All right, I think we're ready to get going with our next session here. So thanks, everyone, again for joining us for our conference this year, the inaugural Healthcare Innovation Conference here for Guggenheim, day three. And still a lot of energy and excitement, so that's good, good to see. I'm Vamil Divan from the one of the biopharma analysts here at Guggenheim. For those of you who don't know me, joined on the stage here by Daniel Krizay, one of the other members of the team. And next up here, we have ANI Pharmaceuticals. We have Nikhil Lalwani, the president and CEO of the company, and Steve Carey, the CFO of the company. So it's been a pretty active time for ANI. You've been doing some, obviously closed the Alimera Sciences deal, reported earnings, and a lot of sort of continued progress. Maybe I'll just start with a more broader question. So we're coming out of the quarter, just an overview on the progress you're making in your various segments, and then we'll dive deeper into each one. Sure. So good morning and thank you, Vamil. Thank you to you and Daniel for having us here for the inaugural Healthcare Innovation Conference. Yeah, look, it's been, you know, we've had a strong quarter. We delivered $148 million in sales and saw strength across all business units. Our Rare Disease business unit, which will be the largest driver of our growth, has saw strong performance across our lead asset, Purified Cortrophin Gel, where we delivered, you know, $52 million in sales, $52.6 million in sales in the third quarter, as well as the two assets, the ophthalmology assets that we got from the Alimera Sciences deal, ILUVIEN and YUTIQ, were in the stub period, which is September 16th through year-end, sorry, through quarter-end, we had $3.9 million in sales. So strong performance from Rare Disease. Our Generics business continues to perform with, you know, high single-digit, low double-digit growth on the back of new launches largely. We have 16 new product launches that we've done this year, displaying our strong R&D capabilities. Also, it's supported by strong operational excellence and our U.S.-based manufacturing footprint, which has a strong FDA compliance track record. And then, you know, our established brands business is a strong cash flow generator, and that continued to contribute in the third quarter. So overall, really just strength across all business lines, with Rare Disease being the largest driver of growth. Yeah. So why don't we dive into that a little bit more? So Cortrophin, obviously, you have done very well with the launch. Again, sort of beat expectations and raised your guidance for the full year on this last quarter. Maybe you can just sort of share an overview of sort of the progress you've made there so far, where that growth is coming from, and what are you doing to sort of continue to strengthen that franchise and the growth it has? Oh, great. Yeah, Cortrophin Gel is a product that our lead asset in our Rare Disease front business is one that we're very excited about. It is on a strong multi-year growth trajectory. A little bit of history for those that are new to ANI and to Cortrophin. Purified Cortrophin Gel is a repository corticotropin, porcine-derived, that we acquired this NDA from Merck in September 2015. And we spent six years in development to bring this drug back to the market and launched it in January of 2022. At the time of the launch, the class, which is the ACTH class, which at its peak was $1.2 billion in 2017, had declined and had only one player in that class at the time. And that's when we launched. At the time of our launch, initially, we focused on three therapeutic areas. First is neurology with multiple sclerosis. Second is nephrology with proteinuria caused by nephrotic syndrome from FSGS, IgAN, as well as membranous nephropathy. And then third being rheumatology with rheumatoid arthritis, right? And that's what we focused on at launch. Since then, since launch, we have, you know, last year, between last year and this year, we've expanded into pulmonology and now ophthalmology. And look, we see growth across, right? We've seen growth across all indications, across the launch indications, as well as the new indications, and we see strong growth. We've obviously expanded the ophthalmology sales force with the Alimera acquisition. And, you know, if you talk about trajectory, you know, we did $42 million in the launch year 2022, $112 million in the second year 2023. And then this year, our guidance, which we gave, you know, a few days ago, is $196 million-$200 million, which is 75%-78% growth. As I said before, the underlying demand is from the patient pool, and the number of patients on therapy at this time is substantially lower than patients that were on therapy even when the drug was at, the class was at its peak a few years ago. So there is a significant multi-year growth opportunity here with Cortrophin Gel. Now, your next question was, you know, what are we, where is the future growth going to come from, as well as, you know, what are we doing to strengthen the franchise? So in terms of future growth, it's really from, you know, again, the patients across these indications are, at this time, significantly lower from patients that were on therapy even a few years ago. So that's, you know, that's a runway. And then second is, when you look at it from an epidemiological perspective, right? Purified Cortrophin Gel is used as a, you know, as a late therapy for patients with certain chronic autoimmune disorders that are either intolerant to steroids or that have, you know, yeah, that they're intolerant or, you know, for whom steroids don't work, right? And so when you look at it from an epidemiological perspective, that patient pool is substantially higher than even the patients that were on therapy a few years ago. So the growth runway is significant. Now, those are in the core indications that we were talking about. We also have the indication in acute gouty arthritis flares, which the other competitor in the category does not have that indication. And so that is an entirely new patient population. We launched a 1 mL vial for that. It's early days for the gout indication, but that's, again, over and above, you know, this category, I mean, just again, overall ACTH category. In this year, when it's back to growth, right, we'll grow about 20% or more than 20% to about $660 million, around, you know, ballpark-ish, if you add our guidance and their guidance. The market at its, the ACTH market at its peak was $1.2 billion. So the runway for growth is, again, significant. The third part of your question, Vamil, is what are we doing to strengthen the Cortrophin Gel franchise? Look, we're doing a number of different things, right? Number one is we expanded the indications that we were pursuing and, you know, put commercial teams behind it in pulmonology and ophthalmology beyond the launch indications of nephrology, rheumatology, and neurology. Second, we've tried to bring new product offerings, right, that address specific needs. Our original product is in a 5 mL vial configuration and it's self-administered at home. We've launched a 1 mL vial, which is appropriate for patients with acute gouty arthritis flares. Then more recently, we announced that we filed an SNDA for a prefill syringe to make it easier and reduce the number of steps needed for patients with dexterity issues and that make it easier for administering Cortrophin because it's self-administered. We were also working on other steps to increase patient convenience and reduce HCP pain points. We'll shed more on that as we move forward. That's, you know, expanded commercial team, number one. Number two, you know, investment in expanding the product offering, right, to cater to the needs of physicians as well as patients. And then third is we're increasing the body of scientific evidence that will support the use of Cortrophin Gel, right? So most recently, we published a couple of abstracts supported by Rujun Gong and the American Society of Nephrology. And that's, you know, those are steps in that, again, to increase the scientific evidence to support the use of Cortrophin Gel. So sorry for the long answer, but there were three questions, so. Yeah, that's great. So let me turn to Daniel. Just going to move off of Cortrophin to the new asset you've acquired. Sure. Yeah, definitely, so as we discussed, you guys recently expanded the Rare Disease franchise with the acquisition of Alimera Sciences and YUTIQ and ILUVIEN, so maybe if you could discuss this acquisition in a little more detail and maybe describe why this was the right acquisition for ANI. Sure. So thank you, Daniel, and good morning. ANI is committed to expanding the scope and scale of our Rare Disease business. What we were looking for at the time of the acquisition was, one, growing in durable assets. Second, so durable as in with extended, you know, exclusivity period. Second is in an indication area that is synergistic with Cortrophin, right? And then third is with peak sales of a certain range so that it's a deal that ANI could, you know, do with the capital structure that we had. Alimera Sciences is the right deal, was the right deal for ANI because it sort of ticked each of those boxes, right? The two assets, ILUVIEN and YUTIQ, have a long runway, both for exclusivity as well as for growth. That's number one. Number two is they were in the deal size that, you know, in the range of what we were looking for. And third, and probably most importantly, they were synergistic. The ophthalmology is an area that is synergistic with Cortrophin. And so what we've done now is we have a, we've expanded the sales force, the combined sales force to 46 reps. They had about 30 plus reps. So we have a combined sales force of 46 reps that are, you know, out promoting all three products, Cortrophin, ILUVIEN, and YUTIQ. And again, there's synergy in the call points as well as their synergy in other parts of the organization too. Yeah. Okay, great. And then maybe could you discuss the expectations for these products going forward? Sure, yeah. So ILUVIEN is indicated for diabetic macular edema, and YUTIQ is indicated for non-infectious uveitis in the posterior segment of the eye. And for both, we think that the patient population that can benefit from these therapies is substantially higher than is currently being treated. And we see these as double-digit growth assets. Yeah. Okay, great. So there's an ongoing head-to-head trial with ILUVIEN, the NEW DAY Trial in DME. Can you maybe discuss the details of this trial and when we should be expecting top-line data and what a positive trial readout would mean for the future growth of it? Sure, yeah, thank you. So NEW DAY is a trial. It's a 306-person trial that investigates the use of combination, ILUVIEN in combination with anti-VEGFs, right, for patients that suffer, that are indicated with diabetic macular edema. And the positive readout from this trial would allow for earlier use of ILUVIEN for patients with diabetic macular edema. Today, ILUVIEN is given to patients that have failed on multiple anti-VEGFs and then shown, you know, positive response to steroid. So it's used much later in the therapy. In the trial, there are two arms. In one arm, patients are given ILUVIEN right out of the gate. So these are early, early DME or naive to DME or naive to treatment DME patients. And they're given ILUVIEN. And in the other arm, they're given anti-VEGFs from day one. And in one arm, they're given ILUVIEN and then given anti-VEGFs. Again, they're investigating the combination or use of ILUVIEN earlier in the treatment cycle for DME patients. That will expand the patient pool that ILUVIEN is used for. Okay, yeah, that makes sense. I'd just like to clarify one thing though, that, you know, our deal case, when we did the deal, did not, was not anchored on a positive top-line results from the NEW DAY study. This is, you know, would be a significant, it would be upside on beyond that, yeah, yeah. Okay, yeah, understood. And you touched upon this a little bit, but maybe a little bit more specifically, can you discuss the longevity or the IP for each of your three Rare Disease assets? Yeah, yes. So we have a very interesting scenario with all three assets and similar. So Cortrophin, as I mentioned before, is a porcine-derived repository corticotropin. We've brought in an NDA back from Merck in 2015. While the, you know, so, and since we brought it back, we've strengthened the patent, the IP around it. We have a couple of new patents that go out till 2042, 2043. Having said that, it is a tough drug to genericize. We obviously, you know, have development capabilities, so we understand that. And because it's derived from the pituitary gland of a pig, that, you know, characterizing the API and characterizing the impurities, it's a, you know, it's tough to genericize. And so we see significant runway, whether it'll be two players as the class currently has. I think that, you know, that is our, so for Cortrophin, again, we see a very long runway and durability. When it comes to ILUVIEN and YUTIQ, the patent IP, you know, is, I think in the 2027, 2028 timeframe. But that was not the anchor of what we saw as durability. We see durability from it being both these assets being, again, tough to genericize. And the reason is the path to genericization for both these assets involves a three-year clinical trial that shows that, you know, as the reference product behaves, which is, you know, eluting small amounts of fluocinolone in the eye to show equivalence, you know, a company will need to run a three-year clinical study. So the timeframe for doing that, the investment needed for doing that, you know, you'll want to run some studies before you launch a trial like that. You'll have to recruit patients, run the trial by the FDA, then get the results, run a three-year study, then get the results, then file the ANDA. I mean, that timeframe is very long, and I mean, honestly, there are more attractive opportunities for generic companies that are pursuing, you know, to pursue, and so again, we see a very long pathway and durability on both these assets. Yeah. Okay, so maybe, why don't we shift gears? Obviously, a lot of the growth now coming on the Rare Disease side, but generics still, like, so the core of the company, and so maybe, I know you can't give too much detail or want to get too precise right now, but just as you think about the progress you're making in generics, how you see that sort of runway for that side of the business, especially as we look into 2025? And then similar question on established brands right now, there's sort of less focus and less, maybe, investment being done right now, but sort of how should we think about that size outlook? Sure. There's one more question on Rare Disease that, or one more sound bite on Rare Disease that I'd like to share before we go to the other two, which is, you know, as we think about ANI, ANI is very much looking forward to continuing to expand the scope and scale of our Rare Disease business. The launch of Cortrophin, our foundational asset, our lead asset, and then the acquisition of Alimera Sciences are steps in that direction. But you can look forward to us, you know, continuing to be active from a business development perspective as we look to find assets that are synergistic with the current assets and that expand the scope and scale of our Rare Disease business. And from a capital allocation perspective, that is where the company is focused, right? And that's the first area of priority for the company. So I just wanted to make sure that that was understood. Maybe just one quick follow-up on that. Sure. And similar to, you said sort of synergistic, but size-wise, kind of therapeutic area-wise, similar to what you've done with Alimera or any? Yeah, no, I think that that's, you know, we are fortunate that our lead asset is indicated, has multiple indications, neurology, nephrology, rheumatology. So, and obviously now we have, you know, a platform in ophthalmology too. So the game board for us for M&A or BD is pretty, you know, it can be pretty broad. And so as we look forward, you know, we would, I mean, I think you can look to us to do an Alimera-type acquisition, you know, bringing assets on. There's obviously, these are commercial assets. Both the Alimera assets are commercial assets. And as we evolve, the further evolve ANI as a Rare Disease company, right? I think you can expect, you know, down the field, us building development capability, us adding assets that have, you know, in phase three. So those are the steps that, as you see, think of ANI's evolution as a Rare Disease organization. You can very much see that down the pipe. Yeah. Okay. And then maybe just comments on generics and how to think about that and establish? Right. So for generics, completely different business, right? It's where ANI started. And, you know, it's the success there is driven by success. High single-digit, low double-digit growth is driven by, on the back of a strong R&D capability. We've launched about 16 products this year already. And we have a cadence of new product launches. And that combined with operational excellence, you know, a U.S.-based manufacturing footprint and, you know, a strong FDA compliance track record enables us to continue delivering the high single-digit, low double-digit growth. So that's how I would think about the generics business. You know, to fuel that growth, you know, there's a certain percentage of sales, generic sales that we'll continue to invest in R&D. And that's the fuel for growth for the generics business. When you come to the established brands, this is a, you know, I guess a legacy part of ANI. It was BD deals that, you know, the ANI used to do, bringing in old sort of established brands, and you know, we're exploring different, again, creative commercial techniques because it is a unique commercial capability that we have with those established brands, but you can expect modest decline, you know, on, as you think of the overall portfolio in the absence of us doing a, you know, a bite-sized BD deal for that. Established brands play the role of being a strong cash flow contributor to, in the mix of, you know, high margins, low working capital, strong cash flow generation in the mix of businesses that we have, but again, I'd like to just reiterate that from a capital allocation perspective, our focus is on Rare Disease, on expanding the scope and scale of our Rare Disease business. Yeah. Okay. And then maybe we have a couple of minutes left. So one question we do get occasionally, and maybe Steve or whoever wants to, is this litigation ongoing with CG Oncology? So I don't know how much you can share or what, maybe just sort of what the next things are that we should watch out for there. And I know you know, again, as we go into 2025, any sort of updates we should be looking for? Yeah, so the litigation is active. The latest that has occurred was back in the August timeframe. CG Oncology had filed a motion for summary judgment against ANI, and both parties are awaiting the judge's decision in that motion. That being said, you know, ANI is preparing, full-fledged preparing for trial, which we would expect to occur sometime in 2025. And I would also just highlight, you know, the disclosures in our public filings in the 10-Ks and the 10-Qs regarding the litigation. Okay. I would just, the only sound bite I would add is that we, as we're preparing for trial, we're obviously going through discovery and other aspects as you would. And we feel very strongly that our position is, and we'll do everything that we need to defend our position in this matter. Yeah. Okay. All right. I think we're pretty much out of time. So why don't we leave it there? Congrats on all the progress with getting the deal completed and obviously the growth with Cortrophin and generics and everything. So look forward to staying in touch and continuing to follow things closely. Yeah, and thank you for having us again.