Good afternoon, everyone. From ANI is CEO Nikhil Lalwani. Nikhil, over to you. Thanks for joining us.
Good afternoon, everybody, and thank you for joining this afternoon's presentation. Thank you, Brandon, for the warm welcome. These are our standard disclaimers on forward-looking statements and the explanation of the presentation of financial information. Our deck, obviously, is available on our website. This is our new corporate presentation. So ANI Pharmaceuticals, we have three business lines that serve as our primary growth drivers. Rare disease is our primary growth driver with three growing and durable commercial assets: Purified Cortrophin Gel, ILUVIEN, and YUTIQ. And we drive growth in our expansion in our rare disease business, both organically, and I look forward to sharing that with you, as well as through M&A and in-licensing.
We also have a generics business with superior R&D capabilities, driving new product launches and strong operational excellence, and an established brands or brands business where we use a unique commercial capability, high margins, and strong cash flow generation. The way we think about our company and these three business segments is that we are in a virtuous cycle of growth. We take the EBITDA and cash flows from the generics and our brands business and reinvest that into our rare disease business, which drives growth and is the primary area of allocation from a capital perspective. For our generics business to fuel that growth, we invest in R&D, right? We have a strong R&D engine that came to us through the acquisition of Novitium in 2021.
To talk about ANI and numbers, our guidance for 2025 is $768 million-$793 million in revenues, $195 million-$205 million in adjusted non-GAAP EBITDA. The revenues represent about 25%-29% year-over-year growth. We also have a healthy balance sheet with $150 million of cash as of March 31st, 2025, and 2.7 x of net leverage on a pro forma prior 12-month basis. Important, as we are navigating this tariff environment, to point out that ANI is well-positioned relative to our peers, with over 90% of our revenues coming from products, finished goods that are manufactured in the U.S., and with less than 5% direct reliance on China. We're well-positioned to continue driving growth. You see the trajectory.
In 2022, we were at $316 million of revs and $56 million of EBITDA, and growing on the basis of our rare disease business, as well as continued growth in our generics business to give guidance of $768 million-$793 million in revs in 2025, and then $195 million-$205 million in adjusted non-GAAP EBITDA. We are really well-positioned to continue driving growth both organically as well as inorganically. To touch on the Q1 results, which we reported a couple of weeks ago, we delivered record results in Q1 2025 with revenues of $197 million and adjusted non-GAAP EBITDA of $51 million. What you'll see is that this came on the back of continued growth in our lead rare disease asset, Purified Cortrophin Gel, where we had record new cases initiated and record new patient starts. We had growth across therapeutic areas and also between new prescribers and existing prescribers.
We'd like to note that acute gouty arthritis, which is an indication that we have and the competitor in ACTH does not have, accounts for approximately 18% of our usage, and the use in ophthalmology and new area that we did the Alimera acquisition in increased 50% quarter over quarter. The two ophthalmology assets, or retina assets, ILUVIEN and YUTIQ, were temporarily impacted. Their revenues were temporarily impacted in Q1 due to three factors. One is the typical Q4 to Q1 dynamic. Second is reduction in copay support or patient support for Medicare patients due to foundations running out of funding. Third is turnover that we saw in our sales force. Last, but certainly not the least, our generic revenues reached a record high of $98.7 million on the back of successful new product launch execution and strong operational excellence.
I would like to point out the six-month exclusivity that we have on the Prolensa generic, which we launched right towards the end of Q4. Our revised full-year guidance, I covered a lot of that on the first page, but I would like to point out here that Purified Cortrophin Gel, our guidance for the year is $265 million-$274 million, which is a 34%-38% year-over-year growth. This is our lead rare disease asset. ILUVIEN and YUTIQ, our full-year guidance is $97 million-$103 million. When you add those two, it is about $364 million-$377 million, and that represents about 48%-49% of ANI, right? Almost half of ANI revenues comes from rare disease assets. Rare disease is expected to continue as the primary driver of growth. As we just pointed out, it started with our lead asset, Cortrophin, being launched in 2022.
We did $42 million in the first year, and this year our guidance is $362 million-$377 million, Cortrophin, all organic, and then ILUVIEN and YUTIQ through the acquisition of Alimera. Our rare disease business has three assets, right? Cortrophin, ILUVIEN, and YUTIQ. What's common amongst these three assets is that they're all operating in large addressable markets. The patient populations that can benefit from these therapies, the appropriate patients, are much larger than the numbers that we're treating today, giving significant headroom for expansion. Cortrophin has multiple indications, 22, across multiple autoimmune and inflammatory conditions. The ones that we've focused on since launch are multiple sclerosis, rheumatoid arthritis, excess urinary protein due to nephrotic syndrome, acute gouty arthritis flares, and acute and chronic allergic and inflammatory processes affecting the eye, as well as sarcoidosis.
These are the main indications that we've focused on out of the 22 indications that Cortrophin has, and it's obviously across therapeutic areas, which is extremely helpful as we think about inorganic growth, right? It gives us call points that we're already attending to and to find other assets that we can go into. We'll show you how we did that. We did just that with the Alimera acquisition. Our two retina assets are ILUVIEN and YUTIQ. ILUVIEN is indicated for diabetic macular edema and chronic non-infectious uveitis affecting the posterior segment of the eye, and that is also what YUTIQ is indicated for. Again, all three assets operating in large addressable markets, as well as being tough to genericize and therefore having a significant amount of longevity associated with them.
The rare disease portfolio, when ANI thinks of rare disease, we focus on patients that are underserved by other therapies. These can be low prevalence diseases such as chronic uveitis, which YUTIQ and ILUVIEN address, or underserved patients in high prevalence diseases such as multiple sclerosis and nephrotic syndrome, which Purified Cortrophin Gel addresses. That is how ANI thinks about rare disease. Purified Cortrophin Gel, right? It is a purified corticotropin. It is a treatment option for patients that are struggling with certain chronic autoimmune disorders. I spoke about that. This was an estimated $600 million ACTH market in 2022 when we entered, and it grew to $684 million in 2024. After many years of degrowth, which I will show you in a second, it started. We and the competitor have been able to turn the tide and start regrowing the market and getting the drug to patients in need.
It was us bringing a much-needed choice. There was only one treatment option for ACTH, and we brought choice into the ACTH market in 2022. We've also launched a prefilled syringe. Right now, Cortrophin Gel is available in multiple presentations. There is the 5 ml vial, which is largely used for self-administration at home, the 1 ml vial, which is used both for self-administration as well as administration in the physician's office, and then we have a prefilled syringe, which is also used for self-administration. The prefilled syringe is available in the 1 ml and 0.5 ml configurations. The ACTH market was $1.2 billion in 2017 and went through many years of significant degrowth. Starting in 2022, when we launched, it started stabilizing. The deceleration slowed, and in 2024, you add our performance and the competitor's performance, there was 27% growth.
Even in 2025, when you add our guidance and the competitor's guidance, it shows that the market will grow 16% to $792 million. If you assume that the competitor is saying high single digit, we've taken that at 7.5%. What's important to note, though, is that the number of patients, right? Therapeutics are all about patients. The number of patients on therapy today are almost half the number of patients that were on therapy in 2017, and that 40% of our Cortrophin Gel prescribers were naive to ACTH before we entered. You will also remember that I said acute gouty arthritis, which accounts for about 18% of our usage, right, was not in the $1.2 billion, right? Three different data points.
When you look at it from an epidemiological perspective, the number of patients that were on therapy, even in 2017, is substantially lower than the addressable market. The addressable market is many multiples higher than what was on therapy even in 2017. In short, the headroom for expansion for this therapeutic, Cortrophin Gel, is significant, and we believe that Cortrophin is on a strong multi-year growth trajectory. Coming back to the quarter, right, we continue to see strong growth across the initially targeted specialties of rheumatology, nephrology, and neurology. These are the indications we targeted right at launch. We continue to see strong growth there across existing prescribers and new prescribers. In fact, in Q1, the momentum continued with us having record new cases initiated and new patient starts in typically what is a seasonally low quarter for rare disease products, right? Again, the momentum is significant.
We've continued to invest behind these initially targeted specialties by expanding the sales team. We added roughly 20 members across what we call our portfolio sales team targeting these initial specialties. We did that in Q1, and we'll see the benefit of that in Q2 and beyond. We're also continuing to gain traction in the newer therapeutic areas. We expanded our ophthalmology sales team with the acquisition of Alimera to about 46 reps. And we saw in Cortrophin a 50% increase in volume between Q4 and Q1. Acute gouty arthritis is also a newer indication, and we've already mentioned that we've gotten to about 18% of our usage coming from acute gouty arthritis. Also, interestingly, 15% of physicians that write first for acute gouty arthritis also then write for other indications. Our focus, small pulmonology team, continues to yield positive results.
We believe that Cortrophin is on a strong multi-year growth trajectory and are continuing to strengthen the franchise, right? What are we doing? We're working on evidence generation. We're investing in research to provide additional support for the use of Cortrophin Gel. At our earnings, we announced that we are going to initiate a clinical study for acute gouty arthritis, and we'll look forward to sharing more details of that. We recently presented two abstracts at the American Society of Nephrology. From a development perspective, we launched the new presentation of the prefilled syringe in April of 2025, and we're continuing to explore other ideas to enhance the convenience for patients and prescribers. We continue to invest in high ROI commercial efforts, such as the expansion of our sales team to drive growth across all specialties.
The addressable market being large, we continue to find appropriate patients for this therapy. This is more details on the opportunity in gout, acute gouty arthritis flares. I have covered a number of these points on the previous slides. The main thing that I'll highlight here is when we think about the addressable market in gout, of the 9 million plus patients in the U.S. with gout, we consider our addressable market to be the roughly 300,000 patients that are using some form of injectable therapy for treatment of their flares. Next, we'll move to the Alimera acquisition. This acquisition was used to expand the scope and scale of our rare disease business, and it would align with our M&A strategy, which was used to add commercial assets, ones that were synergistic with Cortrophin. It was in a priority therapeutic area.
Ophthalmology had grown to be almost 10% of total ACTH usage. That is why it was synergistic with Cortrophin and assets with durability and growth, right? Again, operating in large addressable markets, which I will detail shortly for ILUVIEN and YUTIQ, as well as with high durability, right? The barriers to genericization are significant for both ILUVIEN and YUTIQ. That is how we thought about the acquisition of Alimera. ILUVIEN and YUTIQ, these are intravitreal implants, right, that are used to treat different indications. ILUVIEN is indicated for diabetic macular edema, right? With approximately 4% of diabetic patients that get impacted by that, there are about 900,000 patients in the US impacted by DME. Chronic NIU, which is chronic non-infectious uveitis affecting the posterior segment of the eye, there are about 500,000 patients in the US. These are intravitreal implants.
In a couple of minutes, they're implanted into the eye, and they last for about three years. One move that we have made recently is we're consolidating both indications into ILUVIEN, right? They're essentially both identical sort of products with a slight difference in concentration. They're both fluocinolone acetonide. We're combining the labels. We're doing that more for supply security rather than anything else. The additional benefits that we have seen is there's value to the customer. It simplifies. They order one product. Now NIU-PS, which is the indication that YUTIQ originally had, is also there on the ILUVIEN label. Customers, as they're ordering, can just order ILUVIEN and maintain single product inventory levels. Most physicians that have used ILUVIEN have also used YUTIQ, or most physicians that have also used YUTIQ. Sorry, it's the other way around.
Most physicians that have used YUTIQ have also used ILUVIEN. The slight difference in the implanter, or the feedback that we have gotten, will not be much. What it does is, most importantly, and the primary reason for us making this change is that it enhances supply security significantly. ILUVIEN is manufactured at Siegfried, which is a CMO in Irvine, California. We've worked with them to expand the manufacturing capacity there. We're co-investing with them to expand the manufacturing capacity. We've also extended the contract till 2029. Again, it's a strong CMO for us to work with to ensure supply security for ILUVIEN. I'm going to start moving faster given time.
ILUVIEN is operating in a large addressable market with less than 5,000 patients being addressed, even though there are more than 53,000 patients that can benefit, which are patients that are suffering from DME, are less responsive to anti-VEGFs, which is the standard of care for DME, and they show positive response to steroid trial. That patient population is 53,000, of which only less than 5,000 patients are currently being treated with ILUVIEN. You have this similar larger addressable market for YUTIQ. Again, in the interest of time, I'll keep moving. The whole purpose of this acquisition is 46 combined reps selling all three products. There's overlap in the ophthalmology call points, and we factor that in as we thought about the acquisition. We're realizing that synergy as we execute. The acquisition of Alimera also provided us a rare disease business with an international commercial footprint.
Approximately 30% of our ILUVIEN and YUTIQ revenues comes from sales outside the U.S. We're direct to market in four countries: Germany, United Kingdom, Ireland, and Portugal. We work through partners, very strong partners in many other countries, about 18 countries. We're also continuing to support evidence generation with studies, with long-term clinical studies, both for ILUVIEN and YUTIQ. We're in the process of analyzing the data from the completed New Day trial and the Synchronicity study at the six-month time point, and we'll provide updates on the results of both studies in the near term. Next, moving to generics. Generics is really driven by strong R&D capability. We launched 17 products in 2024, including two competitive generic therapy products with 180-day exclusivity. In Q1 2025 was the largest generics quarter in terms of revenues.
You see that to date with 41% year-over-year and 26% quarter-over-quarter growth driven by new product launch execution as well as operational excellence, including the first-to-market launch of Prolensa. We have a US-based manufacturing footprint. We have three manufacturing facilities, two in Baudette, Minnesota, and one in East Windsor, New Jersey. In 2024, slightly different from our rare disease business, we supplied over 1.8 billion with a B doses to patients in need. Of course, for generics, it's important to continue having a strong GMP track record and a focus on cost excellence. That's a visual of our three manufacturing sites, all US-based manufacturing sites. As I said, 90% of our finished, over 90% of our finished goods, over 90% of our revenues come from finished goods that are manufactured in the US and less than 5% direct reliance on China.
In summary, we have a strategic focus on our growing rare disease business. It will be expected to be approximately half of our 2025 revenues, with our lead asset forecasted to reach approximately $270 million. That is the midpoint of the $265 million-$274 million guidance and the September 2024 acquisition of ILUVIEN and YUTIQ, providing two additional products with growth, sustainability, and durability. We also have a robust foundational generics business that continues to drive high single-digit, low double-digit growth. Look, in 2025, our guidance is mid-double-digit growth, but on an ongoing basis, we look to drive high single-digit growth, high single-digit, low double-digit growth for our generics business. We have successfully done that for the last three to four years. Actually, we have driven double-digit growth across each of the last four years, including this year's guidance.
We have a strong balance sheet, right, with $150 million of cash and 2.7 turns of net leverage on a pro forma prior year 12-month basis. Last, in terms of our 2025 priorities, number one is to expand the adoption of Cortrophin Gel in the targeted specialties and to continue growing the ACTH category. Second is to address the factors impacting ILUVIEN and YUTIQ in Q1 2025 sales and capture the much larger opportunities in both DME and NIUPS. Third, to sustain the momentum in generics to deliver the mid-double-digit growth in 2025. Last is to continue expanding the scope and scale of our rare disease business through M&A and in licensing. With that, thank you. Apologies if I went too fast. Thank you.