Good afternoon. Welcome to the Jefferies London Healthcare Conference. My name is Dennis Ding, Biotech and Spec pharma analyst here at Jefferies. I have the wonderful pleasure of having the CEO of ANI Pharmaceuticals here, Nikhil. Welcome. Obviously, a very exciting story, I think, ANI, a very exciting growth story. For people who aren't familiar with ANI, can you just kind of talk high level about the various franchises within the business and the growth that you guys have seen this year, and maybe even how you're thinking about 2026 as well? Sure. Good afternoon, everybody, and thank you for joining us. Dennis, thank you for having us at your conference. Yeah, you know, ANI is a growing, profitable biopharmaceutical company with a large focus on rare disease. We have three business units that create a virtuous cycle of growth, which I will get into shortly. Our primary area for capital allocation and the largest driver of our growth is our rare disease business, where we have two assets that are growing and sustainable, operating in large, addressable patient populations. Our lead asset, Purified Cortrophin Gel, is used for autoimmune indications across multiple therapeutic areas: rheumatology, nephrology, neurology, pulmonology, and ophthalmology. Our second asset, ILUVIEN, is used for retinal diseases, which are diabetic macular edema and non-infectious uveitis affecting the posterior segment of the eye. Both drugs have longevity or sustainability, as well as growth, as they are both operating in or used for indications where they have large, addressable patient populations. When you think of ANI as a whole, the second part of our business is our generics business, which has been driving strong growth over the last four to five years. The strength of our generics business is driven by our strength in R&D, our operational excellence, our U.S.-based manufacturing footprint, where we have three manufacturing sites in the U.S., and also our strong GMP track record. The way we think about these two businesses, along with our brands business, is this creates a virtuous cycle of growth with our Generics and our Brands business generating EBITDA and cash flows that we reinvest to drive growth in our rare disease business. When you think of our company overall, our guidance for 2025 is total company revenues of $854 million-$873 million, which reflects a 39%-42% year-over-year growth, of which organic growth is 34%-37%. Then you look at total adjusted non-GAAP EBITDA of $221 million-$228 million, which reflects a 42%-46% year-over-year growth. If you look at total adjusted non-GAAP EPS for the total company, that's $7.37-$7.64, again, 42%-46% year-over-year growth. Strong foundation to build in 2020 to build as we go towards 2026 and beyond. Thank you, Dennis. Got it. Okay. If we take a step back, rare disease, generics, right, highly profitable. ANI has historically never been a rare disease company. It has been a generics company. What drove the decision to go into rare diseases with Cortrophin several years ago, but then also doubling down in the area with the Alimera purchase, which gave you guys the ophthalmology assets? Right. We picked rare disease as a strategic area of focus. I've been CEO of ANI for five years. That's one of the early decisions that I made to focus on rare disease, knowing that my predecessor had done the acquisition of Cortrophin Gel from Merck, bought a dormant NDA, and then we basically worked towards getting that to the market. A lot of that work, again, was started before I joined ANI. Once we got Cortrophin approved on October 29, 2021, and then launched it in early 2022, we built a rare disease organization from scratch. Now, as we expanded, we grew it to about $200 million in the third year, which was last year. This year, our guidance is $347 million-$354 million, so 75%-78% growth. Again, this is for our lead asset. As our lead asset was gaining traction, we thought about how do we increase the scope and scale of our rare disease business and picked an indication, ophthalmology, which was a priority therapeutic area for us to "double down on," and then went and secured the Alimera assets to expand scope and scale of the rare disease business, leveraging an area where we had Salesforce synergy. Yeah. Okay. So we have to talk about Cortrophin. Yep. Right? One of the single biggest and most important value drivers of the company. It's a product that not a lot of investors are too familiar with because it is approved for many, many, many different indications. Just remind us where exactly it is used and what are some of the key indications that make up the revenue base. Sure. So Purified Cortrophin Gel is a porcine-derived product. It is used for autoimmune diseases where, as a late-line treatment for autoimmune diseases, patients do not have other options and they show either a bad side effect profile or are refractory to steroids. That is the patient profile. In terms of the autoimmune indications that we have been focused on since launch, it is rheumatoid arthritis, nephrotic syndrome, multiple sclerosis, acute gouty arthritis, in pulmonology, sarcoidosis, and then in ophthalmology, it is uveitis and keratitis. As you correctly pointed out, these are multiple indications across therapeutic areas. We have to be thoughtful about how we have gone about capturing those opportunities. Okay. And I guess just to talk about the guidance that you guys gave for Cortrophin, right? Yeah. Is this the third or fourth time you raised guidance for Cortrophin? Yep. Something like that? What is really driving that growth? How does your outlook look different today than when you initially gave guidance back in January? Sure. The primary driver of Cortrophin growth is the underlying patient demand. We spelled out multiple different indications. When you look across these indications, the addressable patient population, so the patients that can benefit from Cortrophin as an alternative treatment option that have tried other treatment options, including steroids, that addressable patient population is very large compared to what is being treated today. If you take acute gouty arthritis flares, there are 285,000 patients that we believe are in the addressable patient population. This is a small subset of the 9 million patients in the U.S. that have gout. We are taking a handful of patients that essentially currently use injectables for treating their flares. They have acute flares and the number of flares that they have per year, right? That is how we define the addressable patient population. That's many magnitudes higher than anything that's being treated today. That's the same is true across multiple sclerosis, rheumatoid arthritis, nephrotic syndrome. The underlying addressable patient demand is, addressable patient population is, large across indications. What has happened? We've had strong growth. I mean, our trajectory has been strong year over year. We did $42 million in the first year, $112 million in the second year of launch, $198 million last year. This year, our guidance is $347 million-$354 million. Part of being able to address this patient population is being able to reach prescribers that can reach these patients. To do that, we have to expand our Salesforce. We made two, let's call it, major Salesforce expansions over the past year and earlier this year that are bearing fruit. First is with the ophthalmology acquisition, we now have a dedicated Salesforce in ophthalmology that details both Cortrophin and ILUVIEN. Then second, earlier this year for our core indications, right? We have a combined Salesforce that goes into rheum, neph, and neuro. For those indications, we expanded that Salesforce by about 20. Those two Salesforce expansions drove that growth and, of course, the supporting SG&A. What that's doing is allowing us to reach more prescribers. Almost half of our prescribers that wrote Cortrophin had never written an ACTH drug before. They're new to the category. Our ability to talk to them about the benefits of ACTH therapy, who are the appropriate patients as a late-line therapy option for appropriate patients, that's driven our growth. Yeah. I guess thinking about the last 12 to 24 months, what changed, right? It felt like a light switch was turned on, and all of a sudden, growth just accelerated. And not just for Cortrophin, but also the competitor product in the market to Acthar for Mallinckrodt. They have seen tremendous growth as well, which also validates the market and is good for you too. I am just wondering, was there any specific things that happened over the last year or two that really accelerated things? Sure. I think there are multiple. There's not any one thing that's happened. It's multiple growth drivers. Number one, as I said, underlying addressable patient population and the underlying demand is the primary driver. Our ability to address that by expanding resources and then Salesforce is number two. Third is we've also been investing a fair bit in clinical evidence generation. We're doing that of two types. Number one is we've launched and completed multiple preclinical studies that show the differentiated mechanism of action of Cortrophin versus the other therapeutic options. We've been able to publish those, right? That gives physicians additional confidence in or figuring out where to use Cortrophin in their treatment algorithm, right? We've done this across multiple disease states. We did a preclinical mechanism of action study in uveitis, which got published. We've done a preclinical mechanism of action in a study in membranous nephropathy that has been published. In fact, there's a manuscript that's been created for that. That has been an important step or important contributor. We're also generating now in acute gouty arthritis flares, which accounts for about 15% of our volume. We're also doing a phase IV study across 140 patients, which, again, we believe will support physician treatment decision-making, as well as hopefully get Cortrophin to be a part of the treatment guidelines. In addition to that, we've been investing in R&D to drive patient convenience. The original launch of Cortrophin was with a 5 ml vial. It's self-administered at home. When we started foraying into gout, we realized that the appropriate presentation would be a 1 ml vial that would support administration in the office as well as be the appropriate dosage. We launched a 1 ml vial. More recently, earlier this year, we launched the prefill syringe. What the prefill syringe does is it simplifies the administration process by reducing one step in administration. I think that while initially we had thought that the prefill syringe would be used by patients that have dexterity issues or visual impairment, what we've seen is a much broad-based adoption of the prefill syringe. Approximately 70%+ of our enrollments have been for the prefill syringe, and we see that volume increasing significantly going forward. As you can see, there are multiple growth drivers. It's across specialties, right? A large portion of our growth coming from our core indications of rheum, neph, and neuro. Also from 42% quarter-on-quarter growth for our ophthalmology indication, and then also in 15% of our volume coming from acute gouty arthritis flare. We have really strong opportunity across the board, and it's about prioritizing and driving that growth. How big do you think the market can be? Because when you look at 2025, it's already north of $1 billion. Nikhil, you've frequently pointed to Mallinckrodt achieving $1.2 billion in 2017. How much more room is there? Yeah. Yeah. So look, I think that it has been a good thing for the category that both the competitor and us have been focused on addressing the patient population that can benefit from ACTH and are making efforts to expand that patient population. While we're growing, they are achieving strong growth through, and that's a good thing for increasing awareness of ACTH. When it comes back to your question of where this can go, look, if you add their guidance and our guidance for the full year, we're already close to the previous peak. We're at about $993 million. You take the implied Q4 guidance as a run rate, and then we're past the previous peak. I think the previous peak is from the past. It didn't have acute gouty arthritis flares. It was burdened by a number of other factors that are not related to the efficacy of the drug, right, or of the category. As we think about it, I think the frame, and that's why we've been sharing more and more information about the addressable patient population across indications, that's the patient population that is the source of the underlying demand, and that's what the anchor is for growth. We believe there is strong multi-year growth opportunity for Cortrophin and for the category. We're investing in clinical evidence generation, R&D to enhance patient convenience, and high ROI commercial efforts to address this significant multi-year growth opportunity. Can you talk a little bit about access? Sure. We entered this category in 2022, and we immediately started partnering with payers and PBMs to improve the access and to partner with them to get it to the appropriate patients. We've been consistently doing that and working with the payers and the PBMs to expand the access. Yeah. Okay. Some of the doctor feedback that we've gotten is that they look like Cortrophin, Acthar. It's a very effective drug. We like it that these patients have no other options. There is a lot of fatigue in terms of payers actually denying these prior auths, right? I'm just wondering, as a company and as you're thinking about 2026 and 2027, what are ways to kind of educate payers or what kind of initiatives will you start to kind of turn that around and kind of erode some of this fatigue that doctors are having? Sure. I think we tackle this on multiple fronts. I think first is for the physician offices, we provide the appropriate levels of support to tackle the work that goes with the patient filling out a two-page enrollment form, then working with the payers to get the prior authorizations and other clearances. We have a field support team to work with the physician offices to support that, as well as nurse specialists that work with the patients and the specialty pharmacies to coordinate distribution to them. I think continued efforts to support the physician offices appropriately to work through the approval process. We are continuing to do that, continue to refine that as we move forward. The second is clinical evidence generation. I think that plays a big part, not just in physician treatment, but also on the payer decision-making on the category and giving them more and more confidence on what are the appropriate patients that this drug can be used for. What's typically the reason that payers would deny access to Cortrophin or Acthar when a patient has failed four or five different lines of therapy and there's no other options? I'm just curious. Yeah. I think it'll vary by indication, and it'll vary by payer. I don't think that there's a general answer for that. What I would highlight is, in addition to working through this process, we also have a very meaningful Patient Assistance Program to ensure that the appropriate patients get the therapy that they need if they're not able to get it from an access perspective. That's something that we've continued to remain committed to, right? Okay. As we think about this year, one of the major changes, at least through reimbursement or pricing, etc., was the Medicare Part D redesign, right, that lowered the maximum catastrophic out-of-pocket limit from $8,000 to $2,000. That's generally a big tailwind for these very expensive products, right? That was a tailwind this year relative to 2024. What about 2026, right? Once you anniversary this benefit, could that actually cause growth to moderate a little bit? Maybe at the same time, can you qualitatively describe how big of a benefit that IRA Part D redesign was to this year's growth? Sure. For us, the IRA Part D redesign was a moderate tailwind. We did see the benefit of patients having improved access by having a max out-of-pocket at $2,000 and the ability to smoothen that payment across the year. We did see the benefit of that in terms of improved access. The reason why the tailwind was moderated is because we also have the rebates that are due. Medicare has two parts: non-low-income subsidy and low-income subsidy. For the low-income subsidy part of the business, we qualified for the non-specified manufacturers rebate, which we can smoothen over the next five years, right? This year, we paid 1%, and that will increase to 2% next year, and then going up to 20% over five years. For the non-low-income subsidy part of the business, we had to pay the full 20% rebate, right? In 2025, therefore, the benefit was moderate. The tailwind was moderate. As we go into 2026, we expect the same to continue because the only thing that really changes is the rebate on the non-low-income subsidy part of the business goes from 1% to 2%. There is, I guess, a pricing or gross-to-net 1% change. Overall, from 2025 to 2026, we do not expect significant changes from a Medicare and IRA perspective. Okay. I guess in the big picture, it doesn't really matter that much, right? I guess the Part D redesign in 2025 was just kind of like the spark because when you look at the market, the patient growth, the number of prescribers, they're all kind of trending in the right direction. They're all growing substantially. That's right. That's right. We continue to see the strong underlying demand. I think I might have said the word addressable patient population already 10 times in this conversation. That is really there are patients that have tried multiple, as you said, four or five different therapeutics on multiple lines and are still suffering from these autoimmune indications. Those are appropriate for, obviously, as decided by the HCP, for Purified Cortrophin Gel. Sure. Okay. We only have a few minutes left, but can we talk a little bit about ILUVIEN and just sort of the progress that you made there? Yeah. We think of ILUVIEN 2025 as a bit of a reset year for ILUVIEN. The acquisition that we did has had the benefit of us having this sales force in ophthalmology, which was our intent. We're seeing the benefit of that with the ophthalmology sales for Cortrophin. There's been a 42% sequential quarter-over-quarter growth, and we're building momentum there. In terms of industrial logic for building the ophthalmology area, that persists, and we're seeing the results of that. On ILUVIEN specifically, we've talked about this as a reset year for ILUVIEN as we're working through multiple topics. First is from a Medicare part of the business. This is covered by Part B. There's been a drying up of funding for the foundations that support copay for Medicare patients, and that's persisted and has had a significant impact through the year. In addition, we've had to transition ILUVIEN to a combined label. Now, the good thing is both these issues, I guess that's why we think of 20 and sorry. And the third is we have had to work through the sales force organization as we've integrated the sales forces. As we head to 2026, we believe that the 2025 guidance of $73 million-$77 million will serve as a baseline and will grow from there. Our growth will come from the following. One, again, addressable patient population 10 times for both DME and [NIU-PS] than what ILUVIEN is being used for treatment today. Two, our organization is more a commercial organization is more experienced and able to have a positive impact and engagement with the HCPs. They have new marketing materials as well as a ramped-up peer-to-peer speaker education program. Third, our new day clinical study for diabetic macular edema. Those results we're contextualizing and increasingly sharing with the HCPs to drive to make sure that they understand and support their usage of ILUVIEN for the treatment of DME. Lastly, from the Medicare market access issue, our assumption is that the status quo will persist. We have been exploring different alternatives. In Cortrophin, we use the Part D approach and through specialty pharmacy. Essentially, we have been working with physician offices to drive and getting them to, for patients that have the Part D benefit, to use that benefit. We have seen adoption. We have seen growth in that pathway. We have also seen adoption by major retina practices, which gives us hope that if the Medicare copay support does not come back in the next year, then at least this pathway will be explored by us as a good subset of physician offices. That gives us confidence that in 2026, ILUVIEN will build on the reset year that we had in 2025. Perfect. I think that's all the time that we have today. Thank you, Nikhil, for joining us and excited for 2026. Yeah. Thank you, Dennis, and thank you, investors, for joining us.