Hello, everybody. I'm Ekaterina Knyazkova here at J.P. Morgan, and pleased to be introducing ANI Pharmaceuticals. And from the company, we have Nikhil Lalwani, CEO, who will be doing a presentation, and then we will jump into Q&A. And with that, I will turn it over to Nikhil.
Thank you, Ekaterina. Good afternoon, everybody, and thank you for joining this presentation by ANI Pharmaceuticals at the JPMorgan 2025 Healthcare Conference. Thank you for spending time with us. And I'm delighted to be here to share the evolution of ANI's journey and our approach to building a high-growth, profitable, rare-disease therapeutics business while fulfilling our purpose of serving patients, improving lives. First, we'll turn to the standard disclaimers around forward-looking statements. And next, we'll turn to the financial information to suggest data on the financial information that we will be presenting throughout the deck. ANI Pharmaceuticals, we operate in three business segments. Rare disease is our key focus area and the primary driver of growth. Our lead asset, Purified Cortrophin Gel, is on track to doing almost $200 million in sales this year, growing north of 75% from the previous year of $112 million.
We also added two assets, ILUVIEN and YUTIQ, through the acquisition of Alimera, and these assets will add approximately $31 million in sales in 2024 since the closing of the acquisition in late Q3. Our generics business is driven by our high-performing R&D engine, operational excellence, and U.S.-based manufacturing footprint, and we expect this business to be a high single-digit, low double-digit grower for the company. Lastly, our established brands business is a very high-profitable and strong cash flow-generating business, and we expect this business to continue contributing to the future growth of the company. While we're focused on rare disease as our primary area of focus, we're also proud of the performance of our generics and established brands business as they contribute significantly to the financial performance and generate strong financial returns for the company.
ANI delivers superior performance in 2024 and is very well positioned to continue driving strong growth. As you'll see the company's trajectory, we've delivered a 33% CAGR, if you take into account the 2025 numbers too, for revenues, and a 50% compounded annual growth rate since 2022 on adjusted non-GAAP EBITDA. A bit about the 2024 highlights and achievements. We expect the 2024 total net revenues, adjusted non-GAAP EBITDA, and diluted adjusted non-GAAP EPS to be in line or above the previously announced 2024 guidance. Our lead rare disease asset, Purified Cortrophin Gel, will deliver almost $200 million of sales in the third year of launch. We expanded the rare disease franchise with the acquisition of Alimera. And lastly, we launched 17 new generic products, including two with Competitive Generic Therapy designation, and retained the number two ranking in CGT approvals.
We're well positioned for future growth, and this is reflected in our preliminary outlook for 2025. Our total company net revenue guidance shows a 24%-27% growth to $739 million-$759 million. And our adjusted non-GAAP EBITDA reflects a 21%-27% growth to $182 million-$192 million. Some highlights on our Q4 performance in 2024. The business delivered record results in Q4, with the preliminary results, as I said, in line or higher versus guidance. We had Q4 total revenues of $170 million-$178 million, which is a 32% year-on-year growth. This is the previously reported guidance. And our rare disease business contributed 49%-50% of the Q4 revenues, growing 107% year-on-year. The rare disease growth, rare disease revenues came from Purified Cortrophin Gel, lead rare disease asset, which delivered $59-$60 million, a 42% year-over-year growth.
This growth came through steady gains in the indications that we focused in at launch in the therapeutic areas of rheumatology, neurology, and nephrology, as well as in the newer areas that we had subsequently expanded into of ophthalmology and pulmonology. Our new rare disease assets, ILUVIEN and YUTIQ, performed in line with guidance in the first full quarter of ownership. As I mentioned before, we continue to leverage our superior new product launch execution in our generics business, as well as the U.S.-based manufacturing footprint, to reliably supply generics and established brands to the country. Our preliminary 2025 outlook reflects an approximately 25% growth in revenues, as well as a 25% growth in adjusted non-GAAP EBITDA.
We're achieving this even while continuing to invest for the long-term growth of our rare disease franchise in R&D efforts that I will speak a little bit about later in the deck. Then second, in high ROI commercial efforts, such as expansion of our sales team in rare disease. Our rare disease business is well positioned to continue driving strong growth. We launched our lead rare disease asset, Purified Cortrophin Gel, in 2022 and did $42 million in the first year of sales. We'll do $198 million in 2024, or we did. That represents a north of 75% growth over the prior year of $112 million. I'll share later in the presentation about the strong multi-year growth trajectory that we see for Purified Cortrophin Gel.
And the two assets, ILUVIEN and YUTIQ, added $30-$31 million in the period from the close, which was end of September through till the fourth quarter. In aggregate, the rare disease franchise almost doubled from 2023. And as I said, accounted for 49%-50% of Q4 revenues. ANI Rare Disease markets three products with growth and durability. Purified Cortrophin Gel is a repository corticotropin that is porcine-derived and is used to treat certain chronic autoimmune and inflammatory disorders, including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome. It's also used in chronic allergic and inflammatory processes involving the eye and its adnexa. ILUVIEN and YUTIQ are both intravitreal implants. ILUVIEN is indicated for diabetic macular edema, and YUTIQ is indicated for chronic non-infectious uveitis in the posterior segment of the eye.
When ANI thinks about rare disease, we think of patients that are not well served by other therapies. So these are of two types. Rare disease, such as keratitis and chronic non-infectious uveitis in the posterior segment of the eye, are examples of rare disease where the patient populations are small. But we also look at underserved patients in high prevalence disease. So when you think of rheumatoid arthritis, multiple sclerosis, these are high prevalence diseases, but there are small populations that are refractory or intolerant to steroids that are in late line. Many patients could be appropriate for Purified Cortrophin Gel. So that's how ANI thinks about rare disease and our rare disease portfolio. Purified Cortrophin Gel. This asset is the primary growth engine for ANI's rare disease business. It's a purified corticotropin, porcine-derived, and it's approved for multiple indications.
Initially, we launched into neurology, nephrology, and rheumatology, and we've subsequently expanded into ophthalmology and pulmonology. There's only one other ACTH product in the category. The ACTH market has returned to growth following the launch of Purified Cortrophin Gel. In 2017, this category was $1.2 billion, and since our launch in 2022, the rate of decline slowed, and when you look at 2024 and our preliminary results, as well as the competitor's guidance, you'll see that the market will grow 23%-24%. The number of patients on therapy is significantly lower than the number of patients that were on therapy back in 2017 when the category was at its peak.
And more importantly, from an epidemiology perspective, when you think of these chronic autoimmune disorders, whether patients that are intolerant or refractory to steroids and Purified Cortrophin Gel may be appropriate, that patient population is many times higher than what was even treated back in 2017. So we think of the runway for this asset to be very significant and for this category to continue growing back to where it was and beyond. Telling you a bit more about the successful launch, we're continuing to see growth in our core categories. These are indications that we launched, that we focused in at launch: neurology, nephrology, rheumatology. The prescribing momentum continues across existing and new prescribers. And the momentum really continued in Q4 with record-initiated cases as well as new patient starts. We also continue to gain traction in the newer therapeutic areas.
Ophthalmology, we saw new patient starts increase 2X quarter on quarter. And then an indication we'll share more about for the first time, acute gouty arthritis flares has grown to approximately 15% of Purified Cortrophin Gel use as the only ACTH therapy approved for this indication. Seeing the strong multi-year growth trajectory, we're continuing to invest in further strengthening the franchise. We're investing in research to provide additional support for the use of Purified Cortrophin Gel. We are going to launch a pre-filled syringe in the first half of 2025. So again, from a research R&D perspective, we're launching a pre-filedl syringe in the first half of 2025. And we're exploring other ideas to enhance the convenience to patients and providers with our offering.
We're also, as you would expect, investing in high ROI commercial efforts, such as expanding the sales team to drive growth in our core specialties as well as the newer therapeutic areas. Acute gouty arthritis. This is an indication that only ANI has in the ACTH category. Gout affects more than nine million patients in the U.S., with 3.6 million receiving treatment for it annually. Off this large population, we consider our addressable opportunity to be the 300,000 patients, so approximately 8% of the patient population that currently receives injectable therapy. And we've built momentum in this indication. The treatment of acute gouty arthritis flares has doubled. The volume, sorry, Purified Cortrophin Gel volume has more than doubled between 2024 and 2023. And the treatment of acute gouty arthritis flares accounts for approximately 15% of our 2024 volumes.
Interestingly, gout also represents the first patient on therapy for almost 15% of the healthcare professionals using Purified Cortrophin Gel for the first time. Again, in the ACTH category, Purified Cortrophin Gel is the only approved product for acute gouty arthritis flares. We see this indication to play a significant role in the growth of Purified Cortrophin Gel. Next, let me speak to you about the acquisition of Alimera Sciences. It is on track to deliver the financial targets in 2025. We acquired two differentiated commercial assets with high barriers to genericization and significant growth potential. We are projected to meet or exceed the prior guidance of $35 million-$38 million in adjusted non-GAAP EBITDA in 2025, as well as the high single-digit to low double-digit accretion in adjusted non-diluted, sorry, diluted non-GAAP EPS in 2025.
We're also. I say that the integration is on track, but really a lot of the integration has been completed. We are in the process of capturing the over $10 million of synergy in 2025. And even more importantly, the 46-person ophthalmology sales force is out there detailing all three products, ILUVIEN, YUTIQ, and Cortrophin. The Alimera acquisition was aligned with our M&A strategy to expand the scope and scale of our rare disease business in a priority therapeutic area that was synergistic with Cortrophin, with ophthalmology. Ophthalmology accounted for 10% of ACTH prescribers. It added assets with growth, but also with durability. There are high barriers to genericization of both these assets. And there's also IP that's protecting the assets for a few years. ILUVIEN and YUTIQ. These are both novel long-acting implants, intravitreal implants.
ILUVIEN is indicated for the treatment of DME, a chronic disease that is the leading cause of vision loss in diabetic patients. And chronic NIU-PS, right, is an inflammation of the eye that can lead to pain, visual impairment, and vision loss. And this is indicated. So YUTIQ is indicated for the treatment of NIU-PS in the US, and ILUVIEN is indicated outside the US for chronic NIU-PS. So to give you a sense of the opportunity and the in both these products, we'll highlight the patient funnel and the epidemiology flow for ILUVIEN through DME. So the diagnosed DME population is about 900,000 patients. Of these 900,000 patients, there's about 260,000 patients that receive two-plus anti-VEGFs. Anti-VEGFs are the standard of care for DME. And there's about 75,000 patients that show a suboptimal response to anti-VEGFs.
Of these 75,000 patients, there's about 53,000 patients that are showing positive response to steroid trial. So these 53,000 patients are in some ways our addressable market at this time. And today, there's less than 5,000 patients that are starting annually for DME in ILUVIEN. So the headroom for growth or the number of patients that can benefit from this therapy is substantially higher. The industrial logic for the Alimera acquisition was the synergy with Purified Cortrophin Gel. So we took the 35 commercial sales reps that Alimera had. We combined it with our pilot ophthalmology sales team, and now we have a sales team of 46 reps that are out there covering 3,600 ophthalmologists. There is an over 50% overlap in the high prescribers for Purified Cortrophin Gel as well as for ILUVIEN and YUTIQ.
Again, we have been in this combined sales force has been detailing patients for the last three months or so, and the early traction is good. We look forward to continue updating you on that progress. We have two long-term clinical studies as well as real-world use to provide the strong foundation for ILUVIEN and YUTIQ. We have the NEW DAY study that is investigating the use of ILUVIEN in combination with the current standard of care anti-VEGFs for the treatment of DME. If successful, it may expand the use of ILUVIEN earlier in that treatment funnel that I just shared with you for DME using ILUVIEN in combination with anti-VEGF therapy. The last patient last visit for this trial was completed in end December, early January, and the top-line data can be expected in the second quarter of 2025.
SYNCHRONICITY is a multi-center open label study that is investigating the use of YUTIQ across patients with NIU-PS. The last patient last visit for this study is expected in November of this year, and we can expect the top-line data readout in Q1 of 2026. So we spoke a lot, sorry, we spoke a lot about our rare disease business, and as I said, it is the primary driver of growth and key focus area for ANI. We also have a high-performing generics business, which is the second segment I'll speak with you about. We had strong performance in 2024, delivering high single-digit to low double-digit growth by launching 17 new products, including two with Competitive Generic Therapy approval. We have strong operational excellence that enabled us to deliver over 1.8 billion doses of therapeutics to patients in need.
And we maintain a strong GMP track record in our U.S.-based manufacturing plants to continue reliably serving patients in the U.S. As I said, we have three manufacturing sites. We have two in Baudette, Minnesota. For those of you that are not aware, Baudette is the last town in the lower 48 states of the U.S. And the other site is in East Windsor, New Jersey. We believe our U.S.-based manufacturing footprint is a key enabler of the growth of our generics business. So, the investment summary: we have a strategic focus on growing our rare disease business. We have three growing commercial assets in rare disease. We have a robust foundational generics business that can deliver high single-digit to low double-digit growth. And we have a strong capital structure, right?
We have $145 million in cash on the balance sheet, as well as if you take our 2025 guidance and implied net leverage of about 2.7. And as we look forward to 2025, we are focused on delivering strong growth, strong revenue growth and profitability, expanding the adoption of Purified Cortrophin Gel and targeted specialties and to grow the ACTH category, completing the Alimera integration and driving synergies, and to continue exploring further expansion in the scope and scale of our rare disease business. So thank you again for joining us, and I'll be happy to do some Q&A with Ekaterina.
Great. So I guess to start just on 2025 and the outlook you've provided, just what are some of the pushes and pulls investors should kind of keep in mind, and what are you most focused on entering the year?
Yeah. Thank you for that question. So we expect the momentum of 2024 to continue in 2025. Our guidance on top-line is $739 million-$759 million in revenues, which implies a 25% growth. And we see a similar growth profile in the adjusted non-GAAP EBITDA growing to $182 million-$192 million in adjusted non-GAAP EBITDA. And look, rare disease will be the primary driver of growth. It's our key focus area, our rare disease business. And we're taking several steps to strengthen the rare disease business. We are investing from a research perspective for Cortrophin to support the use of Cortrophin. From an R&D perspective, we're launching this prefill syringe in the first half of 2025 for patients that have dexterity issues for the use of Cortrophin, which is self-administered. We're also exploring other R&D initiatives to support Cortrophin, which we will share more.
Again, it's a competitive category, so we try to find a balance between sharing information that is helpful to investors, but also that is competitively sensitive. And then for the ILUVIEN and YUTIQ, sorry, so back to Cortrophin, the other area that we're investing to strengthen is the high ROI commercial efforts, such as expansion of our sales team to drive growth in areas such as gout, which we spoke about, right? So I think that's for Cortrophin. And then you go beyond Cortrophin and rare disease to ILUVIEN and YUTIQ. We have the NEW DAY and YUTIQ study, sorry, NEW DAY and SYNCHRONICITY studies that we'll expect to make significant progress on this year. And then in our generics business, look, it's really about funding our R&D, and that supports and superior execution of that will continue to drive growth of our generics business.
We had momentum early in 2025 with the launch of a CGT product, prucalopride, which is a generic to Motegrity, and we look to keep building on that momentum. Yeah.
Great. And then actually moving on to the rare disease business and the lead asset, Purified Cortrophin Gel, obviously very strong growth for the product in 2024. Just which indications, I guess, are driving most of that growth? You know, how much is coming from rheumatology versus nephrology versus some of the newer areas like ophthalmology and things like that?
Yeah. I promised to say this line as few times as possible, on trying to find a balance between sharing information that is competitively sensitive versus helpful to investors. No, look, we actually see growth across the board. We see growth across indications, across the indications we focused on that launch, neurology, nephrology, rheumatology, as well as the ones we expanded into ophthalmology and pulmonology. So we're seeing growth across. We're seeing growth across existing and new prescribers. And the momentum continues with seeing record new cases initiated as well as new patient starts. So really, what we have is we've figured out how to drive growth across these areas. And our focus is on prioritization and figuring out what is the high ROI approach to driving growth in the business. Yeah.
And then maybe talk a little bit more about the opportunity for ophthalmology. You now obviously have more reps here post-Alimera acquisition. Just what kind of traction are you seeing and how big, I guess, do you think this can get kind of relative to some of the older traditional, quote-unquote, indications?
Yeah. One of the reasons we picked ophthalmology is because for the ACTH category, ophthalmology accounted for 10% of the prescribers last year. And so it is an area that can drive growth for ACTH and for Cortrophin. And in terms of early sort of signs of success, as the combined team has been out there in Q4, we saw 2x the number of new patient starts that we had seen in the prior quarter in ophthalmology for Cortrophin. So that's sort of an early indicator of progress. Yeah.
And then just what are you seeing from a payer standpoint? Kind of any accounts where you're kind of seeing improved access and any other trends, I guess, also relative to the competitor in the market and what they're doing, I guess, with price and access?
Sure. So from a payer and access perspective, we're largely in a parity situation with the competitor. From a pricing perspective, we took a modest price increase at the start of the year, but continue to retain an over more than 20% discount on the WAC versus the competitor. Yeah.
And then I guess just bigger picture question on the category. This used to be for Acthar back in the days, a $1.2 billion product. I think now we're at what, $650 million-$670 million, somewhere in that ballpark. Just how should investors, I guess, think about the growth trajectory for Cortrophin over the next few years? And kind of what are some of the steps you're taking to achieve potential?
Yeah. Yeah, I think I've detailed, I think, a couple of times the steps that we've taken. So we'll steer clear of repeating that to be helpful. But in terms of where we see the trajectory, I think the underlying demand, which comes from the patients that are appropriate for ACTH therapy, we see that the number of patients today are substantially lower than they were in 2017 when the market was substantially higher. And if you even go beyond that from an epidemiology perspective, if you take the top indications for this category and you say, such as multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome, and you say in those indications, patients that are refractory or intolerant to steroids, that patient population is even larger than, and I'm talking multiples larger, than was even being treated back in 2017.
So the opportunity or the underserved patient population is substantially higher. And so we see a substantial multi-year strong growth trajectory. Now, when it comes to, sorry, and then the other thing to add is gout, acute gouty arthritis flares, which ANI has indication for and the competitor does not, was never even part of that 2017 number. So again, we see Cortrophin as a robust, strong, multi-year growth assets with many indications, so multiple products within one product. That's how we see it. And we're taking several steps to strengthen the franchise.
I guess switching gears a little bit to the Alimera acquisition, just can you remind us, I guess, what brought you to the asset initially and kind of how it fits into your both portfolio and broader strategy?
Yeah. Look, we want to expand the scope and scale of our rare disease franchise. And we had built from scratch a rare disease platform with all the infrastructure, sales, market access, medical affairs, patient support. And we wanted to leverage all that infrastructure that we had built. So we started with saying, let's look for an acquisition for assets that are synergistic, in this case, callpoint synergy with Cortrophin, assets that have growth, that have durability, so either patent landscape or high barriers to genericization. And then last is obviously for revenue profile and a deal size that we can absorb without straining our balance sheet. And I think Alimera met all of those different sort of criteria. Yeah.
And then you've had, I guess, both Yutiq and Iluvien, I think, for a few months now. Just any surprises as you've kind of been looking at the market dynamics, the commercial landscape?
No, look, as we learn more, we realize that the number of patients that can benefit from both ILUVIEN and YUTIQ are far greater than anything that we're serving today, and we look forward to continue sort of updating our efforts to getting both these therapies to patients in need.
Then just how are you thinking about the potential kind of growth runway? I think if I'm doing the math right, they're maybe doing something like $100 million. I guess, what do you think peak sales for both of these products could look like?
Yeah. Thank you for not asking me about peak sales of Purified Cortrophin Gel. So look, we obviously see these as significant growth and our point really to the epidemiology, right? In DME, there's 53,000 patients that show suboptimal response to anti-VEGFs that can benefit from this therapy, less than 5,000 patients on ILUVIEN starting annually on ILUVIEN last year. So again, headroom significant. And similarly, in chronic NIU-PS, the patient population that can benefit is again multiples higher than the less than 5,000 patients that start on YUTIQ. And in NIU-PS, steroids are the standard of care. So a lot of people get treated with topical steroids, but there's a patient population that can benefit from the intravitreal implant where this is effective for a much longer period of time. So while we're not sharing peak sales, we're sharing that the underlying demand for both products is very strong.
And then I think you have the NEW DAY study reading out this year. Just what impact do you think could positive data have on the commercial opportunity? And I guess, how can you maximize the impact it has in the market?
Sure. So NEW DAY is investigating the use of ILUVIEN in combination with anti-VEGF therapy for the treatment of DME. And when successful, we can see, and look, the experts are very interested in the outcome of the study. And the Alimera team had engaged with the retina community to a great deal while initiating the study. And obviously, several of them are involved in executing the study. When successful, this study will allow for the expansion and use of ILUVIEN in the earlier treatment of DME. So if you think of that funnel that I was talking about, so 53,000 is patients that are just suboptimal response to anti-VEGF. So this is talking about using it much higher in the funnel over a much broader patient population. So it can have a significant impact on expanding the use of ILUVIEN.
Now, having said that, I will clarify that ANI's deal case while acquiring Alimera did not count on a successful read. The underlying demand, even between the 5,000 and 53,000, is significant enough to capture that opportunity.
And then I guess just turning to the generics, very strong growth for the portfolio in 2024. Just major drivers of that, any particular products that kind of stand out or has it been more kind of broad-based in terms of the growth you're seeing?
Yeah, look, diversification is the strength of our generics business. We had 16 new product launch approvals in 2024 or 17, and two with competitive generic therapy designations. And this speaks to the strength of our R&D engine and our R&D organization and the operational excellence to bring these products to the market and to serve patients. We supply over 1.8 billion doses across 100 plus product families to patients across the U.S. And so it's a combination. And no, there aren't any one or two products that contributed to the high single digit, low double digit growth in 2024. And again, in 2025, we continue to see high single digit, low double digit type growth. And continue to see, look, the 17 products that from the previous year of launches, the annualized impact of that will hit in 2025 and we'll have new launches.
So again, there's diversification in terms of where the growth will come from.
And then just in the last few minutes, just on business development, latest thinking on the priorities from here, and I think is Alimera kind of representative of the type of deals that you would be interested in pursuing going forward?
Yes, absolutely. I think we want to, again, rare disease is the key focus area for the company, primary driver of growth, number one priority for capital allocation. And so as we think about driving growth going forward, we can see that from a BD perspective, the next acquisition could be sort of very similar to, in terms of criteria, commercial assets that are growing, durable, synergistic with Purified Cortrophin Gel. Remember, Purified Cortrophin Gel goes into multiple indications. So there's rheumatology, nephrology, neurology that we haven't even touched yet that we can still expand into. We also spoke about the success in gout. So looking at those types of assets and of a scale that, again, our strong balance sheet can absorb without straining it.
As we continue to evolve and as a rare disease company, we will look to take clinical bets at some point in the future and find ways to bring even greater innovation to our patients in need. Yeah.
Great. Thank you so much. I think we're just about out of time.
Thank you, everybody, for joining us. We appreciate it. Thank you.