Until people catch on. All right, good afternoon, everyone, and let's kick things off. This is David Amselheim from the Piper Sandler Biopharma team, and welcome to our 37th Annual Healthcare Conference. So our next company, fireside chat, is ANI. Lots to talk about. We have Nikhil Lalwani, CEO. Thanks, Nikhil, for joining us. And I wanted to start off high level, just for those in the audience and listening in who might be new to the story, just go through an overview of the company. It's evolved considerably in recent years, particularly given the focus on Cortrophin Gel and more of a broader focus on brands. Talk about the key strategic priorities that you're focused on these days. Sure. Good afternoon, David, and thank you for having us, and thank you, everybody, for taking time to join us at this conference, at the Piper Conference. I really appreciate it. So ANI is a growing, profitable biopharmaceutical company with three business segments. We have our rare disease business with two growing, durable commercial assets, Purified Cortrophin Gel and ILUVIEN. Purified Cortrophin Gel is used for the treatment of certain autoimmune indications for patients that are appropriate and that are refractory to steroids and other treatments. ILUVIEN is used in the treatment of NIUPS, non-infectious uveitis, in the posterior segment of the eye, as well as diabetic macular edema. Rare disease accounts for approximately half of ANI's estimated 2025 revenues. We also have our generics business, which has been delivering strong growth over the past few years. The generics business is driven by a strong R&D capability that leads to a cadence of new product launches. We have strong operational excellence and execution, as well as a U.S.-based manufacturing footprint. And then we have a brands business in addition to the generics business. So we believe across our three businesses, we have what we call a virtuous cycle of growth, where we take EBITDA and cash flows from our generics and brands business and reinvest that to increase the scope and scale of our rare disease business with Cortrophin Gel and Iluvien. Just to give some numbers, when you look at it on an annualized basis, our guidance for 2025 is revenues of $854 million-$873 million, which is 39%-42% growth, of which 34%-37% growth versus 2024 is on an organic basis. When you look at our EBITDA, the adjusted non-GAAP EBITDA guidance is $221 million-$228 million, which is a growth of 42%-46% over the prior year. We have a strong balance sheet with about $263 million of cash as reported on 09/30 and trailing 12-month net leverage of 1.7. So we're in a good position to continue building on the momentum that we have. And from a strategic priority perspective, our top priority is to expand scope and scale of our rare disease business and then to keep this virtuous cycle of growth going by investing in R&D. So percentage of sales in our generics business and R&D to generate the EBITDA and cash flows from generics and brands, which we utilize for our rare disease business. So you sort of answered my second question, which is on your appetite for expanding your rare disease presence. But I'll ask it again and maybe go through it in a little more depth. Talk about how you're thinking about additional acquisitions in terms of size, in terms of where you take net leverage to if you saw something that you have conviction on. Ultimately, help us better understand how you're thinking about M&A as a strategic priority. Sure. I would start by saying that we have a significant amount of growth potential in our assets organically, and so our priority one is to ensure that we get the assets that we have internally to full potential, which is around with Cortrophin Gel, with ILUVIEN, where the addressable patient populations are more than 10x of what is currently being treated, so there is substantial growth opportunity organically, and so the second thing I would say is that we are under no pressure because we have such great organic growth potential, we do not have pressure to do a deal, so we're continuing to scan the market. In terms of the types of deals we're looking for, we're looking for deals that will add to the scope and scale of our rare disease business. We are oriented towards commercial assets, assets that limit the amount of regulatory we may take on some regulatory risk, but unlikely to take on clinical risk at this time. We are looking at assets that can of a size that build on, if you say, of our guidance in the year, about half the we said about half the sales come from rare disease. So it's a $425 million-ish rare disease business, assets that would add meaningfully to that, but at the same time, not over-lever. If you look historically at ANI's leverage ratios, we go north of three for a short period of time with a clear path to deleveraging. And then obviously, we have the cash on the balance sheet. So I think that that's how I would think about. Now, from a therapeutic area perspective, with the Alimera acquisition, we were very focused on finding an asset that was synergistic from a call point perspective with Cortrophin Gel. And in ophthalmology, we got that with the Alimera acquisition. As we look ahead, seeing the significant opportunity that we have with Cortrophin Gel across indications, we are oriented a bit more towards finding an asset that is not necessarily synergistic from a call point perspective with Cortrophin Gel, but leverages the rest of our rare disease capabilities, such as medical affairs, market access, patient support, specialty pharmacy distribution, all the stuff that leads from enrollment to fulfillment. But it's also a core capability of ours. If that requires the deployment of a new sales force in a rare patient population, then we'd absolutely believe that we are confident and have the ability to capture that and ensure that there are adequate efforts being put to maximize the value of Cortrophin Gel by getting Cortrophin Gel to the appropriate patients in need. All right. That's helpful. Let's dive more into Cortrophin Gel, so as I think back about this space, and there's a lot of history here, the ACTH space has really returned to growth, and at one point, Acthar was a billion-dollar-plus product pre-pandemic, and so we're sort of now seeing a nice growth runway here. Where do you see this space going in terms of sales potential? Sure. If you look at the competitor's guidance and our guidance, the market in 2025 will be about $993 million, which is basically close to $1 billion. And I think what's very important to understand is the addressable patient population. We lay that out across multiple indications in our deck for investors that are new. But if I take the acute gouty arthritis flares indication as an example, when you work down from the number of patients that suffer from gout, that need treatment or resolve on their own, and then end up with injectable treatments for their flares, we take that as our addressable patient population, and that works out to about 285,000 patients. We're treating a very small fraction of that patient population as an example. So when you talk about the opportunity, and I'm just taking one indication, and this is replicated across multiple indications, ACTH can be an appropriate treatment option as a late-line therapy for patients who are refractory to steroids and also for whom other treatments may not be working optimally. So the addressable patient population is significant. And even across the competitor and ourselves, we're serving only a small portion, a fraction of that patient population. So we don't give a peak sales number, but we believe in the strong multi-year growth potential for Cortrophin Gel and for the ACTH category. And are continuing to do our part in investing to achieve that strong multi-year growth. Looking at Cortrophin Gel uptake specifically, how much of that is coming from doctors who have been using Acthar Gel previously? How much of that is coming from docs who are new to the category? Yeah. So approximately half of our prescribers were naive to ACTH, and had never written an ACTH prescription before they wrote their first prescription of Cortrophin Gel. The growth is coming from across specialties from rheumatology, neurology, nephrology, which are the core indications we focused on at launch. We then diversified into, then we had a couple of targeted teams going after pulmonology. We were seeing growth there too, as well as in ophthalmology, where we started with a small team and then expanded through the Alimera acquisition and now have a larger sales footprint detailing both Cortrophin Gel and ILUVIEN into ophthalmologists as well as retina specialists. So we see growth across indications, a bit more specificity around that. When you look at acute gouty arthritis, this is an indication that we have and the competitor does not. For that indication, we have seen substantial growth since launch. Approximately 15% of our volume comes from acute gouty arthritis. When you look at ophthalmology, we are seeing revenue synergies from the acquisition and the deployment of a larger sales force for ophthalmology. On a sequential basis, we saw 42% growth quarter on quarter in the volumes in ophthalmology, although off a smaller base, and then a substantial portion of our growth has come from the indications that we focused on at launch, the core indications, the core specialties of rheumatology, nephrology, and neurology, where we had done a sales force expansion earlier in the year, so we're seeing really growth across all specialties and growth in new prescribers as well as existing prescribers. Then, just going back to the main question, half of our growth comes from prescribers that had never written an ACTH drug before they wrote their first prescription of Cortrophin Gel. And so we believe that that gives reason to believe that we can reach this larger addressable patient population as we engage with more HCPs and work with them to understand who are the appropriate patients for Cortrophin Gel. You mentioned pulmonology as well. I think that's been a growth area as well, sarcoidosis. Can you talk to the growth trajectory there? Right. So yes, it has been a growth driver. What's also interesting about pulmonology is patients then stay on therapy for a longer period of time. So when you look at number of vials per patient, a patient on sarcoidosis stays on the ACTH therapy for a longer period of time. And so it's an interesting area for us. I think sarcoidosis has also not seen new innovation for some period of time. So I think that that makes it also interesting. At this point, our commercial footprint has two small teams, one in the east and one in the west, that is focused on pulmonology. And we keep evaluating how to expand our efforts in this area as we look at across therapeutic areas. Coming back to gout, acute gouty arthritis, I know you said it's about 15% of the mix. How big of an opportunity do you envision here? I would imagine the patient penetration is pretty limited. I mean, this is a big population. It's a big unmet medical need. So how do you think about that opportunity, particularly considering that the competitor isn't indicated here? Right. So that is an important point, that this is an indication that we have and the competitor does not have. The competitor has one indication. They have infantile spasms that we do not have. So as we think about areas where we can invest, I think acute gouty arthritis flares has an unmet patient need, right? I talked about 285,000 patients that use injectable treatments to address their flares. So their flares are needing. So there is a significant opportunity in acute gouty arthritis flares. What's also interesting for us is when the prescriber that's using Cortrophin Gel for the first time to address acute gouty arthritis flares also then ends up considering Cortrophin Gel for other indications. So I think that's also been an interesting learning for us. So now what we're doing is we've launched as we think about supporting the use of Cortrophin Gel in acute gouty arthritis flares, we're also investing in clinical evidence generation. So we launched a phase 4 study, which is a 150-patient study, which will look at the use of Cortrophin Gel in patients with acute gouty arthritis flares. And we believe we'll give additional evidence for physicians to consider the use of Cortrophin Gel in the treatment of acute gouty arthritis. Yeah. Wanted to switch gears and talk about the prefilled syringe and the impact that that has had, and where do you see this driving the business, or maybe asking the question differently, what does the uptick look like already this year, and how do we think about the growth runway or how it contributes to the growth runway of Cortrophin Gel over time? Right. So when we launched the prefilled syringe, the intent was to enhance patient and physician convenience by offering an option with a reduced step in the administration process. Cortrophin Gel, the original presentation was a 5-mL vial where you needed one needle. So you have one syringe, but you need one needle to extract the drug and then another needle to inject the drug. So this reduced the step in the administration process by having a prefilled syringe. And so our original intent was for this to be used for patients that had dexterity issues or issues with their eyesight. And as we've learned through the launch we did earlier this year of the prefilled syringe, there's a much wider widespread adoption of the prefilled syringe, with more than 70% of the new cases initiated being for the prefilled syringe. And so we believe that there'll be a much more substantial move towards the prefilled syringe being the dominant SKU of presentation in the future. Are there any other therapeutic specialties that you're considering focusing on beyond your current focus regarding Cortrophin Gel? Not at this time. I think that there is substantial growth opportunity across all the indications that we're targeting, and there are many of them. And therefore, we believe that it's important to continue working on getting Cortrophin Gel to the appropriate patients in these therapeutic areas first before we expand further. You alluded to the sales organization earlier in our discussion, but could you talk about sales force sizing right now? How many boots you have on the ground, so to speak, and potential for further expansion down the road? Sure. I would love if our competitor started doing this too. So we have about 60-ish sales reps that detail into three specialties: rheumatology, nephrology, and neurology. We have two small teams that, one in the east, one in the west, that detail into pulmonology for sarcoidosis. And then we have that combined sales force of about 45-ish reps that detail into Cortrophin Gel and ILUVIEN into ophthalmologists and retina specialists. So that's the sizing of our sales force as it currently stands. Yeah. So I wanted to ask about access, payer access here. So how should we think about access currently? And then also, as the category grows, payers are sophisticated. So how do you see access evolving as the sales footprint of the category continues to grow? Sure. So we went to payers and PBMs early on in our launch and collaborated and partnered with them to improve the access for patients in this category. And we brought competition to a category that for decades had no competition. So I think payers and PBMs recognize and view us in that light. As far as where the ball is at right now, it's largely parity access for both players in the category. And I'll probably have to stop there to find a balance between sharing information that's helpful to investors and sharing information that's competitively sensitive. But I think overall, we are, I think, doing things to ensure that there is greater access. We have taken steps since we launched and are continuing to take steps to keep the access where it is and improving. Maybe I'll ask the question a little differently. Because when you see a category where there's a lot of volume potential, it's not uncommon to see some concessions on price as a means of driving greater access. I mean, we see this in a lot of mass market indications. Is that the way we should think about Cortrophin Gel and your competitor? Yeah. This is where we strike the balance between sharing information that's competitively sensitive. Still have to ask the question. You can ask the question. Yes, you can. Yeah. Soon I will look forward to the competitor's response to on the question. All right. I'll leave it there. So let's move over to Iluvien. So you lower guidance. I guess my question here is, what are you doing to drive the product to improve the trajectory of that product? Yeah. Thank you for that question. We see 2025 as a reset year for ILUVIEN, and as we move forward into 2026, we're looking forward to three things. One is we have a strengthened commercial organization with new marketing material as well as a ramped-up peer-to-peer education program, which we will help create awareness of ILUVIEN both in DME, diabetic macular edema, as well as NIUPS, non-infectious uveitis affecting posterior segment of the eye. Second is, with the NEW DAY study results, we're ensuring that the context and learnings from the study, which is a 300-patient-plus study across ILUVIEN and Anti-VEGF, are shared earlier in the treatment paradigm for DME, shared with physicians to support their usage of ILUVIEN in the treatment of DME. We have very positive feedback from physicians that we have already shared the results with, whether it be at AAO, American Academy of Ophthalmology, at ASRS, the American Society of Retina Specialists, and we keep going from there. So that will be an important for a drug that's been in the market for an extended period of time, this rich body of data, sharing those findings with more and more physicians, I think will be an important part of 2026. So that's number two. And then number three is, obviously, the big factor impacting 2025 sales was the Medicare copay support issue. And what we're doing, and we've seen success with in 2025, is with retina practices going to patients that need the support but have the drug benefit and getting the drug through the Part D program. That's how we use Cortrophin Gel. Oh, sorry. That's how we commercialize Cortrophin Gel. And so, making that as an option. And what we've seen is a significant uptick in all the small volumes, but uptick in the practices that are willing to adopt it, including some larger reputed practices. And we believe that if in 2026, and that's our baseline assumption, that the funding does not come back, there'll be greater adoption by practices to consider this Part D pathway. Got it. So I want to spend the minute we have just quickly talking about generics. What will be the growth drivers for generics in 2026? And can you point to any specific product launches and just talk generally to cadence of new launches as we move in through 2026? Our generics business is really driven by strength of our R&D capability, number one, where we have a cadence of 10 to 15 launches every year. And that is the single strongest driver of our growth. In addition to that, there's strong operational execution. We have three manufacturing plants that are all based in the U.S., two in Baudette, Minnesota, and one in East Windsor, New Jersey. We supply 2.4 billion doses to patients in the U.S. And the three plants, not only do we have strong operational execution, but we have a strong GMP track record with all three plants in good status with the FDA. So I think those three things, the R&D capability, the strong operational execution, and the U.S.-based manufacturing footprint puts us in a great position as we keep growing our generics business. All right. Terrific. Well, we're out of time. Thanks, Nikhil. Thanks, everyone in the audience.