ANI Pharmaceuticals at RBC Conference: Strategic Growth in Rare Diseases

On Thursday, 03 April 2025, ANI Pharmaceuticals (NASDAQ: ANIP) participated in the RBC Inaugural Virtual Ophthalmology Conference, highlighting its strategic focus on rare diseases and ophthalmology. While the company shared optimistic growth projections, it also acknowledged challenges such as market access and competitive dynamics. The conference underscored ANI’s commitment to expanding its rare disease segment, particularly through products like Cortrophin Gel and the newly acquired ILUVIEN and YUTIQ.

Key Takeaways

• ANI Pharmaceuticals projects 2025 revenue between $756 million and $776 million.
• The rare disease segment, including Cortrophin Gel, is a major growth driver.
• ILUVIEN and YUTIQ, acquired from Alimera, bolster the ophthalmology portfolio.
• Market access strategies and tariff impacts were discussed, with a focus on US sourcing.
• Clinical trials, such as New Day and Synchronicity, are pivotal for future growth.

Financial Results

• 2025 Revenue Guidance: $756 million - $776 million

- Rare disease revenue: $362 million - $377 million

- Cortrophin Gel 2025 revenue: $265 million - $274 million

- Ophthalmology revenue (ILUVIEN and YUTIQ): $97 million - $103 million

• 2025 EBITDA and EPS:

- Adjusted non-GAAP EBITDA: $190 million - $200 million

- Non-GAAP EPS: $6.12 - $6.49

• Growth Rates:

- Cortrophin Gel growth since 2022: Over 75%

- Generics business 2025 growth: Low double-digit

Operational Updates

• Strategic Focus: Emphasis on rare diseases and ophthalmology.
• Alimera Acquisition: Completed in late Q3 2024, enhancing ophthalmology assets.
• Manufacturing: Over 75% of generics made in the US; partnership with Siegfried extended.
• Sales Force Expansion: Increased ophthalmology representatives from 30 to 46.
• Label Merging: Consolidating DME and NIUPS products under ILUVIEN.

Future Outlook

• Growth Drivers: Expansion of Cortrophin Gel and ILUVIEN in key markets.
• Clinical Trials: Results from New Day and Synchronicity trials expected in Q2 2025.
• Market Access: Strategies to improve access for ILUVIEN and YUTIQ.
• Competitive Landscape: ILUVIEN’s unique three-year efficacy remains a strong competitive edge.

Q&A Highlights

• Tariffs: Predominant US sourcing mitigates tariff impacts; potential benefits from Indian generics tariffs.
• DME Market: Over 50,000 underserved patients; ILUVIEN offers a long-term treatment option.
• NIUPS Market: Differentiation through product durability; corticosteroids remain essential.

For a detailed understanding, refer to the full transcript below.

Full transcript - RBC Inaugural Virtual Ophthalmology Conference:

Doug Neem: Good morning, and welcome to the first company presentation, ANI Pharmaceuticals at RBC Capital Markets Initial Virtual Ophthalmology Conference. My name is Doug Neem, and I may need to correct my thoughts on whether today is actually going to be a good day. I expect the conference to have a good day, but the broader market is obviously another question. Today, it’s our pleasure to have Nikhil Lalwani, president and c o CEO of ANI. For those not as familiar with NR, I would describe it as a hybrid pharmaceutical company with a high quality focus on branded rare disease and generic products.

The company operates in several verticals, but I believe Nikhil is the best is in the best position to provide an overview of his company. With that, Nikhil, why don’t I turn it over to you, and you can talk about the the business, more broadly before we start talking about the ophthalmology aspects, of ANI. Over to you.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Thank you, Doug, and good morning, everybody, and thank you for, joining us. We really appreciate it. As Doug said, this is an important day, so thank you for taking time, to be with us. So ANI Pharmaceuticals operates in three segments, driving robust profitable growth, rare disease, generics, and brands. In aggregate, the total company guidance so just to tell you a little bit about the company in numbers first.

The total company guidance for 2025 revenues was $756,000,000 to $776,000,000 Adjusted non GAAP EBITDA guidance for 2025 was $190,000,000 to $200,000,000 and the non GAAP EPS guidance was $6.12 to $6.49 ANI’s rare disease business is our key area of focus and the primary driver of growth going forward. Over the past four years, we’ve built our rare disease business beginning with the launch of our lead asset, purified Cortrophin Gel, in January of twenty twenty two. In 2024, we expanded the scope and scale of our rare disease business with the acquisition of Alimera and marking our foray or, I guess, deeper foray into ophthalmology. Rare disease will account for 48% to 49% of our revenues in 2025, at $3.62 to $377,000,000. As I said before, we have two franchises, Cortrophin Gel, which grew north of 75% to almost 200,000,000 in just the third year since launch.

This is the the 2024 number. And our guidance for 2025 for Cortrophin is 265 to 274,000,000, growing approximately 35%. Our ophthalmology franchises, ILUVIEN and YUTIQ, came to us through the Alimera acquisition that closed in late Q3 of ’twenty four, and our guidance for 2025 is 97,000,000 to $103,000,000 Our generics business is fueled by a strong and high performing R and D engine, operational excellence, and a U. S.-based manufacturing footprint. Generics accounted for $3.00 $1,000,000 in revenues in 2024, and we expect our generics business to be a low double digit grower in 2025.

And finally, our brands business is smaller but has very healthy margins and cash flow that we can use to help fund our future growth. So while rare disease remains the key area of focus, you know, and within that, ophthalmology is a critical therapeutic area, we’re also proud of our track record of success and performance in our two other segments, which we expect to continue generating strong financial returns for our company and creating a virtuous cycle of growth.

Doug Neem: Excellent. Great overview. You know, I I was contemplating including this question into today’s overview, but I I think it’s very appropriate that perhaps we touch on how tariffs could affect your company and perhaps the broader pharmaceutical market to start with, and then we can get into, the other aspects of the business.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. Thank you, Doug. Yes. It is clearly a very topical question and fair for you to bring it up first, first thing first thing in the morning. Look.

You know, as I was saying in my overview, our, all our our generics business, our rare disease business, and our brands business has products sourced from, The US. You know? In fact, for our rare disease and brands business, it’s entirely from The US from US based manufacturing. And for our generics business, you know, I would say more than, you know, more than three quarters of our products are sold are, made at manufacturing plants in The US, which are owned by us, two in Bonnet, Minnesota, and one in East Windsor, New Jersey. So when you think about the tariffs, if you you know, in our world or from a pharmaceutical perspective, I would divide it into two buckets.

One is tariffs on finished goods, which, you know, in different pockets of business, it will could be a tailwind for us. Right? Generics, there is a significant amount of generics that comes from products in India for The US market. And so if there are tariffs imposed there, that could be a potential tailwind for us. Again, it depends on, you know, look at this as an evolving situation, but it also depends on who is absorbing the impact of the tariffs.

Right? And that is a market dynamic that, you know, we’ll have to see how that will play out. I think the, the second part is really the input materials. Right? And I think that the administration does wanna support, US manufacturing.

So I I believe that they will be very thoughtful about imposing tariffs on input materials, you know, that are, you know, in excess of what is already in place. Right? There is already some tariffs in place for, you know, active pharmaceutical ingredients or API from China and from other countries. I think the escalation of those could, you know, have an impact on, you know, folks that are manufacturing in The US. And so that’s, I think, I’m sure that the administration will be thoughtful about about implementing tariffs in those areas.

So, obviously, this is an evolving situation, and we continue to closely monitor the same.

Doug Neem: Okay. That’s a great overview. Thanks so much. So where I wanna start is right at the very beginning. And, you know, you have this rare disease focus, and I’m really curious as to why and I originally set up the Salesforce of, call it, ten, eleven people in ophthalmology prior to the acquisition of Alimera.

What was it about that market that was you identified as attractive? Got it.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. Look. Maybe a little bit of background on Cortrophin. So purified Cortrophin Gel, which was our lead asset, is a porcine derived, purified Corticotropin. It’s a late line treatment option for patients struggling with certain chronic autoimmune and inflammatory disorders, and Cortrophin is approved for multiple indications across therapeutic areas.

Now we initially launched, which is in 2022, January 2022, we launched into three areas. Right? Neurology, nephrology, and rheumatology with a combined sales force. So one sales force detailing to these three different therapeutic areas. And as we look to expand Cortrophin Gel, we prioritize ophthalmology as a strategic area of focus for a couple of different reasons.

Number one, in ophthalmology, Cortrophin is indicated for severe acute and chronic allergic and inflammatory conditions affecting the eye, and it’s adnexa such as keratitis. And ophthalmology as a percentage of total ACTH prescribers has almost doubled to more than ten percent over four years. So as we looked at, you know, ophthalmology, we saw that ACTH in itself, you know, was a significant opportunity and therefore synergistic with Cortrophin. And then we we also obviously did a scan of what was available, you know, in in the market in terms of assets because, you know, we do we do not have a development engine at this time, an R and D engine of our own. So we looked at across assets in phase three and beyond, and saw that, you know, this was an area that we could find assets, and would be attractive for M and A.

So for those two reasons, we, you know, first, again, because your question is the initial 11, we did a, targeted sales force to, to explore the area of ophthalmology and launch our presence for Cortrophin into ophthalmology. And then, obviously, we did the acquisition of Alimera to expand it, beyond, beyond just selling Cortrophin. Yeah.

Doug Neem: Okay. So maybe we can continue on a little bit about that. So with, the Alimera acquisition, we’re starting to see the background as to the strategic rationale behind the acquisition. But perhaps you can expand on that a little bit more and the two products that came along with it and what they’re indicated to treat, etcetera, etcetera.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. So the, acquisition of Alimera was aligned with the, you know, M and A strategy we were pursuing, and I started speaking a little bit about. Specifically, it expanded the scope and scale of our rare disease business. It strengthened one of our priority therapeutic areas, ophthalmology, which is a key, area for our lead asset, you know, Cortrophin and the overall ACTH market. And very importantly, the deal gave ANI two durable assets with growth potential.

Importantly, we expect, ILUVIEN and YUTIQ to be durable given their patent protection and high barriers to genericization. And, you know, as far as what are these products indicated for, they’re both intravitreal implants, long acting intravitreal implants, where the active ingredient is flucinnolone acetonide, and they’re in two different strengths, point one nine milligram of flucinnolone and and, point one eight milligrams. And they’re indicated for, Iluvien is indicated for both, diabetic macular edema and non and, noninfectious uveitis affecting the posterior segment of the eye. So that’s ILUVIEN, and then UT is indicated for noninfectious uveitis affecting the posterior segment of the eye.

Doug Neem: Okay. Perfect. Great introduction. So, just before we get into the specifics of DME and uveitis, I wanted to touch on the fact that you’re likely going to transition almost completely over to Iluvien over time from YUTIQ. Could you expand on that?

And if it you know, what are the implications of that for the company and perhaps why?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. Sure. So our decision to merge the labels of ILUVIEN and YUTIQ was driven by the intent to increase the supply security for our ophthalmology franchises. Note, both ILUVIEN and YUTIQ are substantially similar ophthalmic intravitreal implants with the same active ingredient, flucinolone acetonide, almost identical strengths. Right?

Again, a quick reminder, ILUVIEN having point one nine milligrams of flucinolone and YUTIQ having point one eight milligrams of flucinolone. In fact, the clinical trials for both NIUPS, that’s noninfectious uveitis affecting posterior segment of the eye, and DME, diabetic macular edema, were run on implants with zero point one eight milligrams of flucimolone acetonide. The newer manufacturing process used exclusively for ILUVIEN results in the strength of zero point one nine milligrams per implant. And so what we did is we submitted a prior approval supplement, or PAS, to the FDA and successfully received approval to add YUTIQ’s indication of chronic NIUPS affecting, chronic NIUPS to the ILUVIEN label, and we plan to transition commercialization efforts later this year for both DME and chronic NIUPS to a single product, ILUVIEN. As a reminder, ILUVIEN is already approved and marketed for both DME and NIUPS outside The US, including in 17 European countries and The Middle East.

In addition, we extended our partnership with our contract manufacturer, Siegfried, for five years until 2029. Siegfried has been a reliable partner for ILUVIEN for over ten years. As a part of this extension, we agreed to partner with Sickfried to upgrade the equipment on the existing manufacturing line in Irvine and significantly expand capacity through the addition of a second manufacturing line. Both the equipment and equipment upgrade and capacity expansion initiatives are on track.

Doug Neem: Okay. Fantastic. So let’s spend a minute on DME. Yeah. Maybe you can describe the disease state epidemiology and commentary on the current treatment paradigm just so that people can understand where ILUVIEN fits in that whole construct.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Okay. The market opportunity for DME and for ILUVIEN in DME represents more than fifty thousand underserved patients. You know, one in fifteen people with diabetes, develops DME. Anti VEGF, which stands for vascular endothelial growth factor, as many of you would be aware, therapies are considered the mainstay DME treatment, and steroids are usually reserved for patients who are not well served by anti VEGF therapy. So providers typically cycle through anti VEGF treatments, which, you know, doesn’t always end up in success.

And given the multifactorial nature of inflammation, an estimated seventy five thousand patients have a suboptimal response even after treatment with multiple anti VEGF therapies. And seventy percent of those patients respond positively to a steroid trial. So Iluvien is an ideal treatment option for these patients. Iluvien is differentiated from other intravitreal steroids by its duration, durability of therapy. Iluvien is the only approved three year option, delivering a stable dose of steroids for a long period of time.

Most other steroid injections and implants have durability lasting weeks or months, and this makes it a good option for patients for whom a prior steroid was demonstrated to be safe and effective. And so of those fifty thousand patients that I just referred to, less than five thousand patients received ILUVIEN in 2024. And this opportunity supports our confidence in growth for ILUVIEN in The US market.

Doug Neem: Okay. That’s very helpful. So you’re talking about less than five thousand patient starts with the drug with a target opportunity that is 10 times that amount. Are there any practical aspects that have to do with the treatment of this patient population that could materially prevent the company from making inroads relative to that 50,000, or over time, we see reasonable penetration of that market?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. So we believe this is the total addressable market. As our analysis takes into account prior anti VEGF and prior steroid experience, making 53,000 patients a very good estimate of the current ILUVIEN opportunity in DME. We also have a, New Day trial and a positive readout from the New Day trial, which I can describe a little bit for you, the New Day trial, that has the opportunity to expand that market as it could move ILUVIEN, in fact, up in the treatment algorithm. Right?

So there’s about nine hundred thousand patients in the in the country that have DME, you know, and I was talking about a small subset, fifty three thousand being the addressable market. But, you know, positive readout from the New Day trial has the opportunity to expand that market as it could move ILUVIEN up in the treatment algorithm potentially in combination with rather than post anti VEGF therapy. Now the obvious next question is what is the New Day study? So I’m happy to give an overview if you’d like. Yeah?

Doug Neem: Of course.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. Thank you, Doug. So New Day is investigating the use of ILUVIEN in combination with the current standard of care anti VEGFs for the treatment of DME. If the results are positive, it could demonstrate a benefit of moving Iluvien to early line therapy in combination with anti VEGF therapy to provide better outcomes for patients. New day was fully enrolled with 306 patients in approximately 42 sites, and the last patient last visit occurred in early January.

And, we expect top line results, in this quarter, meaning the second quarter of twenty twenty five.

Doug Neem: Okay. And just a a couple of wrap up questions on that trial then. How large was it? And can you describe the entry criteria for the patients who were then naive to treatment, or had they had previous treatments? Just to give us a better idea of the patient population.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. So your first question was the

Doug Neem: Just the size. Wait. I gather it was around

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: 200. Two hundred and six patients. Yeah. I just, yeah, I just said that. 306 patients, and it was conducted across 42 sites in The US.

And then, the the the the second question was inclusion criteria. So on that, essentially, it’s patients early in the treatment, you know, early in the DME treatment. So either they’re naive to, anti VEGFs or they haven’t received an anti VEGF for at least the last twelve months. So less than four or, or not received an anti VEGF in the last twelve months.

Doug Neem: Okay. Fantastic. One question I did have is when you think about that TAM of fifty thousand or fifty three thousand patients, are those patients typically treated bilaterally? And what would be the implications from a pricing perspective and ultimate revenue perspective for the company taking that into consideration?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. So, look, DME can present bilaterally or unilaterally. And even when presenting bilaterally, it may progress at different rates and require different treatment options for each eye. And some studies have shown that over fifty percent of patients with DME have it bilaterally. Now Okay.

The our pricing is based on per implant. Yeah. So I think that’s that’s how we you know, for each eye, that’s the the cost of an implant, and then it’s obviously for a three year period.

Doug Neem: Okay. Okay. Excellent. And what I wanted to do before I move on to uveitis is just talk about the competitive environment, any competitive threats that you may see specific to your product within, the DME, targeted group?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. Look. The common theme amongst new products in the DME market as we see it has, has been to improve durability in hopes to, reduce the need for more injections. So to this day, ILUVIEN remains the only product indicated for DME with efficacy of up to three years. So that’s how we think about the competitive landscape evolving going forward.

Yeah.

Doug Neem: Okay. Perfect. Well, let’s switch to chronic noninfectious uveitis for the posterior segment. Maybe you can talk about that market like you did for DME, and where would ILUVIEN fit in it?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. So noninfectious uveitis affecting the posterior segment of the eye frequently, runs a relapsing and sometimes, smoldering disease course that can cause damage to photoreceptors and may result in cumulative damage to the retina, leading to a significant deterioration of vision. The indication of ILUVIEN and YUTIQ for NIUPS can include chronic, intermediate, posterior, or pan uveitis. It can also include chronic noninfectious uveitis affecting the posterior segment of the eye that develops following ocular surgical procedures. Corticosteroids are the mainstay of treatment in chronic NIUPS, Right?

Unlike DME where anti VEGF was the is the mainstay. Treatment options include, local treatments like YUTIQ and ILUVIEN, other intravitreal corticosteroid employ plants such as dexamethasone, and ocular corticosteroid injections and systemic, steroids and systemic immunomodulatory therapy. There’s no requirement for a steroid challenge in our NIUPS indication, so it can be used early or later in the course of treatment. So, you know, there’s about a hundred thousand, patients with, you know, uveitis in the posterior segment, And that’s, you know, that is the addressable market for us and, you know, very similar to ILUVIEN I mean, sorry, to DME. There are less than five thousand patients that are on therapy today with or or were put on therapy for NIUPS, with YUTIQ last year.

Obviously, going forward, as we had described, you know, we’ll be promoting, ILUVIEN now that the FDA has approved the label for NIUPS with ILUVIEN. So

Doug Neem: Yep. Okay. One of the things other trials that you have ongoing right now is synchronicity. Yeah. But it utilizes YUTIQ, and I don’t think it’s going to be a big issue transition.

However, could you, talk about the potential implications of that trial like you did for, DME?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. So synchronicity is, designed to provide, retina and uveitis specialists with a broader sense of the utility of YUTIQ across and and now ILUVIEN across a variety of patients with chronic, NIUPS. The trial had enrolled it’s an open label study, and the trial had enrolled 110 patients in approximately 25 sites around The US, and we expect preliminary top line results also in the second quarter of twenty twenty five. And then, you know, final results at the end of the year early next year.

Doug Neem: Okay. And then finally, maybe we can wrap up on this space. Just with respect to the competitive threats question again, products like Orzodex and Radicert and where they may fit in this whole thing relative to your product?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. Look. Corticosteroids are the mainstay treatment, in chronic NIUPS due to the inflammatory nature of the disease. And Iluvien and YUTIQ are differentiated by its durability, right, being the longest acting corticosteroid on the market, right, in even in comparison to the two you mentioned, which are in weeks and months versus sorry, Ozurdex, which is in, you know so Iluvien is the longest acting corticosteroid on the market. There are other agents in development, and, you know, we continue to monitor the competitive landscape.

Doug Neem: Okay. Excellent. One of the things I did wanna spend some time on was the U. Ophthalmology force where you’ve gone from 30 to 46 now across the whole company. What KPIs are you watching and why as you look at the three products?

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. Primarily, if you have for sales would be the sales of, Iluvien, YUTIQ, and Cortrophin Gel. We are also monitoring input parameters such as mix of calls, target lists to refine and improve the effectiveness, of our newly combined Salesforce, selling three products.

Doug Neem: Okay. Good. And then, I know that, for q one twenty twenty five, you had indicated some headwinds for the combination of Luvian and YUTEK due to what you described as evolving market access dynamics. Perhaps you could describe that and how long they met that might last before we start to see a continuation of the growth.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. So in the past, patients with, Medicare and Medicare Advantage plans had, access to programs that assisted with, offsetting the cost of the patient responsibility based on financial need. Some of these, programs have not received adequate funding yet in 2025. And so what we’re doing about it is, first and foremost, ANI has in place a patient assistance program that provides access for patients and financial need with free ILUVIEN and YUTIQ as needed. And then secondly, we’re spending time with our HCPs to understand their response to these market access changes and refining our commercial approach accordingly.

You know, as we’ve shared in the prepared remarks, there are currently fewer than 5,000 patients, on therapy for each of ILUVIEN and, YUTIQ, and we estimate that the addressable patient population for each drug is approximately six to 10 times that based on the epidemiological data that we had shared earlier. So while this is a near term issue to work through, we remain confident of the growth prospects, for our products in both DME and in IUPS.

Doug Neem: Okay. You obviously think there’s a great opportunity with these drugs, and I just underscore the fact that you went out recently and, bought the royalties, back, that 3% royalty from SWK. Maybe you can just expand on that quickly as we start to wrap up, and maybe there’ll be one more question before, I thank you.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure. So we did a financial assessment, and it made sense for us to buy the royalty back given the confidence we have in our ILUVIEN and YUTIQ franchises. And, so it as simple as that.

Doug Neem: Okay. Okay. Then maybe, to wrap things up, people might be curious about the IP status of the key drug ILUVIEN and how that fits into, how you’re operating the business.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Sure, Doug. So sustainability of ILUVIEN is driven really in long term by the barriers to genericization. ANI has a strong generics R and D capability and is able to assess the risk effort reward combination for an ILUVIEN, and we believe that that makes it unviable. You know, a genetic development program would require a multiyear clinical program with significant risk and require significant investment. And we believe that, you know, again, the risk effort reward combination for an ILUVIEN generic makes it unviable and and will take a, you know, a long period of time, you know, to get done.

We continue to obviously monitor the competitive landscape and, really remain confident in the barriers to genericization.

Doug Neem: Excellent. I think we’re basically out of time. I want to truly thank you for you taking the opportunity to sit down with us today. It sounds like a really interesting story, And thanks again for being the first company at our inaugural, ophthalmology conference. Appreciate it.

Thank you, Nikhil.

Nikhil Lalwani, President and CEO, ANI Pharmaceuticals: Yeah. Thank you, Doug. We’ll talk to you soon. Thank you, investors. Take care.

Doug Neem: Okay then. Bye then.

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