ANI Pharmaceuticals, Inc. Price & Performance (ANIP)

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 thirty days on our website at ainpharmaceuticals.com ANI. For the benefit of those who may be listening, to the replay or archived webcast, This call was held and recorded on 02/28/2025 ANI. Since then, ANI may have made announcements related to the topics discussed so please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Nikhil Lalwani ANI. Thank you, Lisa.

Good morning, everyone. And thank you for joining us. Today, I'll start by discussing our full year and fourth quarter performance and highlights, and our 2025 guidance. Chris will provide additional color on our rare disease business, including our lead asset, Cortrophin Gel, and ILUVIEN and YUTIQ. Which we recently added to the acquisition of Alimera. Finally, Steve will review our fourth quarter results and 2025 guidance in more detail. Following our remarks, we'll take your questions. We're pleased to report record fourth quarter and full year 2024 results and are raising our 2025 guidance for total revenues and adjusted non GAAP EBITDA. The upward revision of our guidance is based on further confidence in higher demand for cortrophin gel a strong start for generics with the launch of Procalopride, with one hundred and eighty day exclusivity and increased demand in the first quarter as we have seen in the past. For our established brands portfolio. Which is now referred to as brands under our new segment reporting structure. We now expect 2025 revenue of $756,000,000 to $776,000,000 which represents growth of 23% to 26% over 2024 versus our prior guidance of $739,000,000 to $759,000,000 We expect adjusted non GAAP EBITDA of $190,000,000 to $200,000,000 which reflects growth of 22% to 28% over 2024 versus our prior guidance of $374,000,000 Steve will provide more specifics on our financial guidance. 2024 was another year of strong execution for ANI.

Capped by a record fourth quarter with total MEP revenues adjusted non GAAP EBITDA and adjusted non GAAP diluted EPS all coming in above our previously announced guidance for the full year. [indiscernible] was our primary driver of growth in 2024 with our lead rare disease asset, Cortrophin Gel, generating close to $200,000,000 of sales, in just the third year since launch. And our generics business delivered 12% revenue growth driven by operational excellence and new product launches. Making 2024 the third straight year of achieving double digit top line growth for this In addition, we expanded our rare disease franchise in 2024. With the acquisition of Alimera Sciences in September. In keeping with our long term with our longer term strategy, to broaden our presence in the rare disease space. We also successfully executed the refinancing of our prior debt and put in place a more efficient and effective capital structure. Turning now to our fourth quarter results. Our financial performance in the fourth quarter was the strongest in our history. Total revenues were 190,600,000.0 representing a year over year increase of 45% on an as reported basis and 24% on an organic basis. Driven by accelerating demand for Cotrofen gel continued strong growth for generics our full quarter contribution of from ILUVIEN and YUTIQ and higher demand for brands.

Adjusted non GAAP EBITDA was $50,000,000 ANI adjusted non GAAP EPS was $1.63 For Frozen Gel, generated $59,400,000 in revenues during the quarter, up 42% over the fourth quarter of twenty twenty three. The quarter reflected continued momentum with the highest number of both quarterly new patient starts and new cases initiated, since we launched the product in January 2022. We saw increased demand across all targeted neurology, rheumatology, nephrology, pulmonology and ophthalmology. For Trophin Gel, remains on a strong multiyear growth trajectory. The overall ACTH category returned to growth in 2024 While the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of headroom for expansion. We expect the strong momentum to continue in 2025 and our new guidance forecast Cotrophengell revenues to grow between 3438% to $265,000,000 to $274,000,000 in 2025. Chris will talk more about our initiatives to increase awareness of the benefits of ACTH therapy for appropriate [indiscernible] and further drive demand for Cotropine Gel. Our new ophthalmology product ILUVIEN and UTATE generated revenues of 27,600,000.0 in the fourth quarter. Our first full quarter of ownership following the acquisition of Alimera Our expanded ophthalmology team also drove significant growth in new patient starts for Cotrophen gel in which doubled in Q4 versus Q3.

A core strategic rationale for acquiring Alimera was to add assets that are synergistic with cordurofen gel and leverage our rare disease infrastructure. And proven commercial commercial execution capabilities in order to unlock the potential of ILUVIEN and YUTIQ as well as accelerate the growth of Cortrophin, sorry, as well as accelerate the growth of Cortrophin Gel in ophthalmology. We believe there is significant room for both ILUVIEN and YUTIQ given the novel long acting nature of the products. And size of the addressable market. We have taken steps and are continuing to execute that will enable us to capture these growth initiatives. Let me lay these out for you. Commercially, we expanded the U. S. Ophthalmology sales team of approximately 30 representatives that we acquired from Alimera to 46 sales reps. Who began promoting ILUVIEN YUTIQ and Portofin gel in mid October. Of 2024. We are continuing to invest to drive growth in international markets both direct markets such as Germany and partner markets such as France and Spain. Clinically, we continue to invest behind the New Day clinical trial for ILUVIEN and Synchronossity clinical for YUTIQ, For NewDay, if the clinical trial results are positive, it could significantly expand the use of ILUVIEN earlier in the DME patient journey in combination with anti VEGF therapies.

We expect top line data from both trials in the second quarter of twenty twenty five. Operationally, we have taken steps to increase supply security for both ILUVIEN and YUTIQ. For ILUVIEN, we extended our partnership with our contract manufacturer, Siegfried, for five years until 2029. Fixed fleet has been a reliable part As a part of this extension, we agreed to partner with Sicreit to upgrade equipment on the existing manufacturing line in Irvine, California and significantly expand capacity through the addition of a second manufacturing line. Both the equipment upgrade and capacity expansion initiatives are on track. We have also been executing a strategy to transition the manufacturing of YUTIQ to SYKREED in 2025. We submitted a prior approval supplement or PAS to the FDA to add YUTIQUE's indication of chronic non infectious uveitis affecting the posterior segment of the eye or NI UPS to the ILUVIEN label. Note both ILUVIEN and YUTIQ are substantially similar of talvic implants with the same active ingredient [indiscernible] an almost identical strength with ILUVIEN having zero point one nine milligram of fluocinolone and YUTIQ having zero point one eight milligrams In fact, the clinical trials for both NI UPS and DME were run on implants with zero point one eight milligrams of flusinolone acetonide the newer manufacturing process used exclusively for ILUVIEN results in a strength of zero point one nine milligrams per plant.

Per implant. We engaged with the FDA prior to the PAA submission order to understand the regulatory requirements, and submitted an application aligned with FDA's guidance. Since submission we have been engaged with the agency during the review period and expect action on the PAS in the second quarter. Following approval, we plan to transition commercialization efforts for both the DME and chronic NI UPS indications to a single product ILUVIEN, As a reminder, ILUVIEN is already approved and marketed for both ANI and NI UPS. Outside The U. S. Including in seven European countries and The Middle East. Operationally, the above initiatives will significantly enhance supply security for both ILUVIEN and YUTIQ. Positioning the franchise for a strong multiyear growth trajectory. In conjunction with these initiatives, ANI an eye point have agreed to non renewal of the current supply agreement for YUTIQ. With an effective date of May 31, 2025. Moving now to our 2025 guidance for ILUVIEN and YUTIQ. Our Q4 net sales for ILUVIEN and YUTIQ was $27,600,000 Typical Q4, Q1 impact driven by insurance resets and purchasing patterns for products such as ILUVIEN and YUTIQ, causes Q1 to be lower than Q4 by levels that are similar to other products.

In addition, Q1 twenty twenty five for ILUVIEN and UTIX will have the added impact of the change in U. S. Market access dynamics since early January, that has reduced access for Medicare patients. Which is particularly important for ILUVIEN's DME indication. We are working with ACPs to understand their response to the market access changes and refining our commercial approach accordingly. Stepping back to the overall picture, there are currently fewer than 5,000 patients on therapy for each of ILUVIEN and YUTIQ. And we estimate that the addressable patient population for each drug is approximately six to 10 times higher based on epidemiological data. So while there are near term topics to work through, we remain confident of the growth prospects for our our products in both DME and NI UPS. As we strengthen the foundation of our ophthalmology business, through these transitions, end market dynamics in 2025 we expect to deliver $97,000,000 to $103,000,000 in sales for ILUVIEN and YUTIQ. And we remain enthusiastic about the product's long term runway for growth. Chris, will further detail our commercial and clinical initiatives that we expect will drive significant quarter on quarter growth through 2025 and beyond. Turning now to our generics business.

We delivered another solid quarter with revenues of $78,600,000 an increase of 9% over the fourth quarter of twenty twenty three. The performance reflected strength in our base business coupled with contribution from new product launches. We continue to leverage our U. S.-based manufacturing footprint to deliver over 1,000,000,000 doses to patients in The U. S. Our R and D team was highly productive in 2024, submitting multiple new ANDAs and securing 17 new product approvals Are proud that we retain the number two ranking in CGQ approvals in 2024. One of these approvals was for Calipri tablets, which we launched [indiscernible] late December, early January into $168,000,000 branded market with one hundred and eighty days of exclusivity. Our ability to be first to market with this important generic product is a testament to the quality of our R and D team. We expect another year of low double digit growth for our Genets business in 2025 supported by our high performing R and D engine, operational excellence, and U. S.-based manufacturing footprint. Our brands portfolio which we previously referred to as Established Brands, continues to address patient needs with reliability of supply a unique set of commercial capabilities and opportunistic business development to expand the portfolio.

Our overall portfolio of businesses is strengthened by this high gross margin low working capital and strong cash flow generation business. During the fourth quarter of twenty twenty four and into the first quarter of twenty twenty five. We experienced an increase in demand for some of our brands portfolio as we have periodically seen in the past. Our new reflects this increased demand in the first quarter followed by a return to a more normalized run rate in the second quarter. As I reflect on our year of accomplishments, and look forward to 2025, I would like to thank our customers, suppliers, partners, [indiscernible] and the entire ANI team for their collaboration, and significant contribution in delivering on our company's purpose of serving patients improving lives. I'll now turn the call over to Chris Mutt, our Head of Rare Disease. [indiscernible] Thank you, Nikhil. And good morning, everyone. Our rare disease team drove strong demand for Cortrophin Gel in the fourth quarter We were pleased to see demand growth across all targeted specialties. Neurology, rheumatology, nephrology, pulmonology and ophthalmology. Prescribing momentum continued across both existing and new prescribers and the number of initiated cases and new patient starts reached record levels in the quarter.

We saw particularly strong growth from our newer therapeutic areas, in ophthalmology, number of new patient starts roughly doubled from the third quarter as our new larger ophthalmology sales team expanded our promotional activities to a broader group of physicians. Prescribing for acute gouty arthritis flares, for which cortrophin gel is the only approved ACTH therapy also continues to ramp and now represents approximately fifteen percent of cortrophin gel use. Notably, gout is serving as a gateway indication for many physicians that are new to ACTH therapy. Approximately fifteen percent of healthcare professionals prescribing cortrophin gel for the first time a gout patient is their first patient on therapy ANI. We expect the gout indication to remain a key growth driver for Cortrophin Gel in 2025. As Nikhil mentioned, we believe Cortrophin Gel is on a strong multi year growth trajectory. The overall 25% to approximately $660,000,000 in 2024 based on the reported sales for Cortrophin Gel and the guidance given for the other ACCH product by our competitor, We believe the growing recognition of cordurofen Gel as a safe and effective treatment option for appropriate patients is reflected by the recent growth dynamics for the overall ACTH category. While the market is growing, ACTH prescribing is is still well below historical levels.

Based on our analysis of claims data, we believe the number of patients on ACTH therapy now is approximately half the level of patients on therapy when the category previously peaked in 2017. Treatment of flares and exacerbations continues to be a [indiscernible] We believe the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago. Our belief is anchored in the prevalence of and need for alternative treatment options for the autoimmune disorders that cortrophin is indicated for. It's worth noting that approximately forty percent of cortrophin gel prescribers are new to the ACTH category. Which illustrates the need for our therapy in certain patients our ability to expand the market. Our messaging has resonated with physicians who see patients with severe autoimmune disorders who need alternative therapies for continued flares and exacerbations. We've also taken important steps to strengthen and grow the Cortrophin gel franchise over the last several quarters. We launched dedicated sales teams in ophthalmology and ophthalmology ANI, and with the Alimera acquisition, we now have a much larger ophthalmology sales team that is already driving greater prescribing in this important therapeutic area. We've also seen continued strong growth in our initially targeted therapeutic areas of rheumatology, neurology and nephrology.

Given our view on the unmet need in these areas, the utility of ACTH therapy, we recently increased the size of our sales team to help expand our promotional efforts to additional physicians. The largest sales team has already contributed to growing the number of Cortrophin Gel prescribers in the first quarter and the number of new cases in initiated reached a new monthly all time high in February Despite the quarter tending to be seasonally low for Cortrophin Gel, and other rare disease therapies due to insurance resets and market dynamics. We're also investing in initiatives to improve patient and physician convenience We have a prefilled syringe under FDA review that we expect to launch in second quarter of twenty twenty five. The prefilled syringe will provide benefits to patients and physicians by reducing the steps needed for self administration. We're excited about the potential of this new presentation and look forward to making the Cortrophin Gel prefilled syringe available in the second quarter as we continue to advance our rare disease portfolio. We're also exploring other ideas to enhance convenience for patients starting on Cortrophin Gel and the healthcare providers who treat them. We look forward to sharing more details on these initiatives in the future.

Overall, we believe in and are committed to investing in the cortrophin gels franchise and continuing to deliver strong multiyear growth for the product. Turning now to our new ophthalmology products, ILUVIEN and EUTIQ. As a reminder, ILUVIEN and YUTIQ are both novel, long acting intravitreal implants In The U. S, ILUVIEN is used to treat diabetic macular edema or DME, the leading cause of vision loss in diabetic patients. And YUSIQ is used to treat chronic non infectious uveitis affecting the posterior segment of the eye or NIUPS. ILUVIEN and YUTIQ are the only long durable therapies available that can reduce disease recurrence. Through extended disease control for up to three years. We believe there is significant room for growth for both products. As we move through 2025, we expect to increasingly deploy the same commercial acumen with ILUVIEN and YUTIQ that has driven our success with Kotrophin JAL. In sales, we have fully transitioned into the new larger footprint 46 territories and key customer handoffs are not complete. We also are beginning to see meaningful increase in call activity, which we've In marketing, are making significant investments in increasing peer to peer education, well as conference and Congress engagements.

Further amplifying awareness of ANI's commitment to the ophthalmology space. Additionally, in the coming weeks, we are launching new and enhanced marketing materials informed by a significant investment in market research to help physicians better identify appropriate patients for our long acting implants. We've continued to make progress on the clinical trials New Day and New Day is investigating the use of ILUVIEN in combination with the current standard of care ANI digest for the treatment of DME. New Day is fully enrolled with three zero six patients in approximately 42 sites. The last patient last visit occurred in early January ANI we expect top line results in the second quarter of this year. Synchrony City is designed to provide retina and uveitis specialists with a broader sense of the utility of YUTIQ across a variety of patients with chronic NIUPF. The clinical trials enrolled 110 patients in approximately 25 sites around The U. S. We expect preliminary top line results also in the second quarter of this year. Looking across our overall rare disease business, we are pleased with the continued strong performance of Korchorphan Gel, Furthermore, we remain excited about the long term growth runway for ILUVIEN and YUTIQ, and we are laser focused on optimizing our commercial strategy and increasing supply security for these products.

Our new ophthalmology sales team has been promoting all three products since mid October and we expect the team to drive greater awareness of the products and the patients that can benefit from treatment. For 2025, [indiscernible] for the financial update. [indiscernible] Thanks, Chris. Good morning to everyone on the call. I'll review our fourth quarter results and then discuss our 2025 guidance in detail. ANI generated of 190,000,000 up 45% over the prior year period. Beginning with this reporting period, we have redefined our reporting segment. We continue to have two segments, However, they are now defined as rare disease and brands and generics and other. This change reflects how we analyze business post the Alumera acquisition The new segment presentation can be found in our earnings release MD and A in our Form 10 ks and the footnotes to our financial statements filed this morning. Prior period disclosures have been recast to be consistent with the go forward presentation. Revenues from rare disease and brands were $106,900,000 in the fourth quarter, up 97% from the prior year period as reported and 24% on an organic basis driven by gains in both rare disease and brand, Rare disease revenues more than doubled to 87,000,000 Revenues from Cortrophin Gel were $59,400,000 up 42% from the prior year period driven primarily by increased volume ANI a record number of new patient starts.

Revenues from our new ophthalmology products ILUVIEN and YUTIQ were $27,600,000 As a reminder, we completed the acquisition of the Alumera on [indiscernible] And therefore, the fourth quarter represents our first full quarter of owning these assets. Revenue for brands were $19,800,000 in the quarter, an increase of 59% over the prior year period. The quarter benefited from higher demand related to changes in market dynamics for certain products, similar to what this portfolio has experienced in the past. Revenues for our generics and Other segment were $83,700,000 an increase of 8% over the prior year period driven by increased volumes ANI contributions from new product launches in 2024, and the full year impact of products launched in 2023. Now to move down the P and L. As a reminder, when I speak to our operating I will be referring to our non GAAP expenses, which are detailed release. Generally, our non GAAP operating expenses exclude depreciation and amortization, stock based compensation certain costs related to litigation and M and A activity. Please refer to table three for a reconciliation to our GAAP Non GAAP cost of sales excluding depreciation and amortization, increased 31% compared to the prior year period to $69,500,000 in the fourth quarter of twenty twenty four primarily due to net growth in sales volumes of pharma Significant growth of royalty bearing products and a full quarter of ILUVIEN and YUTIQ sales.

Non GAAP gross margin was 63.5% increase of approximately 3.9 percentage points primarily driven by favorable product mix due to higher revenues from Cortrophin Gel and Brands, and a full quarter of ILUVIEN and YUTIQ sales. Non GAAP research and development to $16,200,000 in the fourth quarter due to the inclusion of costs related to the New Day and Synchronicity clinical trials, development of the Cortrophin gel prefilled syringe, and ongoing investments in generic R and D programs. Non GAAP selling, general ANI administrative increased 42% to $54,800,000 in the fourth quarter driven by a full quarter of spend for our new larger ophthalmology sales force ILUVIEN and YUTIQ, Continued investment in rare disease sales and marketing activities increased employment related costs including incentive based compensation tied to our record financial In 2024, and an overall increase in activities required to support the ongoing growth of our business. Adjusted non GAAP diluted earnings per share was $1.63 for the quarter compared to one point per share in the prior year period. Adjusted non GAAP EBITDA for the fourth quarter 50,000,000,000 compared to $30,200,000 in the prior year period. We ended the quarter with $494,300,000 of net debt comprised of $144,900,000 in Andres and 639,200,000.0 in principal value of about inclusive of our senior convertible notes, and our term loan, Utilizing the midpoint of our revised 2025 adjusted non GAAP EBITDA guidance at the end of the fourth quarter, our net leverage was approximately two point two point five times on a forward basis Turning to our 2025 financial guidance.

As Nikhil previewed, we are raising our guidance for total revenue and adjusted non GAAP EBITDA from the preliminary targets that we announced on January 13 ANI, based on recent strong trends for Cotrofengel the continued evolution of our generic [indiscernible] and higher first quarter demand for our brands portfolio We now expect total revenue For culture of Ingel, we expect revenue of $265,000,000 to $274,000,000 representing growth of 34% to 38%. We anticipate continued adoption of Portrofen gel the therapeutic areas of rheumatology, neurology, and nephrology helped in part by our expanded commercial team. And strong growth in ophthalmology, as well as for the GAL indication. We also expect continued growth for the overall ACTH market in twenty twenty five. As you consider the quarterly progression for Cortrophin Gel, please note that the general pattern of revenue in twenty twenty five is expected to be similar to that reported in 2024 with a quarter over quarter decline in the first quarter due to prescription re authorizations, followed by strong sequential growth in the second quarter. This pattern is generally consistent with other rare disease drugs. We expect combined ILUVIEN and YUTIQ net revenues of $97,000,000 to $103,000,000 which reflects the impact of the first quarter dynamics out as well as the commercial and operational transitions they discussed.

First quarter net revenues of ILUVIEN and YUTIQ are expected to be impacted both by both the typical Q4 to Q1 drop seen in rare disease products, as well as the added impact of the change in U. S. Market access dynamics since early January. We expect this franchise to return to sequential growth in the second quarter of twenty twenty five. For generics, we anticipate low double digit revenue growth driven by strength in our base business and contribution from new launches. Including the full launch of PRUCALIBRIBE in early January For brands, we saw increased demand in the fourth quarter for certain products as we have periodically experienced over the past two years. [indiscernible] increased demand has persisted in the first two months of twenty twenty five Our guidance assumes that this increase demand does not persist beyond the first quarter ANI thus we assume normalized performance in quarters 02/2004 Moving down the P and L. We expect total company non GAAP gross margin to be between 6364% which reflects modest growth relative to 2024 driven primarily by higher sales for our rare disease franchise. We expect adjusted non GAAP operating expenses of $293,000,000 to $3.00 2,000,000 which reflects sales and marketing investments to drive rare disease growth and a full year of SG and A and R and D associated with Iluvia and then UT.

Taking all of these factors into account, we expect 2025 adjusted non GAAP EBITDA of $190,000,000 to $200,000,000 which reflects 22% to 28% growth over 2024 and adjusted non GAAP earnings per share, but and $6.49 We currently expect our U. S. Effective tax rate to be approximately 25% and consistent with the prior year, we will tax effect non GAAP for computation of adjusted non GAAP diluted earnings per share using our estimated statutory rate of 26%, unless the item being adjusted is non tax deductible in whole or part. We anticipate between 20,100,000.0 and 20,400,000.0 shares outstanding for purpose of calculating diluted EPS. With that, I'll turn the call back to Nikhil. Thank you, Steve. We'll open it up for questions. So operator, Bo, you please help us with the questions? Certainly, Mr. Lewani. Ladies and gentlemen, at this time, if you would like to ask go first this morning to David Amsellem at Piper Sandler. Thanks. So just got a couple. First, just on business development and M and A, and obviously you've built out the rare disease business and brand business overall. Can you just talk about your deal capacity right now ANI how high would you take pro form a net leverage up to to execute on a deal And then also how are you thinking about The sizing of the brand business or maybe the mix over time?

I mean, right now, it's sort of it has been kind of mirror fifty-forty, fifty-fifty brand generics, but ultimately where are you looking to take the company longer term in terms of its in terms of the brand presence. So that's number one. And then secondly ANI Cortrophin, just ANI to drill down a little more deeply on the the mix here, how much of gout in the mix, you cited that as a higher growth OpEx opportunity. I'm just wondering how you we should think about that particular opportunity ANI how much it could drive the business in 2025 and beyond? Thanks. Good morning, David, and thank you for your questions. [indiscernible] first question on BD and M and A, As we have shared before, in terms of the areas we focus our BDM and A efforts on rare disease. And then your second part of the question was, what is the deal capacity ANI where are we willing to take pro form a leverage. So look, if you look at E and I's history and as we've built the company ANI done two acquisitions, as well as launched our lead rare disease product you will see that this management team is very thoughtful about the leverage ratio, the net leverage ratio and what we're willing to extend that to.

And historically, it has it has always been kept under three. And at some point, for short periods, of time such as during the launch of PortRolf and it went slightly above, but then quickly de levered. And as you look at how we did the Alimera acquisition and refinancing of the loan ANI putting in place a more efficient capital structure, I think that it our intent and we believe it gives us the ability to pursue additional BD and M and A. While not straining the balance sheet. So that's how I would answer the question on BD M and A. Your second question on where are we taking this company? ANI has to very strong as a strong portfolio of businesses. Both the rare disease business as well as the generics business are are growing. ANI the brands business where we used to refer to as established brands, plays a role in terms of being high margin, strong cash flow generation and low working capital. But in terms of focus area and capital allocation, rare disease will be the primary driver of growth and the area in which we will continue to [indiscernible] Right. Through BD, through M and A?

We will invest in in R and D to fuel high single digit, low double digit growth for the generics business? But if you look over a period of time and just natural evolution, the center of gravity [indiscernible] shift with greater percentage coming from rare disease and brands. So that's that's point number two. And then the third question on gout ANI, I think there's two data points to share. 15% of the volume of cortrofen currently is coming from gouts. Then as Chris talked about Gout is ending up being a gateway in some ways with fifteen percent of prescribers writing their first that were naive to ACTH, writing their first prescription in gout and then moving on to considerate for other types of patients. Thank you, David. Thank you. Thank you. We go next now to Vamil Divan at Guggenheim Securities. Great. Thanks for taking the question. So couple that I have. One, just on the comments around the Alameda asset access issues since January.

Just provide a little more insight on how that I guess your plans ANI there in terms of what we should look at in terms of time to resolution the guidance this year suggests sort of the $100,000,000 or so in the midpoint. Is not really much year over year growth from where you left in the fourth quarter. So how should we think about the the longer term impact of this access issue? And year over year growth maybe looking at 2026 and 2027 for example.

Then the other question more on cordropen, you talked a lot about the seasonality obviously with the Almira assets.

For Cortrophin, how should we think about that Given it sounds like you're the growth has been very good. It looks like you're initial trends are good for the year, but you're raising your guidance. Partially based on that though, should we think about any sort of seasonality impact in 1Q or ANI maybe you can just comment on sort of how we should think about quarter over quarter growth for that as well.

Yes. Good morning, Mamma, and thank you for your question. First question on the ILUVIEN YUTIQ, access issues So in the past, patients with Medicare and Medicare Advantage plans had access to programs that assisted with offsetting the cost of the patient responsibility based on financial need. And some of these programs have not received adequate funding yet in twenty twenty five. In terms of what E and I is doing about it, look, first and foremost, E and I has in place a patient assistance program that provides access for patients in financial need with free ILUVIEN and YUTIQ as needed. And then secondly, we're spending time with our HCPs to understand their response to these market access changes. And refining our commercial approach accordingly. And you asked a great question about what's the outlook ANI as we've talked about, there are currently ANI stepping back looking at the overall picture, for each of ILUVIEN and YUTIQ, and we estimate that the addressable patient population for each drug is approximately six to 10 times higher based on epidemiological data So while This is a near term topic to work through. We remain confident of the growth prospects for our products in both DME and NI UPS.

The second question was around seasonality in PCG. You will see typical Q4 to Q1 dynamic in PCG also is typical for all rare disease drugs driven by purchasing patterns as well as insurance resets. What we do have Is that As we shared in February, Right. We've had the highest number of new cases initiated. Right? So we built momentum early and is one of the reasons why we raised our guidance that we had shared a few weeks ago [indiscernible] you will see a drop but ANI then there'll be sequential growth building on building on from there. Just again typical Q4 to Q1 type [indiscernible] Dynamic core in terms of sales for PCG? Thank you, Ramu. You. We go next now to Gary Nachman at Raymond James. Hey, thanks ANI good morning. So, yes, back to ILUVIEN in I'm also trying to better understand the guidance.

Of the $97,000,000 to $103,000,000 given a lot of different moving parts that you have that you're working through in the near term. So are you anticipating any issues or hiccups as you transition supply from iPoint to Siegfried, is that factored in there at all? And then I guess how much do you think adding the uveitis indication for YUTIQ will help And also with those additional data sets coming, how much could those help And how soon do you think those could benefit the overall franchise? And then I have one for Got it.

Thank you, Gary. Thank you for your question. Yes. Your first question is on the guidance ANI as As we've talked about that there are several commercial, clinical and operational initiatives that will drive the significant quarter on quarter ramp for the rest of 2025 and beyond. As we work through the the access issues that we're seeing in early January as well as the transitions, Commercially, as you would expect with an acquisition and integration like this, we've made positive changes to and Chris spoke a little bit about this. And strengthen the peer to peer education programs, for further increasing awareness of ILUVIEN YUTIQ and amplifying ANI's commitment to ophthalmology and retina marketing materials to help physicians identify appropriate patients and also continuing to refine our approach to selling three products across The U. S. ANI in the international markets, we're investing in higher ROI activities such as expansion of the team in Germany and providing increased support for our partner products. You then asked about New Day, So ANI the clinical front, we've continued to push forward with the key programs NewDay and Synchronossity. And we're pleased that both programs will readout preliminary top line data in the second quarter of twenty twenty five.

If the due date results are positive, it could significantly expand the use of ILUVIEN earlier in the DME patient journey. And we have in place a robust plan for publishing and awareness building of the clinical results amongst the retina community who are eagerly awaiting these results. And instead that, we've been measured in our full year guidance and not resumed a tailwind from New Day results our 2025 guidance.

And then then I'll just come back to the earlier question you also asked about the label combination and how that will work commercially. Look, we'll look to I think a couple of things. First is EyePoint is committed to working with us to support the transition and ensure patients ensure continued supply security So that's from a supply perspective ANI transition and obviously we submitted the PAS a while ago. We knew this transition was coming, so we are building up ILUVIEN inventory to do that. ANI we talked a lot [indiscernible] But from a commercial perspective, we'll drive fast and broad awareness of the label consolidation during the YUTIQ and label YUTIQ and ILUVIEN transition period. We'll introduce the new consolidated label while gradually transitioning accounts from YUTIQ to ILUVIEN for NI UPS. And we'll do this through the field team, marketing initiatives ANI the [indiscernible] and we'll deliver a succinct messaging on value added customers ANI the retina community. I look when you merge these when you add the uveitis label to ILUVIEN, you consolidate to one injector. Right, which is the only real difference between the two implants. And it also simplifies the ordering and process for the offer.

So there's value add to the customers. Which we will reinforce. Your next question was on sorry, your I think you also had a question around the data sets in New Day ANI hopefully I answered that as I was talking about the guidance and what's factored in and what's not factored in. Thank you, Carey. [indiscernible] Yes. No, that's great. And then I just had a follow-up on Quotrophin ANI. I mean, you're seeing a nice benefit in ophthalmology and acceleration in gout.

Just maybe just talk about how much did you add to the sales force Across what indications and how you evaluate that ROI if you think the market should really grow that much At what point you could add to that even further?

Yes. Thank you for that question. Gary, so The increase in the Cortrophin sales force added about 15 to 20 ish between reps and business directors. These are largely focused on the core indications that we initially launched with rheumatology, nephrology, neurology, and in terms of ROI, I think as we've grown this product from over three years from $0 to $200,000,000 ANI we've driven growth across both the specialties we targeted at launch as well as the which is rheumatology, neurology ANI nephrology as well as the newer specialties of pulmonology and ophthalmology I think we've developed and under Chris' leadership developed a a good understanding of [indiscernible] how to drive sort of high ROI Commercial investments Right. Leveraging the rare disease infrastructure that we also have in place. And also an understanding of the type of sales profile that succeeds with a product like I think all of those come together and help us to continue sort of driving growth here. Now having said that, there's a number of other things that we're also doing to to support the growth of this franchise, right? ANI we're investing in R and D project spend for improving patient and physician convenience, We'll share updates on these projects as we progress them.

We've obviously talking about the resource syringe and launching that getting approval for that and launching that in the second quarter. We're investing in research to provide additional support for the use of Cortrophin And then obviously what we already talked about, which is the high ROI commercial spend such as expansion of our Portrofen sales team to drive in the growth of the core specialties [indiscernible] Thank you, Gay.

Great. Thanks, Nikhil. You. We go next now to Faisal Khorshid at Leerink Partners. Hey, good morning guys. Thanks for taking me on the call. Just want to ask, you spoke a little bit about their reimbursement changes with Medicare. Can you talk a little bit more about that and the impact? Like is that just the kind of Medicare Part D redesign and how does that affect the products? And then are there other kind of product specific kind of factors at play with regards to reimbursement that we should be considering? [indiscernible] Good morning, Fessel, and thank you for your question. Look, this is not a redesign What it is, is patients with Medicare and Medicare damaged plan that had access to programs that assisted with the offsetting the cost of the patient responsibility or the copay based on financial need. And these some of these programs have not received adequate funding yet in 2020 Hi. 5,000 patients as we've discussed with you, on either ILUVIEN ANI YUTIQIT. So the addressable market is is much, much higher. And so while we're working through this in the short term, ANI we're trying to understand how But while this is a near term issue to work through, we remain confident of the growth prospects for our products in both DME and NI UPS.

Got it. And is this dynamic specific to Vigniteq or is this impact Kurtrophin as well? ANI now this does not impact Korthrophin.

Because it's [indiscernible] It's for Part B And then the Part B As some of the positive tailwinds from IRA changes such as maximizing the co pay at $2,000 and then allowing for smoothing So that's those changes are impacting the Part D of Medicare. However, this is [indiscernible] [indiscernible] These programs provide assist with the cost setting, the cost of patient responsibilities also for other products. Not just ILUVIEN and UJI.

Got it. That's helpful. Thank Thanks, Cecile. Thank you. We go next now to Orrin Limnath at H. C. Wainwright.

Thanks. Apologies in advance. I have a really bad cough now, so might have to use the mute button if I drop off, periodically. To talk about YUTIQ and Oluvia again.

I'm just a little confused. So hopefully you can help me understand this transition. You mentioned we had expected, but also planning to stop promoting the product. So I'm just trying to understand, is this just supporting it ongoing supply as you transition or do you intend to continue long term manufacturing Utic at Siegfried Also how close are you threading the needle regarding this supply agreement and with five point and then this new indication and switch And sorry, a third part if you if I may. How disruptive could this be in terms of training and technique? Is there any difference with these new applicators and new training require And do these have different costs or access, which [indiscernible] cause some insurance transition period to happen as well? And then I have a quick follow-up. Good morning, Norin, and thank you for your question ANI thank you for joining despite being under the weather. So I think the first question was on on the transfer of manufacturing to six feet. The way we are transferring the manufacturing to SIGFREED is by adding the label of the indication of uveitis [indiscernible] guidance affecting posterior segment of the eye to the Iluvia That is possible because these two products are extremely similar.

In fact, as I mentioned, the clinical trials were both run on the zero point one eight milligram of flusinolone aspicionide. So the only real difference between the two is the ILUVIEN has a newer manufacturing process has a slightly different strength. So essentially that we will have one product which is ILUVIEN. That ILUVIEN product will have both indications on the label. Diabetic macular edema as well as chronic non infectious uveitis affecting posterior segment of the eye. Dick Freed already manufactures ILUVIEN and will continue manufacturing ILUVIEN. Anticipating this potential label consolidation we extended the six feed manufacturing agreement by five years to 2029. Upgraded the equipment on the existing manufacturing line, as well as are adding a second manufacturing line. And all those initiatives are on track. We've known that this label consolidation is coming what we've been building up ILUVIEN inventory Right. To to allow for the transition. And as I said to you, High Point is committed to continue to work with us to ensure supply continuity For patients, right? And work with us through these changes. Having said that, the agreement with them we've agreed for both iPoint and ANI have agreed for non renewal starting 05/31/2025.

So we've talked through the the The inventory transition and have been preparing for it. And regarding the timing, also, right, look, we've engaged with the FDA. We knew exactly what they wanted. To support the indication addition right, even before we submitted the the PAS, And then we've been having ongoing dialogue with them to ensure to be understand what they're asking for and look you can read the T lease and we've been satisfactorily answering the questions that they've been asking on the label. So that's why Q2 we expect approval of this PAS. And we'll transition from YUTIQ, to from selling both YUTIQ and ILUVIEN to only selling ILUVIEN. And then your third question was on on physicians and what they actually use and the fact that there are two implanters. So we believe that there is significant value add to customers and simplicity because there's consolidation to one injector into the retina community and for the offices who buy and build this, they can it simplifies the ordering and processes. They don't have two SKUs to maintain. They can only maintain one. So we think that this is actually a value add to our customers and the retina community.

Thank you, Ornd.

Okay. And just so I can get some clarity on that last point, aside from the simplicity of having one product instead of two, is the procedure the same for each relative indication Across different I guess, injectors? Is there any would patients would doctors who are already using YUTIQ now for NIU switching to ILUVIEN have to do anything differently? And not in any material way in this slight difference, but nothing material And lot of the retinal physicians have [indiscernible] The ability to use different kind of in stores, right? This is not the only they do use different kinds of inserts. For The ability to and these are substantially similar to the ability to sort of learn the slight tweak or change, we don't think that that's material. And obviously, look again, contemplated this even well before our acquisition. If A and I had never acquired Alimera, this is exactly what they would have done. And they obviously and we've just picked up from where they left off right, in terms of merger the consolidation of the two labels. And again, to clarify, is the insurance coverage and cost similar or identical for these products, so the transition shouldn't be disruptive on that front or and theory could there even be tailwinds with pricing differences?

The pricing is reasonably close for both the listed price ANI we do not foresee market access to be to cause any issues from a coverage perspective? [indiscernible] Okay. And lastly, I appreciate all the time. On cortrophin, how important is that one milliliter prefilled syringe launch assuming it's a approved. Do you know what share Acthar is similar self check product has achieved since launch? And assuming some new uptake or switching from the five milliliter vial to your prefilled thread, would there be any material impact on average net selling price per patient potentially? [indiscernible] Thank you for your question. Look, [indiscernible] are introducing the prefilled syringe to enhance [indiscernible] So the five ml vial is a requires a multi step administration And so what the pretail syringe does is reduce once administration process for the patients and so that's helpful to them. So there's a subset of patients that have for whom it is helpful to have one less step in the administration process. And that's that's a new presentation that we're bringing to the market. We believe that this will continue as we had done with the one ml vial that we launched for acute arthritis wears.

We're focused on acute gouty arthritis wears. We believe that this will continue to present offer new presentations and options for different segments of patients ANI will drive overall growth of the ACH market and that's how we see the launch of the the approval and launch of the prefilled syringe. And as we said that we're continuing to look into other explore other ideas for improving patient convenience ANI we'll look forward to sharing updates on these projects as we progress them.

All right. Thanks so much. Thank you, Oren.

I hope you feel better.

Thank you. We'll go next now to Les Saluski at Chorus Securities.

ANI good morning. Thank you.

Taking my questions. This is Jeevan on for Les. Are there any developments that could potentially disrupt the qurotrophin market given its growth and do you see potential for synthetic versions or other pipeline products potentially from overseas competitors?

Thank you. [indiscernible] Thank you, Gilead, and good morning. [indiscernible] Look, the ACTH market has returned to growth.

The [indiscernible] our actuals and add the competitors guidance the they last reported in November. This market is seeing north of around 25% growth to $660,000,000 ANI you hear their rhetoric and what we're saying ANI essentially we're all talking about we're both talking about increasing awareness of the ACTH therapy for the appropriate patients. And then the data point that we shared, which is when you look at number patients on therapy today, it's about half the number of patients of therapies that were at the peak. And from an epidemiological perspective were much lower than the addressable than what the addressable market was, right? So again, the opportunity is very substantial And I think the data point the new data point that we shared for the first time today is that almost forty percent of our prescribers are HCPs that were naive to ACTH So our ability to get to when you talk about the epidemiological addressable market on our ability to get to newer physicians and to reach the appropriate patients think it's proven as we over the last three years. So I think that tells you about sort of the why we continue to believe and continue to invest behind the long term multiyear growth trajectory of the ACTH market.

And regarding competition, look, you know, I would say that for both for both products the competitor ANI ours, We've continued to see this over time that it is just tough to bring a a generic or a biosimilar to this product So I think that's path to generalization ANI both the competitor and us have added IP to strengthen And so, obviously, we keep tracking this from a competitive standpoint. We just we do see that the outlook for the ACTH category is is one where it will be two of our the two competitors trying to continue to build awareness and bring this therapy to patients in need. Thank you, Jiva.

Further questions this morning. We go next now to Glenn Santangelo with Jefferies. Hi, Glenn. Thanks for taking my question. Hey, I'm kind of curious, I mean, we've seen an uptick in Form 483s ANI that's led to certain shortages. And I'm just trying to reconcile some of your comments that you made with respect to the outlook for fiscal twenty five in terms of assuming continued double digit growth. And what I was really hoping that you could do is maybe just sort of unpack that growth algorithm for me and give us a sense for maybe how much of that you expect to come from maybe organic volumes ANI price versus new product launches maybe fully appreciating the comments you made on the timing on PUKALIPRIde the tablets that you just recently launched and how that may impact the first half versus the second half?

Thanks. [indiscernible] Thank you, Glenn. ANI Thank you. Great to have you on our call for the first time. So appreciate that. Regarding the generics business, look, I think it's a combination of two or three things that's helping us drive low double digit growth this year. I think first and foremost is the new product launch cadence that we have. We launched 17 new products in 2024. We'll obviously see the full year impact of those launches. As we launched them at different points in the year. Second is the launches that we'll do this year. Right, including Procalo Pride, right, which gives us a with one hundred and eighty days of exclusivity. What you will see is that the generics business sales because of the one hundred and eighty days or exclusivity will see a a jump in Q1 and Q2 [indiscernible] but so but there are other launches through the year. So I think it's a combination of the annualization of 20 the seventeen twenty twenty four launches, the new launches from 2025 ANI you balance the erosion that we'll see In the what I call the class of 2023 and before products from additional competition and that's I think that's typical generic pricing as you're well aware of. [indiscernible] to a question All of our growth will largely come from volumes.

Rather so new volumes either from new product launches or from from taking additional share in part that we're already in the market for. In the guidance that we have shared of low double digit there isn't any material positive benefit from [indiscernible] ANI supply related issues that competitors may have. Thank you, Glenn. Thank you for joining.

Questions this morning. Mr. Lohani, I'll turn things back to you for any closing comments. Thank you, both. 2024 was a record year for our business. And we expect to continue building on this momentum in 2025. [indiscernible] and our ophthalmology franchise are already off to a good start and are leading us to raise our 2025 outlook. I'm confident that ANI is well positioned to deliver another year of strong revenue growth and profitability in 2025. We look forward to seeing many of you in person next month at the Raymond James Annual Institutional Investor Conference in Orlando and the Leerink Global Healthcare Conference in Miami Beach. Thank you for joining us today. Thank you.

Thank you very much, Mr. Lewani.

ANI, ladies and and gentlemen, that will conclude today's ANI Pharmaceuticals fourth quarter twenty twenty four earnings results call. Again, thanks so much for joining us everyone ANI we wish you all a great day.