ANI Pharmaceuticals Inc (ANIP) 2025 Q3 法說會逐字稿

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Good morning everyone and welcome to today's ANI Pharmaceuticals 3rd quarter 2025 earnings results call. Please note this call is being recorded. After the speaker's opening remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, then the number 1 on your telephone. We ask that you please limit yourself to one question. If you would like to withdraw your question, please press star, then the number 2. It is now my pleasure to turn the conference over to Ms. Courtney Mogerle, Investor relations. Please go ahead, ma'am.

Thank you, operator. Welcome to ANI Pharmaceuticals Q3 2025 earnings results call. This is Courtney Moberly, industrial relations for ANI.

With me on today's call are Nikhil Awani, President and Chief Executive Officer, Steven Carey, Chief Financial Officer, and Chris Mutz, senior Vice President and head of ANI's rare disease business.

You can also access the webcast of this call through the investors section of the AI website at AIPharmaceuticals.com.

Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.

These forward-looking statements are based on information available to AI Pharmaceuticals Management as of today, and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC.

Such forward-looking statements are not guarantees of future performance.

Actual results may differ materially from those projected in the forward-looking statements.

ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law.

The archived webcast will be available for 30 days on our website, ANI Pharmaceuticals.com.

For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on November 7th, 2025. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and FEC filings.

And with that, I will turn the call over to Nikhil Awani.

Thank you, Courtney.

Good morning everyone and thank you for joining us.

The 3rd quarter was another remarkable quarter for ANI Pharmaceuticals, marked by record revenue, adjusted EBITDA, and adjusted EPS, all driven by continued momentum across our rare disease and genetics business units.

We grew total company revenues by 54% year over year and 46% on an organic basis.

In addition, we nearly doubled Corofin gel net revenue compared to the 3rd quarter of 2024 and generated adjusted EBITDA growth of 70% year over year.

Based on our very strong third quarter performance and future outlook, we're pleased to raise our top and bottom line 2025 financial guidance.

Compared to 2024, we now expect to grow 2025 net revenues 39% to 42% and 34% to 37% on an organic basis, with rare disease becoming essentially half of our total revenues for the year.

We expect our lead rare disease asset Cotrophin gel to grow 75% to 78% year over year to generate revenues of 347 million to 352 million. We expect to grow adjusted EBIDDel between 42% and 46% compared to 2024.

Later in the call, Steve will provide more detail on our increased guidance.

Growing our rare disease business is a is a top strategic priority for us, creating long-term value for our stakeholders and advancing our purpose of serving patients, improving lives.

Turning to our lead rare disease asset cotrophin gel.

To drive strong multi-year growth, we're focused on clinical evidence generation to support physician decision making.

Investments to enhance patient convenience, and high ROI commercial efforts to drive growth.

Our team has made significant progress on these initiatives to grow cotrophin gel across our target specialties.

In the 1st quarter, we expanded our portfolio sales team and we're seeing very positive results highlighted by our strong momentum in new cases initiated and growth in new patient starts.

We also launched the prefilled syringe in the second quarter, reducing administration steps for patients.

We're seeing sizable increased demand for the prefilled syringe and expect it to be an important growth driver.

Importantly, to support our commercial team's efforts to drive awareness for cotrofen gel, we're committed to generating data to help clinicians, patients, and pair make informed treatment decisions, including a phase 4 clinical trial in acute gouty arthritis flares.

Pre-clinical data on protrophin gel's mechanism of action across multiple disease states, and presentations and publications at prominent medical meetings.

We remain confident in the strong multi-year growth trajectory of Cotrofin based on multiple factors.

The ACTH market has returned to growth following the launch of Cotropin in 2022 and is expected to increase approximately 40% to 957 million in 2025, with Cotropin growing by 75% to 78%.

Despite this growth, we believe that the addressable patient populations across key indications are significantly under penetrated.

For example, the addressable patient population for acute gouty arthritis alone is 285,000 patients, an indication that is unique to Corofen gel's label. Importantly, the number of Cotrophin gel prescribers who were previously naive to ACTH represent approximately half of our total prescriber base, and this group continues to grow.

Turning now to our retina portfolio, diluvian sales in the 3rd quarter were lower due to the further impact from the continued reduced access for Medicare patients and the utilization of the remaining unique units at physician offices.

In addition, adoption of Iluvian for NIUPS began in the 3rd quarter, and the company continued to make tangible progress toward full adoption of the label transition.

We see 2025 as a reset year for Euvian and believe that we can grow in 2026 and beyond for several reasons. First, we believe the addressable patient populations for Eluvian in both BME and NIUPS are at least 10x the current number of patients treated with Eluvian.

Second, we expect to see the ensuing results of our strengthened and more experienced ophthalmology organization that is coalescing and deploying an expanded peer to peer education program, speaker education program, and new marketing initiatives.

In addition, we continue to disseminate and contextualize findings of the new day clinical study and create greater awareness on the potential use of alluvium.

Lastly, we are seeing signs that there is a growing number of physician offices exploring alternative access pathways, including Medicare Part D through specialty pharmacy. This is the path we use for corofen.

Moving now to our generics business, we had a very strong 3rd quarter performance due to an opportunistic partner generic launch that occurred in the second half of the 3rd quarter.

This launch once again highlights our strength in creativity, R&D, business development, operations, and execution intrinsic to ANI's genetics business, and we will continue to leverage these strengths to unlock future opportunities.

Based upon upside from this launch, we expect generics growth for the full year in the low 20% range.

We're proud of the continued execution of our genetics business and how it provides ongoing foundational support that enables us to invest in our initiatives to grow our rare disease business.

In summary, we delivered another record quarter driven by strong performance across our rare disease and genetics business. As we head into 2026, we expect our virtuous cycle of growth to persist. Rare disease is our primary focus area and largest driver of growth. We expect continued strong momentum in cotrophin and positive impact from multiple initiatives outlined to grow alluvium in 2026.

In addition, we will continue to explore inorganic opportunities to expand the scope and scale of our rare disease business.

These efforts will be supported by continued performance in our generics and brands business.

And now turn the call over to Chris Mutz to discuss our rare disease business in more detail, Chris.

Thank you, Nikhil, and good morning, everyone.

Echoing Akhil, our rare disease team delivered another excellent quarter marked by continuing record demand for cotrophin gel. The number of cases initiated and new patient starts reached another record high, and we saw broad-based growth across all of our targeted specialties rheumatology, nephrology, neurology, pulmonology, and ophthalmology.

To capture the multi-year growth opportunity for Quattrofragel, we are focused on three key priorities. First, we're investing in high ROI commercial initiatives to fuel growth. In the first quarter of 2025, we expanded our portfolio sales force by approximately 1/3, so they're optimizing their territories. Our expanded portfolio sales team added new prescribers and drove meaningful increases in new patient starts across our core specialties during the third quarter. In addition, our specialty focused teams produce sizable growth in our newer areas of pulmonology and ophthalmology, and we believe we are still in the early stages of penetrating these therapeutic areas.

C Cotrofragel prescribing for acute gouty arthritis flares remained a key driver in the 3rd quarter. Notably, the acute gouty arthritis indication is unique to Cotrofragel's label among ACH therapies.

And accounts for over 15% of quatrophfragel use. Further, the gout indication has contributed significantly to the growth of new prescribers, many of whom are historically unfamiliar with ACTH.

Turning to ophthalmology, we continue to realize meaningful revenue synergies and saw a record number of new patient starts and a 42% sequential quarterly increase in quatrophin volume.

We believe there's further growth potential.

To expand awareness of cortrophin for patients with severe allergic and inflammatory eye conditions.

Additionally, we continue to strive to enhance patient convenience. Our new cortrofin prefilled syringe offering, which we launched in April, provides a simplified administration that we believe has been well received by patients and prescribers. The prefilled syringe continues to be an important growth driver for Cotrophin gel.

And finally, we are investing in clinical evidence generation to support physician decision making. As previously announced, we're conducting a phase 4 trial on acute gouty arthritis flares. We believe the 150 patient study will provide physicians with valuable insight on the treatment of acute gouty arthritis flares with cortrophin gel and could support positioning and treatment guidelines.

We continue to generate robust preclinical data for our key stakeholders on quatrophin's differentiated mechanism of action across multiple disease states. This is an important growth initiative as we believe increasing the body of evidence supporting cotrophin gels use across indications will help physicians make further informed treatment decisions.

Our pre-clinical study of quatrophin gel and uveitis that was presented earlier this year has been published in Ocular Immunology and Information.

We also had a poster at the American College of Rheumatology 2025 annual meeting that highlighted preclinical data supporting the use of cortrophin gel for the treatment of inflammatory arthritis and its anti-inflammatory mechanism of action.

Additionally, a manuscript for a pre-clinical study of quatrophin gel and membranous nephropathy was accepted for publication in molecular therapy. The study demonstrates the steroid independent mechanism of action of quatrophin gel in an animal model of membranous nephropathy, specifically its effect on the complement system, and areas of significant interest in ongoing membranous nephropathy drug development.

Subsequently, this publication was highlighted in a commentary paper in molecular therapy and presented at the American Society of Nephrology meeting.

Turning to our retina franchise.

We are making progress on multiple initiatives to improve alluvium sales. Our commercial team is fully hired, onboarded, and dedicated to educating and supporting the retina community. We are strengthening our promotional efforts, including a ramp up of new peer to peer educational speaker programs and the continued execution in the field with new marketing materials to increase the understanding on retina physicians of alluvium and its two indications.

In mid-June, we began promoting Alluvian under the combined label for chronic NIUPS and DME. Our sales teams are educating customers across the country, and our market access team has worked with payers to establish coverage for Alluvian's new chronic NIUPS indication.

6 of the 7 Medicare administrative contractors or MAC have updated their policy to cover Euvian for NIUPS, and we're working with the other contractors to update their policy. Among the TOP20 commercial payers, all payers who have a policy specific to Euvian have updated it to reflect both DME and NIUPS indications.

We continue to receive positive clinician feedback on the convenience of a single product covering both indications.

Next, we have initiatives in place to help physician practices navigate the market access challenges for Medicare patients that have persisted since January 2025. As a reminder, patient support foundations such as Good Days did not receive sufficient funding for 2025, which affected their ability to assist Medicare patients with copay support across retina products broadly.

Our team has been gaining traction with HTPs with leading retina practices exploring the pathway to get Eluvian accepted for appropriate eligible patients through Medicare Part D benefits using a specialty pharmacy. This is the same approach used for access to quatrophin.

In addition, We continue to present the results of our new day study of alluvium in patients with DME at numerous prominent medical meetings. This includes a late-breaking oral presentation at the American Academy of Ophthalmology 2025 meeting, a presentation at the American Society of Retina Specialists annual meeting, and an oral presentation at the EU Retina Innovation Spotlight 2025 meeting.

Looking forward, we are preparing to present these data at additional upcoming conferences to further disseminate and contextualize these findings.

With that, I'll turn the call over to Steve for the financial update, Steve.

Thanks, Chris, and good morning to everyone on the call. Today, I'll review our third quarter results and our revised guidance in more detail.

We delivered strong top and bottom line growth, generated significant cash flows, and are raising our 2025 financial guidance based on our exceptional performance this quarter.

ANI generated revenues of 227.8 million in the third quarter, up 53.6% over the prior year period.

Revenues from rare disease and brands were 129.1 million in the third quarter, nearly double the prior year period on an as reported basis, and up 82.2% on an organic basis, driven by growth in our rare disease franchise.

Rare disease revenues were 118.5 million, up 109.9% from the prior year.

Revenues from Cotropin gel were 101.9 million, up 93.8% from the prior year, period, driven by increased volume on a record number of new patient starts.

Alluvian net revenues were 16.6 billion.

Revenues for brands were 10.7 million in the third quarter, up 16.1% versus the prior year period due to an increase in demand for certain products. On a sequential basis, revenues were down 2.5 million as we saw the expected trend toward normalization in demand during the quarter.

We expect that the normalization trend will continue and therefore expect modestly lower demand in the 4th quarter.

Revenues for our generics and other segment were 98.7 million, an increase of 19.3% over the prior year period.

Revenues for generics were 94.4 million, an increase of 20.6% over the prior year period, driven by the successful launch of a partner generic product in the second half of the third quarter. They overcame our previous expectation for a sequential dip in generics.

Generics were up 4.1 million as compared to second quarter of 2025 due to the strength of this launch.

Note that the gross margin for this partner generic product is lower than typical gross margin for our generics portfolio given the profit share element with our partner.

Now moving down the P&L, as a reminder, when I speak to operating expenses, I will be referring to our non-GAAP expenses, which are detailed in table 3 of our press release. Generally, our non-GAAP operating expenses exclude depreciation and amortization, stock-based compensation, certain costs related to litigation and M&A activity, as well as certain non-cash charges.

Please refer to table 3 for a reconciliation to our GAAP expenditures.

Non-GAAP cost of sales increased 56% to 92.9 million in the third quarter of 2025 compared to the prior year period, primarily due to net growth in sales volumes and significant growth of loyalty bearing products.

Non-GAAP gross margin was 59.2%. A decrease of 63 basis points from the prior year period principally due to product mix including the lower gross margins on our partner generic products.

Non-GAAP research and development expenses were 11.8 million in the third quarter, an increase of 36% from the prior year period driven by higher investment to support future growth of our rare disease and generics businesses.

Non-GAAP selling general and administrative expenses increased 41.1% to $63.6 million in the third quarter, driven by spend for our new larger ophthalmology sales team promoting quatrophin gel and alluvian and continued investment in rare disease sales and marketing activities, including the expansion of the rare disease team in the first quarter.

Adjusted non-GAAP diluted earnings per share was $2.04 for the third quarter compared to $1.34 per share in the prior year period.

Adjusted non-GAAP EBITDA for the third quarter was 59.6 million, up 69.8% compared to the prior year period.

We ended the third quarter with 262.6 million in unrestricted cash, up from 217.8 million at the end of the second quarter, and 144.9 million as of December 31st of the prior year.

Cash flow from operations was 44.1 million in the third quarter of this year and 154.9 million on a nine month year-to-date basis.

As of September 30th, we had $633.1 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan.

At the end of the third quarter, our gross leverage was 3 times and our net leverage was 1.7 times our trailing 12 month adjusted non-GAAP EBITA of 214.5 million.

During the third quarter, we concluded our 2021 pipe financing transaction with Ampersand by converting all previously issued 25,000 shares of Series A convertible preferred stock to 602,900 shares of common stock.

As of September 30th, 2025 balance sheet, there were no further shares of Series A convertible preferred outstanding, and all mandatory dividends were paid in full.

Now turning to our updated 2025 financial guidance.

We are raising our guidance for total revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS based upon higher estimates for quatrophin gel net revenue and the continued outperformance of our generics business while temperinging our alluvian estimates.

Our updated guidance is as follows.

Full year 2025 net revenue of 854 million to 873 million, up from our prior guidance of $818 million to 843 million, representing year over year growth of approximately 39% to 42%.

Quattrophin gel net revenue of 347 million to $352 million up from our prior guidance of $322 million to 329 million, representing year over year growth of 75% to 78%.

Driven by continued volume gains, we continue to expect sequential growth of quatrophin revenues in the 4th quarter.

Combineddiluvian and Uique net revenue of $73 million to $77 million versus our prior guidance of $87 million to $93 million. This guidance assumes no meaningful change in the co-pay funding gaps facing Medicare patients in retina for the remainder of the year.

Generics revenue growth in the low 20% range driven by strong contribution from new product launches. We expect generics revenue in the fourth quarter to be down on a sequential basis due to competitive entrance into the market in which our third quarter partnered product competes in.

Adjusted non-GAAP EBITDA of 221 million to 228 million, up from our prior guidance of 213 million to 223 million, representing year over year growth of approximately 42% to 46%.

Adjusted in non-GAAP earnings per share between $7.37 and $7.64 up from our prior guidance of $6.98 and $7.35.

We are revising our full fiscal year guidance for adjusted gross margin to 61% to 62% compared to our previous guidance of 63% to 64% driven by the revised revenue mix in this morning's guidance with lower alluvian and higher generics forecast as compared to our previously issued guidance.

We currently anticipate a full year US GAAP effective tax rate of approximately 21% to 22%.

And consistent with prior quarters, we will tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate.

Of 26%.

We now anticipate between 20.5 million and 20.7 million shares outstanding for the purpose of calculating full year non-GAAP diluted EPS.

Please note that in periods in which A&I common share price is greater than the conversion price of our underlying convertible debt of $74.11 and lower than the conversion price of our corresponding capped coal transaction of $114.02 per share.

We will exclude from our adjusted non-GAAP diluted EPS calculation the diluted shares included in the GAAP diluted EPS calculation which are expected to be offset in full by the cap call transaction.

The 3rd quarter was the 1st reporting period in which this condition exists.

With that, I'll turn the call back to Nikil.

Thank you, Steve.

In closing, we've made exceptional progress as we continue to execute our strategic priorities. Rare disease remains our top strategic area and primary driver of growth, and we'll focus our efforts on driving further growth in cotrophin. And improving performance. We are encouraged by our performance this quarter, having reached more patients with our portfolio of high-quality medicines, nearly doubling cotrophin gel net revenues compared to the 3rd quarter of 24, and significantly growing both the top and bottom line made possible by the efforts of our employees, customers, suppliers, and investors, and their dedication to our mission of serving patients, improving lives. Operator, please open the line for questions.

Certainly, Mr. Leboni, thank you. Ladies and gentlemen, at this time, if you do have any questions, please press 1. You can always remove yourself from the queue by pressing 2. Again, we do ask that you please limit yourself to one question. We'll go first this morning to Dennis Bing of Jeffries.

Hi, good morning. Thanks for taking my question.

One on resin, so Medicare Part B redesign lowered the catastrophic coverage limit this year, and that's been a big tailwind, but that also makes for a really tough comp next year where growth will be driven more organically and through expanding the breadth of prescribers. Do you agree with that take, and I guess how much confidence do you have that you're able to do that with the sales force you have currently?

Thank you.

Yeah, good morning and thank you, Dennis. So, I think I'll take your question in two parts. First is, what's the impact of IRA on 2025, and then, how do we see this going forward? So I think, as you pointed out, IRA improve affordability and access for appropriate patients to needed medicines by capping the co-pays at $2000 as well as introducing the ability to evenly spread the payments throughout the year.

Now we did see a modest, tailwind from that, this is consistent with what we've said in the prior quarter, and the reason it's modest is while this did get additional patients on therapy, it was tempered by the mandatory Medicare manufacturer payments that we need to make, and so overall Cuprofen saw a modest, net positive impact from the Part re redesign through IRA. And then, as far as far as your second question on next year and going forward, look, it's, we believe that, there is significant multi-year growth opportunity for crofin in 2026, and beyond, and that's driven by the, really the strong underlying demand and the demand sort of is centered in. The addressable populations, right? Addressable patient populations across key indications are significantly under penetrated.

For acute gouty arthritis alone, it's about 285,000 patients, and our ability to expand the market is highlighted by the fact that approximately half of our prescriber base had never used ACTH therapy before. And, as Chris had mentioned in his remarks, we continue to see growth from both the existing prescribers as well as new prescribers. So we remain confident. Of, being able to reach, the appropriate patients in need, by working with the ACPs.

Thank you, Dennis.

We'll go next now to Faisal Khurshid - Leerink Partners.

Hey guys, thanks for raising the question. Could you speak a little bit more to, what this, kind of new partner and generic, product is, and then also what you expect for that in the 4th quarter and kind of going into, 2026 as well, and then everyone after Tros as well.

Good morning and thank you. So, for competitive reasons we're not specifying the name of the partner generic. It's a product that we launch obviously as it's intended. With a, with another, manufacturer and we're able to capture, be the sole generic for a period of time, a majority of which was in Q3. In Q4, we, have seen some competition enter on that product. So, that's why, our guidance for Q4 for generics is showing a sequential, drop versus the much higher. Q3 that we had and because it's a partner, generic, it's also has profit share in it and therefore, the gross margins on that product are lower, going into 2026, we will see at least the existing competition continue and, we look forward to updating you more on the guidance for 2026, in early next year.

Got it. Okay. .

And then on kuprofen, are there any inventory or gross to net, situations that we should be aware of, aware about just because it seems like the, volume growth kind of outpaced the actual dollar growth, in this quarter.

No. The trophin gel growth is driven by a strong underlying demand, highest number of new patients starts and new cases initiated, since launch, growth across all targeted specialties, the expanded portfolio sales force that we did in the first quarter to a growth in nephrology, neurology, and rheumatology.

Gout, which is one of the newer target specialties, now represents 15% of cotrofinan gel use that contributed significantly to the growth, in fact, to the growth, not just in cotrophin volume, but also to the growth of ACTH naive prescribers, and then the combined ophthalmology sales force, continued to build momentum with a 42% increase in volume. Volume versus the second quarter of 25 and then underlying just from a, presentation perspective there's strong demand for the prefilled syringe with with it accounting for almost 70% of the new cases initiated so it's it's strong underlying demand that's driving the growth in introphin.

Got it.

Thank you.

Thank you, pass on, yeah.

We'll go next now to David M. Selim at Piper Sadler.

Thanks. So just a couple of quick ones for me, and I'm sorry if I missed this earlier in the prepared remarks.

Can you talk about regarding cotrofin, the growth trajectory in pulmonology and what portion of the mix that is? I think you talked about it the other. Therapeutic areas and then secondly, just given just the wide label and all the different indications, where do you envision untapped opportunities that aren't really a big part of the current mix for the product?

And then lastly, I know this is a priority, but just wanted to get your latest thoughts on business development in M&A and you know how large of a transaction you would contemplate given the current capital structure.

Thank you.

Yeah, good morning and thank you, David. So pulmonology and sarcoidosis is a, is an important, therapeutic area for us. We have a dedicated, a smaller team, but dedicated for pulmonology, and we are seeing a growth in that area too. Again, it's a smaller part of the overall, cotrophin picture at this time, but there is, significant growth opportunity there and in pulmonology. We see, a larger number of vials per patient, so I think that's another factor that makes pulmonology, an important area for us. So that's on pulmonology, regarding the wide label, look, I think, currently, as you've seen.

The addressable patient populations and the indications that we're addressing today is much larger than anything that we're penetrating today. And so our immediate focus is, or near term focus is on tapping these different opportunities and, it's across the board, right? It's in neurology, nephrology, rheumatology, we talked about gout, we talk about ophthalmology, the quote unquote growth. So there's multiple areas and. Part of, as we think, as Chris thinks about, where to, drive the growth is, where to, make the high ROI commercial investments to achieve that growth because there's really, we're fortunate that there's opportunities, across specialties and that we're able to, drive growth through existing prescribers as. As well as, have new prescribers who've never, some that are naive to ACTH and some that were never not even familiar with ACTH, adopt coropin or use them in their treatment paradigm for appropriate patients. And then lastly, to your question on BD, we continue to explore opportunities to expand scope and scale of rare disease business. I think that our filters are similar to what they were last time, which is at this time, which is, late stage or close to commercial or commercial.

Some, and synergistic with, either our sales force, right, so call point synergy as was in the case of Alomera or leveraging the rest of our rare rare disease infrastructure, right, which is the market access, patient support, especially pharmacy distribution, and across the board there. So, that's how we think about, BD efforts and we're continuing to explore opportunities, but as I said.

As I highlighted, if you look at even the growth this year, We had 34% to 37% growth based on our guidance organically, right? So, and there's significant growth opportunity both in Cotrophin and Euvian. So we're not in a in a hurry to do a deal.

We're, wanting to make sure that we do the right deal, as we expand the scope and scale of our rare disease business.

Thank you, David.

And we'll go next now to Vimal Daniel at Guggenheim.

I agree. Yeah, this is, Daniel onrivamo. Thanks for taking our questions and congrats on the quarter.

So maybe just one question on retropin. Maybe if you could expand a little bit on like what exactly currently is driving doctors to use this drug across these various indications.

I know you mentioned that you're focused on, generating more evidence, around this mechanism now, but maybe currently with what you have, like, who are the patients that doctors think are the right ones, for ratropin, versus the other alternatives that are available, for each of these different conditions.

Thanks.

Sure. And, good morning and thank you, Daniel. So I'll start and then I, I'll get, can jump in. So, cotrofein is a late line treatment, for appropriate patients for which other therapies, have been sort of less effective and the real, sort of the standard of care and the treatment options that are varying by, I guess by specialty and by indication. So, when it fits into the treatment algorithm, it sort of varies. But it, but essentially it's a late line, treatment option. It's used for, also for patients that have, with this nonsteroidal mechanism of action, used for patients that are refractory to steroids or have a high side effect profile. Chris, would you like to add anything?

Yeah, no, I'd just say, taking care of patients with autoimmune disorders is challenging, and thank goodness there are a lot of great options across for physicians to use, right, these modifying therapies, new innovations across the spectrum and the patients we serve, but. There are still, patients, select patients that are really tough to take care of, and physicians are coming to the kind of end of the road in terms of, good options for those patients that they can rely on, and there's a significant number of those patients as we've outlined. Find, who needs something different and a, and a new choice of treatment, and I think that's where we focus on those, we think there's, that's a large patient population, it's a difficult to treat patient population, and we are, just getting started.

Thank you, Daniel.

We'll go next now to Gary Nachman with Raymond James.

Hey, thanks and congrats on another strong quarter. So back on quatrophin, you just added reps and saw a good ROI on that immediately.

Is this market.

Really that promotion sensitive? Maybe just characterize that a bit more. And are there still some pockets where you could add more reps, and would you do that in the near term, given the great returns there? And then the prefilled syringe seems to be having a big impact on the acceleration.

Was administration really.

That much of a factor.

That previously held back use? So just explain more why you're seeing such a benefit from the prefilled syringe helping growth. Thanks.

Yes, thank you.

I think Gary, to your, good morning, Gary, and thank you for your questions. The first question on on the the impact of an impact of sales reps.

I would say that, the way we think about it is, we expanded our, the underlying patient.

Demand is is very high right versus anything that we're capturing so there are opportunities to reach prescribers right? That with our sales force there's opportunities to get in front of more prescribers and spend more time with them that we can keep building on where we are. So if you looked at if you think about where we expanded the sales force, we had a combined sales force detailing into neurology, nephrology, and rheumatology.

As you can imagine that even within a territory it's tough to cover all three indications, so we expanded the sale, the number of sales reps in that area and what that did is it reduced, what's called windshield time. And allowing the reps to spend more time, speaking with docs about corofen.

And yes, there is opportunity to, across specialties, across indications as we think about, make increasing awareness, for the appropriate patients of Cotrophin. There is, there's certainly opportunity to do that, across multiple areas, right, across the portfolio area, across gout, across ophthalmology. Well, ophthalmology, I think we, we're sack with the combined sales force we have right now, but there's opportunities, sort of across, multiple specialties and something that we'll continue evaluating, high ROI commercial efforts, there. And then your second question on prefilled syringe, yeah, look, when we launched the prefilled syringe.

We had expected the prefill syringe would be used for patients that had dexterity issues or, issues with their eyesight, but as we're seeing there's much greater adoption and it's across specialties, I think when given an option, I think prescribers are just prescribers and patients are choosing the reduced administration step because in the in the original or in the 5 mL vial there are two steps to the administration. You have to obviously draw the drug from the vial and then administer it and actually use two different needles for doing so. So a prefilled syringe is, it reduces that step in administration and it has therefore driven more widespread adoption. What it has done is there are prescribers that are sort of willing to TRY a prefilled syringe, probably a bit more than going to a 5 mL vial that requires, which is, a larger use, but, I mean, essentially, the growth is coming from the strong underlying demand.

Which would have been there also with the 5 mL vial and the 1 mL vial, the other presentations that are there, the adoption of the prefilled syringe has driven, has been driven by just the reduced steps of administration, yeah.

Thank you, Gary.

Thank you very much.

Thank you. We'll go next now to Ekaterina Naaskova at JPMorgan.

Thanks so much and congrats on the quarter. So just a quick one for me, just remind us how you're thinking about the durability of cartrophin gel over time. Just latest thoughts on the possibility of, potential generic competition eventually em merging, and I'm not talking like next year, 5, 1,015 years from now. I think there's obviously a lot of barriers to entry there, but just I guess you know this class is becoming bigger and probably garnering more attention from potential generic manufacturers. Thanks.

Sure, good morning and thank you, Katrina. Yeah, the benefit of having a capability in generics, ourselves is we're able to sort of, pretty, we have expertise and capability in assessing the pathway to developing a generic, and our position sort of stays that, given this is porcine derived and the mix of, and the formulation that it is, what it will take to actually develop a generic, it's a very tough pathway, and that's why, while many folks have tried it, and have not succeeded, it's it's a very complex thing. Development and there are examples of of that, products like this that are that are tough to genericize so we continue to believe in the long-term durability, of the of either ACT product being tough to genericize.

Thank you.

Yeah, sorry, one other thing I would highlight is, both us and the competitor have also added, patents, strengthened our IP around the products that go into the 2040s, so that's another, point on durability.

Thank you, Katrina.

Thank you. We go next now to Brandon Folks with HC Wainwright.

Hi Thanks for taking my questions and congrats on another good course here. Nikhil, just following on from that prior question, can you just remind us of the challenges of label expansion in the ACH category for these products? Just sort of, in the past, has this label expansion been a cost benefit decision or practicality decision? And then just sort of any color in terms of, if this market does double, the confidence around, maintaining exclusivity on gout as a label claim, and then does that phase 4 data give you any potential additional IP around that. Thank You.

Good.

Yeah, good morning and thank you, Brandon. I think that the, our interaction on your question on label expansion, our interaction with the FDA suggests that any label expansion will need to, follow the current rules of the FDA which requires a.

Phase 4 clinic, sorry, phase 3 clinical trial, and all the associated rules that are that are in place today. So, that's what we'll need to do and that's what our competitor will need to do, whether that's us trying to, that's our understanding whether that's us, exploring, infantile spasms or which is an indication they have that we don't, or us exploring or them exploring, acute gouty arthritis flares, and then. On the phase 4 data, look, that study was designed and is being executed, more to inform, and assist physicians in their treatment and hopefully, in their treatment decisions and hopefully, could be included in the treatment guidelines which can drive, sort of, further adoption, yeah.

Thank you, Brandon.

Thank you. We'll go next now to Les Slowsky at Trua Securities.

Good morning.

Thank you for taking my questions. 3 from me. So just to touch on the Salesforce again, what are some of the KPIs that you're tracking to back, the right sizing of this team, and, what trends have you seen in the sales per rep from the Salesforce expansion, and any of these metrics, will drive your reasoning to potentially increase the salesforce. And then second, can you provide any more color around that that partner generic program? Are there additional opportunities?

In similar scope or is this a one-off situation?

And then third, maybe for Steve, as you close out the year, could we potentially anticipate an intangible asset impairment charge tied to the revaluation of the Elera acquisition?

Thank you.

Right, good morning and thank you for your questions, Les.

So I think, first is on the sales force, as we believe, well, on the KPIs, we're going to, it's, we TRY to share information that's helpful to investors and competitively sensitive, so, I'll steer away from the KPIs, but on the trends, I mean, there is, there's clearly. Expansion of the sales sales force in the appropriate areas, is a high ROI commercial effort, as is evidenced, as evidenced by the expansion that we did earlier this year for our portfolio sales team. So that's something that we will continue to evaluate and explore as we move forward, on the partner generic.

Yeah, on the part of generic, there are, definitely opportunities like that, ones that have been in the hopper, that ones that we continue to work on, and it really just highlights, our end to end capability, right, in BD, in R&D.

In commercialization and obviously in operational excellence, so across the board, I think we're uniquely positioned with our, US manufacturing footprint, right, with, more than, 90% of our revenues, coming from products that are made in the US with about 3 manufacturing facilities that are in the US, so we're uniquely positioned, from that standpoint, and, we are absolutely.

Plan to and are already, working on such opportunities, to capture and to bring to market. And then on the, I think the euvian long-term question, I think that there is, our So beyond Q4 and 2026, we believe the addressable patient populations for uvian in both DME and NIUPS are at least 10x the current number of patients currently being treated with alluvium.

We expect to see the results of our strengthened ophthalmology organization deploying. The expanded peer to peer speaker education program and new marketing initiatives, and then in addition, we continue to disseminate and contextualize the findings of the new day clinical study and create greater awareness on the potential, use of alluvium. So while we see 2025 as a reset year, we are confident in the, in being able to drive growth in 2026 and beyond, for alluvium. And Steve, I don't know if you want to add anything to Les's question. With that backdrop, yeah.

Good morning.

Good morning, Les. Yeah, I would only add that, we evaluate all of our intangible assets on a quarterly basis and, the 3rd quarter for alluvian was no different and obviously, passed that test. Thing in the 3rd quarter and as Nikhil just outlined, right, when we think about the mid to long-term forecast for the product, we remain confident in the mid to long-term opportunities as Nikhil just laid out.

Very helpful. Thank You.

Thank you.

Thank you and Mr. Lawani, it appears we have no further questions this morning, sir. I'd like to turn the conference back to you for any closing comments.

Thanks everybody for joining and we look forward to updating you on our progress in the future. Thanks everybody.

Thank you very much, Mr. Lalwani. Again, ladies and gentlemen, that will conclude today's ANI Pharmaceuticals 3rd quarter earnings call. Again, thanks so much for joining us, everyone, and we wish you all a great day. Goodbye.