ANI Pharmaceuticals at H.C. Wainwright: Rare Disease Growth Focus

On Tuesday, 20 May 2025, ANI Pharmaceuticals (NASDAQ:ANIP) presented at the H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025. The company emphasized its strategic focus on expanding its rare disease business, spearheaded by Cortrophin Gel, while also maintaining robust performance in its generics segment. Despite temporary setbacks in some product lines, ANI projects significant growth in revenue and EBITDA for 2025.

Key Takeaways

• ANI Pharmaceuticals projects 2025 revenue between $768 million and $793 million, indicating a 25% to 29% growth.
• Cortrophin Gel is expected to generate $265 million to $274 million, reflecting a 364% to 377% year-over-year increase.
• The generics segment achieved a record $98.7 million in Q1 2025, driven by new product launches.
• The company maintains a strong balance sheet with $150 million in cash and a net leverage of 2.7 turns.

Financial Results

ANI Pharmaceuticals provided a positive financial outlook for 2025, with revenue guidance set between $768 million and $793 million. The company anticipates adjusted non-GAAP EBITDA to range from $195 million to $205 million, reflecting a substantial year-over-year growth. In Q1 2025, ANI reported $197 million in revenue and $51 million in adjusted non-GAAP EBITDA. The company also highlighted its strong cash position of $150 million as of March 31, 2025.

Operational Updates

Rare diseases remain a key focus, with assets like Cortrophin Gel, ILUVIEN, and YUTIQ contributing significantly to revenue. Cortrophin Gel’s growth is driven by its application across various autoimmune and inflammatory conditions. Meanwhile, ILUVIEN and YUTIQ faced temporary revenue impacts in Q1 2025 due to seasonal dynamics and sales force turnover. The generics business reached new heights with $98.7 million in revenue for Q1 2025, thanks to successful product launches and operational excellence.

Future Outlook

Looking ahead, ANI Pharmaceuticals plans to sustain the growth trajectory of Cortrophin Gel through continued research and evidence generation. The company is also addressing factors that impacted ILUVIEN and YUTIQ sales, aiming to capture larger opportunities in diabetic macular edema (DME) and non-infectious uveitis posterior segment (NIUPS). ANI is committed to expanding its rare disease portfolio through strategic mergers and acquisitions and in-licensing activities.

Conclusion

For a deeper understanding of ANI Pharmaceuticals’ strategic plans and financial performance, readers are encouraged to review the full conference call transcript.

Full transcript - H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025:

Nikhil Luwani, CEO, ANI Pharmaceuticals: Good afternoon, everyone. And from ANI is CEO, Nikhil Luwani. Nikhil, over to you. Thanks for joining us. Good afternoon, everybody, and thank you for joining this afternoon’s presentation.

Thank you, Brandon, for the warm welcome. These are our standard disclaimers on forward looking statements and the explanation of the presentation of financial information. Our deck, obviously, is available on our website. This is our new corporate presentation. So ANI Pharmaceuticals, we have three business lines that serve as our primary growth drivers.

Rare disease is our primary growth driver with three growing and durable commercial assets: purified Cortrophin Gel, ILUVIEN and YUTIQ. And we drive growth in our or expansion in our rare disease business, both organically, and I look forward to sharing that with you as well as through M and A and in licensing. We also have a generics business with superior R and D capabilities, driving new product launches and strong operational excellence and then Established Brands or Brands business where we use a unique commercial capability, high margins and strong cash flow generation. So the way we think about our company in these three business segments is that we are in a virtual cycle of growth. We take the EBITDA and cash flows from the generics and our brands business and reinvest that into our rare disease business, which drives growth and is the primary area of allocation from a capital perspective.

And for our generics business to fuel that growth, we invest in R and D, right? And we have a strong R and D engine that came to us through the acquisition of Navidium in 2021. To talk about ANI numbers, we our guidance for 2025 is $768,000,000 to $793,000,000 in revenues, dollars 195,000,000 to $2.00 $5,000,000 in adjusted non GAAP EBITDA. The revenues this represents about 25% to 29% year over year growth. We also have a healthy balance sheet with $150,000,000 of cash as of 03/31/2025 and two point seven turns of net leverage on a pro form a prior twelve month basis.

Important as we are navigating this tariff environment to point out that relative to our peers with over 90% of our revenues coming from products, finished goods that are manufactured in The U. S. And with less than 5% direct reliance on China. We’re well positioned to continue driving growth. You see the trajectory in 2022, we were at $316,000,000 of revs and $56,000,000 of EBITDA and growing on the basis of our rare disease business as well as continued growth in our generics business to give guidance of $768,000,000 to $793,000,000 in revs in 2025 and then 195,000,000 to two zero five million dollars in adjusted non GAAP EBITDA.

So we’re really well positioned to continue driving growth both organically as well as inorganically. To touch on the Q1 results, which we reported a couple of weeks ago, we delivered record results in Q1 twenty twenty five with revenues of $197,000,000 and adjusted non GAAP EBITDA of $51,000,000 And what you’ll see is that this came on the back of continued growth in our lead rare disease asset Cortrophin Gel, where we had record new cases initiated and record new patient starts. We had growth across therapeutic areas and also between new prescribers and existing prescribers. We’d like to note that acute Gauri arthritis, which is an indication that we have and the competitor in ACTH does not have, accounts for approximately 18% of our usage. And the use in ophthalmology, a new area that we did the Alimera acquisition in increased 50% quarter over quarter.

The two ophthalmology assets are retina assets, ILUVIEN and YUTIQ saw a were temporarily impacted. Their revenues were temporarily impacted in Q1 through due to three factors. One is the typical Q4 to Q1 dynamic. Second is, reduction in co pay support or patient support for Medicare patients due to foundations running out of funding. And then third is, turnover that we saw in our sales force.

Last and but certainly not the least, our generic revenues reached a record high of $98,700,000 on the back of successful new product launch execution and strong operational excellence. I would like to point out the six month exclusivity that we have on the procalopride generic, which we launched right towards the end of Q4. Our revised full year guidance, I covered a lot of that on the first page. But I would like to point out here that Cortrophin Gel, our guidance for the year is $265,000,000 to $274,000,000 which is a 384% to 38% year over year growth. This is our lead rare disease asset.

And ILUVIEN and YUTIQ, our full year guidance is 97% to 103%. So when you add those two, it’s about 364% to 377% and that represents about 48% to 49% of ANI, right? So almost half of ANI revenues comes from rare disease assets. Rare disease expected to continue as the primary driver of growth. As we just pointed out, it started with our lead asset Cortrophin being launched in 2022.

We did $42,000,000 in the first year and this year our guidance is $362,000,000 to $377,000,000 Cortrophin all organic and then ILUVIEN and YUTIQ through the acquisition of Alimera. So our rare disease business has three assets, Cortrophin, ILUVIEN and YUTIQ. What’s common amongst these three assets is that they’re all operating in large addressable markets. So the patient populations that can benefit from these therapies, the appropriate patients are much larger than anything than than the numbers that we’re treating today, giving significant headroom for expansion. Cortrophin has multiple indications, 22, across multiple autoimmune and inflammatory conditions.

The ones that we’ve focused on since launch are multiple sclerosis, rheumatoid arthritis, excess urinary protein due to nephrotic syndrome, acute Gauri arthritis flares, and then acute and chronic allergic and inflammatory processes affecting the eye as well as sarcoidosis. These are the main indications that we focused on out of the 22 indications that Cortrophin has, and it’s obviously across therapeutic areas, which is extremely helpful as we think about inorganic growth, right? It gives us call points that we’re already attending to and to find other assets that we can go into. And we’ll show you how we did that. We did just that with the Alimera acquisition.

And our two retina assets are ILUVIEN and YUTIQ. ILUVIEN is indicated for diabetic macular edema and chronic noninfectious uveitis affecting posterior segment of the eye, and that is also what YUTIQ has indicated for. Again, all three assets operating in large addressable markets as well as being tough to genericize and therefore having a significant amount of longevity associated with them. So the rare disease portfolio, when ANI thinks of rare disease, we focus on patients that are underserved by other therapies. These can be low prevalence diseases such as chronic NIUPS, which YUTIQ and ILUVIEN address, or underserved patients in high prevalence diseases such as multiple sclerosis and nephrotic syndrome, which Cortrophin Gel addresses.

So that’s how ANI thinks about rare disease. Cortrophin Gel. Right? It’s a purified corticotropin. It’s a treatment option for patients that are struggling with certain chronic autoimmune disorders.

I I spoke about that. This this was an estimated $600,000,000 ACTH market in 2022 when we entered, and, you know, it grew to $684,000,000 in 2024. So after many years of degrowth, which I’ll show show you in a second, second, it started driving us and the competitor have been able to turn the tide and start regrowing the market and getting the drug to patients in need. And really it was us bringing a much needed choice. There was only one treatment option for ACTH and we brought choice into the ACTH market in 2022.

We’ve also launched a prefilled syringe. So right now Cortrophin Gel is available in multiple presentations. There’s the five ml vial, which is largely used for self administration at home. The one ml vial, which is used both for self administration as well as administration in the physician’s office and then we have a pre fill syringe, which is also used for self administration. And one and the pre fill syringe is available in the one ml and zero point five ml configurations.

So the ACTH market was $1,200,000,000 in 2017 and went through many years of significant degrowth. And then starting 2022, when we launched, it started stabilizing, called the degrowth, the deceleration slowed. And then you’ll see in 2024, you add our performance and the competitors’ performance, there was 27% growth. And then even in 2025, when you add our guidance and the competitors’, guidance, it shows that the market will grow 16% to 792,000,000. If you assume that the competitor is saying, you know, high single digit, we’ve taken that at seven and a half percent.

What’s important to note, though, is that the number of patients. Right? Therapeutics are all about patients. The number of patients on therapy today are almost half the number of patients that were on therapy in 2017, and that forty percent of our Cortrophin Gel prescribers were naive to ACTH before we entered. You will also remember that I said acute gouty arthritis, which accounts for about eighteen percent of our usage, right, was not in the one point two billion.

Right? So three different data points. And when you look at it from an epidemiological perspective, the number of patients that were on therapy even in 2017 is substantially lower than the addressable market. The addressable market is many, many multiples higher than what was on therapy even in 2017. In short, the headroom for expansion for this for this therapeutic Cortrophin Gel is significant, and we believe that Cortrophin is on a strong multiyear growth trajectory.

So coming back to the quarter, right, we continue to see strong growth across the initially targeted specialties of rheumatology, nephrology and neurology. These are the indications we targeted right at launch. We continue to see strong growth there across existing prescribers and new prescribers. In fact, in Q1, the momentum continued with us having record new cases initiated and new patient starts in typically what is a seasonally low quarter for rare disease products, right? So again, the momentum is significant.

We’ve continued to invest behind these initially targeted specialties by expanding the sales team. We added roughly 20 members across what we call our portfolio sales team targeting these initial specialties. We did that in Q1, and we’ll see the benefit of that in Q2 and beyond. We’re also continuing to gain traction in the newer therapeutic areas. We expanded our ophthalmology sales team with the acquisition of Alimera to about 46 reps.

And we saw in Cortrophin a 50% increase in volume between Q4 and Q1. Acute cardiac arthritis is also a newer indication, and I’ve already mentioned that we’ve gotten to about eighteen percent of our usage coming from acute cardiac arthritis. Also interestingly, fifteen percent of physicians that write first for acute gouty arthritis also then write for other indications. Our focus, small pulmonology team continues positive results. So we believe that Scrotropin is at a strong multiyear growth trajectory and are continuing to strengthen the franchise, right?

So what are we doing? We’re working on evidence generation. We’re investing in research to provide additional support for the use of Cortrophin Gel. At our earnings, we announced that we are going to initiate a clinical study for acute Gaudi Arthritis, and we’ll look forward to sharing more details of that. We recently presented two abstracts at the American Society of Nephrology.

From a development perspective, we launched the new presentation of the prefilled syringe in April of twenty twenty five, and we’re continuing to explore other ideas to enhance the convenience for patients and prescribers. We continue to invest in high ROI commercial efforts, such as the expansion of our sales team to drive growth across all specialties. So the addressable market being large, we continue to find appropriate patients for this therapy. This is more details on the opportunity in gout, acute gouty arthritis flares. I’ve covered a number of these points on the previous slides.

The main thing that I’ll highlight here is when we think about the addressable market in gout, of the nine million plus patients in The U. S. With gout, we consider our addressable market to be the roughly three hundred thousand patients that are using some form of injectable therapy for treatment of their flares. Next, we’ll move to the Alimera acquisition. This acquisition we used to expand the scope and scale of our rare disease business, and it will align with our M and A strategy, which was used to add commercial assets, ones that were synergistic with Cortrophin.

So it was in a priority therapeutic area. Ophthalmology had grown to be almost 10% of total ACTH usage. So that’s why it was synergistic with Cortrophin and assets with durability and growth, right? So we are operating in a large addressable markets, which I will detail shortly for ILUVIEN and YUTIQ as well as with high durability, right? The barriers to genericization are significant for both ILUVIEN and YUTIQ.

And so that’s, you know, how we thought about the acquisition of Alimera. ILUVIEN and YUTIQ, these are intravitreal implants, that are used to treat different indications. Iluvien is indicated for diabetic macular edema, with approximately four percent of diabetic patients that get impacted by that. There’s about nine hundred thousand patients in The US impacted by DME. And then chronic NIUPS, which is chronic noninfectious uveitis affecting posterior segment of the eye, there are about five hundred thousand patients in The US.

So these are intravitreal implants. In a couple of minutes. They’re implanted into the eye, and they last for about three years. One move that that we have made recently is we’re consolidating both indications into ILUVIEN. Right?

They’re essentially both identical sort of products with, you know, a slight difference in concentration. They’re both flucidolone acetonide, and so we’re combining the labels. We’re doing that more for supply security rather than anything else. But the the additional benefits that we have seen is there’s value to the customer. It simplifies.

They order one product. And now NIUPS, which is the indication that Youtique originally had, is also there on the Illuvium label. And so, you know, customers, as they’re ordering, can can just order Illuvian and maintain, you know, the single product inventory levels. There’s also most most physicians that have used Illuvian have also used Youtique or most physicians that have also used Youtique. Sorry.

It’s the other way around. Most physicians that have used YUTIQ have also used YUTIQ, so the slight difference in the implanter or the feedback that we have gotten will not be much. And what it does is, most importantly and the primary reason for us making this change change is that it enhances supply security significantly. ILUVIEN is manufactured at Siegfried, which is a CMO in Irvine, California. We’ve worked with them to expand the manufacturing capacity there.

We’re co investing with them to expand the manufacturing capacity. We’ve also extended the contract till 2029. So again, it’s a strong CMO for us to work with to ensure supply security for ILUVIEN. I’m going to start moving faster given time. So ILUVIEN is operating in a large addressable market with less than 5,000 patients being addressed, even though there are more than 53,000 patients that can benefit, which are patients that are suffering from DME, are less responsive to anti VEGFs, which is the standard of care for DME, and they show positive response to steroid trial.

And so that patient population is 53,000, of which only twenty thousand patients only less than five thousand patients are currently being treated with ILUVIEN. And you have the similar larger addressable market for YUTIQ. Again, the interest of time, I’ll keep moving. The whole purpose of this acquisition is 46 combined reps selling all three products. There’s overlap in the ophthalmology call points and we factor that in as we thought about the acquisition and we’re realizing that synergy as we execute.

The acquisition of Alimera also provided us a rare disease business with an international commercial footprint. Approximately 30% of our ILUVIEN and YUTIQ revenues comes from sales outside The U. S. Were direct to market in four countries, Germany, United Kingdom, Ireland and Portugal. And then we worked through partners, very strong partners in many other countries, about 18 countries.

We’re also continuing to support evidence generation with studies, with long term clinical studies, both for ILUVIEN and YUTIQ. We’re in the process of analyzing the data from the completed New Day trial and the synchronicity study at the six month time point, and we’ll provide updates on the results of both studies in the near term. Next, moving to generics. Genetics is really driven by strong R and D capability. We launched 17 products in 2024, including two competitive generic therapy products with one hundred and eighty day exclusivity.

In Q1 twenty twenty five was the largest generics quarter in terms of revenues. You see that to date with 41% year over year and twenty six percent quarter over quarter growth driven by new product launch execution as well as operational excellence, including the first to market launch of procalipride. We have a U. S.-based manufacturing footprint. We have three manufacturing facilities, two in Borat, Minnesota and one in East Windsor, New Jersey.

And in 2024, slightly different from our rare disease business, we supplied over $1,800,000,000 with a B, doses to patients in need. Of course, for generics, it’s important to continue having a strong GMP track record and a focus on cost excellence. That’s a visual of our three manufacturing sites, all U. S.-based manufacturing sites. As I said, 90% of our finished over 90% of our finished goods over 90% of our revenues come from finished goods that in The U.

S. And less than 5% direct reliance on China. So in summary, we have a strategic focus on our growing rare disease business. It will expect it to be approximately half of our 2025 revenues with our lead asset forecasted to reach approximately $270,000,000 That’s the midpoint of the $265,000,000 to $274,000,000 guidance. And the September 24 acquisition of ILUVIEN and YUTIQ providing two additional products with growth, sustainability, growth and durability.

We also have a robust foundational generics business that continues to drive high single digit, low double digit growth. Look, in 2025, our guidance mid double digit growth. But on an ongoing basis, we look to drive high single digit growth high single digit, low double digit growth for our generics business. We’ve successfully done that for the last three to four years. Actually, we’ve driven double digit growth across each of the last four years, including this year’s guidance.

We have a strong balance sheet, right, with $150,000,000 of cash and 2.7 turns of net leverage on a pro form a prior year twelve month basis. And then last, in terms of our 2025 priorities, number one is to expand the adoption of our Ofcotropin gel in the targeted specialties and to continue growing the ACTH category. Second is to address the factors impacting ILUVIEN and YUTIQ in Q1 twenty twenty five sales and capture the much larger opportunities in both DME and NIUPS. Third, to sustain the momentum in generics to deliver the mid double digit growth in 2025. And then last is to continue expanding the scope and scale of our rare disease business through m and a and in licensing.

So with that, thank you, and apologies if I went too fast. Thank you.

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