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Okay, good afternoon, everybody. My name is Daniel Cohen. I'm a Managing Director in Morgan Stanley. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, we can begin. We are pleased to host Nikhil Lalwani, CEO of ANI Pharmaceuticals, with us today. Nikhil, why don't we start out by, maybe if you can just give us a high-level overview of each of your businesses. You have multiple businesses under the ANI Pharmaceuticals umbrella. Talk about the different drivers in each segment, and how investors should think about growth in those segments.
Yeah. Thank you, Daniel, and good afternoon, everybody. Thank you for joining us here at the Morgan Stanley Conference. Much like Daniel, let me clarify that any disclaimer, any information I speak to is per the disclaimers on forward-looking statements and the corporate deck that we APKed yesterday, as well as references to non-GAAP information, non-GAAP financial information. The guidance that I speak to is the guidance that we gave on August 8, 2025. With that, yeah, really pleased to be here to share with you the ANI journey towards building a rare, high-growth, and profitable rare disease therapeutics business. We have three business segments. Rare disease is the key focus area and largest driver of growth. We have two assets, Cortrosyn and ILUVIEN, in the rare disease business. Rare disease will account for approximately 50% of 2025 revenues as per our guidance on August 8.
You know it's our key focus area going forward, also the top priority for capital allocation. We also have a generics business that has driven strong growth on the basis of superior new product launches by our strong R&D capability in generics, operational excellence, and a U.S.-based manufacturing footprint that enables us to compete and do well in the U.S. generics market. We have a brands business, which plays a role of providing high margins, strong cash flow generation. We think of a virtual cycle of growth where we're using EBITDA and cash flows from the generics and margins in the brands business to drive growth and increase in scope and scale of the rare disease business. When you think about the total company in terms of guidance for the year, total revenues is $818 million to $843 million, adjusted non-GAAP EBITDA of $213 million to $223 million.
The revenue that I just stated represents 33% to 37% estimated growth over last year, and the adjusted EBITDA is a 34% to 41% growth over last year. That's an overview of ANI.
Are you able to talk a little bit about the differences in growth and margins between each of those three segments?
Sure. Cortrosyn will be, sorry, our rare disease business with Cortrosyn and ILUVIEN will be the largest driver of growth and the key focus area. It's grown from, you know, when we launched Cortrosyn, our lead asset in 2022, being zero, to half the company's revenues in 2025, where it'll be rare disease will be $409 million to $422 million in terms of guidance. The generics, typically, we've guided to high single-digit, low double-digit type growth. What we've actually delivered over the last three to four years is much higher than that. The guidance for 2025 is a mid-teens growth versus the 2024 number of $301 million in revenues.
Yes. Pretty strong performance, growth and margin-wise, this year in particular. We'd note that you've raised guidance three times this year. Can you talk a little bit about what has gone better than anticipated this year?
Sure. Yeah, really pleased with the performance this year and the ability to raise guidance three times. This year, some of the drivers that went better than anticipated were number one, Cortrosyn. Specifically, Cortrosyn gel, we expanded our sales force in the first quarter of 2025. The impact of that expanded sales force came sooner than anticipated, or it's a much more impact than earlier anticipated. Second is we launched a new presentation of Cortrosyn, the prefilled syringe, to enhance convenience for patients and HCPs. There is a very strong demand that we've seen for the prefilled syringe. Originally, we anticipated that the prefilled syringe would be used for patients that had dexterity issues or visual impairment. We're seeing a more widespread adoption of the prefilled syringe. We spoke about 70% of enrollments in July being for the prefilled syringe. That's the second thing that went better than anticipated.
The third is on acute gouty arthritis flares. We're continuing to see a strong ramp there amongst indications. That's an indication that only we have and that the competitor, which is the only other ACTH drug in the category, does not have acute gouty arthritis flares. That's on the rare disease and Cortrosyn side. On generics, per our cadence of new product launches, we launched a generic to Motegrity, prucalopride, towards the end of last year, in late December, early first quarter. What we saw is full value of six months without the launch of an AG or any other competition entering the market. We saw the full value of the first six months of prucalopride. These are really Cortrosyn and the upside from generics driving the three raises that we've done in the year.
Okay, great. Maybe just another high-level question before diving a little bit deeper into each of the segments. Some of the themes that are in investors' minds, in terms of from a global perspective, how you mentioned the generics business of U.S. manufacturing capacity. You've also got a portfolio of rare disease drugs. How does the evolving tariff, MFN situation, how does that impact each of your businesses?
Yeah. ANI is very well positioned versus our peers with regards to both tariffs and MFN. ANI has been focused on the U.S. pharmaceutical industry, and 95% of our revenues come from products sold in the U.S. That speaks to the MFN exposure. Only one product is sold outside the U.S., our retina product, ILUVIEN. We have a small number of one main product and then a couple of small generic products that are sold internationally, but less than 5% of revenues coming from outside the U.S. When it comes to tariffs, over 90% of our revenues comes from products that are manufactured in the U.S., right? We have three manufacturing facilities, two in Baudette, Minnesota, and one in East Windsor, New Jersey. A huge U.S. manufacturing footprint and a commitment to U.S.
manufacturing and being part of the solution when there are disruptions in the supply chain and supporting American patients with U.S. manufactured products. From a tariff perspective, we're very well positioned because, again, over 90% of our revenues come from products that are finished goods that are manufactured in the U.S.
Got it. Okay. Makes sense. Maybe just diving deeper on Cortrosyn, can you talk a little bit about that market, the competitive field in that market, and some of the dynamics that you're experiencing right now?
Sure. So I think that, especially for investors that are new to ANI Pharmaceuticals, Cortrosyn Gel, our lead product, is a repository corticotropin that is used to treat certain chronic autoimmune disorders and has multiple indications, you know, almost over 20. We focus on six indications. This ACTH market has only had one competitor for an extended period of time until we entered in 2022. What we've seen is that since we entered, the market has most recently started growing again. It has been through a period of deceleration, but has started growing again. The growth in 2024 was 27%, and the growth in 2025, if you add our guidance and the competitor's guidance, is 39%. Most importantly, the key driver of this growth is the underlying patient demand.
Even today, the number of patients being treated is almost half the number of patients that were being treated when the market was at its peak in the past. What is most heartening to see is between our efforts and the competitor's efforts, we are able to get ACTH therapy to patients in need across indications. Going beyond that, we believe strongly that Cortrosyn has a strong multi-year growth trajectory. The reason we believe that is when you look across indications, even the six indications that we focus on, the addressable patient populations in each of those different therapeutic areas, in each of those different indications, is much larger than anything than the patients that are being addressed by the combined efforts of the competitor and ourselves. The growth opportunity is significant.
Reasons to believe that we will be able to capture more of that addressable patient population are as follows. Firstly, over the past four years, 50% of our prescribers are prescribers that were naive to ACTH. That is, their first ACTH prescription was Cortrosyn Gel. We are able to reach more prescribers, talk to them about the appropriate patients and the benefits of ACTH therapy, and have them use Cortrosyn. Second is that we see growth across specialties. The growth is not coming from any one specialty. We have, you know, as I said, six different indications: multiple sclerosis, rheumatoid arthritis, nephrotic syndrome, sarcoidosis, and then a couple of ophthalmology indications and acute gouty arthritis flares. We see growth across indications. That's another reason to believe. Third is we see growth from both new prescribers and existing prescribers.
All of these different factors enable us to see that the ACTH market, while it's returned back to growth, the addressable patient populations are much larger, and that between our efforts and the efforts of the competitor, we're able to go out and get this therapeutic or this class of therapeutic to patients in need.
Can you talk a little bit about what happened in that market before you kind of made a dip and now it's returning to growth? How should we think about that and the possibility for that happening in the future?
Sure. Look, I think this was obviously before we entered the market. I have to be thoughtful about what I share here. What I can say comfortably is that the reasons for the decline were largely external to the product itself. The competitor had to deal with other issues when they were the sole product and had the sole product in the category. There were other company-related issues that were not specific to the ACTH category. They had to deal with bankruptcy too that they've successfully worked through, and congratulations to them on that. The decline was driven by factors that had nothing to do with the efficacy of ACTH therapy. That's what we've seen is when we've come back or when we've launched Cortrosyn gel, not only have we been able to convince ACTH believers to write Cortrosyn, but also to use Cortrosyn for their appropriate patients.
We also have new prescribers, right? Almost 50% of our prescribers are prescribers that had never used ACTH before.
You mentioned a new prefilled syringe and expanded sales force and that you have six indications out of 20 or more theoretical indications. Are there any other initiatives that one should be thinking about as we look out into the future around Purified Cortrophin Gel?
Sure. We believe in the strong multi-year growth trajectory for Cortrosyn. Our guidance for this year is $322 million to $329 million. We think that there's strong multi-year growth potential beyond, driven largely by the addressable patient population that we can capture. We're investing in three types of initiatives to strengthen the Cortrosyn franchise and capture this multi-year growth. First is evidence generation and research. The evidence generation and research falls into two buckets. First would be, there's a bunch of work we're doing on preclinical to establish the mechanism of action, or not establish, but share more information on the mechanism of action. We were fortunate to be able to do this with industry-leading KOLs that add more credibility to the category and are able to show the non-steroidal mechanism of action, which is a key part of growth in the ACTH category.
In addition, we launched a phase four clinical study for acute gouty arthritis flares, and our hope is that with a successful outcome there, we will be able to get Cortrosyn added to the ASN guidelines. That's number one, which is evidence generation and research. Second is from a product presentation standpoint. We've launched initially with a 5 mL vial, which was our original presentation, and then we launched a 1 mL vial. Cortrosyn is self-administered, so the 5 mL vial was being used for self-administration. For gout, the right dosing, acute gouty arthritis flares, the right dosing is a 1 mL vial, so we launched a 1 mL vial. Most recently in April of this year, as you referred to, Daniel, we launched a prefilled syringe, and this is really for patients that have dexterity issues or visual impairment. Now we've seen broad adoption of this.
We're continuing to work on other steps in this second group of presentations to improve patient and HCP convenience. Third is high ROI commercial initiatives, as you would expect, to continue expanding the Cortrosyn market and capturing this addressable patient population that we have.
What is the prefilled syringe? Is that unique to Cortrosyn gel, or does the competitor product have a similar prefilled syringe?
The competitor does have a self-check, what they call a self-check, and we have the prefilled syringe.
Got it. Okay. Final question on Cortrosyn from me. Can you talk about LOE, risk of how you think about end-of-protection, if you will, for the product?
Sure. Yeah, this is, you know, both the competitor and we have a complex formulation of peptides that are porcine-derived from the pituitary glands. These mix of peptides are then dispersed in a gel. Therefore, this is a complex formulation that is hard to copy and show equivalence. It is a tough drug to genericize. There are other analogs of animal-derived products that have been hard to genericize. That's one level of protection. The second level of protection is both the competitor and us have added IP that goes into the 2040s, into 2040 to 2043, that again provides additional protection against generics. We are strong believers in the durability of the ACTH category and see this as a multi-year growth opportunity.
I would be remiss before we move on on Cortrosyn to again point out that, you know, even with all the growth that we've seen and that the competitor has seen, remember the competitor has seen 20% to 30% growth this year, even with both of us, we're still treating a very insignificant part of the addressable patient population. Just as an example, if I may, right, if you take multiple sclerosis, there's 750,000 patients that are diagnosed with multiple sclerosis. Only a small subset of patients are those who get exacerbations and do not respond to a steroid. There's about 300,000 flares for MS that we think is an addressable patient population for ACTH. What we're treating is insignificant. In our deck, in the new corporate deck on slide 16, you'll see we lay that out across five indications.
That's a tremendous opportunity for getting patients in need the appropriate therapeutic that can be helpful as a late-line therapeutic to the efforts of both us and the competitor.
Okay. Anything else you want to cover?
No, I'm good on Cortrosyn.
Happy to partner.
Thank you.
Okay. Good. Maybe let's shift to the ophthalmology portfolio. I think certainly earlier in the year, in particular, there were some headwinds that impacted Medicare patients. Can you talk a little bit about what changed this year? What are the headwinds and where do we sit today?
Sure. So, you know, we really, 2025, we think of it as a bit of a reset year for our ophthalmology and retina franchise that we acquired from Alimera. There's been a number of different factors. Obviously, the one that's most prominent and the biggest one is the non-availability of copay support for Medicare patients that do not have any supplementary insurance. That funding went away in the early part of this year and has not returned. At this point, I think we're all, all organizations, ANI and other organizations in ophthalmology and retina are focused on finding solutions for the patients, assuming that this copay support doesn't come back. Having said that, there are a number of organizations that have spoken about efforts to bring that copay support funding back.
At this point, our assumption in the guidance given on August 8th was that the copay support would not come back. In addition, we had churn in our sales force as we combined the original Alimera sales force with the ANI ophthalmology team to create a combined sales force to sell both Cortrosyn and ILUVIEN. We have all those replacements in place, and we have a full team that's out there detailing both Cortrosyn and ILUVIEN. In addition to strengthening that team, we have new marketing materials, a newly launched peer-to-peer marketing and speaker program. Very importantly, we had New Day, a phase four clinical study for ILUVIEN that was done, and we announced the results in July. In this new corporate deck, we've detailed the publication and presentation plan where we're presenting the results of New Day. We presented it at ASRS. We presented it at EU Retina.
When we say we, leading KOLs, right, Dr. Singer, Dr. Wykoff, Dr. Gonzalez, and we'll now present it at American Academy of Ophthalmology in a podium presentation and then at Hawaiian Eye. This is a rich new set of data across 300-plus patients for the use of ILUVIEN early in the treatment of DME in conjunction with anti-VEGF. When you think of the ophthalmology and retina franchise as a whole, while we're working through challenges in 2025, and it's a bit of a reset year for the franchise, the underlying patient demand is very strong, both in DME and NIUPS. We're treating less than 5,000 patients out of more than 50,000 patients addressable in DME and more than 75,000 patients in NIUPS. Equally important, we have a slew of these initiatives that I talked about, right?
The New Day clinical study results, the new peer-to-peer speaker program, a stronger sales organization, all of these that will enable driving stronger performance as we move forward.
Okay. Anything else you want to cover on the ophthalmology franchise?
Yeah, I would say the one other piece that I forgot to mention, thank you for that, Daniel, is that for ILUVIEN, we now, for simplicity of supply chain and securing the supply chain, we added the Non-Infectious Uveitis of Posterior Segment of the Eye label indication to the ILUVIEN label that are now marketing just ILUVIEN. That simplified the supply chain, and you know, we're working through that transition in the third quarter.
Thank you for that, Daniel. I wanted to shift to your generic business, which has been a double-digit growth business for the past two years, which is a little bit contrary to what others have seen perhaps in the U.S. generics market. You've talked about mid-teens growth for this year. Can you talk a little bit about what differentiates your business relative to the broader U.S. generics sector?
Sure. Yes, we have been able to deliver almost 2.3 billion doses to American patients in the last 12 months of generic products. We do that on the back of strong operational excellence and three U.S.-based manufacturing facilities, two in Baudette, Minnesota, and one in East Windsor, New Jersey. The U.S.-based manufacturing footprint is unique to ANI. All these three sites are in strong GMP status, strong GMP track record with either VAI or NAI status across these three sites. Really, the crux of generic success is new product launches, right? Our pipeline, the product selection and then the execution of the pipeline and being able to consistently bring lower, lesser competition products to the market quicker. We launch between 10 to 15 products every year. That's been our cadence across the last four to five years.
We've actually, while we speak about high single-digit, low double-digit growth, in reality, we deliver even higher than that and have done consistently over the past four years. This year, we talk about mid-teens growth. I think, and as an example of the strength of our R&D, we'll talk about Prucalopride, which is a 180-day exclusivity and sole generic approval that we got earlier this year or late last year, earlier this year, where there were 12-plus competitors pursuing this product. We were able to get the approval first and consequently get 180-day exclusivity. Really, strong pipeline selection, superior R&D execution, and then an operational backbone that is strong and U.S.-based to support the generics business. That's the driver of success in our generics business.
Is the strategy in the generics business driven by 180-day exclusivities, or is it broader than that?
No, it is broader than that. I think we always try to find an angle on the pipeline selection. Whether it's the API, whether it's lesser competition, lesser focus areas, one of the things we benefit from is the scale. As we were growing, we're now a $300 million business that's growing mid-teens. The value of launches that is meaningful for us is different from what is meaningful to a much larger player. Being able to identify those opportunities and then execute and capture those opportunities has been important.
Okay. How do you think about, just shifting a little bit to close out, how do you think about capital allocation for the company?
Yeah, thank you. We are focused on expanding the scope and scale of our rare disease business. We have a strong balance sheet with about $218 million of cash as of June 30, 2025, and 1.9 times of net leverage, assuming the guidance that we gave on August 8. That gives us a strong balance sheet and the ability to use that balance sheet to expand the scope and scale of our rare disease business. That is our focus area, identifying products that are synergistic with one of two things, right? Either call point synergy with Cortrosyn, like the Alimera Sciences acquisition where ophthalmology was a key focus area for Cortrosyn. We found another product, ILUVIEN, that is synergistic from a call point standpoint. We have that opportunity now in the other therapeutic areas: rheumatology, nephrology, neurology, pulmonology.
We also have a capability in rare disease of using the back infrastructure, which is basically medical affairs, patient support, market access, especially pharmacy distribution. Finding rare disease assets that may not be synergistic from a call point perspective, but can have small patient populations, small sales forces, maybe in a newer therapeutic area, but leverage the rest of the rare disease infrastructure that we have and the core capabilities we have. That's how we are looking for assets like that too. Two other things to add. We are in no hurry to do an acquisition next. We have strong organic growth drivers and are exploring that. Having said that, we are continuing to explore. There is no immediate need to do an acquisition. That's one.
The second thing is in terms of the type of acquisition we would look to in rare disease, we would look at commercial assets as a next step. As we continue to expand the scope and scale, taking appropriate-sized clinical bets at some point in the future and building the development capability too, as we build an integrated rare disease company in the future.
How would you characterize, how do you see the market for whether it's product or company acquisitions right now? Is it particularly competitive, or over the last few years, do you see it as being more or less competitive than it has been?
Yeah, I think we're not the only people looking for rare disease assets. The advantage we have is that we have beachheads in multiple therapeutic areas. That's an advantage for us as we scan and look for assets. We have a strong performance and a strong balance sheet to support as we pursue our growth, pursue our M&A strategy. To recap, we're not under pressure from a time standpoint to do because we have organic growth opportunities to pursue an acquisition. We can do it in the right time and take our time to do the right deal.
Thank you. Nikhil, a lot of success from your leadership at ANI Pharmaceuticals, proven ability to get products approved, make acquisitions, and commercial success. Congratulations to you on all your success. Happy to open the floor to any questions if anybody has any. Feel free to raise your hand. If not, we can close there.
Thank you, Daniel, and thank you, everybody, for joining us. We look forward to updating you on our progress in the future. Thank you.
Thank you.