered strong growth in 2024, and we expect that trend to continue and us to participate in the growth of the market.
And then as you look forward here now in the next few years, where would you, in terms of the new indication, like with gout, is the other indication, where do you see the growth most likely to come from going forward?
Yeah, look, as I said, the underlying epidemiology support says that there are underserved patients both in the indications we targeted at launch as well as the newer indications, newer as in pulmonology, sorry, ophthalmology, acute gouty arthritis, and pulmonology, so there's growth available across the board. What we need to, what we're continuing to do is think about what are the high ROI efforts to invest behind to go capture that growth, and so that's what we're thinking through and executing, obviously.
Okay. And then maybe the last question on the Cortrophin side. So you talked about the peak being 1.2 back in the 2010s. The pricing was a little different, I think, than what it is now. So maybe as you think about the opportunities with new indications to expand into maybe getting new prescribers right, but then maybe a little bit of a lower pricing, net pricing, where do you see sort of peak opportunity out in time? And I know you don't usually give sort of product-level guidance, but just kind of your ability to capture how much of that market can you capture?
Yeah, look, I think there is, with the ACTH market returning to growth, the number of patients that can benefit, appropriate patients that can benefit from this therapy has increased. And we see that trend continuing. And as I said before, look, it's really just about, it's really not about the $1.2 billion in our minds, right? It's really about the number of patients that we're able to get to today, even between us and the competitor, being substantially lower than the addressable market. So I think that the opportunity is significant to serve patients. And we haven't dimensionalized how large that can be. We haven't given peak sales. But what I can say is that both the competitor and we are continuing to invest in increasing awareness of ACTH and then making different steps to strengthen the respective franchises. I can speak on our behalf.
We're doing two sets of things to, or three sets of things to invest and strengthen the Cortrophin Gel franchise. Number one is we're about to launch a, in the first half of 2025, we will launch a pre-filled syringe to help patients that have dexterity issues. It reduces the, from a two-step process, it takes out one step of the injection process, so with the launch of a pre-filled syringe. In addition, we're working on other efforts to further reduce the pain points and enhance convenience for patients and the physicians. So that's one. Second is we're also investing behind generating data that will support the use, support physicians in their use of Cortrophin. So I think that's number two. And then number three is we are continuing to evaluate and invest behind high ROI commercial initiatives, as I spoke about, that will further strengthen the Cortrophin Gel franchise.
Okay. That was great. So let me turn to Daniel to just kind of dive deeper on the Alimera.
Thank you.
Yeah, great. So as you mentioned earlier, you recently expanded the Rare Disease business with your acquisition of Alimera and their products, YUTIQ and ILUVIEN. So can you maybe discuss this acquisition in a little bit more detail and why this was the best business development move for ANI?
Sure. So ANI is committed to growing our Rare Disease business and expanding the scope and scale of the Rare Disease business. And the Alimera acquisition was pursuant to a very sort of clear BD or M&A strategy, right, which was we wanted to add commercial assets with durability and growth. We wanted to add it in a therapeutic area that was synergistic with Cortrophin. So ophthalmology, ophthalmology had grown to be about 10% of ACTH prescribers. So that's why we picked ophthalmology. And then it had to be in a peak sales range that was meaningful to what ANI had in Rare Disease, but also of a size and scale that we could do and would not strain our balance sheet. And so we achieved all of that with the Alimera acquisition, and it ticked all of those boxes as we thought about ILUVIEN and YUTIQ.
Okay. You pre-announced the full year 2024 revenues of around $31 million for these two products. Can you discuss the expectations for these products in 2025 and beyond, and maybe dive a little bit deeper into how these products synergize with Cortrophin, as you just mentioned?
Yeah. So we haven't issued product-specific guidance for 2025 for ILUVIEN and YUTIQ. What we have said is that the total company sales will be in our guidance, $739 million-$759 million for total company, and then 50% of that revenues-ish will come from Rare Disease. And obviously, ILUVIEN and YUTIQ are a subset of that. We do see significant growth opportunity for both ILUVIEN and YUTIQ. ILUVIEN is indicated for diabetic macular edema. ILUVIEN is used for less than 5,000 patients. Patients that ILUVIEN is appropriate for are patients that have DME but show suboptimal response to the standard of care, which is anti-VEGF therapy, and show positive response to steroid trial. We think that that patient population is about 50,000-55,000 versus the less than 5,000 that are being treated with ILUVIEN. So the opportunity is significant. The growth opportunity is significant.
And as we think of YUTIQ, which is indicated for the non-infectious uveitis in the posterior segment of the eye, again, we treat less than 5,000 patients per year, and the growth opportunity is significant because the patient population that suffers from uveitis is substantially larger. So I think that the growth opportunity for both is significant. Now, what we have done is we launched a combined ophthalmology sales force of about 46 sales reps, and they are out there detailing ILUVIEN, YUTIQ, and Cortrophin. And as you can see from the first quarter results, that we've had good traction from the start with all three sort of out there detailing those three products. We did about $27 million in Q4 ILUVIEN and YUTIQ sales as pre-announced.
Okay. To maybe dive a little bit deeper into how you're going to reach these additional patients, one way you guys are doing this is with the NEW DAY trial, which you're comparing ILUVIEN in combination with aflibercept versus aflibercept alone in DME. So can you discuss this trial in a little bit more detail? Maybe go into when we should expect this top-line data and what a positive trial would mean for the market opportunity of this product?
Yeah. So the NEW DAY trial, the last patient last visit has finished in the end of Q4, first week of January. And we expect that the readout will happen in early the second quarter in terms of the results. And then to your point on the NEW DAY trial explores the use of ILUVIEN in combination with the current standard of care anti-VEGF therapy. And when successful, it will allow physicians to consider using ILUVIEN earlier in the treatment of diabetic macular edema in combination with anti-VEGF therapy. So I think that's we're looking forward to the results, and so is the retina community.
Okay, and maybe beyond that, what do you see as the competitive outlook for these products?
Yeah, you know both ILUVIEN and YUTIQ are intravitreal implants that are long-acting. And at this time, we do not see anything under development that is in the same timeframe that both YUTIQ and ILUVIEN work for.
Okay. And then maybe my last question before passing it back to Vamil, can you discuss the high barriers of genericization for all three of your R&D assets and the longevity that they have?
Yeah. No, thank you for asking that. So the ACTH market obviously has been around for many years. And as we've talked about a few times, the competitor had peak sales of over $1 billion. At that time, many companies made efforts, and we're talking about Cortrophin here, sorry. At that time, many companies made an effort to genericize the ACTH product, and it was very tough, right? Both from a combination of analytical techniques, product development, FDA guidance, multiple different factors. And so many programs were stopped. And large companies tried and stopped that development programs. So look, we do see that the path to genericization on Cortrophin in itself is tough or the barriers are high. And in addition, we have IP that we have been newly granted by, and that will help protect Cortrophin until, I think it's in the early 2040s, right?
So any potential generic player will need to not infringe that IP. As it comes to ILUVIEN and YUTIQ, the high barriers to genericization really come from what we believe it takes to genericize this product or to show clinical equivalence. And that requires a multi-year clinical trial. And we believe that that will take a long, long time and is not easy to do. And honestly, at the size at which each of these individual products are at in the U.S., not one that is probably worth pursuing for any player, right? Because it's a multi-year, expensive generic development process and clinical trial. So keeping that in mind, we see that as high barriers to genericization for all three products.
Okay. So maybe I'll take over just on that. It's obviously a big deal having gotten Alimera done. Just your future business development plans now that you've closed that, just the similar sort of deals we should be looking for and what's the sort of level of urgency to do something again?
Yeah. Look, as I said before, from a capital allocation perspective, we think of Rare Disease as the focus because it's a primary driver of growth going forward. And we will look to M&A and BD to drive to further expand the scope and scale of our Rare Disease business. You can look for us to do a similar type of acquisition as we did with Alimera, where something that's synergistic with Cortrophin has a commercial, durable, growing, right? And is in a therapeutic area that's synergistic with Cortrophin and with a peak sales range that is a meaningful addition to our Rare Disease business. We will also look at, and we've talked about this in the past, is in addition to the sales force, we also have the rest of the Rare Disease infrastructure that is essential to as a platform, right?
So we have market access, medical affairs, patient services, hub, right? So all of the strategic development and advocacy, I think all the other elements of a Rare Disease infrastructure that is critical to launching and commercializing Rare Disease products. So you can also look for us to evaluate opportunities in a Rare Disease area that may not be synergistic with Cortrophin, but requires a very small sales force, but leverages the rest of the infrastructure that we have.
Okay. So we just have a few minutes left here. So maybe just one, you touched a little bit on Generics in yours. Look, they're high single- digit, low double- digit sort of growth. Just what are the drivers for that growth? What do you see as your advantage there?
Yeah, it's strong. Thank you for that question. We have a high-performing R&D team. We delivered 17 new product launches in 2024 and look to have a similar cadence of new product launches in 2025 and beyond. And that really is the key driver of the high single- digit, low double- digit growth. That R&D engine is also supported by a very strong operational execution, strong U.S.-based manufacturing footprint, and a strong GMP track record across facilities. So that allows us to bring new products to market and launch them and capture the share needed and deliver the high single- digit, low double- digit type growth.
Okay. Great. And then last question, maybe just around your capital position now after doing the Alimera deal, maybe just lay out for everyone what your financial outlook is here.
Yeah. So we're looking to do $739 million-$759 million in sales in 2025 and adjusted non-GAAP EBITDA of $182 million-$192 million on a total company basis. We have about $640 million of debt, including a convert as well as a Term Loan A. And yeah, I think as of last reported 12/31, we're obviously generating cash flows through the year, but as of 12/31, we had about $145 million of cash on the balance sheet. At the time of closing of the deal, we were about 2.7 turns of net leverage. And through the cash generation and through the performance in 2025, taking into account the total company guidance we gave in terms of adjusted non-GAAP EBITDA, it will lever down, right, as we delever as we go forward.
Yeah, so I think we have a very strong financial position and ability to continue driving growth in both our Rare Disease as well as our Generics business. Obviously, Rare Disease remains as the primary area of focus and the driver of largest absolute growth going forward.
Okay. All right. Great. So yeah, great to see all the progress and.