Thank you for joining us today. My name is Faisal Khurshid. I'm one of the senior biotech analysts at Leerink Partners, and we're here in Miami at the 2025 Leerink Partners Global Healthcare Conference. Really pleased to have with us today Nikhil Lalwani. Nikhil is the CEO of ANI Pharmaceuticals, a really interesting company that kind of, you know, straddles a few different business segments and has an interesting growth story ahead of it. Nikhil, why don't you start by sort of, you know, introducing yourself and the company? Maybe you can lay out a little bit for us, like, the different business segments and the role that these each play in the future of the company.
Great. Thank you, Faisal. Thank you for having us, and good afternoon, everybody, and thank you for joining. ANI operates in three business segments. Overall, as a company, our guidance for 2025 was to deliver $756 million-$776 million in revenues and $190 million-$200 million in adjusted non-GAAP EBITDA and $6.12-$6.49 in adjusted non-GAAP EPS. The rare disease business is the primary driver of growth for ANI, and in 2025, will account for almost half of the company's revenues. Our rare disease business has Purified Cortrophin Gel as our lead rare disease asset, which we launched in 2022 and delivered about $200 million in sales last year, in our third year since launch. For 2025, our guidance for Purified Cortrophin Gel is $265 million-$274 million, you know, another 35% plus of growth.
ILUVIEN and YUTIQ are the other franchise that we have in our rare disease business. Our guidance for 2025 has them doing $97-$103 million in sales, and this franchise came to us through the acquisition of Alimera as we expanded the scope and scale of our rare disease business. Rare disease, primary driver of growth, about half the company. We also have a growing generics business that has been delivering high single-digit to low double-digit growth. In fact, has delivered low double-digit growth for the last three years, and our guidance for this year is for it to also deliver low double-digit growth. Last year, we did about $301 million in sales in generics, and, you know, we'll have low double-digit growth. This grows really on the back of a strong R&D capability and execution, a U.S.-based manufacturing footprint, and operational excellence.
The third business line is our brands portfolio, formerly known as established brands. Our brands portfolio is a very high-margin, strong cash flow generation business. Across these three businesses, we have a virtuous cycle of growth, right? We have the rare disease business, which will be the primary driver of growth, and that's fueled by the generics business, which is also a growing business, and the brands business, which generates high profitability and strong cash flows.
Got it. That's a helpful overview, and kind of good to see a healthy, growing, cash flow-generating company in this environment. You recently upped your 2025 guidance, and I think those are the numbers you just ran through. Can you explain kind of what happened that led you to kind of have the confidence to up the guidance, like, already within Q1?
Yeah. No, thank you. I think three things. One, we saw strong trends in Purified Cortrophin Gel, our lead rare disease asset, driven both by positive impact from IRA. You know, again, early in the story, but we saw a slightly more positive impact from IRA. Also, and probably more importantly, the fact that our sales force expansion we had thought would take a little longer to do, but we were able to add about 20 reps early into the first quarter, and we had the impact of that for a longer period of time. That is the first reason. The second is we launched a first-to-file generic prucalopride, which is generic to the brand Motegrity, and the first couple of months' performance gave us a strong orientation towards generic performance for the year.
The third is, you know, we saw increased demand in our brands portfolio in Q4, and, you know, we saw two months of that continuing into Q1. These three things helped us, these three factors helped us raise our guidance from the preliminary guidance that we had given in early January.
Got it. That's helpful. Let's talk about Purified Cortrophin Gel. Like, as you mentioned, it's kind of the crown jewel of the growth story over the next few years, at least. Your 2025 guidance implies, like, you know, year-over-year growth in the mid-30%. Can you talk about sort of, like, what kind of leading to that level of growth, what underscores your confidence there?
Sure. Cortrophin, you know, saw very strong momentum in the fourth quarter, where we had the highest number of new patient starts and new cases initiated. That momentum continued in the first quarter, where in February, we saw the highest number of new cases initiated. We see growth for chloroquine across the therapeutic areas that we operate in, which is rheumatology, neurology, nephrology, ophthalmology, and pulmonology. You know, when we think about the opportunity for chloroquine, right, I would anchor it in a couple of things. I think we believe it has a strong multi-year growth trajectory, and that, you know, I guess two data points or three data points to give you on that. I think first is the ACTH category was at its peak in 2017, when there was only one competitor in the market, and that market declined.
When you look at, and then we launched in 2022, and since we've launched, the deceleration has slowed, and then in 2024, for the first time, you know, if you add the competitor's guidance given in November plus our actuals, that's about a 25% growth to around $660 million versus the peak sales of $1.2 billion in 2017. The headroom from that perspective is significant. Second is when you look at the number of patients, when you look at claims data, the number of patients on therapy today are almost half the number of patients on therapy in 2017. Again, that's another sort of, you know, clear indicator of the significant headroom that there is to serve the appropriate patients.
Third, when you step back and look at it even from an epidemiological perspective, in 2017, the number of patients that were being treated versus you'd look at patient pools, you know, that Purified Cortrophin Gel is appropriate for, which is treatment for exacerbations and flares in patients with chronic autoimmune diseases, where they would benefit from an additional line of treatment or a treatment alternative, then that number is much larger than even was being treated in 2017. That gives us a high degree of confidence that Purified Cortrophin Gel is on a strong multi-year growth trajectory. The last and very important point to share with you is that 40% of prescribers that have written for Purified Cortrophin Gel had never written an ACTH prescription, were naive to ACTH, at least for the last 10 years, right, when we look at the claims data that's available.
That gives us confidence on our ability to go, you know, talk to new prescribers about the benefit of ACTH therapy and navigate the discussion with them on what are the appropriate patients that could benefit from ACTH therapy.
Got it. That's helpful. Remember, when you disclosed that 40%, very impressive.
Yeah.
In terms of the, you know, you have this interesting acute gouty arthritis indication that is unique to your label, not the competitor's label. Can you talk about, you know, why this is an area of importance and what you see that indication kind of being for the brand going forward?
Yeah. Acute gouty arthritis flares is an indication that we have that the competitor does not, and it accounts for approximately 15% of Purified Cortrophin Gel usage. Interestingly, when we look at acute gouty arthritis flares, for 15% of prescribers for which acute gouty arthritis flares is the first prescription, they go on to use it for other indications too. It ends up becoming a gateway for other indications too. Therefore, we believe that, you know, acute gouty arthritis flares is a key indication, and it will be an important part of the Purified Cortrophin Gel growth in the future.
Got it. I think you recently got the, or you did recently get the approval for the prefilled syringe presentation of Purified Cortrophin Gel. I think that also might have been a little bit ahead of schedule also. Can you talk a little bit about the, you know, the extent to which this is a part of the growth story or part of the extent to which this is a growth driver for this year?
Sure. Look, we're continuing to, you know, we believe in the strong multi-year growth trajectory for Purified Cortrophin Gel, and we're taking several steps to invest in this franchise. You'll recall that we launched originally, the original presentation of Purified Cortrophin Gel is the 5 mL vial. Many years ago, we launched the, sorry, a couple of years ago, we launched the 1 mL vial, which was appropriate for gouty arthritis flares because that's the right dosage for that. We were launching a prefilled syringe. We got approval on and announced it on March 3rd. The prefilled syringe is to help patients who can benefit from a one-step reduction in the administration process. Rather than having to draw the drug and then administer it, it reduces the steps in administration by allowing the patient to just inject.
We believe that this will be helpful to continue providing patients an option, again, for the appropriate patients for their treatment. Yeah.
Got it. You mentioned that, you know, part of your guidance revision was the IRA changes. Can you talk a little bit more specifically for the Purified Cortrophin Gel business, how the reimbursement landscape changes with IRA, with the Part D redesign for 2025, how that impacts the business?
Sure. You know, for ANI, the impact of IRA is the following. First is, obviously, we have the manufacturer's rebate that is owed for a portion of the Medicare business. There is one portion of it, which is the low-income subsidy for which ANI has qualified for the specified manufacturer smoothing. It sort of smoothens the path to the levels of the rebate. That is one portion, which is increased sort of rebate expectation from the manufacturer. On the flip side, patients benefit from, which is the whole purpose of the Inflation Reduction Act, they benefit from affordability options where their copay or the out-of-pocket max is at $2,000, and there is an option to smoothen the paying off the $2,000.
What we've seen early on is that patients have stepped into and taken advantage of these affordability options because then they can, you know, they can use the smoothing of the copay over the period of the year to bear the burden of the out-of-pocket. Net-net, at least early days, we think that this may be a bit helpful, again, for the appropriate patients.
Got it. Interesting. You know, can you speak a little bit to the competitive dynamics in the space? Like, obviously, there was an incumbent product that reached blockbuster status. You spoke to the trend, you know, over time, how it, you know, came down due to the turbulence at the manufacturer, and now it's kind of back to a growth trajectory. You know, kind of from this point forward, can you speak to your kind of track record so far of competing effectively against this competitor and how you see that kind of moving forward?
Yeah. Look, I think at this point, again, I just go back to the number of patients, right? The number of patients that are benefiting from ACTH therapy today is half the number of patients that were benefiting from the therapy in 2017. The best that we can tell, there has been no reduction in terms of a patient need, right? Or there are appropriate patients which are the addressable market is much larger than even what was being treated in 2017. What you have is now, instead of one player talking about increasing awareness of this therapy, you have two players that are out there increasing awareness of ACTH therapy, and I think that that's a good thing. You know, the appropriate patients are benefiting from the availability of ACTH therapy for, you know.
You know, I think that, yeah, I think that that's what I would say. I guess the other thing to add is patients are also benefiting because, you know, both the competitor and us are investing in strengthening their individual franchises, right? They launched, you know, different presentations. We've launched the 1 mL vial. We've launched the prefilled syringe. We're working on additional research to support the usage of chloroquine. We're working on other projects to improve the convenience and enhance the convenience, sorry, to enhance the convenience for patients and for prescribers. I think these are all good things for the patients in need.
Got it. Helpful. Maybe just one last one on chloroquine. You know, I know you haven't given long-term guidance, but just to the extent that you can speak to it qualitatively, how should investors think about the long-range trajectory for chloroquine? You know, I think the class when it was that one product at its peak was, I think, $1.2 billion, $1.3 billion, right? Like, how should we think about the kind of durability of the growth trend that we're seeing over the last couple of years?
Sure. I would say a couple of things. The first is, you know, these are drugs that are very complex and hard to genericize. They're derived from the porcine derive, so they're derived from the pituitary glands of porcines, and that makes it tough to genericize, right? Companies have tried, and it hasn't worked. Both companies have added IP or strengthened their position by adding IP that goes into the 2040s. That's an important thing. In terms of, you know, how big can this be? Is $1.2 billion the right size, or is it bigger than that? I mean, again, I just anchor it back to number of patients, right?
Number of patients being treated today is nearly half the number of patients that were being treated in 2017 when the market was at its peak, and that number is still a subset of the much larger addressable market of appropriate patients. You know, strong multi-year growth trajectory for chloroquine.
Got it. Let's switch gears and let's talk about ILUVIEN and YUTIQ. These are the two ophthalmology assets that you acquired last year with the acquisition of Alimera. At your recent earnings call, you announced a few kind of moving pieces with these brands across kind of label changes, you know, manufacturing, reimbursement, just, you know, for the benefit of investors. You know, can you just give us a quick recap of these different moving parts associated with these brands?
Sure. Sure. And again, just to anchor, the ILUVIEN and YUTIQ franchise will contribute our guidances, $97-$103 million out of our total rare disease business of $362-$377 out of a total company revenues of $756-$776. There are a couple of changes that we're working through on ILUVIEN and YUTIQ, the franchise. First is in the near term, you know, with regards to market access, there are a subset of patients that benefit from foundation support or program support for their financial responsibilities towards treatment, and that has run into some headwinds in Q1. What we're doing about that is, first of all, for the right patients, there is a patient assistance program in place to ensure that, you know, patients that need the support can get the patient assistance and can get the therapy they need.
Second is we are also working with our HCPs to understand how they're navigating these changes and then evolving our commercial strategies to adapt to the new normal. That is on market access changes, right? When you come to the second piece, which is around the ILUVIEN and the consolidation of the two indications, diabetic macular edema and non-infectious uveitis affecting the posterior segment of the eye, consolidating both indications into the ILUVIEN label for the US, let me talk about that next. ILUVIEN is currently indicated for non-infectious, sorry, for diabetic macular edema. ILUVIEN and YUTIQ are both substantially similar ophthalmic implants. The active ingredient in both is fluocinolone acetonide, and there is a very small difference in the concentration. You know, one is 0.19 milligram and the other is 0.18. It's really a rounding error difference.
The clinical study was actually done, you know, on the same product. What we did is we went to the FDA, and this is being done to enhance the supply security. We went to the FDA and tried to understand from them what will it take to add the non-infectious uveitis affecting the posterior segment of the eye, which is the indication for YUTIQ, onto ILUVIEN so that we can only be commercializing one label, one product with two indications. The FDA was very clear. Obviously, the Department of Ophthalmology has reviewed and approved both applications. They were very clear when they asked us to do, and then we did exactly what they asked us to do.
We have since, we submitted the application late last year to, you know, to consolidate the NIU-PS indication onto the ILUVIEN label and have been going through the review process with the FDA as they've been engaged with them, answering their questions as they came up. We look forward to, you know, to consolidating the label in the second quarter, right? We look forward to getting the approval and then working through the transition of consolidating the label. We'll sell only ILUVIEN going forward after the transition. Now, to support this larger volume at ILUVIEN, we expanded the agreement with Siegfried, which is the CMO for ILUVIEN. Siegfried is a CMO. That's what they do. EyePoint, which was the CMO for YUTIQ, really doesn't want to be a CMO. You know, they have a development program that is going very well.
Siegfried has been manufacturing ILUVIEN for 10 years. We struck an expansion agreement with them until 2029 and agreed to expand the capacity. You know, there's a small sort of co-investment in CapEx to be able to do that. Look, Siegfried was audited by the FDA in 2023 and had zero 483s. We believe we have enhanced the supply security for the franchise by adding the NI-UPS indication onto the ILUVIEN label and strengthening our partnership with Siegfried to increase their capacity and extend the partnership until 2029.
Got it. That's helpful. You know, you're kind of sitting here like seven months, right, post-acquisition close of Alimera. You're taking the necessary steps to kind of position these, or I guess the ILUVIEN product well for the future. You know, I know the 2025 guidance is what it is, and I know you will not give future year guidance, but just qualitatively, how should investors think about the growth trajectory for these brands as we kind of get on the other side of these changes over the next few years?
Sure. No, look, clearly we have some near-term topics to work through, which we are working through. I'll remind investors that, you know, Purified Cortrophin Gel didn't get to be $200 million with no speed bumps along the way. We navigated some challenges. So, you know, we've got this, right? We know what issues we need to work through, and we will. Look, again, both for ILUVIEN and for YUTIQ, the reason we were excited about the acquisition and the main investment thesis remains, which is that ILUVIEN is indicated for diabetic macular edema. There are about 53,000 patients in diabetic macular edema. The standard of care is anti-VEGFs. There are about 77,000 patients in the US for whom anti-VEGFs stop showing optimal response. Of those 77,000, 53,000 patients show positive response to steroid trial. That means you try a steroid on them and they show positive response.
These are patients that would be appropriate for ILUVIEN. Today, less than 5,000 patients a year get ILUVIEN. Again, there's a 10x headroom between addressable market and the number of patients on ILUVIEN today. You look at the non-infectious uveitis affecting posterior segment of the eye, which is the other indication. Again, there are less than 5,000 patients that are currently being treated for that indication with our product, currently YUTIQ, but we'll shift to ILUVIEN. The number of patients that are the addressable market for that is, you know, 40,000 plus. The word, you know, we're still, you know, the headroom, the opportunity is significant. You know, to remind investors or to tell investors who are new to the story, when we acquired Alimera, they had about 31, about 30 reps that were going around the country.
We've expanded that to 46 reps for a combined sales force that details Purified Cortrophin Gel, ILUVIEN, and YUTIQ, both, you know, all three products. And we believe that, you know, that increased awareness and stronger commercial execution will help bring ILUVIEN and YUTIQ, which is the specific question Faisal will ask, to a lot more of the addressable market than is currently being done.
Got it. Helpful. I want to transition a little bit. Like, you know, you bought Alimera last year. You got it at a, you know, decent multiple to the revenue run rate that the products were at. What is the current appetite and capacity for additional M&A in this branded rare disease segment? Are there a meaningful number of targets out there that are like Alimera-like, that kind of fit in that sweet spot, that are easy plug and play to the really nice commercial machine that you have?
Yeah. We're in the near term focused on organic execution with, you know, we have a tremendous amount of growth in Purified Cortrophin Gel, in ILUVIEN, you know, and integrating the ILUVIEN and YUTIQ franchise as well as driving growth in generic. Significant opportunity there organically. Having said that, we are constantly looking and believe that there are opportunities to expand the scope and scale of our rare disease business, and that is what we're looking to do. We're looking to move the center of gravity of our company towards rare disease and having and adding more rare disease assets. In the near term, we're focused on organic execution, and we'll keep looking, and as opportunities come up, we'll look to engage. We're not looking to transact any in the near term.
Got it. Is the gating step to that like deleveraging, or is it just waiting for the opportunity set, or what's the kind of?
I think it's a combination of a couple of different things. I think it's a combination of continuing to execute organically and working through the near-term topics on the, you know, on the ILUVIEN and YUTIQ franchise. You know, again, there's a lot of growth that we have to drive organically. Delivering on that and then just finding the right opportunity, right? There's no hurry to do a deal. We need to find the right deal to continue to expand scope and scale of our rare disease business.
Got it. That's helpful. You know, it's been a journey with the company, you know, like since you took the helm. You know, it didn't happen overnight, but the company's in a, you know, nice spot today. You know, your guidance, I think, implies a roughly 50-50 split between the kind of branded rare disease segment and the generics business. You know, assuming the path you're on continues will shift more and more, you know, to the rare disease side. You know, I guess the question I want to ask is like, what does the company want to be like when it grows up? You know, like, does this become just a branded company? Does the generics business stay with the company? Does it make sense in the company? Just like, what does this story look like? Yeah, like another five years from now?
Yeah. Yeah, I think, you know, and maybe this is one thing that I know you're going to ask this question because I heard you ask the prior presenter the same question about what do you think is misunderstood about the company or least understood or, you know, investors understand a bit less.
Can I ask you my last question?
You know, I heard you ask the last presenter, so I imagine it's coming my way. I think we're in this virtuous cycle of growth with three businesses: a high-performing generics business that's driving growth. It's driven low double-digit growth over the last three to four years, but let's say it's a high single-digit to low double-digit grower. It generates growth, profitability, cash flows. We have a brands business, formerly known as established brands, that's also generating high profitability and strong cash flows. Both of these help fuel the rare disease business, right? Investments in the rare disease business. You know, we talked about launching a prefilled syringe. We talked about launching, you know, or doing additional research to support Purified Cortrophin Gel usage and additional projects to enhance convenience. Convenience for Purified Cortrophin Gel physicians and prescribers.
There's this virtuous cycle or even the expansion of our sales force, right, for chloroquine. There's this virtuous cycle where these three businesses are, the two businesses, the generics and the brands, is fueling the growth of the rare disease business. Sure, we want to move the center of gravity there towards the rare disease business and expansion of scope and scale through M&A. I think that's an important thing that we have this virtuous cycle and, you know, and, you know, we will shift the center of gravity towards rare disease, but we believe we're in a strong position by having these three businesses that have this virtuous cycle of growth.
Got it. That makes sense. All right. Since you stole my last question, I have to kind of think of a different one. I guess as you kind of think about, you know, as you go through, you know, 2025 and you're sort of, you know, like navigating all of these changes, you know, how do you think about where you kind of put emphasis between, you know, like continuing to execute on Purified Cortrophin Gel versus trying to sort of unlock the next opportunity in ILUVIEN with regards to like, you know, the new study that you have reading out and kind of expanding the addressable market there?
Sure. The beauty is we have a very strong organization. We've built this, you know, taken this company. I've been the CEO for over four and a half years. One of the best things that we've done is build a strong organization that can continue to deliver on both, right? Deliver the Purified Cortrophin Gel growth with the expansion of the portfolio sales team and capture the opportunities that the NEW DAY study will bring and capture the larger addressable markets both for Purified Cortrophin Gel, ILUVIEN, and YUTIQ. That is the rare disease organization. We have a generics organization fueled by our R&D capability and our operations, right? Strong US manufacturing that'll deliver the low double-digit growth in generics. We really have the capability to, and the organizational bandwidth to do both and, you know, build from strength to strength.
Got it. Great. Thank you so much for joining us. I really appreciate it. That was a helpful overview of the story.
Thank you. Thank you, Faisal. And thank you everyone for joining.