Happy to welcome ANI Pharmaceuticals this morning. We have Nikhil Lalwani, CEO, and also Stephen Carey, CFO. Nikhil will be going through a presentation, and then afterwards, we'll have a breakout Q&A downstairs in Amarante 1. Follow us afterwards for that. Without further ado, thank you, Nikhil, and welcome.
Thank you, Ryan. Good morning, everybody, thank you for joining us for this morning's presentation at the Raymond James Conference. I'm here to tell you about ANI Pharmaceuticals. These are disclaimers on our forward-looking statements and explanation of the financial information, especially the non-GAAP financial measures that I will be referring to during our presentation this morning. ANI is a profitable high-growth biopharmaceutical organization transforming into a leading rare disease company. We're projecting more than $1 billion in sales in 2026 with significant growth. In 2025, we delivered 44% year-over-year growth on a total company basis. In 2026, we're projecting to grow another 23%. The rare disease business is our primary focus and will expect to represent about 60% of total company revenues in 2026.
Our lead asset, Cortrophin Gel, is expected to provide substantial multi-year growth opportunity for us. I'll talk about that in more detail as we go along. Our Generics business delivers strong cash flows enabled by superior R&D capabilities, operational execution, and a US-based manufacturing footprint. These two businesses believe will create what we call a virtual cycle of growth, where EBITDA and cash flows from our Generics and brands businesses help fuel our rare disease business and accelerate our transformation into a leading rare disease company. ANI has a proven track record of delivering top and bottom-line growth. Since 2022, we've delivered 36% compound annual growth until 2026, taking into account the 2026 guidance and 50% adjusted non-GAAP EBITDA growth. Delivering strong top and bottom-line growth across the few years and looking into the future.
In 2025, we drew a robust expansion across our business lines. On a total company basis, we delivered $883 million in revenues, which was 44% year-over-year growth and adjusted non-GAAP EBITDA of $230 million, which was 47% year-over-year growth. Rare disease generated 84% top-line growth, with our lead asset, Cortrophin, growing from $198 million- $347 million for a year-over-year growth of 76%. This growth came from across our key specialties of neurology, rheumatology, nephrology, and pulmonology, included a sales force expansion. acute gouty arthritis flares grew to over 15% of our Cortrophin Gel use, and we realized synergies from the combined ophthalmology sales force that we had launched. We established ILUVIEN, our second asset, commercial and access initiatives to support growth in 2026.
Our Generics business outperformed with 28% year-over-year top-line growth. This outperformance was driven by superior R&D capabilities and operational execution. We delivered a strong cadence of new product launches, including the first-to-market launch of Prucalopride and a partner generic launch. As we head into 2026, we have three priorities to drive long-term growth and value creation. Number 1, we will accelerate ANI's transformation into a leading rare disease company. Cortrophin Gel has our lead asset has a multi-year growth opportunity, and we will maximize that growth opportunity by addressing significant unmet need across indications. We'll build on the momentum in the under-penetrated specialty indications in nephrology, neurology, rheumatology, ophthalmology, and pulmonology. We'll build and deploy a 90-person organization dedicated to acute gouty arthritis flares, this is an expansion, by mid-year.
We'll advance the phase IV trial to establish further evidence supporting Cortrophin in acute gouty arthritis, will continue to evaluate opportunities to enhance patient convenience. For our second asset, ILUVIEN, we'll return to growth by leveraging the commercial and patient access initiatives that we launched in 2025 or reestablished in 2025. Priority number two, we'll continue execution on our Generics business. We'll continue leveraging our superior R&D capabilities, operational execution, U.S. manufacturing footprint, and business development expertise to expand cash generation. We'll deliver a cadence of 10- 15 launches every year. Third, we'll execute a disciplined capital allocation strategy. We'll explore opportunities to expand the scope and scale of our rare disease business, so that's inorganic.
We'll invest in dedicated organization for Cortrophin Gel in gout, that's organic, and invest high single-digit % of Generics, our revenue into Generics R&D to support the cash generation. These are our 2026 priorities and will help drive long-term growth and value creation. Our 2026 guidance reflects strong top-line growth of 19%-26% for a guidance of $1.055 billion-$1.115 billion. Bottom line growth of 20%-26% with adjusted non-GAAP EBITDA of $275 million-$290 million. Cortrophin Gel, our lead asset, is expected to grow 55%-65% to $540 million-$575 million. Let me tell you more about our rare disease business. Our rare disease business represents the primary driver of growth.
Since 2022, when we launched our lead asset, we've grown this business into $423 million in 2025, delivering 84% growth. Even in 2026, we're gonna grow it 51%, and it will become $618 million-$658 million in sales in 2026, accounting for 60% of the company's revenues in 2026. Cortrophin Gel, our lead asset in rare disease, is a purified corticotrophin, a late-line treatment option for patients struggling with chronic autoimmune disorders. You heard me refer to different specialties because Cortrophin is approved in multiple indications in neurology, nephrology, rheumatology, ophthalmology, and pulmonology. We have a potential for strong multi-year growth as key indications have significant unmet need and are under-penetrated, I'll show that to you in a couple of slides. The ACTH market is fast-growing.
It's a two-player market. It approached $1 billion in sales in 2025, up 45% year-over-year growth. The long-term sustainability of the ACTH market and of Cortrophin is driven by high barriers, regulatory and IP, to generic entry. It's a tough drug to genericize. We have multiple presentations available to enhance patient convenience, prefilled syringes, and vials. When you look at the overall ACTH market, this shows the year-over-year evolution, and you see that it returned to growth in 2022 when ANI launched Cortrophin. We expect strong multi-year growth. In 2024, it grew 27%. This is the total market. In 2025, it grew 45%. We have a proven ability to reach new HCPs and end patients, with over half of our prescribers being naive to the ACTH category and to Cortrophin before we launched.
That means they had never written a prescription of any ACTH drug, including Cortrophin, and the first ACTH product that they wrote for was Cortrophin. This shows you the significant opportunity that we have in addressing addressable patient populations across indications. I'll take gout to illustrate my point. There are 9.9, let's call it 10 million patients that are diagnosed with gout. Approximately 36% of these patients receive treatment annually and have 1.5- 2 average flares per year. Only 8% of these patients require an injectable flare treatment because their flare is severe. That is what we believe is our addressable patient populations, patients that have severe acute gouty arthritis flares who can benefit from an alternate treatment options. That puts us at 285,000 patients.
Similarly, we've illustrated across multiple sclerosis, rheumatoid arthritis, sarcoidosis, and nephrotic syndrome, the addressable patient populations. The significant multi-year opportunity comes from the fact that across both products, each of these indications are significantly under-penetrated. There is a large opportunity across years to continue growing and serving patients that we have. We are investing in Cortrophin Gel to build momentum in 2026 and beyond. What are we doing? We're investing in high ROI. We're doing three things. We're investing in high ROI commercial initiatives, such as the focused efforts to continue the momentum in the indications we had started with, which is in nephrology, neurology, rheumatology, and pulmonology as the ACTH market expands. This year in the mid-year, we will launch a new 90-person organization dedicated to acute gouty arthritis flares that targets primary care and podiatrist offices.
In addition, we'll realize synergies with our integrated ophthalmology team. Second, we're enhancing convenience. We launched a prefilled syringe in 2025 and have seen significant adoption of that form or presentation, and we're continuing to evaluate opportunities to enhance patient convenience. Third, we're generating scientific and clinical evidence. We're advancing a phase IV clinical trial for Cortrophin in acute gouty arthritis flares, and we have a robust pipeline of investigator-initiated trials across disease states. We continue to invest in preclinical data to show the differentiated mechanism of action of Cortrophin Gel. These investments have given us the tremendous growth that you've seen across the years and the significant multi-year growth opportunity that we have with the significantly under-penetrated therapeutics, sorry, therapeutic areas. Why are we building this 90-person organization for gout?
Number one, it's a large under-penetrated market opportunity. We're focused on the most severe patients, 285,000, who are currently treated with injectables for their flares. There is a need for new treatment for those patients that are not well-served by the first-line options. The comorbidities may limit certain treatment options. There's a large under-penetrated market opportunity. Second, we have a successful track record in gout. We are the only approved ACTH therapy to treat acute gouty arthritis flares. The gout indication generated approximately 15% of Cortrophin Gel volume in 2025, largely from nephrologists and neurologists. Sorry, and rheumatologists. The prefilled syringe and the subcutaneous option for Cortrophin self-administration enables flare readiness, unlike most injectable options. Third, our approach to serving more patients. In 2025, we ran successful pilots across 10 territories in primary care and podiatry.
By the middle of 2026, we deployed a new 90-person commercial organization. We will deploy a new 90-person commercial organization to target the high-priority PCPs and podiatrists who see the most severe acute gouty arthritis flares patients. We're also investing in evidence generation through the phase IV trial. We have a large under-penetrated market opportunity. We have a proven track record. We have proof of concept with the 10 successful pilots, and that's why we're investing to expand into severe acute gouty arthritis, serving primary care and podiatrist offices. Next, let me tell you about our second asset, ILUVIEN. ILUVIEN is a long-acting ocular therapy approved for DME, diabetic macular edema, and chronic non-infectious uveitis affecting the posterior segment of the eye. DME is a disease that causes...
is the leading cause of vision loss in diabetic patients, with approximately 4% of diabetic patients de-developing significant, clinically significant macular edema. There are more than 50,000 patients in the U.S. that are not well-served by anti-VEGF therapy, which is the standard of care. There's only less than 5,000 patients that are starting annually for DME for ILUVIEN. There's significant opportunity for growth. There is strong global clinical evidence in DME, which was further supported by the NEW DAY clinical study results, which we released last year. 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. There are more than 75,000 patients in the U.S. that are candidates for treatment, and steroids are the standard of care.
We have less than 5,000 patients starting annually for ILUVIEN, giving significant headroom for growth. ILUVIEN is the only longest-acting ocular therapy approved for DME and chronic NIU-PS, with 36 months of continuous microdosing of fluocinolone acetonide in patients with retinal disease. It's an intravitreal injection that microdoses fluocinolone acetonide. In 2025, we returned ILUVIEN to growth by leveraging established commercial and patient access initiatives, we will carry this momentum forward. We have new strategic investments in marketing and medical affairs to support increased awareness of the NEW DAY clinical data. We've established coverage for both DME and NIU-PS with ILUVIEN, we merged both indications into the ILUVIEN label, enabling the HCPs to use one product across both indications.
We've also grown the use of alternative access channels to navigate the market access challenges for Medicare patients, and we strengthened our commercial team and further enhanced our promotional efforts. I'll move to our Generics business. Our Generics business drives strong cash flow generation with superior R&D capabilities, U.S. manufacturing footprint, and operational excellence. We've delivered very strong growth over the last five years and are, you know, equipped to continue delivering growth and cash generation with our Generics business. In 2024, we grew the business 12%, and in 2025, we grew the business 28%. We have a robust pipeline in place to deliver 10-15 new product launches annually. We invest a high single-digit % of Generics sales into R&D to support this business.
We have a diversified portfolio of 125 product families with the largest product expected to account for less than 5% of Generics revenues in 2026. We have very low concentration in the Generics business. As you can see, a very different business than the two assets in rare disease that are generating north of $600 million in sales. Our Generics business is fueled by a strong operational backbone with a focus on cost efficiency. We have three U.S.-based manufacturing sites, two in East Windsor, New Jersey. Sorry, one in East Windsor, New Jersey, and two in Baudette, Minnesota, with a strong GMP track record, all sites currently in VAI or NAI status. We've manufactured and supplied over 2.5 billion doses of therapeutics in the last two months.
That's right, $2.5 billion with a B doses of therapeutics in the last 12 months. We have a systematic approach to reducing raw materials and finished goods cost and leaning out corporate spend to remain competitive in our Generics business. We have a strong U.S.-based manufacturing footprint, with over 90% of our revenues come from finished goods that are manufactured in the U.S., and only 5% of our revenues have a direct reliance on China. These are pictures of our three sites across East Windsor, New Jersey, and Baudette, Minnesota. In summary, ANI is well-positioned to deliver long-term growth and value creation. We're accelerating our transformation into a leading rare disease company. We're using our virtual cycle of growth with cash flows that are generated by continued excellence in Generics R&D and operations and reinvesting that into rare disease.
We're executing a disciplined capital allocation strategy. These are our 3 2026 strategic priorities. We enter 2026 with financial strength, with over $286 million of cash on the balance sheet and a 2025 year-end net leverage of 1.5x debt. Obviously, that will continue to delever as we generate cash. A 2026 adjusted non-GAAP EBITDA of $283 million at the midpoint and sales in excess of $1 billion. Rare disease will account for 60% of our total revenues in 2026, with our lead asset delivering 60% year-over-year growth and our strong Generics cash flows further enabling investments in our rare disease business. We look forward to updating you on our progress as we accelerate ANI's transformation into a leading rare disease company. Thank you once again for joining us this morning.
Thank you very much. I guess we'll just head over then to the breakout, and we'll do questions, Q&A in, Amarante 1.
Sure.
Right after this.
Thank you.