Ani Pharmaceuticals Inc (ANIP) September 2026 Conference Transcript

Good morning, everyone, and thanks for joining us. I'm Daniel Cohen from Morgan Stanley, and it's my pleasure to welcome you to this fireside chat with A&I Pharmaceuticals. A&I is a diversified biopharmaceutical company that has transformed itself into a rare disease growth story, led by Cortrofingel and a growing ophthalmology portfolio, supported by strong cash-generative generics and established brands and businesses. It's been a standout year, results ahead of expectations, multiple guidance raises, and real acceleration, across the rare disease franchise. I'm joined by two leaders who can take us through it. Nikhil Lalwani is A&I's President and Chief Executive Officer, a role he's held since 2020 and the architect of the company's pivot to rare disease strategy. And Steve Carey is A&I's Chief Financial Officer and Senior Vice President of Finance, who has been with the company since 2016 and leads its financial strategy and capital allocation. Nikhil, Steve, thank you for joining us. Let's get into it.

Thank you, Daniel. Good morning, everybody, and thank you for joining us bright and early.

Nikhil, you've now been the CEO for six years. How do you feel about the progress made thus far, and what's your vision for the future of A&I?

Yeah.

Thank you, Daniel.

I'm really pleased with the progress made by the team across the last six years. We have made several important steps for the company and the company's trajectory, starting with when I joined as CEO in 2020, we were largely a BD shop. We did business development in generics and in established brands or older brands. And we sat together with the board and a big believer in moving capability forward and building capabilities in the organization. And there are two successful capabilities that we've built as a result to successful high-performing businesses. First is our rare disease business, right, and the commercialization that goes with So the capability to commercialize rare disease products, that's a key capability we've built. And then the second is generics, right, developing, manufacturing, and commercializing generics So I'll just talk you through those two. On the rare disease front, our lead acid purified cortrophin gel, we got that the SNDA approved in October 2021 and launched that drug in January of 2022. When we built that team, we really went out there and hired the best talent that we possibly could from leading rare disease organizations. And, you know, most of those individuals are still with us. And really, that's the anchor of the capability that we've built in rare disease. And it's across the sales team, medical affairs, market access, patient support, specialty pharmacy distribution. It's across the board. It's really the platform or the infrastructure that we've built with the team as the anchor to it and obviously strengthen the systems and processes along the way. And then second is our generics business where we were a BD shop, as I was saying, And we went and acquired NVIDIA, which is a leading generics R&D organization, massive R&D capability, and capability that was well ahead of what they could fund. And over the past four years, five years, we've been able to have significant success with that acquisition. So both Cortrofen and the Nubidium acquisition have been runaway successes for us and then really just built that capability where we can do 10 to 15 new product launches every year on the back of that R&D capability and generate EBITDA and cash flows that, as you pointed out in your introduction, we are taking to reinvest into the rare disease business. Vision for the future is very clear. We're leading our transformation into, accelerating our transformation into a leading rare disease company. In 2026, you know, approximately 60% of our revenues, approaching 60% of our revenues will come from rare disease. So really, just overall, very pleased with the progress over the last six years, taking revenues from right around $200 million to north of a billion this year, 5X, and similar growth in EBITDA, and building two high-performing businesses in rare disease and in genetics.

Great. Thanks, Nikhil. Let's start with the rare disease product, Cotropin Gel. Could you talk through the unmet need that it addresses and how big the addressable market is?

Sure. So, Purified Cotropin Gel is a repository of Cotropin. It's derived from the pituitary glands of porcines, so it's a naturally derived product. and it is shown to bind in an in-retro basis with all five melanocortin receptors, which are cell-to-surface proteins. What cortrophin gel is used for is across multiple autoimmune indications to deal with inflammations or exacerbations and flares, and it is appropriate for treatment of patients who generally are not responding to other treatments such as steroids or have high side effect profile with steroids. So that's the role that cortrophin gel plays. We are approved in multiple indications. The six or seven specialty areas or indications we focus on are rheumatology, nephrology, neurology, ophthalmology, pulmonology, and acute cardiothoritis. When you talk about addressable market, across the different specialties and indications, we believe there are approximately 1 million patients, right? As I walk you through that, the indication itself may not be rare, but the addressable patient population or the appropriate patient population is much smaller across the broader incidence disease. And let me just explain that. So if you take acute gaudi arthritis flares, there are 10 million patients in the U.S. that suffer from acute gaudi arthritis flares. A number of those flares resolve on their own. Some get treated well by treatments such as prednisone and colchicine, etc. But there's a very small subset of patients, which we see is about 285,000, that their flares require IV or injectable treatment. So that's 285,000 out of 10 million, and that's what we think of as addressable market. So similarly, you know, if you do the same analysis across multiple sclerosis, rheumatoid arthritis, nephrotic syndrome, and the sarcoidosis, et cetera, you get to about a million patients. And we're just getting started. Between the competitor and us, right, because there's one other player in the ACTH category, we are currently, you know, both a combined basis serving a fraction of that one million, in a very small fraction of that 1 million addressable patient population.

Can you talk a little bit more about the expansion to primary care and podiatry for the Gaudi flares and how that's going?

So we're in year five of our launch, and every year as we're trying to reach more patients, one of the ways we do that is by reaching new prescribers. And while this category has existed for a while, an important metric is that over half of our prescribers, even before this most recent expansion, comes from prescribers that were naive to ACTH, that had never tried ACTH before, the ACTH category. So as we were working across the first four years, what we found is that approximately 18% of our usage came from acute cardiac arthritis prayers. There was a real need there. However, the call points that we were going to, the specialties we were going to, which are rheumatology and nephrology, only tackle a small subset of the addressable patient population. And, you know, there's an increasing, we learned that there's an increasing number of patients that are seen by primary care and podiatrists. It's just early, it's easier to get appointments with them, etc. So there's a lot of patients that suffer from acute gaudi arthritis flares that's being seen at primary care and podiatry. So last year, in 25, mid of 25, we launched pilots in 10 territories, 10 existing territories we had, where we asked a number of our reps in those territories to go out there and obviously with a coordinated effort with corporate, figure out what are these patients, prescribers that actually write primary care and podiatrists that actually write for acute cardiac arthritis. So we saw huge success there and believe that this is something that could be scaled. And so in May of this year, we launched a 60-person sales force, which is about a 50% expansion in our sales force. We had about 120 reps before, and then we added 60 reps. The 120 went into other specialties, which I can cover later. But the 60, the expansion we did, went to primary care and podiatrists. And by the end of June, all of them had been trained in the field, and we've had very strong indicators of leading indicators of demand from what we've seen so far. All the reps that were hired in May and June have had two or more cases initiated. In fact, we've actually started seeing refills already from a number of the patients. We see over a third of our prescribers, actually that number is probably higher by now, that have written two or more cases. So you're seeing both width and depth of prescribing. and we're seeing demand generation, in fact, across regions. There's just one or two regions that are seeing that. So what we saw in those 10 pilots has been scaled up to across 60 territories, and we're very pleased with the success that we've had to date, and we believe that this acute gouty arthritis flares expansion or just gout expansion will help us with the investment we've made this year to get operating leverage next year. So next year, going into 27, we'll see a lot more sales in 27 from the investment we made. It takes three to six months for the reps to ramp up, right? And basically, in 27, we'll see a lot more sales. Of course, there's a significant impact that they will also have in the back half of 27. And then last important fact to share with you regarding this Gout expansion is that acute gaudi arthritis flares is an indication that we have that the competitor does not have the other player in the ACTS category. So when you think about why did we select this area for investment, it was because we saw proof of concept in the 18% volume we saw in nephrology and rheumatology for gout. It's an indication that we have that the competitor doesn't have, and then we also saw success in the 10 pilots. So we're very pleased with that progress.

And then just closing out on Quartrofen gel, in Q2 you raised guidance to $520 to $540 million for sales for the year. Is that dependent on the existing specialties, or is that more driven by the new expansion that you just discussed?

Sure. So when you think about our sales last year was $348 million, and our guide is $520 to $540 million, which is an adjustment that we made in the guidance in the second quarter. The growth, majority of the growth from $348 to $520 to $540 will come from the existing specialties, which are room, neph, neuro, and ophthalmology and pulmonology. That's the existing specialties. And then the gout expansion will contribute significantly in the back half. But if you think of the 348 going to 520 to 540, majority of that growth will come from the existing specialties where we've continued to have strong impact. I mean, if you take the first half of the year, we've had 45% growth in the first half of the year where we've done $192 million across Q1 and Q2. And all of that, because the GAUT expansion team only came in midway through May and then was really operational, so their impact on Q2 was minimal. So all the growth that you've seen, the 46% year-over-year growth in H125 versus H126 came from the existing specialties. And that momentum we expect to continue into the back half, compounded by the impact from the gout expansion.

Impressive growth on Cortro from gel. Maybe just turning to the ophthalmology franchise and Illuvian, you're planning to present additional data, synchronicity data, at a conference in the fall. Can you speak to what's new with Illuvian and that data and how that could drive growth in the future? Sure.

So, Synchronicity was an open-label study that we completed. It shows the use of Illuvian in chronic non-infectious uveitis in the posterior segment of the eye. We believe that this—we have released the six-month data earlier this year and will be releasing the more comprehensive analysis at an upcoming conference in Q4. We believe that this data will provide additional insights and real data to clinicians, both retina specialists and uveitis specialists, to show the use of Illuvian, which is a durable reduced treatment burden option for the treatment of chronic non-infectious uveitis in the posterior segment of the eye. And so we're sharing additional analysis both on efficacy as well as safety and use cases that we believe will be very helpful for clinicians as they evaluate alternate treatment options for the treatment of these patients.

Okay, thanks, Nikhil. We talked a bunch about the rare disease franchise, but as you mentioned in the intro, So your generics business has been a strong performer. Can you just talk a little bit more, expand upon more how that fits in with your business and how it contributes to the overall goals for the company?

Sure. So we have a high-performing generics business. We've delivered north of 20% CAGR growth for the last four or five years. the success of our generics business is anchored on a strong R&D capability where we launch 10 to 15 new products every year we invest a high single digits percentage of our generics sales into R&D for generics and that fuels the 10 to 15 launches that we've had every year we have the number two position in competitive generic therapy launches which, again, highlights the strong capability we have in generics R&D. In addition, what we have is a U.S.-based manufacturing footprint that we are very proud of. We have three manufacturing facilities, one in East Windsor, New Jersey, and two in Baudet, Minnesota. 95% of the products that ANI sells are sourced from plants in the U.S., and we're very proud of that. We have a very strong GMP track record. So it's a combination of... So we have a strong GMP track record across our manufacturing sites. So it's a combination of the superior R&D capability and execution along with strong operational excellence across our manufacturing sites that has enabled us to deliver very strong growth from our generics business. And the role that the generics business plays, is even though it's a high-performing business, from a capital allocation perspective, we invest high single-digit percentage of OPEX into GenX R&D, sorry, high single-digit percentage of GenX sales into GenX R&D, and then use the EBITDA and cash flows for reinvestment as we accelerate the transformation of A&I into a leading rare disease company. But very pleased and proud of the progress and the success of our genetics business. Great.

Yeah, it's been certainly a bright spot for the company, certainly relative to the industry. Maybe turning a little bit to some financial-related questions, and here I think obviously Steve should weigh in as well, but how do you think about capital allocation for the company overall between reinvesting in the business? You talked a bunch about BD at the outset as the history of the company and share repurchases. How do you think about that? Yeah, thanks, Daniel.

First of all, I should start off by just saying the culmination of all of the efforts and the business building that Nikhil has been discussing, we're very pleased with the way that's manifesting on our balance sheet. As of June, we had $360 million approximately on the balance sheet, kicking off significant free cash flow. In the first six months ended June of 2026, we had $100 million of free cash flow as compared to $150 million for the full year of 2025. So that accelerating cash flow, the organic de-levering, where we stand at about one time net levered as of June, really allows us a lot of flexibility in terms of how we continue to operationalize and build the business. And when we think about those capital allocation choices, really, I think job number one for the cash is to continue to reinvest in the business organically, to have a high degree of flexibility to make choices like building the additional 60-person GAU field force. um then number two would be um as we've stated we're building the next great uh rare disease business um and we uh intend to do that through future m&a and business development um and that would be uh number two for a cash and then also back in may we uh put in place a hundred million dollar three-year share repurchase program in place that just allows us flexibility as we move out in time in terms of how we use that capital as well. A little bit more on BD and M&A aspirations as we think about the next steps there. We're focused on deals that will allow us to expand the commercial portfolio, so more likely than not, focusing in on products that are either commercialized already and fairly early in their commercial life cycle or right on the cusp of getting approval. And then we look to build out in the years to come around that type of strategy.

And would you expect, in terms of BD, would that be rare disease generally or any particular area?

Yes, yes. Very clear that our aspirations there are to expand the rare disease side of the business.

Yeah, and just to build on what Steve said, there are really two types that we're looking for, and we're pretty actively searching and scanning and diligencing. One is, you know, with our lead asset, we have the benefit of having multiple call points that our sales force engages with. And so an asset that can be synergistic with that, right, whether it's just into rheumatology, neurology, nephrology, ophthalmology, pulmonology, and now primary care and podiatry. So that's multiple call points. It's a wider aperture, which is beneficial for us. But second and equally important is we have the rest of the infrastructure, right? Patient support, medical affairs, market access, specialty pharmacy distribution, all of the other aspects of a rare disease business that is required for commercialization. So the sales force gets you the prescription or the enrollment, but then the rest of the infrastructure works with the physician's office and the insurance company and the patient to actually get the patient on therapy. And that is a core capability, too. So if we were to look at an asset which requires a setup of a small sales force but into a new call point which has rare indications or even ultra-rare, that is okay because that's an area that we know how to work with the prescriber's office to find the patient. the appropriate patient, of course, but then also the rest of the infrastructure to pull that enrollment onto therapy or paid drug.

So you have an infrastructure that can be further utilized and leveraged. Correct, correct.

Both of the sales force and the back-end infrastructure, correct.

Maybe just looking to the future, Can you talk about guidance for 2026 and then outlook for 2027?

So as far as 26 goes, our guidance for the year is $1,080,000 to $1,140,000 in REVs, which is about 26% growth. And for adjusted non-GAAP EBITDA is $285,000,000 to $300,000,000, which is approximately 27% growth. This is even in a year, so you're seeing EBITDA growth faster than top line, in a year where we're investing approximately $50 million in additional OPEX for that gout expansion that we spoke about. So it's important for us to keep balancing growth and profitability as we're driving the business forward. As we look to 27, we're not going to give guidance, but I think in terms of the outlook, from a rare disease perspective, the investments we've done this year will continue to bear fruit next year. What do I mean by that? That there will be significantly higher sales from the expansion that we did this year. So with the same level of SG&A, you'll see higher sales next year driving operating leverage. For our genetics business, in 25, we had a very, very strong year. And then in 26, our guidance has been to be roughly flattish. Historically, we've always guided the genetics business to be high single digits to low double digits type growth. And we will reorient back to that overall time frame for the 27 and beyond. But we'll obviously get to the specifics when we give overall total company guidance. So, yeah, look, we have a strong platform to high-performing businesses, and that will continue to drive growth and success of A&I in 27 and beyond.

Thank you. And maybe just to wrap, what are you most excited about for A&I in the future? And perhaps, you know, what do investors not appreciate?

Sure. Yeah, look, I think it's been an honor and a privilege to be here for six years and build and work with an amazing team to serve patients and improve lives. That's the purpose of our company, serving patients, improving lives. And every day we get a chance to make that difference, whether it be for the appropriate patient in a small patient population through our rare disease business, right, where there's a significant unmet need and existing therapies, are not sufficient, and so to bring the appropriate therapy for them, that makes a big difference in the lives of those people and of the patients and their families, but also at scale, right, where our generics business delivers 2.5 billion doses to patients in the U.S., and I think that is a different level of impact. So every morning, you wake up, and no matter what you're dealing with, you have the chance to make an impact in patients' lives. That's what excites me, and working with our amazing team and continuing to build that. That's what excites me the most, serving patients improving lives. As far as what we believe the investors appreciate a little bit less, at least in the near term that's what's been happening, is just the long-term growth and durability of our rare disease business and of our overall business. The opportunity for cortrophin is intact. The addressable market for cortrophin is very large. between the competitor and us. We're serving a small fraction of the patients that are appropriate, we believe. And there is a significant multi-year growth opportunity for Cotrophin. A very important fact that I didn't address earlier is it's a tough drug to genericize, both ours and the competitors. We have IP that goes into 2043. And so the durability, I believe that the durability and the significant multi-year growth potential that our company has, I don't think we're getting enough credit for that.

Thank you. Well, I want to thank Nikhil and Steve for being here bright and early and kicking off this year's Morgan Stanley Healthcare Conference. We'll turn it over to the crowd to the extent there's any questions. If not, thank you very much.

Yeah, thank you, Daniel, and thank you all the Stanley team. Thank you for being here.