ANI Pharmaceuticals, Inc (NASDAQ: ANIP) FY 2026 Earnings Call dated Mar. 10, 2026
Corporate Participants:
Nikhil Lalwani — President and Chief Executive Officer
Stephen P. Carey — Senior Vice President, Finance and Chief Financial Officer
Analysts:
Thomas J. Smith — Analyst
Presentation:
Thomas J. Smith — Analyst
Good afternoon, everyone. Thanks for joining us here, day two of the Leerink Partners Global Healthcare Conference. My name is Tom Smith, one of the senior biotech analysts here at Leerink and really happy to welcome our next company to the stage, ANI Pharmaceuticals, represented today by CEO Nikhil Lalwani and CFO Steve Carey. Gentlemen, thanks for joining us.
Nikhil Lalwani — President and Chief Executive Officer
Thank you for having us, Tom.
Stephen P. Carey — Senior Vice President, Finance and Chief Financial Officer
Thank you.
Thomas J. Smith — Analyst
Maybe you guys could just start high-level, level set. It’s been a busy last 12 months for you guys, lot of really strong execution. Maybe just walk us through kind of like high-level highlights on 2025 and what we’re looking forward to most in 2026.
Nikhil Lalwani — President and Chief Executive Officer
Great. So just to give a baseline, ANI is a high-growth biopharmaceutical company accelerating our transformation into a leading rare disease company. We have, you know, a high-growth rare disease business with two assets that are very durable, Cortrophin Gel and ILUVIEN, which I will tell you about in a second, and then a generics business that has continued to perform. And across our generics and brands business, we have what we believe is a virtual cycle of growth, where we take the EBITDA and cash flows from our generics and brands business and reinvest it to accelerate our transformation into a leading rare disease company.
2025 was a very strong year for ANI. We delivered very strong growth to end the year at $883 million in revenues, which is about a 44% growth over the prior year and a strong EBITDA of $230 million, again 47% growth over the prior year. As we head into 2026, rare disease continues to be the primary driver of growth for the company and will account for approximately 60% of revenues in 2026, driven by our lead rare disease asset, Cortrophin Gel.
Cortrophin is a ACTH product that is used for certain autoimmune indications. It’s an alternative treatment option for patients that are — that can benefit from an alternate treatment option that are steroid resistant or refractory to steroids or have high side effect profiles to steroids. It operates in a large under-penetrated markets across several indications. And then we have ILUVIEN, which is a intravitreal injection used to treat diabetic macular edema and chronic non-infectious uveitis. Again, operating in a large TAM that is under-penetrated.
And so as we look to 2026, Cortrophin did $347 million in sales in 2025 and will grow to $540 million to $575 million in sales in 2026. And then our overall company will grow about 19% to 26% to $1.055 billion to $1.115 billion. And EBITDA will grow to $275 million to $290 million, which is also 20% to 26% growth.
Thomas J. Smith — Analyst
That’s great. Thanks for the background and the overview. You issued 2026 guidance earlier this year. Massively, I think, exceeded expectations on the guidance, specifically around the Cortrophin revenue trajectory and revenue growth. You’ve highlighted some new initiatives that help drive that growth. One of them is the sales force expansion into acute gouty arthritis. Like, how much of the step up here in 2026 is being driven by that expansion and then how much comes online, I guess, like, this year versus 2027?
Nikhil Lalwani — President and Chief Executive Officer
Yeah. Thank you, Tom. Yeah. Look, we did $347 million in sales last year with Cortrophin. Cortrophin, as I said, has multiple indications that are significantly underpenetrated. So there’s a large amount of growth from $347 million to our current year guidance of $540 million to $575 million that will come from just growth in our existing indications and the existing team that’s driving it, right? We had done an expansion last year, too.
So we have a portfolio team that goes into rheumatology, nephrology, and neurology. That team was expanded last year to about 60 plus reps. A dedicated pulmonology team and then a combined team selling Cortrophin and ILUVIEN into ophthalmology. These teams will drive the bulk of the growth from $347 million to $540 million to $575 million.
In the middle of the year, we are launching a dedicated team for acute gouty arthritis flares, but detailing into primary care and podiatrists. This team will be about. Our total organization expansion is about 90 people, 65-ish in sales, and then eight business leaders. That is a completely new set of physicians that we’re going after. And the reason is, we’re trying to address a much broader patient population that is available to us in gout. And so in the back half of the year, we’ll have the impact from this sales force expansion.
But as everybody knows, you know, we’ll get the sales force going in May and June timeframe. Takes time for the sales force to have impact and you’ll see some impact in Q3, Q4, but you’ll see much greater impact or the full-scale impact of this expansion in 2027, giving us operating leverage as we go into 2027.
Thomas J. Smith — Analyst
So maybe just level set us on, you know, the driving force behind that expansion.
Nikhil Lalwani — President and Chief Executive Officer
Sure.
Thomas J. Smith — Analyst
Why acute gouty arthritis and I guess why we feel like 90 is the right number for resourcing?
Nikhil Lalwani — President and Chief Executive Officer
Sure. So there are, in the ACTH category, there are two drugs that are available, and acute gouty arthritis flares is an indication that we have and the competitor does not. So that’s one reason. Second is, we’ve had success since we’ve launched, with acute gouty arthritis flares becoming approximately 15%, more than 15% of our volume and these sales come primarily from rheumatologists and nephrologists. So that’s the second.
The third is, we had successful pilots last year. So through last year, we ran 10 successful pilots. So we took 10 territories and asked them to focus on podiatry and primary care and see if we could reach more patients with that. We had very good success with those pilots and that gave us a proof of concept or even more confidence to do another sales force expansion. Remember, we’ve done multiple sales force expansions since we’ve launched in 2022. And this is allowing us to reach 7,000 new HCPs split between primary care and podiatry.
We have about 64 reps, right, and eight Area Business Directors that allow us to reach this — these HCPs, 7,000 HCPs. So who are these 7,000 HCPs? So Cortrophin for acute gouty arthritis flares, we believe is appropriate for patients that are for whom other treatment options are — or patients who can benefit from alternate treatment options. If you think about there are 9.9 million patients in the US that have gout, 36% of them get treated annually.
Of the 36%, only 8% are treated with injectables. Their flares are so acute and severe that they get treated with injectables. And that 285,000 patient population is our TAM for Cortrophin. And when we did these pilots, we understood that there are patients that have two or more flares. And who are the — and we were able to develop an algorithm that helped us identify the physicians in primary care and podiatrists that are seeing these patients. So we were able to identify about 7,000 HCPs to allow us to reach these patients that treat these patients and a subset of these patients will be appropriate for Cortrophin.
So that’s how we thought about we’re the only ACTH that has the acute gouty arthritis flares indication. We had success with rheumatologists and nephrologists, with acute gouty arthritis being 15% of our volume. And third, we had proof of concept with 10 successful pilots. That’s the reason behind the expansion into acute gouty arthritis flares for primary care and podiatry.
And I think the last point I would say, Tom, is, for us, the growth in Cortrophin is really from growth of the market. For us, it’s about reaching new patients that can benefit from this treatment option. And therefore, we picked the one indication where we have the indication, the competitor does not, and also reaching a completely new physician set that we hadn’t gone to before.
Thomas J. Smith — Analyst
Maybe if you could expand on that last point and you ran the 10 pilot programs. You said, like, a lot of success coming out of those that drove the sales force expansion. Just what is the conversation, I guess, like with a PCP or podiatrist? Like, I think investors tend to think of these as sort of like less specialized, less likely to reach for a biologic in general. But it sounds like you saw very good results from these pilot programs. So what were some of, I guess, those learnings, and like how do we detail these two new specialties versus like rheumatologists and our existing core business?
Nikhil Lalwani — President and Chief Executive Officer
Sure. I think that the learning, so we’ve had, you know, more than 150 plus podiatrists and HCPs, PCPs that have written for acute gouty arthritis flares in our pilots. And what we learned is, the discussion with them is really anchored around the patient. Who are the appropriate patients, who are the patients that they believe have issues with having their flares continued and who are having repeat flares. And that’s where you anchor the conversation, and then you work with them and their office.
And we obviously have the support, the other support systems like field reimbursement directors, etc., to work and patient support in our hub to work with the physician offices to once there is an intent to prescribe, to actually help the office, you know, get the right paperwork and the enrollment and prior auths in place, to be able to get the patient on therapy.
Thomas J. Smith — Analyst
That makes sense. I want to talk about some of the maybe more near-term dynamics. Q4 earnings you called out. I mean, there’s typical seasonality, insurance reverification. You also called out weather in January as a potential headwind as we think about Q1 revenues, but it sounded like there was a recovery in February. You know, we’re almost two weeks into March. I guess, what are we seeing in recent trends and how do we feel about Q1 Cortrophin dynamics?
Nikhil Lalwani — President and Chief Executive Officer
Sure. So Q4 to Q1 has typical seasonality. What we highlighted was in the early part of Q1, on the insurance reverification process, we had seen that it takes a little bit longer. And it took a little bit longer, driven largely by the very high volumes, right? In Q4 of ’24, we had about $59 million in sales. In Q4 of ’25, there was a — we had $110 million sales of Cortrophin. So there was a much larger volume of patients that were going through the insurance reverification process. And the insurance reverification requires three act — three players, right? It’s the company, the manufacturer and their hub and field reimbursement support, also the physician’s office and then the patients.
And really, at the physician’s office with this much larger volume, it just took a little bit longer. This larger volume impact would have been there regardless of any weather impact, but it just got exacerbated a bit more with the fact that in some of our highest performing territories, you lost more than three to seven days in the office, which in a short timeframe of five to six weeks, that’s a meaningful amount of time. So what it has done is, it’s impacted, you know, the Q1 number and shifted revenues from Q1 into Q2.
We’re almost through the insurance reverification process. You know, all the patients that were on therapy on December 31, 2025, have been the ones that need a reverification, which are, you know, have gone through the reverification process or, you know, over 90% of them have gone through the reverification process. And we’re just, you know, — we’ll see — and we’re seeing the ramp up in February, right? February had 25% higher volumes in mls than January.
We also saw in February, very importantly, demand to top of the funnel, the second highest number of new cases initiated of all time in a shorter month. Right? So which is also a very healthy sign of demand. And then we saw an acceleration in new patient start. So, yeah, I think that in terms of our full year guidance, we’ll see the Q1 dynamic and then we’ll catch up in Q2 and build from there when the full 60-person team, 60-person-plus acute gouty arthritis flares team will be out in the field.
Thomas J. Smith — Analyst
So we think this, somewhat like seasonal, a little bit weather-related backlog is cleared basically in Q2 and then we have new sales force augmentation coming online kind of middle of the year that starts to boost Q3 and Q4.
Nikhil Lalwani — President and Chief Executive Officer
That’s right.
Thomas J. Smith — Analyst
With full impact in ’27.
Nikhil Lalwani — President and Chief Executive Officer
Right. And I’ll just go back to — when you think of $347 million to $540 million to $575 million, bulk of that growth comes from the existing team. So you will see a significant ramp in Q2 from Q1, right? Including the shifting of some sales that will happen from Q1 to Q2 because of insurance reverification. That team in itself will keep ramping through the year, just like we did in ’25, right? Where we went $52 million Q1, $80 million Q2, $100 million Q3, and then $110 million Q4. So that team that’s in the building today will keep driving that ramp through the year.
In addition, you will now have 60 plus people — 64 reps that will walk into the building and will start detailing from the May, June timeframe that will have impact in the back half of the year and into ’27.
Thomas J. Smith — Analyst
Yes. You also — you just recently introduced the prefilled syringe. Form of the product. I think you said towards the end of ’25, this was accounting for 70% of volumes. I guess anything to note there in terms of either kind of like patient — clearly, the market is speaking to you, there’s a preference for the prefilled syringe, but are you seeing anything across specialty types or patient types, indication types?
Nikhil Lalwani — President and Chief Executive Officer
Yeah. No, it’s actually across the board. Initially, we thought that this was meant for patients that — we’re preferred by patients that have dexterity issues — it’s dexterity issues or visual impairment. And we’ve seen just a much broader adoption across the board with over 70%, and that number keeps going higher use of the prefilled syringe.
Thomas J. Smith — Analyst
And on the acute gouty arthritis, you also have a Phase 4 study.
Nikhil Lalwani — President and Chief Executive Officer
Correct.
Thomas J. Smith — Analyst
Clinical study. Just walk us through kind of the goal, like what you’re hoping to achieve with that study, and how that could also help you drive penetration into that TAM that you described.
Nikhil Lalwani — President and Chief Executive Officer
Yeah. So there are two doses — so this is a 160-person study. We have in the two arms, the two different dose levels of Cortrophin. And the primary endpoint is to compare the reduction in, you know, symptoms related to gout, right, at day three. And what we have in one arm is the 1 ml, and the other arm is the 0.5 ml. And obviously, there’s a number of secondary endpoints too.
And the purpose of this study is to generate more data, clinical evidence to support the use of Cortrophin Gel for acute gouty arthritis flares. And we believe this can also support the inclusion of Cortrophin in the treatment guidelines for gout. So we’re looking forward to continue making progress on this study and that, you know, when appropriate updating you all on the progress that we’re making.
Thomas J. Smith — Analyst
That’s great. And when we think about the potential impact from the guidelines, is that — there’s obviously like a increased awareness among prescribers. Does that also make things easier for you on the reimbursement access side?
Nikhil Lalwani — President and Chief Executive Officer
Absolutely. It will get it into standard of care and yeah.
Thomas J. Smith — Analyst
Cool. One other question on just the ACTH market. And I think you’ve thrown a data point out there, like, you know, 50% of current prescribers were previously ACTH naive. Like, I guess how do we think the prescriber uptake here evolves over the course of ’26? And then just like, high-level market-wise, like, how big could this market be in totality as you have a duopoly essentially, but it seems like growth on all sides.
Nikhil Lalwani — President and Chief Executive Officer
Sure. Yeah. You know, the addressable patient populations across indications is very significant compared to what is currently being treated. So across indications, we are significantly under-penetrated. And so, we believe by reaching more physicians, we can reach the appropriate patients for the treatment of acute — sorry, of the various indications that we have.
Now, in terms of how do we achieve that, you’ve seen that over the past four years, we’ve achieved that not only by going to believers in ACTH, right? But also by convincing or engaging with new prescribers, folks that were naive to ACTH and over 50% of our prescribers are such. And if you think about our expansion, we’re going to a completely new prescriber base, primary care and podiatrists, that will also be naive to ACTH. Most of them will be.
And so, you know, this is really about expanding the physician base that gets us access to the appropriate patients to treat this indication. And look, we don’t give a peak sales outlook or — but we believe that there is you know, a very significant multi-year growth runway available for the category, driven really by the fact that the addressable patient population is just dramatically larger, orders of magnitude larger than what is currently being treated with either ACTH drug. And both companies are investing, right? They’re investing in different areas. We’re investing in acute gouty arthritis flares. So yeah, I think both companies are investing across different areas to make sure that the appropriate patients get this, the ACTH therapy.
Thomas J. Smith — Analyst
Got it. So there — yeah, there’s a much broader.
Nikhil Lalwani — President and Chief Executive Officer
Correct.
Thomas J. Smith — Analyst
ACTH market expansion story underway. I want to switch gears and talk about the ophthalmology retina franchise and ILUVIEN specifically. You guided to $78 million to $83 million for ’26. That represents 4% to 11% growth, return to growth. You have NEW DAY data. I guess what is the strategy here for moving ILUVIEN into earlier lines of DME?
Nikhil Lalwani — President and Chief Executive Officer
Right. So with ILUVIEN in diabetic macular edema, we have the, you know, again, the standard of care are anti-VEGFs. There are patients that there are about 50,000 patients that do not show optimal response to two or more anti-VEGFs, and also show positive response to steroid trials. So that’s who we consider our addressable market for ILUVIEN, for DME.
There are less than 5,000 patients that come, that get the ILUVIEN injection, intravitreal implant, sorry, every year. So there is a significant opportunity for more patients to benefit from ILUVIEN. When you think about the NEW DAY results, what that results showed, this is over 300 patients, data from over 300 patients with ILUVIEN versus the aflibercept arm.
And what you see in the data results and the feedback that we’ve gotten from clinicians as we’ve shared it, initially at leading conferences, but now, you know, through increased marketing and sales efforts, is that there is data that supports the use of ILUVIEN earlier in the treatment of DME. And that will help us sort of capture more of the addressable market that we have for ILUVIEN. There’s a number of other initiatives that we’ve launched in 2025 and are, you know, in high gear in ’26, such as our strengthened commercial team, use of alternate pathways to get patients that have Medicare co-pay funding issues onto therapy, and then just a broader continued investment in both marketing and sales to drive the success of ILUVIEN.
And just as a reminder, ILUVIEN is indicated for both for two indications, the one that we’ve been talking about, diabetic macular edema, but also for chronic non-infectious uveitis affecting posterior segment of the eye, where steroids are the standard of care. So fluocinolone acetonide, which is what ILUVIEN is used as a way to reduce the treatment burden, right? It has both long-term efficacies and a reduced treatment burden to treat chronic NIU-PS.
Thomas J. Smith — Analyst
You just got that label expansion in March of last year.
Nikhil Lalwani — President and Chief Executive Officer
Correct.
Thomas J. Smith — Analyst
So we’re about kind of a year into that. What’s been the receptivity among the retina clinicians to having both indications?
Nikhil Lalwani — President and Chief Executive Officer
Sure. Yeah, look, most retina physicians had used both ILUVIEN and YUTIQ, which is the original product for uveitis. They’re very similar in terms of the actual fluocinolone acetonide. There’s a 0.01 difference in the strength, but the difference was really in the injector. And because most physicians had used both, you know, I think the adoption was welcome. Also, it’s more convenient to have to stock one product rather than two separate products, so it made it more convenient for physicians in retina offices. Of course, there are some clinicians that are new, right?
That had only been using uveitis specialists, that had only been using ILUVIEN, sorry, YUTIQ, that you know, it’s taken a bit of time for them to learn how to use the new injector. And yeah, but I think overall it’s been very positive. And then from an access perspective too, we have secured all the coverage needed that YUTIQ had on ILUVIEN for NIU-PS.
Thomas J. Smith — Analyst
That makes sense. I guess thinking beyond 2026, like as you continue to invest in the business, how should investors think about the growth and profitability profile for ANI going forward?
Nikhil Lalwani — President and Chief Executive Officer
Sure. So ANI is continuing to drive growth and profit, balancing that with profitability, so it’s not growth at all costs. So if you look at ’26, you know, we growing the top line 19% to 26%, we’re growing the bottom line 20% to 26%. This is in a year when we’re, you know, having a significant investment. If you look at the implied opex, there’s a $50 million increase from ’25 to ’26. Majority of that is for this 90-person acute care organization expansion. Despite that investment, we’re keeping the EBITDA margin profile as a percentage the same between ’25 to ’26 at the midpoint of our guidance.
So we’re balancing growth and profitability and as we mentioned earlier, with this acute care team, you will see operating leverage as we head into ’27 with the same level of SG&A supporting a much higher revenue in ’27.
Thomas J. Smith — Analyst
That makes sense. And you’ve shown a nice appetite for business development historically. When we think about capital allocation and go-forward appetite for deals, maybe you could talk about sort of, I guess, frame expectations and talk about what areas that you’re interested in. Do they have to be direct adjacencies to places that you already are? What’s your appetite for clinical development risk?
Nikhil Lalwani — President and Chief Executive Officer
Sure. Yeah, look, we’re focused from a capital allocation perspective. We’re very disciplined. Our focus is on rare disease, on expanding scope and scale of rare disease. We’re looking at commercial assets of two types. One that are synergistic from a call point perspective with our existing call points, and we have the benefit of Cortrophin going into multiple different call points. In addition, we also have a backend infrastructure and knowing how to work with small patient populations. And so, you know, patient support, medical affairs, market access, specialty pharmacy distribution, all of that back infrastructure.
So even if there are rare diseases where you have a small patient population, where we can work with the physicians to reach that patient population, that’s an area. And a therapeutic area or a specialty that’s not synergistic with Cortrophin, we would explore that too.
Thomas J. Smith — Analyst
That makes sense. We have about 30 seconds left. Maybe just when we think about sort of the strength of the underlying business, and I guess, what’s your sense of how the market is evaluating that? What do you feel like is the most underappreciated aspect of what you guys are executing against here in ’26?
Nikhil Lalwani — President and Chief Executive Officer
Yeah. I think the long-term growth and durability of our businesses, right, both Cortrophin, right? This is Cortrophin and ILUVIEN both have very long runways from a growth and from a durability and sustainability standpoint. And at the same time, our generics business, right, has grown at 25% CAGR since ’21. And with our investment in R&D to support the continued growth of our generics business, I think that we have a virtuous cycle of growth where, with our own cash flows, we’re reinvesting to drive growth of our rare disease business and really accelerating our transformation into a leading rare disease company.
Thomas J. Smith — Analyst
Great. Well, unfortunately, we’re up against time, but thank you so much, Nikhil and Steve, for joining us, and looking forward to a strong 2026.
Nikhil Lalwani — President and Chief Executive Officer
Thank you, Tom.
Stephen P. Carey — Senior Vice President, Finance and Chief Financial Officer
Thank you, Tom.
Nikhil Lalwani — President and Chief Executive Officer
We appreciate it.