Hi, good afternoon. Welcome to the Jefferies Healthcare Conference, Day One. My name is Dennis Ding, biotech analyst here at Jefferies. I have the great pleasure of having ANI Pharmaceuticals here with us. Nikhil Lalwani, CEO, here to give us a brief corporate overview.
Good afternoon, Dennis, and thank you for joining us. Thank you, investors, for joining us for this afternoon's presentation. These are our standard disclaimers on the forward-looking statements and a description of the presentation of financial information. This deck is available on our website and was AK'd this morning. ANI Pharmaceuticals, we have three business units: our rare disease business unit, our generics business unit, and our brands business unit. Rare disease is the primary driver of growth for ANI. It has three growing and durable commercial assets: Cortrophin Gel, ILUVIEN, and YUTIQ. We have our generics business that also drives high single-digit, low double-digit growth with superior R&D capabilities, operational excellence, and new product launches. We have a brands business that is high margins, generates strong cash flows.
We look at these three businesses as a virtuous cycle with generics and brands generating positive EBITDA and cash flows to contribute to continued driving growth in our rare disease business. On an aggregate basis, ANI guidance for 2025 is $768 million-$793 million in revenues and $195 million-$205 million in adjusted non-GAAP EBITDA. The revenue growth represented is 25%-29%, and we have about $150 million of cash on the balance sheet. From a net leverage perspective, 2.7 turns on a pro forma last 12 months basis. It is important to highlight that 95% of our revenues come from products that are sold in the U.S. More than 90% of the products that are sold have finished doses that are manufactured in the U.S., and we have less than 5% direct reliance on China for API.
ANI is well positioned to continue driving growth in 2025. On this slide, you see both the strong revenue growth over the years since 2022 of about 35% CAGR and then adjusted non-GAAP EBITDA growth of about 53% CAGR, going from $56 million to the current year guidance of $195-$205 million. When it comes to Q1, just a few highlights from Q1 performance. Our total company revenues was $197 million, with rare disease accounting for $94.1 million of that. Cortrophin had about $53 million in revenues, and our two retina assets, ILUVIEN and YUTIQ, had $16 million in revenues. The adjusted non-GAAP EBITDA was $51 million, and the adjusted non-GAAP EPS was $1.70. A few highlights: the lead asset, Cortrophin Gel, had strong momentum in Q1 with the highest number of new patient starts and the highest number of new cases initiated.
Acute gouty arthritis flares account for approximately 18% of the usage of Cortrophin, and we've also seen a 50% increase in ophthalmology volume for Cortrophin, sorry, quarter over quarter. ILUVIEN and YUTIQ Q1 revenues were temporarily impacted by first quarter dynamics, lack of Medicare patient support funding, and Salesforce turnover in the U.S., and the ex-U.S. performance was on track. The demand has accelerated in Q2 2025. Generic revenues reached a new record on superior new product launch execution, including the Q4 CGT launch of Prucalopride, operational excellence, and our U.S.-based manufacturing footprint. A very strong Q1, setting up a strong foundation for the full year. When you look at ANI and in this current regulatory situation around tariffs as well as MFN, I think it's important to highlight three things. One, 95% of our revenues are from products sold in the U.S.
The only products that are sold for ANI outside the U.S. are retina products that are sold in Europe and other international countries. When you talk about country of origin, the finished goods, right, 93% are manufactured in the U.S. at our own facilities or at CMOs. From an API perspective, only 5% of our revenues comes from products where the API is sourced from China. Yeah, sorry. Again, looking at full-year guidance, we've covered a number of these, so I'll just touch the ones that I didn't. Rare disease guidance breaks up into Cortrophin Gel, which is $265 million-$274 million of revenue guidance, which is a 34%-38% growth over the previous year. Then ILUVIEN and YUTIQ, which came to us through the Alimera acquisition, having a guidance of $97 million-$103 million.
That's the revenue growth projected for, sorry, that's the revenues projected for ILUVIEN and YUTIQ. Rare disease will continue as the primary driver of growth. This shows the trajectory of our rare disease business where we launched Cortrophin in January of 2022 and the growth that we've had since then for our rare disease business, with the current year guidance being at $362 million-$377 million, almost 106% CAGR over the last four years. When ANI thinks of rare disease, we think of it in two areas. One is low-prevalence e diseases like the chronic non-infectious uveitis affecting the posterior segment of the eye, or smaller patient populations, underserved patient populations, and high-prevalence e diseases like multiple sclerosis. ANI rare disease currently markets three therapeutics with growth and durability. Cortrophin, it's an FDA-approved ACTH option with 22 indications. We focus on a handful of those indications, six of those indications.
The ones that we focus on are rheumatoid arthritis, nephrotic syndrome, acute gouty arthritis flares, multiple sclerosis, sarcoidosis, and chronic and inflammatory processes involving the eye and its adnexa. We also have ILUVIEN, which is indicated for both diabetic macular edema as well as chronic non-infectious uveitis affecting the posterior segment of the eye, and YUTIQ, which is for chronic NIU-PS. What those three assets have in common is that they all operate in large addressable markets, which are under-penetrated at this time. They have growth and durability and strong multi-year growth. Those are the sort of key features of our three assets in rare disease. Turning to our first asset, Cortrophin Gel, this is a purified corticotropin, a treatment option for patients with certain chronic autoimmune disorders.
It's approved for multiple indications, 22, but we have call points into neurology, nephrology, rheumatology, and also we've subsequently expanded into ophthalmology and pulmonology. We've launched multiple presentations. We see such strong multi-year growth in this asset, and we've launched multiple presentations. A 5 mL vial, which is what we started with, which is meant for self-administration in January 2022. We then subsequently launched a 1 mL vial to bring a presentation that was more appropriate for acute gouty arthritis flares and for buy and bill in October of 2023, and then a prefill syringe, which we just launched in April to enhance patient and HCP convenience. We launched into a limited competition. There was only one other ACTH product in the market for multiple decades, and it has long-term sustainability driven by high barriers to entry. The ACTH market was about $600 million when we launched in 2022.
It grew to $684 million in 2024 and is poised to grow to $792 million in 2025 based on our guidance and the competitor's guidance. There is really potential for significant multi-year growth, both by new and returning prescribers serving appropriate patients across indications. This shows the ACTH market trajectory. There was a decline until we entered in 2022. The market at its peak with just one competitor was $1.2 billion. As I said, there is an opportunity for strong multi-year growth. The number of patients being treated today is almost half the number of patients being treated when the ACTH market was at its peak. Very importantly, the epidemiology work that we've done suggests, or that we've understood, suggests that the patient population that can benefit from ACTH therapy across indications is significantly higher than even what was being treated, what were being treated at its peak.
Importantly, our ability to capture newer patients and convince newer prescribers is highlighted by the fact that 40% of our Cortrophin prescribers currently are folks who were naive to ACTH before we had entered. Some more highlights on Cortrophin performance. We see continued growth across the initially targeted specialties of neurology, nephrology, and rheumatology. There is prescribing momentum across existing and new prescribers. The momentum in Q1 2025 continued with record cases initiated and record new patient starts. We are also gaining traction in the newer therapeutic areas. We expanded into ophthalmology with the acquisition of Alimera and an expanded sales team of 46. Ophthalmology saw a 50% increase in volume quarter on quarter. Acute gouty arthritis flares, also a newer indication, an indication that only we have, the competitor does not have, has grown to 18% of Cortrophin Gel usage and is the only approved ACTH for this indication.
This focus smaller pulmonology sales force is also gaining traction. Seeing the strong multi-year growth potential of this asset, we are continuing to invest to strengthen the franchise. We are investing in research to provide additional support for the use of Cortrophin. We have also launched, we announced at our prior earnings, first quarter earnings, we announced the start of a clinical trial in gout, in acute gouty arthritis flares, again, to generate data that will hopefully support additional Cortrophin Gel in the treatment guidelines. From a presentation perspective, as we had highlighted, we have launched a prefilled syringe in addition to the 1 mL vial and the 5 mL vial, and are also looking at other ways to enhance the convenience for patients and providers. We continue to think of high ROI commercialization investments such as expansion of the sales force for the portfolio team, which we did recently for Cortrophin.
Again, we believe in the strong multi-year growth trajectory for Cortrophin, our lead asset in rare disease. A bit more about acute gouty arthritis. This is an indication we have, the competitor does not. When you think of acute gouty arthritis, there are 9 million patients in the U.S. suffering from gout, but the patient population that we think of as our addressable patient population is the 300,000 patients, approximately 8% of the broader population, that currently receives some form of injectable medication for acute gouty arthritis flares. One other interesting soundbite is that when you look at 2024, gout represented the first patient on therapy for almost 15% of HCPs using Cortrophin Gel for the first time. Once they used it for gout, those prescribers also used it for other indications. An important indication for us.
Moving next to our retina assets, ILUVIEN and YUTIQ, these are novel long-acting implants for serious eye disease. ILUVIEN, the active for both ILUVIEN and YUTIQ is fluocinolone acetonide. They're in slightly different concentrations. ILUVIEN is indicated for DME, which is diabetic macular edema, impacting vision loss in diabetic patients, and also for chronic non-infectious uveitis, which is affecting the posterior segment of the eye. ILUVIEN and YUTIQ are very similar products with slightly different implanters. Going forward, starting the middle of this month, we'll be combining both by adding, the FDA has approved the addition of chronic NIU-PS as an indication into the ILUVIEN asset. What we'll be doing now is commercializing and selling one asset, which is ILUVIEN.
Obviously, YUTIQ retains the label that it has, and physicians will be able to continue using the YUTIQ inventory that is available, but we'll gradually move in this, starting this quarter, starting this month really, to using just ILUVIEN for both indications and commercializing one. What that does, really two main benefits. One is supply chain security. We've struck a long-term contract with, or extended the long-term contract with our CMO, Siegfried in Irvine, to expand that till 2029. We've also co-invested with them to add another manufacturing line to support the volume expansion. We believe that drives enhanced supply chain security. Secondly, it also simplifies it for the prescriber offices because it allows them to now just order, keep one product on inventory and use the same implanter and the product for both indications, yeah, NIU-PS as well as DME.
Both NIU-PS and DME have significantly significant addressable markets. I'll show you the example for DME, where there are 900,000 patients, of them about half are treated. Even from that, the standard of care are anti-VEGFs, right? 260,000 patients are treated with anti-VEGFs, with two plus anti-VEGFs. There are about 75,000 patients, right? 75,000 out of the 900,000 patient pool that show suboptimal response to multiple anti-VEGFs. That's the addressable market for ANI. Of that 75,000, 53,000 show positive response to steroid trial and low IOP risk, right, which is a side effect of steroid use. Currently, ILUVIEN is being used for less than 5,000 patients per year. 5,000 out of 53,000. Significant headroom for growth for ILUVIEN and multi-year growth.
We have a similar situation with NIU-PS where there is about 100,000 patients, which we consider as the addressable market, and less than 5,000 patients on therapy each year for YUTIQ and now going forward on ILUVIEN. The reason for the Alimera acquisition, which we closed in September 2024, was a combined sales force, right, synergistic with Cortrophin. We now have a combined sales force of 46 reps that go out to ophthalmologists, where there is a high degree of overlap between ophthalmologists that are targets for both ILUVIEN as well as Cortrophin, right? Having a call point synergy and having this sales force of 46 persons going out and selling both Cortrophin, ILUVIEN, and YUTIQ into the ophthalmology community. That was the rationale for the deal, and just wanted to lay that out.
The acquisition of Alimera also provided ANI with an international footprint. As a reminder, 95% of sales comes from the U.S., but 5% of sales comes from outside the U.S. in international markets. We have direct commercial operations in Germany, the U.K., Portugal, and Ireland, and then partnered high-quality partnerships in another 18 countries. Thirty percent of our ILUVIEN and YUTIQ revenues approximately are generated outside the U.S., right? Total ILUVIEN and YUTIQ revenue guidance is $97-$103. Approximately 30% of that comes from outside the U.S. This is an international footprint that we really got, commercial footprint that we got through the Alimera acquisition and did not have it before, the commercial footprint. We are continuing to do long-term clinical studies to support the real-world use. There are two ongoing trials for ILUVIEN and YUTIQ.
We obviously talked about the clinical trial we just initiated for gout for Cortrophin, but on ILUVIEN, there's New Day, which is investigating the earlier utilization of ILUVIEN in combination with anti-VEGFs for the treatment of DME. Earlier in that patient funnel that we talked about, right? It was 306 treatment naive or almost naive DME patients that were split into two arms and being treated with anti-VEGFs in one arm and then ILUVIEN plus anti-VEGFs in the other arm. That study has been completed. We're in the process of analyzing the data and look forward to sharing an update on the results in the near term. In addition to that, we have a Synchronicity study, which is a multi-center open label study evaluating the use of YUTIQ, now ILUVIEN, across patients with NIU-PS.
That study will complete last patient, last visit in end of 2025, but we have a six-month readout that we're planning to do in the near term and are again analyzing the data and will provide the results of both studies in the near term. Turning now to our generics business, there are strong R&D capabilities and operational excellence that really drives our growth in generics. We launched 17 new products in 2024, including two with competitive generic therapy designation with 180-day exclusivity. Q1 2025 was the largest generics quarter ever at $98.7 million, up 41% year on year and 26% Q on Q. It was driven by strong launch execution, including the first-to-market prucalopride tablets launched with 180 days of exclusivity. We also have a strong operational backbone and U.S.-based manufacturing footprint with three plants in the U.S.
During 2024, we supplied over 1.8 billion doses of therapeutics to patients in need. We continue to make substantial progress in 2024 with the capacity expansion, which is almost complete at our New Jersey site. In generics, it is important. Cost excellence is important, and we continue to stay focused on cost excellence in reducing our raw material and finished goods costs as well as optimizing our conversion costs. This slide gives an overview of our three sites: two in Baudette, Minnesota, and one in East Windsor, New Jersey. Our R&D is also listed across these three sites with a center of gravity at the East Windsor, New Jersey site, which came to us through the acquisition of Novidium in 2021.
In summary, we have a strategic focus on a strong and growing rare disease business with three assets that are growing and durable, Cortrophin Gel and ILUVIEN and YUTIQ, which we are merging into ILUVIEN. We also have a robust foundational generics business delivering high single-digit to low double-digit growth in 2025. We are guiding to mid-double-digit growth, but on an ongoing basis, I think high single-digit to low double-digit growth. We have a strong balance sheet with $150 million of cash and 2.7 turns of net leverage. Our focus is on growing both these businesses, the rare disease and generics, as we continue with our purpose of serving patients, improving lives. Thank you.
Great. Thank you, Nikhil. That was a great overview.
Can we talk a little bit about 2025 and just remind us of what happened with guidance that you gave at the beginning of the year? What you saw that drove the revised guidance just a few weeks later and then Q1, the updated guidance there. Just tell us about the trajectory of what happened that was driving that confidence.
Sure. Thank you, Dennis. We gave total company guidance at a conference in January. We saw strength in our rare disease business, Cortrophin Gel, especially in Cortrophin Gel, and then in our brands business and generics, across three different business lines. We raised it when we gave the guidance on February 28 at our Q1 earnings, where we gave total company guidance and also broke it down by the different business lines, and then raised it again. Second guidance raise at our Q1 earnings on May 9. That was based on going from February 28 to May 9, based on the strength that we had seen with the generics as well as the increased demand in our brands business.
Overall, in 2025, we are seeing strong momentum with our Cortrophin Gel business, which is the largest driver of growth for the company. We're seeing strong growth in our generics business, where our guidance is to mid-double-digit growth, right? Where we increased from high single-digit, low double-digit to mid-double-digit and double-digit being defined as 11-20, not 11-99, just to clarify. The third is on our brands business, where we saw increased demand in the first quarter into then the beginning of second quarter. Those three things, we see strong momentum. Obviously, we've talked about the topics that we're working to in the near term with the about $70 million of revenues that we have in ILUVIEN and YUTIQ in the US. That's an overall picture on 2025.
If we kind of focus in on Cortrophin, because that's obviously a big growth driver for the company, and I appreciate you guys reiterated the guidance on your first quarter earnings call, but where do you see upside from that guidance as you go through the year? What are you guys doing? What are you guys doing on the back end that investors may not appreciate that could drive better than expected growth in Cortrophin?
Sure. I think the most important thing to know about Cortrophin is across indications, the addressable market is a lot larger than anything that has been addressed. There are a lot more patients that can benefit from Cortrophin therapy across indications that are being addressed today and even higher than what was being addressed at the peak. What we've been doing is, in a systematic manner, investing across both the product, right, by bringing multiple presentations. We launched the prefilled syringe recently. We obviously have the 1 mL and the 5 mL vial. In addition to that, we're also doing evidence generation, right? There's looking into the mechanisms of action, giving additional evidence to the prescribers for supporting the use of Cortrophin.
We launched this clinical trial for acute gouty arthritis flares to hopefully support the introduction of Cortrophin into the treatment guidelines. On top of that, from a commercial perspective, we strengthened our sales force for Cortrophin. We added about 20 reps in what we call our portfolio team, focusing on rheumatology, nephrology, and neurology. These are sales reps that detail across these three indications. These are multiple steps that we have taken. We continue to see strong momentum in Q1, which is seasonally a low quarter for rare disease products given the channel dynamics and, more importantly, the insurance resets that happen. We saw the largest number of new cases initiated and new patient starts, which bodes really well for follow-through and growth on a follow-on basis for the rest of the year.
Just to dimensionalize, we did $198 million in sales last year in Cortrophin, and our guidance for this year is almost 34%-38% growth to about $270 million in sales.
Sure. Can you expand on your comment that you expanded your sales force for Cortrophin by an additional 20? What is the base? Is it like 60 going to 80? Why is that so important? How are the territories run? What is the goal of that in order to drive more touches, etc.?
Right. We have three sets of sales force that sell Cortrophin. The first is our portfolio sales force, which details into neurology, nephrology, and rheumatology. We have about 60 reps in that group. That number was about 40, and then we added about 20. Let's call it 42 going to 62, but then there are managers with that, right? We have a smaller team, dedicated team on pulmonology focusing on sarcoidosis, where we have two teams, one in the east, one in the west, detailing, but focusing just on pulmonology. The third team is really the combined team into ophthalmology, which is about 46 reps that are detailing both Cortrophin as well as ILUVIEN.
Right. So you're roughly increasing your sales reps, at least in the first bucket.
First bucket by.
From 40-60, that's essentially 50%.
Correct.
All that was done in Q1.
Correct? That was essentially completed in Q1.
Yeah. So now that we're in Q2 and we're practically towards the end of Q2, can you talk a little bit about how those new sales reps have been doing, if there's any kind of color that you could provide on productivity?
Yeah. I think, look, Cortrophin is a drug that it takes some time for the sales force to get traction. Also, there's time from when you get a prescription to the patient actually getting on drug, because there's an enrollment to fulfillment process that takes time, prior authorization and other steps that need to be completed. We think of, so it takes a few months for a sales rep to get to the productivity level that you're talking about. We're seeing, I think ANI as a company has been able to increasingly attract top talent from leading rare disease players. We've been able to get better and better as we've grown and have shown that half our sales comes from rare disease. We're able to attract better and better talent as we've been able to build on the efforts of our existing top-tier sales talent.
We'll be able to see that in the results as we go through 2025.
Great. For your 2025 guidance for Cortrophin, how much of, did you account for or consider the incremental 20 new sales reps for Cortrophin into that guidance, or is it all upside?
It was factored into the guidance.
It was factored into the guidance.
It was factored into the guidance sale.
Okay. That's helpful. Lastly, in the last minute or two, just maybe talk about ILUVIEN and YUTIQ and just some of the dynamics that we saw in Q1 and what needs to happen for there to be sort of an acceleration to the second half to hit your guidance.
Sure. I think we are taking multiple steps. One is we're up to essentially one vacancy in our sales force at this point, one open position. Our sales force, the turnover that we've seen, we've been able to address that and bring new reps on board and have them out there detailing. In addition to that, the second thing is from the issue with Medicare copay support, we've been able to work with physician offices and understand how they're dealing with the issue and make sure that we're tailoring our commercial approach from a team perspective and where they're spending their time to ensure that the appropriate patients get the therapy that they need.
We believe at a time like this, a long-acting steroid has an important role to play, which is what ILUVIEN is, has an important role to play in the treatment of DME, right, especially for patients that have access issues. We have seen, obviously, as you saw in our slide, that we have seen demand acceleration as we have been able to get the newer reps into the team as well as focus where they spend their time. Yeah.
Perfect. I think that's all the time that we have. Thank you so much, Nikhil. It's great to see you. It's great to have you here. Looking forward to the exciting path ahead.
Thank you, Dennis. Thank you for your time. Thank you, everybody.