2024 Global Healthcare Conference. It's my pleasure to now introduce Nikhil Lalwani, CEO of ANI Pharmaceuticals. Just a reminder that this will be a 25-minute presentation. Thank you.
Good afternoon, everybody, and thank you for joining us at this wonderful Jefferies Healthcare Conference. I'm Nikhil Lalwani, President and CEO of ANI, and I'm delighted to be here to tell you about the evolution journey of ANI's Rare Disease therapeutics business. We start off with the standard disclaimers on forward-looking statements, as well as guidance on additional financial information that is being presented throughout this deck. ANI's Rare Disease business will account for more than 50% of the company's revenues in 2025 and will be the primary driver of growth going forward. We also have a generics business that is delivering high single digits to low double digits growth, fueled by our R&D engine, our strong and high-performing R&D engine, operational excellence, and the U.S.-based manufacturing footprint.
When you think of ANI numbers, our guidance for 2024 is $594 million-$602 million in revenues, which represents a 22%-24% year-over-year growth, $149 million-$153 million in adjusted non-GAAP EBITDA, and we have $145 million of cash on the balance sheet. ANI is well positioned to continue driving strong growth. When you look at our revenue growth profile from 2021, you see that the guidance of $594 million-$602 million represents a 40%-41% CAGR since 2021. On the profitability side, the adjusted non-GAAP EBITDA guidance of $149 million-$153 million represents a 43%-44% CAGR since 2021. So we are well positioned to continue driving strong growth. Our momentum has continued in 2024, with ANI delivering record results in Q3. We delivered $148.3 million in Q3 revenues, which represents a 13% year-over-year growth.
And our Rare Disease business accounted for $56 million, accounting for a 90% year-over-year growth over the previous year. The steady gains in Rare Disease, and I'll talk you through more details in a bit, came across therapeutic areas, the ones that we focused on at launch of Cortrophin, our lead asset, neurology, nephrology, and rheumatology, as well as the newer indications of pulmonology and ophthalmology that we have embarked upon. On the generic side, as I said, we continue to leverage the new product launch execution. We've had 16 new product launches to date, and that helps drive the high single digit, low double digit growth that we're looking forward to in our generics business. Our 3Q diluted non-GAAP EPS was $1.34, and our 3Q adjusted non-GAAP EBITDA was $35.1 million. I've talked through most of the guidance metrics.
The two that are the additional ones that are highlighted here that I'll talk through, Cortrophin Gel, our lead Rare Disease asset, our guidance for 2024 is $196 million-$200 million, and ILUVIEN and YUTIQ, which are the assets we acquired through the Alimera acquisition, we're guiding for $30 million-$32 million. This includes about $3.9 million in the stub period. We closed the deal on September 16, and then the rest in the fourth quarter, and then our guidance for adjusted diluted non-GAAP EPS was $4.90-$5.05, so let's talk about our Rare Disease business. Our Rare Disease franchise is expected to drive strong growth in 2024 and beyond. In January 2022, we launched our lead Rare Disease asset, Purified Cortrophin Gel. We did $42 million the first year of sales, which is 2022.
This year, our guidance for Cortrophin is $196 million-$200 million, and then you add ILUVIEN and YUTIQ of $30 million-$32 million, giving you $226 million-$232 million, which is [$132 million]. It's almost 5x over that period. Our Rare Disease business has three commercial products. The lead asset, Purified Cortrophin Gel, is a repository corticotropin that's used to treat patients with certain chronic autoimmune disorders that would benefit from alternate therapies. Many of our patients are intolerant or refractory to steroids. What's listed here are the chronic allergic and anti-inflammatory conditions that affect the eyes, because this shows you the ophthalmology overlap and indications. Our second asset, ILUVIEN, is indicated for diabetic macular edema. Again, we'll tell you a little bit more about that as we go along. YUTIQ is indicated for non-infectious uveitis in the posterior segment of the eye.
What you see is ANI's Rare Disease business as three commercial assets, growing, durable, to expand the scope and scale of our Rare Disease business. When ANI thinks of Rare Disease, we think of Rare Disease in the small patient populations that suffer from Rare Disease, such as the chronic non-infectious uveitis in the posterior segment of the eye, or keratitis as examples, but then also underserved patients in high prevalence diseases. That's where we give the example of diabetic macular edema, and I'll walk you through the patient funnel shortly, or even rheumatoid arthritis and multiple sclerosis. Let's start with our foundational Rare Disease asset, Purified Cortrophin Gel. This is a purified corticotropin, porcine-derived. It's a treatment option for patients struggling with certain chronic autoimmune disorders. We launched into a limited competition market, and even today, there's only one other competitor in this category.
This category was $1.2 billion at its peak and has returned to growth since we've launched. As I've referred to earlier, Cortrophin Gel is approved for multiple indications. We initially launched into three areas: neurology, nephrology, and rheumatology. And recently, we've expanded into ophthalmology as well as pulmonology. Cortrophin Gel has been a successful launch. In year three, we're on track to doing between $196 million to $200 million in revenue, and we have continued strong demand. We see Cortrophin on a strong multi-year growth trajectory. We see growth in the specialties that we targeted at launch, as I told you, nephrology, neurology, and rheumatology. There's prescribing momentum across existing prescribers and new prescribers, and there's momentum continuing in Q3 with the highest number of new patient starts as well as unique prescribers.
In fact, even in October, which is the first month of Q4, we've had the highest number of record new enrollments. We've also gained traction in the new therapeutic areas that we've expanded into. In ophthalmology, our sales team pilot was successful in early 2024, and then through the Alimera acquisition, we now have an ophthalmology sales team of 46 sales reps that are out there promoting three products, and I'll speak a little bit about that. We also launched a 1 mL vial size of the Cortrophin Gel. Cortrophin Gel's initial presentation was a 5 mL vial. We also launched a 1 mL vial size for Cortrophin during the fourth quarter of 2023 because it's the only approved ACTH therapy indicated for acute gouty arthritis flares.
Our expansion of the pulmonology sales team, so we launched with a pilot sales team in 2023, and then expansion into a second region in 2024 has also been yielding positive results. So we've seen growth in the specialties targeted at launch as well as into the specialties that we've expanded into. We believe that Cortrophin has a strong multi-year growth trajectory and are continuing to invest to strengthen the franchise. A couple of examples include investing in research to provide additional support for use of Cortrophin Gel. Recently, we had two abstracts published at the American Society of Nephrology. We've also completed the development of a prefilled syringe for Cortrophin Gel. This is to make it easier for patients that have issues with self-administration of Cortrophin Gel. We've submitted the supplemental NDA and planned a launch for the first half of 2025.
We're also exploring other ideas to enhance the convenience for patients and providers. Our full year guidance for Cortrophin Gel, and you see the quarterly cadence on the right-hand side, was $196 million-$200 million. We believe that both Cortrophin and the overall ACTH market has a strong trajectory, multi-year growth trajectory. What you see on this slide is the ACTH market in 2017 was $1.2 billion in size, and then it declined significantly until we entered in 2022, and you see on top that the rate of decline first slowed down, right, so it was minus 7%, minus 14%, minus 19%, minus 23%. It slowed down after we launched, and in this year, if you add our guidance and the guidance of our competitor, the overall market is growing 23%-24%.
Equally important, the number of patients on ACTH therapy are substantially lower than patients on therapy several years ago when the market was at its peak. And this $1.2 billion market doesn't even include acute gouty arthritis flares, which is an indication that we have and the competitor doesn't. So we believe in the strong multi-year growth trajectory for Cortrophin Gel and are continuing to invest to grow this franchise and strengthen it. Next, let me tell you about the Alimera Sciences acquisition. This is a highly synergistic acquisition that we closed in September, and the integration is progressing well. We bought two differentiated commercial assets with high barriers to genericization, significant growth potential, which can be further unlocked through commercial synergies and execution.
We will add, or we're projected to add, $35-$38 million in additional adjusted non-GAAP EBITDA in 2025, and the deal will be or forecast to be high single digit to low double digit accretion in adjusted non-GAAP diluted EPS. The integration is progressing well. The combined 46-person ophthalmology sales team has been cross-trained across all three products. We also completed the recruitment, so that's in place. They've been cross-trained, and they're promoting all three products, ILUVIEN, YUTIQ, and Cortrophin, since mid-October. We've successfully retained key Alimera employees and taken actions to ensure that we are on track to capture $10 million of synergies in 2025. The Alimera acquisition was aligned with our M&A strategy that we had spoken about leading into the acquisition. It expands the scope and scale of our Rare Disease business, adding two commercial assets. It also gives us an increased geographic footprint ex-U.S.
The Alimera acquisition is in a priority therapeutic area, which is synergistic with Cortrophin, and there are assets that have durability and growth, double-digit growth assets with patent protection and high barriers to genericization, so the two assets, ILUVIEN and YUTIQ. ILUVIEN, they're both novel long-acting implants that are implanted in the eye for serious eye diseases. ILUVIEN is used to treat diabetic macular edema, which is a chronic disease that is the leading cause of vision loss in diabetic patients. Less than 4% of diabetic patients develop clinically significant macular edema. For chronic non-infectious uveitis, in the U.S., we have YUTIQ indicated, and outside the U.S., we have ILUVIEN indicated, and chronic non-infectious uveitis affects the posterior segment of the eye. It's an inflammation of the eye that can lead to pain, visual impairment, and vision loss, so both our implants are novel, long-acting for serious eye diseases.
Our larger ophthalmology sales team, which is really, this is the industrial logic for the deal, took the pilot team that we had in ophthalmology for Cortrophin and then added the two commercial assets from Alimera, ILUVIEN and YUTIQ. They had a team of about 35 reps, and we now have a combined team of 46 ophthalmology specialists. When we looked at the potential prescribers, there's a greater than 50% overlap amongst those with the highest prescribing potential. And what it's done with the 46-person team is it expanded our reach to about 3,600 ophthalmologists. We obviously have the complementary patient support capabilities to ensure that the patients get on the therapy that they need. So this is the patient funnel for DME to reflect the underserved patient population that ILUVIEN is attempting to support. The diagnosed DME population in the U.S. is approximately 900,000 patients.
The treated DME population is 450,000. Patients that receive, and the standard of care is anti-VEGFs. Patients receiving two-plus anti-VEGFs, that number comes down to 260,000, and this is a progressive disease. And the patients that have suboptimal response to anti-VEGFs are about 75,000. Of those 75,000, there are 53,000 patients that show positive response to steroid trial, which becomes the addressable market at this time for an ILUVIEN-type product. And so there is significant room for ILUVIEN growth, right? There's less than 5,000 patients that are starting annually at this time for DME in the U.S. versus 53,000 patients that show positive response to steroid trial. So significant room for ILUVIEN growth. Next, let me tell you about two clinical studies that we have ongoing for ILUVIEN and YUTIQ. For ILUVIEN, we have a study called NEW DAY.
NEW DAY investigates the earlier use of ILUVIEN in combination with anti-VEGF therapy for the treatment of DME. It's a multi-center, single-masked, randomized control trial that compares in one arm ILUVIEN in combination with anti-VEGF therapy and only anti-VEGF therapy in the second arm, and anti-VEGF therapy is the current standard of care for DME. The study has enrolled 306 naive or near-naive patients in DME, and the last patient's last visit is expected in December 2024 and top-line results towards the end of the first quarter, early second quarter of 2025. Again, as I said before, what it's investigating is the earlier utilization of ILUVIEN in patients with DME, so you think about that funnel that we just showed you is basically having it used earlier rather than just limiting it to the 53,000.
The second study I'd like to tell you about is Synchronicity, which is for YUTIQ. This is a multi-center open-label study investigating YUTIQ across patients with chronic non-infectious uveitis. The study has enrolled 110 patients in approximately 25 sites across the U.S., and the last patient's last visit is expected in November of 2025, with the top-line data readout expected in the first quarter of 2026. Now, let me move to our generics business. We have strong R&D capabilities and operational excellence driving growth in generics. We launched 16 new products in 2024 year to date, including a competitive generic therapy approval. We're number two ranked in the U.S. in competitive generic therapy approvals and a top 15 manufacturer in a number of product approvals. We also have a strong operational backbone. Year to date, we've supplied, sorry, in 2023, we supplied over 1.5 billion doses.
There's about 1.7 billion prescriptions in 2024 that have been filled with ANI product. We have an excellent compliance track record. We have three manufacturing plants in the U.S., one in East Windsor, New Jersey, and two in Baudette, Minnesota. We've made progress in bringing online in Q3 a capacity expansion that we did at our New Jersey site. The New Jersey site has successfully completed multiple audits. There's an example of a couple here. On the generic side of our business, cost excellence is crucial. We have a systematic and relentless approach to cost excellence across raw materials, finished good products, as well as corporate spend. As you see on the right-hand side is the quarterly evolution of the generics sales, and we expect on an annual basis to deliver high single digit to low double digit type growth. These are visuals of our three manufacturing plants.
Two of them are in Baudette, Minnesota. For those unfamiliar, Baudette is the last town on the Lower 48 and the one plant in East Windsor, New Jersey. We have a very strong compliance and GMP track record, including successful FDA audits at all three sites, and that is a strong capability and expertise that we have. So in summary, ANI has a strategic focus on growing our Rare Disease business and evolving the company focused on Rare Disease therapeutics as the largest area. In 2025, Rare Disease will account for 50% of 2025 revenues and the largest driver of 2024 growth. Cortrophin Gel, our foundational and lead Rare Disease asset, is expected to reach $198 million. The guidance is $196 million-$200 million with a strong multi-year growth trajectory.
And the two assets we acquired, ILUVIEN and YUTIQ, we believe that that acquisition adds two growing and durable assets to the platform, as well as gives us a commercial platform in ophthalmology and rare ophthalmology, where now we have a 46-person sales team out there promoting ILUVIEN, YUTIQ, and Cortrophin. So Rare Disease, and it's the primary area of focus for capital allocation going forward. We also have a robust foundational generics business delivering high single digit to low double digit growth, a highly seasoned R&D, manufacturing, and commercial infrastructure delivering the value to our customers. We have a well-diversified product portfolio with over 100 product families. So we have diversification, we believe, is one of the strengths of our generics business. And we have a reliable U.S.-based manufacturing footprint with a strong GMP track record. I spoke about the FDA audits across all three sites.
And we deliver over 1.7 billion prescriptions annually. ANI also has financial strength, and that's grown substantially over the years. We have $145 million in cash and cash equivalents with a disciplined approach towards debt levels. In conjunction with the Alimera acquisition, we made several changes to our capital structure, bringing on a term loan A as well as issuing a convertible. And the post-acquisition starting net leverage is 3.0. In 2024, our projected revenues, again, just to recap, are $594-$602. The adjusted non-GAAP EBITDA, this obviously shows a midpoint, is of $151 million, and the adjusted non-GAAP diluted EPS of $4.98. And the team, it's really the team that makes this all happen in the ANI organization. We have over 1,000 purpose-driven employees and team members across the organization living our purpose of serving patients, improving lives.
We have a highly seasoned executive management team with best-in-class experience and expertise, and they are performance-driven, purpose-driven, and they have very strong collaboration among them to deliver the growth that we have and to take ANI forward, so thank you again for joining us, and I'm happy to take a question or two since we have a couple of minutes. All right, thank you, and enjoy the rest of the conference.