Good morning, everyone. My name is Brandon Foulks, and I am one of the biopharma analysts here at HC Wainwright. Next up, we have a presentation from ANI Pharmaceuticals, and presenting from ANI, we have CEO Nikhil Lalwani. Nikhil, over to you.
Thank you, Brandon. Good morning, everybody, and thank you for joining us here this morning. I'm Nikhil Lalwani, the President and CEO of ANI Pharmaceuticals, and I'm thrilled to be here to share with you our journey of building a high-growth, profitable, rare disease therapeutics company while fulfilling our mission of serving patients, improving lives. Here are our forward-looking disclaimers on forward-looking statements and some commentary on the non-GAAP financial measures that we're presenting throughout the deck. ANI Pharmaceuticals has three business segments. Rare disease, as I mentioned right at the start, is our primary driver of growth and key focus area: generics and then brands. In rare disease, we have two growing and durable commercial assets: Purified Cortrophin Gel and ILUVIEN, and we work on expanding the scope and scale of our rare disease business through M&A.
The generics business has delivered growth through superior R&D capabilities, a U.S.-based manufacturing footprint, new product launches, and operational excellence. Our brands business deploys unique commercial capabilities but generates high margins and strong cash flows that help create this virtuous cycle of growth where we keep investing in rare disease to expand the scope and scale of the rare disease business. If you think about it in numbers, ANI Pharmaceuticals' guidance, as issued on August 8 at our second quarter earnings, was $818 million to $843 million in net revenues, which is about a 33% to 37% year-over-year net revenue growth, and $213 million to $223 million of adjusted non-GAAP EBITDA.
We generated over $100 million of cash in the first half of the year and have a strong balance sheet with $218 million of cash on the balance sheet as of June 30, 2025, and 2.2x net leverage on a trailing 12-month basis. ANI Pharmaceuticals is well positioned to continue driving strong growth. We've delivered 38% CAGR in revenues from $316 million to $818 million to $843 million in 2025, and on an adjusted non-GAAP EBITDA basis, 57% CAGR from $56 million in 2022 to $213 million to $223 million as per the guidance issued on August 8. Our lead rare disease asset, Purified Cortrophin Gel, has been a key driver of that growth and is expected to reach $326 million of sales in the fourth year of launch and our expanded rare disease franchise with the acquisition of Alimera Sciences in Q3 of 2024.
Generics continues to grow, driven by the strength of R&D productivity, and we retain the number two position in competitive generic therapy approvals, highlighting the strength of our R&D engine. In Q2 2025, we delivered record results, setting a strong foundation for the full year. Our lead rare disease asset, Purified Cortrophin Gel, delivered exceptional sequential and year-over-year growth. This was driven by record new patient starts and new cases initiated in the second quarter. We had growth across therapeutic areas, across new and existing prescribers, very strong demand for the new presentation of the prefilled syringe that we launched for Purified Cortrophin Gel, and revenue synergies in ophthalmology with 33% sequential quarterly volume growth. The ILUVIEN and YUTIQ revenues were in line with expectations, and with the lack of Medicare patient support, funding persisted. We announced the NEW DAY study results and added NIU-PS indication to the ILUVIEN label.
Finally, generics revenues reached a new record on superior new product launch execution, operational excellence, and U.S.-based manufacturing. The Q2 total net revenues was $211 million, adjusted non-GAAP EBITDA of $54 million, which represented 63% year-over-year growth. Purified Cortrophin Gel was $82 million net revenues, which represented 66% year-over-year growth. An important thing to highlight about the ANI Pharmaceuticals story is our commitment to the U.S. pharmaceutical industry and to local manufacturing, especially important in light of the evolving tariff situation. Over 90% of our revenues come from finished goods that are manufactured in the U.S. Only 5% have a direct reliance on China, and approximately 95% of our revenues come from products that are sold in the U.S. We believe we're well positioned relative to our peers and uniquely positioned with a focus on U.S. manufacturing and on the U.S. pharmaceutical market. These are our three U.S.
manufacturing sites, two in Baudette, Minnesota, and one in East Windsor, New Jersey. All three have been inspected recently and have either VAI or NAI status. We have a strong GMP track record across our manufacturing sites, all in the U.S. Our full year 2025 guidance, as issued on August 8, 2025, had net revenues at $818 million to $843 million, which represented a 33% to 37% growth. Purified Cortrophin Gel net revenues of $322 million to $329 million, which represents 63% to 66% year-over-year growth. ILUVIEN and YUTIQ at $87 million to $93 million. Adjusted non-GAAP EBITDA of $213 million to $223 million, which represents 37% to 43% year-over-year growth. Adjusted non-GAAP EPS of $6.98 to $7.35, which represents a 34% to 45% year-over-year growth. Now let's double-click on the rare disease business.
When we look at the rare disease business, you see that we've grown over the last four years from zero in 2022, or 2022 is when we launched our first asset, Purified Cortrophin Gel, and did $42 million in that year, growing to our guidance for this year implies $409 to $422 million. Within that, Purified Cortrophin Gel is $322 to $329 million, and ILUVIEN and YUTIQ are $87 to $93 million. Strong rare disease growth in net rare disease net revenues. Importantly, to reiterate, rare disease will account for 57% of 2025 H2 revenues as per our guidance issued on August 8. How does ANI think about rare disease? We think of rare disease in two buckets. One is very small patient populations, example here being chronic non-infectious uveitis affecting the posterior segment of the eye or sarcoidosis, but also underserved patients in high prevalence diseases.
Here examples are multiple sclerosis and rheumatoid arthritis. We'll show you the patient funnels for these for Purified Cortrophin Gel a little later in the deck. ANI rare disease markets two high-growth durable therapeutics with multiple indications. Purified Cortrophin Gel has 22 indications. It's a repository corticotropin for patients suffering from specific chronic autoimmune and inflammatory conditions. ILUVIEN and YUTIQ, or ILUVIEN, now that we've merged the label, is indicated for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids, and chronic non-infectious uveitis affecting the posterior segment of the eye. I'll tell you a little bit more about Purified Cortrophin Gel, the primary growth engine for ANI rare disease. Purified Cortrophin Gel is a purified corticotropin. It's a treatment option for patients suffering with certain chronic autoimmune disorders. It's approved for multiple indications.
Initially, we launched in 2022 into the therapeutic areas of neurology, nephrology, and rheumatology, and subsequently expanded it into ophthalmology and pulmonology. There's a potential for strong multi-year growth as key indications are significantly underpenetrated. We believe in the long-term sustainability of Purified Cortrophin Gel, driven by the strong barriers to generic entries, as well as limited competition. There's only one other ACTH product in the market, and that's been true for multiple decades. The overall ACTH market was $600 million, approximately, in 2022 when we launched. The market has grown to $684 million in 2024 and is estimated to reach $933 million if you add our guidance and our competitor's guidance. We've launched, as you can see in the visuals, we've launched multiple presentations.
We started with a 5 mL vial in January of 2022 and then launched a 1 mL vial in October 2023, which was appropriate for certain indications, appropriate dosing for certain indications. Most recently, we've launched a prefilled syringe to help patients that have dexterity issues, to enhance patient convenience. When you look at the overall ACTH market, and this is a historic look at it, the ACTH market was at its peak in 2017 at $1.2 billion and then degrew over years until we launched in 2022. Since then, the class has stabilized and returned to double-digit growth. When you look at 2024, the ACTH market grew 27% on a dollar basis. When you look at 2025, if you add our guidance and the competitor's guidance, the market's expected to grow 39%.
We believe that there is strong multi-year growth potential for cortrophin based on the fact that the number of patients that are being treated today are still substantially lower than patients that were being treated in 2017. Equally or more importantly, the key indications are significantly underpenetrated. I'll talk a little bit more about that shortly. Also important to note that since we've launched, about half of cortrophin gel prescribers were naive to ACTH, that their first prescription of ACTH was cortrophin gel. We are able to speak with them, explain to them the use of cortrophin, the appropriate patient populations, and therefore believe that we can address the larger patient populations that can benefit from this therapy because the indications are significantly underpenetrated. When you look at cortrophin gel, it's been a successful launch and driven really by the robust underlying demand.
We've seen growth in the specialties that we targeted at launch, which were neurology, rheumatology, and nephrology. We see prescribing momentum in existing and new prescribers. 50% of our prescribers are folks that were naive to ACTH. Cortrophin was their first ACTH prescription. We saw increasing momentum in Q2 2025 as we expanded our sales team for the initially targeted specialties of neurology, rheumatology, and nephrology. We're also gaining traction in the newer therapeutic areas. We had expanded our ophthalmology sales team to 46, and we're beginning to capture revenue synergies as Cortrophin ophthalmology volume grew approximately 33% quarter on quarter in the second quarter of 2025. We've also seen strong growth in acute gouty arthritis. This is an indication that only we have, the competitor does not have it. Acute gouty arthritis flares as an indication has grown to approximately 18% of Cortrophin Gel use in the second quarter.
Our focused smaller pulmonology sales team is yielding positive results. As we're seeing Cortrophin with this strong multi-year growth trajectory, we're continuing to strengthen the franchise, and we're taking multiple steps to do that. We're investing in research to provide additional support for the use of Cortrophin Gel. As an example, we've initiated a phase IV clinical trial for acute gouty arthritis flares. We believe that this could help have Cortrophin Gel added in the ASN guidelines. We look forward to updating investors on the progress of this phase IV clinical trial. We also launched multiple presentations of Cortrophin Gel, as I had indicated earlier. Most recently, we launched the prefilled syringe in April of 2025, and that has seen very strong demand. In the second quarter, 70% of our, or in July, 70% of our new enrollments came for this presentation, the prefilled syringe.
We're continuing to explore other ideas to enhance the convenience for patients and providers. We also invest in high ROI commercial efforts to drive growth across all specialties. You look at the revenue trajectory on the right-hand side. We grew from, we're in the fourth year of our launch, growing from $42 million in year one to $112 million in the second year, $198 million, and now $322 to $329 million, really driven by expanding the ACTH market, and that's key. We believe in the strong multi-year growth potential for Cortrophin, and that's really driven by the addressable patient populations across indications being significantly underpenetrated. While we highlight five indications on this slide, I'll talk you through a couple. If you take acute gouty arthritis flares, there are 9.9 million patients that are diagnosed with acute gouty arthritis, or sorry, 9.9 million flares. 36% receive treatment annually.
Sorry, that 9.9 million was patients. Approximately 36% of these patients receive treatment annually, and they get one and a half to two average flares per year. Only 8% of these flares, for those flares, they receive an injectable flare treatment. That's what we consider as our addressable flare population and patient population. That's 500,000 addressable annual flares and about 285,000 patients. If you take rheumatoid arthritis, there are 1.6 million patients diagnosed with rheumatoid arthritis. Of these, 17% to 25% experience a flare annually. Only 30% of these patients do not respond to a steroid, so that's about 100,000 addressable annual flares and about 480,000 patients. Then you take nephrotic syndrome, where there are 35,000 patients diagnosed, 12.5% to 20% of these patients do not respond to a steroid, and therefore there are only 6,000 addressable patients.
When you look at the flares and the patients, the numbers that we're treating today with Purified Cortrophin Gel, or even the ACTH market is addressing with the competitor's product, is insignificant compared to these numbers. That's why we believe that there is a strong multi-year growth potential with these addressable patient populations across indications significantly underpenetrated. I'll also highlight to you that acute gouty arthritis flares is an indication that only we have, the competitor does not have that, and that almost half of our prescribers were naive to ACTH before they wrote their first prescription of Cortrophin. What that means is we're able to access this larger addressable patient population by working with ACPs to identify the appropriate patients that are appropriate for Cortrophin. Moving next to the other assets in rare disease, ILUVIEN and YUTIQ, these are durable ocular therapies.
They provide 36 months of continuous therapy, microdosing of fluocinolone acetonide, and they're indicated for two indications: diabetic macular edema, chronic disease that is the leading cause of vision loss in diabetic patients, and 4% of diabetic patients develop clinically significant macular edema. Chronic non-infectious uveitis affecting the posterior segment of the eye is inflammation of the eye that can lead to pain, visual impairment, and vision loss. The visual on the right is a small pellet that is an intravitreal implant into the eye and then does continuous microdosing for up to 36 months. Earlier this year, we expanded the label for ILUVIEN and got approval for ILUVIEN to have treatment of chronic non-infectious uveitis affecting the posterior segment in addition to diabetic macular edema. We market only ILUVIEN in the U.S. under the combined label.
What that does is it makes it simpler from a supply chain perspective and provides operational efficiency. Most importantly, it brings customers value. It simplifies the ordering and processing for the healthcare providers, offering a single injector for both indications and transitions to a single product, allowing for streamlined marketing and sales efforts too. All of these efforts position the franchise for strong multi-year growth by enhancing supply security. As we did with Cortrophin, I want to highlight that both indications of ILUVIEN also have large underserved patient populations with DME representing more than 50,000 patients in the U.S. alone. You'll see here the diagnosed DME patient population is 900,000 patients. Of this, only half are treated. It's about 450,000 patients. Patients that receive two plus anti-VEGFs is about 260,000 patients. Anti-VEGF is a standard of care in DME.
There are 29% of these patients that show suboptimal response to anti-VEGFs. Of those, the ones that show positive steroid trial with low IOP risk is about 70%, which is 53,000 patients. Of those 53,000 patients, today ILUVIEN serves less than 5,000 patients for DME per year. There's significant headroom for growth in DME. The same is also true in uveitis, where there are 78,000 to 112,000 patients that can be candidates, of which less than 5,000 are being treated currently with ILUVIEN for NIU. Significant opportunity there too. ANI's international business accounts for approximately 30% of ILUVIEN revenues. $87 to $93 million was the guidance we issued on August 8. 30% of those ILUVIEN revenues come from international. We have direct commercial operations in Germany, the UK, Portugal, and Ireland, and high-quality partnerships in 18 other territories in Europe, the Middle East, and Asia.
ANI announced the NEW DAY clinical study results for ILUVIEN in DME. This was exploring the use of ILUVIEN earlier in the treatment of DME in conjunction with anti-VEGFs. We announced these NEW DAY study results in July of 2025, earlier this year. Since then, we have begun presenting and sharing these results at national and international conferences. In July, we presented at ASRS. In September, we just presented last week at EURETINA. We have a plan to present a podium presentation at AAO, American Academy of Ophthalmology, and at Hawaiian Eye, another podium presentation. There is a clear plan to share the results of the NEW DAY clinical study and increase awareness supporting the use of ILUVIEN earlier in the treatment of DME in conjunction with anti-VEGFs. Next, we will move to our generics business. Everything we've talked about so far, Purified Cortrophin Gel and ILUVIEN, is rare disease.
Our generics business has grown on the back of strong R&D capabilities and operational excellence. We delivered $90 million in revenues in the second quarter of 2025. We've launched seven new products in 2025 and are on track to deliver several new launches through the rest of the year. The second quarter revenue was up 22% year over year, again driven by strong new product launch execution. For reference, we sell over 110 products in the U.S. in generics. We have a strong operational backbone and U.S.-based manufacturing footprint to support this generics business. We had talked about our manufacturing facility that supplied over 2.3 billion doses of therapeutics to patients in need in the last 12 months. We maintain a strong GMP track record with all sites in VAI or NAI status.
Success in generics is also driven by a focus on cost excellence with a systematic and relentless approach to reducing costs across the board in generics. We expect to deliver mid-double-digit growth in 2025. We did about $301 million last year and expect to deliver mid-double-digit growth for our generics business in 2025. In summary, ANI is looking to continue building a highly profitable, high-growth rare disease therapeutics business with a strategic focus on the strong and growing rare disease business, which we expect to represent approximately half of 2025 revenues and be the largest driver of future growth. Rare disease will account for 57% as per the guidance issued on August.