Earnings Call Transcript
ANI PHARMACEUTICALS INC (ANIP)
Earnings Call Transcript - ANIP Q4 2024
Operator, Operator
Good morning, everyone. Welcome to today's ANI Pharmaceuticals Fourth Quarter 2024 Earnings Results Call. Please note, this call is being recorded. After speakers’ remarks there will be a question-and-answer session. Instructions will follow. Now at this time, it's my pleasure to turn the call over to Ms. Lisa Wilson, Investor Relations of ANI Pharmaceuticals. Please go ahead, ma'am.
Lisa Wilson, Investor Relations
Thank you. Welcome to ANI Pharmaceuticals Q4 2024 earnings results call. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Stephen 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 ANI website at anipharmaceuticals.com. Before we get started, I would like to remind everyone that any statement made on today's conference call that expresses 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 ANI Pharmaceuticals management as of today, and involve risks and uncertainties included in 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 on our website at anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 28, 2025. 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.
Nikhil Lalwani, CEO
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, ILUVIEN, and YUTIQ, which we recently added through the acquisition of Alimera. Finally, Steve will review our fourth quarter results and 2025 guidance in more detail. Following our remarks, we will take your questions. We are 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 in our guidance is based on further confidence in higher demand for Cortrophin Gel, a strong start for generics with the launch of Prucalopride with 180-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 million to $776 million, which represents growth of 23% to 26% over 2024 versus our prior guidance of $739 million to $759 million. We expect adjusted non-GAAP EBITDA of $190 million to $200 million, which reflects growth of 22% to 28% over 2024 versus our prior guidance of $182 million to $192 million. Steve will provide more specifics on our financial guidance. 2024 was another year of strong execution for ANI capped by our record fourth quarter with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS, all coming in above our previously announced guidance for the full-year. Rare Disease was our primary driver of growth in 2024 with our lead rare disease asset, Cortrophin Gel, generating close to $200 million 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 business. In addition, we expanded our rare disease franchise in 2024 with the acquisition of Alimera Sciences in September in keeping 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 $190.6 million, representing a year-over-year increase of 45% on an as-reported basis and 24% on an organic basis, driven by accelerating demand for Cortrophin Gel, continued strong growth for generics, our full quarter contribution from ILUVIEN and YUTIQ and higher demand for brands. Adjusted non-GAAP EBITDA was $50 million, and adjusted non-GAAP EPS was $1.63. Cortrophin Gel generated $59.4 million in revenues during the quarter, up 42% over the fourth quarter of 2023. 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 specialties, including neurology, rheumatology, nephrology, pulmonology, and ophthalmology. Cortrophin 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 forecasts Cortrophin Gel revenues to grow between 34% and 38% to $265 million to $274 million in 2025. Chris will talk more about our initiatives to increase awareness of the benefits of ACTH therapy for appropriate patients and further drive demand for Cortrophin Gel.
Christopher Mutz, Senior Vice-President, Head of Rare Disease
Thank you, Nikhil, and good morning everyone. Our rare disease team drove strong demand for Cortrophin Gel in the fourth quarter. We are pleased to see demand growth across all targeted specialties, including 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. The growth we experienced in 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 continued to ramp and now represents approximately 15% of Cortrophin Gel use. Notably, gout is serving as a gateway indication for many physicians that are new to ACTH therapy. For approximately 15% of healthcare professionals prescribing Cortrophin Gel for the first time, a gout patient is their first patient on therapy. 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 multiyear growth trajectory. The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024 based on the reported sales for Cortrophin Gel and the guidance given for the other ACTH product by our competitor. We believe the growing recognition of Cortrophin 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 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 significant unmet need for autoimmune disorders and inflammatory diseases. 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 40% of Cortrophin Gel prescribers are new to the ACTH category, which illustrates the need for our therapy in certain patients and 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 pulmonology and ophthalmology. 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 and 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 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 are also investing in initiatives to improve patient and physician convenience. We have a prefilled syringe under FDA review that we expect to launch in the second quarter of 2025. 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, and 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 Gel franchise and continuing to deliver strong multiyear growth for the product. Turning now to our new ophthalmology products, ILUVIEN and YUTIQ. 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 YUTIQ is used to treat chronic non-infectious uveitis affecting the posterior segment of the eye or NIU-PS. ILUVIEN and YUTIQ are the only long-term 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 Cortrophin Gel. In sales, we have fully transitioned into the new larger footprint of 46 territories and key customer handoffs are now complete. We also are beginning to see meaningful increases in call activity, which we expect to drive performance in both ILUVIEN and YUTIQ throughout the remainder of 2025. In marketing, we are making significant investments in increasing peer-to-peer education, as 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 SYNCHRONICITY. NEW DAY is investigating the use of ILUVIEN in combination with the current standard of care anti-VEGF for the treatment of DME. NEW DAY is fully enrolled with 306 patients in approximately 42 sites. The last patient's last visit occurred in early January, and we expect top-line results in the second-quarter of this year. SYNCHRONICITY is designed to provide retina and uveitis specialists with a broader sense of the utility of YUTIQ across a variety of patients with chronic NIU-PS. The clinical trial has 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 Cortrophin 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, we expect our rare disease business, which includes Cortrophin Gel, ILUVIEN, and YUTIQ, to be ANI's largest growth driver. With that, I'll turn the call over to Steve for the financial update.
Stephen Carey, CFO
Thanks, Chris, and good morning to everyone on the call. I'll review our fourth quarter results and then discuss our 2025 guidance in detail. ANI generated fourth quarter revenues of $190.6 million, 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 the business post the Alimera acquisition. The new segment presentation can be found in our earnings release, MD&A in our Form 10-K, 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 $106.9 million 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 Brands. Rare disease revenues more than doubled to $87 million. Revenues from Cortrophin Gel were $59.4 million, up 42% from the prior year period, driven primarily by increased volume on a record number of new patient starts. Revenues from our new ophthalmology products, ILUVIEN and YUTIQ, were $27.6 million. As a reminder, we completed the acquisition of Alimera on September 16, and therefore, the fourth quarter represents our first full quarter of owning these assets. Revenue for brands were $19.8 million 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 $83.7 million, an increase of 8% over the prior year period, driven by increased volumes on contributions from new product launches in 2024 and the full year impact of products launched in 2023. Now to move down the P&L. As a reminder, when I speak to our operating expenses for the purposes of this earnings call, I will be referring to our non-GAAP expenses, which are detailed on Table 3 of our press release. Generally, our non-GAAP operating expenses exclude depreciation and amortization, stock-based compensation, and certain costs related to litigation and M&A activity. Please refer to Table 3 for a reconciliation to our GAAP expenditures. Non-GAAP cost-of-sales, excluding depreciation and amortization, increased 31% compared to the prior year period to $69.5 million in the fourth quarter of 2024 primarily due to net growth in sales volumes of pharmaceutical products of royalty-bearing products and a full quarter of ILUVIEN and YUTIQ sales. Non-GAAP gross margin was 63.5%, an increase of approximately 3.9 percentage points from the prior year period 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 expenses increased 68% to $16.2 million 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&D programs. Non-GAAP selling, general and administrative expenses increased 42% to $54.8 million in the fourth quarter, driven by a full quarter of spend for our new larger Cortrophin Gel, 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 performance 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 $1 per share in the prior year period. Adjusted non-GAAP EBITDA for the fourth quarter was $50 million, compared to $30.2 million in the prior year period. We ended the quarter with $494.3 million of net debt, comprised of $144.9 million in unrestricted cash and $639.2 million in principal value of outstanding debt, 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 is approximately 2.5 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, based on recent strong trends for Cortrophin Gel, the continued evolution of our generics business, and higher first quarter demand for our Brands portfolio. We now expect total revenue of $756 million to $776 million, which represents growth of 23% to 26% over 2024. For Cortrophin Gel, we expect revenue of $265 million to $274 million, representing growth of 34% to 38%. We anticipate continued adoption of Cortrophin Gel in 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 gout indication. We also expect continued growth for the overall ACTH market in 2025. As you consider the quarterly progression for Cortrophin Gel, please note that the general pattern of revenue in 2025 is expected to be similar to that reported in 2024 with a quarter-over-quarter decline in the first quarter due to prescription reauthorizations 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 million to $103 million, which reflects the impact of the first quarter dynamics outlined by Nikhil and Chris earlier in the call, as well as the commercial and operational transitions they discussed. First quarter net revenues of ILUVIEN and YUTIQ are expected to be impacted 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 2025. 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 Prucalopride in early January with 180 days exclusivity. For Brands, we saw increased demand in the fourth quarter for certain products as we have periodically experienced over the past two years. This increased demand has persisted in the first two months of 2025. Our guidance assumes that this increased demand does not persist beyond the first quarter, and thus we assume normalized performance in quarters two through four.
Nikhil Lalwani, CEO
Thank you, Steve. We'll open it up for questions.
Operator, Operator
Operator Instructions. We go first this morning to David Amsellem at Piper Sandler.
David Amsellem, Analyst
Thanks. I have a couple of questions. First, regarding business development and mergers and acquisitions, you've expanded the Rare Disease business and overall brand business. Can you discuss your current deal capacity and how high you would be willing to increase pro forma net leverage to pursue a deal? Additionally, how do you view the future size and mix of the brand business? Currently, it seems to be about 60-40 or 50-50 between Brand and Generics, but where do you envision taking the company's brand presence in the long term? Secondly, I would like to focus on Cortrophin and understand the mix better. How significant is gout in this mix? You mentioned it as a higher growth opportunity, and I’m curious about how we should assess that particular opportunity and its potential impact on the business in 2025 and beyond. Thank you.
Nikhil Lalwani, CEO
David, thank you for your questions. So your first question on BD and M&A, as we have shared before, in terms of the areas we would focus on rare disease. And then your second part of the question was, what is the deal capacity and where are we willing to take pro forma leverage. So look, if you look at ANI's history and as we've built the company and 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. Historically, it has always been kept under three. And at some points for short periods of time, such as during the launch of Cortrophin, it went slightly above, but then quickly de-levered. As you look at how we did the Alimera acquisition and refinancing of the loan and putting in place a more efficient capital structure, I think that it is our intent and we believe it gives us the ability to pursue additional BD and M&A without straining the balance sheet. So that's how I would answer the question on BD, M&A. Your second question on where are we taking this company, ANI has a strong portfolio of businesses. Both the Rare Disease business, as well as the Generics business are growing. The brands business, what 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 build rights through BD, through M&A. We will invest in R&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 will shift with a greater percentage coming from Rare Disease and Brands. So that's point number two. And then the third question on gout. I think just two data points to share: 15% of the volume of Cortrophin currently is coming from gout. And then as Chris talked about, gout is ending up being a gateway in some ways with 15% of prescribers writing their first prescription in gout and then moving on to consider it for other types of patients. Thank you, David.
David Amsellem, Analyst
Thank you.
Operator, Operator
Thank you. We go next now to Vamil Divan at Guggenheim Securities.
Vamil Divan, Analyst
Thank you for taking my question. I have a couple of inquiries. First, regarding the Alimera assets and the access issues since January, could you provide more details about your plans and the expected timeline for resolution? The guidance this year implies that the midpoint of around $100 million represents minimal year-over-year growth compared to what you reported in the fourth quarter. How should we consider the long-term effects of this access issue on growth, particularly looking ahead to 2026 and 2027? My second question pertains to Cortrophin. You mentioned seasonality with the Alimera assets, but how should we view that in the context of Cortrophin, given its strong growth? It appears your initial trends for the year are positive if you are raising your guidance based on that. Should we expect to see any seasonality effects in the first quarter? Additionally, could you comment on quarter-over-quarter growth expectations for that franchise? Thank you.
Nikhil Lalwani, CEO
Yeah, good morning Vamil and thank you for your question. So your first question on the ILUVIEN and YUTIQ access issues, 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 2025. In terms of what ANI is doing about it? Look, first and foremost, ANI has in place a patient assistance program that provides access for patients in financial need with free ILUVIEN and YUTIQ as needed. Secondly, we are 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. As we've talked about, 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 6 times 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 NIU-PS. The second question was around seasonality in PCG; you will see the typical Q4 to Q1 dynamic in PCG, which is also 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, we've had the highest number of new cases initiated. So we built momentum early, which is one of the reasons why we raised our guidance that we had shared a few weeks ago. You will see a drop, but there will be sequential growth building on from there. This is just a typical Q4 to Q1 type dynamic for sales for PCG.
Vamil Divan, Analyst
Okay, thank you.
Operator, Operator
Thank you. We go next now to Gary Nachman at Raymond James.
Gary Nachman, Analyst
Hi, thanks and good morning. So yes, back to ILUVIEN and YUTIQ. I'm also trying to better understand the guidance of the $97 million to $103 million given a lot of different moving parts that you have that you're working through in the near term. Therefore, are you anticipating any issues or hiccups as you transition supply from EyePoint 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 soon do you think those could benefit the overall franchise? And then I have one for Cortrophin.
Nikhil Lalwani, CEO
Got it. Thank you, Gary. Thank you for your question. Yes, your first question is on the guidance. As we've talked about, 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 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 and Chris spoke a little bit about this and strengthened the peer-to-peer education programs for further increasing awareness of ILUVIEN and YUTIQ, amplifying ANI's commitment to ophthalmology and retina. We're investing in market materials to help physicians identify appropriate patients, and we're continuing to refine our approach to selling three products across the U.S. and in international markets. We are investing in higher ROI activities such as expansion of the team in Germany and providing increased support for our partner products. You asked about NEW DAY. On the clinical front, we've continued to push forward with the key programs, NEW DAY and SYNCHRONICITY, and we are pleased that both programs will read-out preliminary top-line data in the second quarter of 2025. If the NEW DAY results are positive, it could significantly expand the use of ILUVIEN earlier in the DME patient journey. We have a robust plan for publishing and awareness building of the clinical results among the retina community, who are eagerly awaiting these results. Having said that, we've been measured in our full-year guidance and not resumed a tailwind from NEW DAY results in our 2025 guidance. Regarding the transition, EyePoint is committed to working with us to support this transition and ensure supply continuity for patients; we have been preparing for it. Regarding the insurance coverage and cost, the pricing is reasonably close for both the listed price and we do not foresee market access to cause any issues from a coverage perspective.
Gary Nachman, Analyst
Yes. And then I just had a follow-up on Cortrophin. I mean, you're seeing a nice benefit in ophthalmology and acceleration in gout. Just talk about how much did you add to the sales force across what indications? And how do you evaluate that ROI if you think the market should really grow that much at what point you could add to that even further?
Nikhil Lalwani, CEO
Yes, thank you. Thank you for that question, Gary. So we increased the Cortrophin sales force. We've added about 15 to 20 representatives between reps and area business directors; these are largely focused on the core indications that we initially launched with: rheumatology, nephrology, and neurology. In terms of ROI, as we've grown this product over three years from zero to about $200 million, we've driven growth across both the specialties we targeted at launch and the newer specialties of pulmonology and ophthalmology. Under Chris' leadership, we have developed a good understanding of how to drive high ROI of commercial investments while leveraging the rare disease infrastructure. I think all these factors come together to help us continue driving growth here. Besides that, we'll be investing in R&D project spend for improving patient and physician convenience. We'll share updates on these projects as we progress them. We've discussed the prefilled syringe and the plan to launch it in the second quarter; we aim to improve patient convenience. Additionally, we continue looking into other ways to enhance convenience for patients starting on Cortrophin Gel.
Gary Nachman, Analyst
Great. Thanks again.
Operator, Operator
Thank you. We'll go next now to Faisal Khurshid at Leerink Partners.
Faisal Khurshid, Analyst
Hi, good morning guys. Thanks for taking me on the call. I just wanted to ask. You spoke a little bit about the reimbursement changes with Medicare. Can you talk a little bit more about that and the impact? 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 factors at play regarding reimbursement that we should be considering?
Nikhil Lalwani, CEO
Yes, good morning Faisal, and thank you for your question. This is not a redesign; patients with Medicare and Medicare Advantage plans have access to programs that help offset their copays based on financial need, but some of these programs have not received enough funding yet in 2025. Regarding our actions, the number of patients or the addressable market for Medicare is six to ten times larger than what we're currently treating, with fewer than 5,000 patients using either ILUVIEN or YUTIQ. Therefore, the addressable market is significantly greater. While we work through this short-term situation and analyze prescribers' responses, we remain confident in the growth potential for our products in both DME and NIU-PS.
Faisal Khurshid, Analyst
Got it. And is this dynamic specific to ILUVIEN and YUTIQ? Or does this impact Cortrophin as well?
Nikhil Lalwani, CEO
This does not impact Cortrophin because it's for Part B, while Part D has some positive tailwinds from IRA changes such as maximizing the co-pay at $2,000 and allowing for smoothing. So these changes impact the Part D of Medicare. However, these programs provide assistance with the cost setting and the cost of patient responsibilities for other products, not just ILUVIEN and YUTIQ.
Operator, Operator
We go next now to Oren Livnat at H.C. Wainwright.
Oren Livnat, Analyst
Thanks. I'm dealing with a bad cough, so I might need to mute myself occasionally. I want to revisit YUTIQ and ILUVIEN. I'm a bit confused by the transition. You mentioned moving YUTIQ manufacturing to Siegfried, which we anticipated, but also that you plan to stop promoting the product. I'm trying to understand if this is just to support ongoing supply during the transition or if there are plans for long-term manufacturing of YUTIQ at Siegfried. Additionally, how close are you to finalizing the supply agreement with EyePoint and the new indication? Lastly, how disruptive could this be in terms of training and technique? Will there be any differences with the new applicators that require additional training? Are there any associated costs or access changes that might lead to an insurance transition period? I have a follow-up after that.
Nikhil Lalwani, CEO
Hi, Oren, thank you for your question, and I appreciate you joining despite being under the weather. So I think the first question was on the transfer of manufacturing to Siegfried. The way we are transferring the manufacturing to Siegfried is by adding the label of the indication of uveitis, specifically chronic non-infectious uveitis affecting the posterior segment of the eye to the ILUVIEN label. This is possible because these two products are extremely similar. In fact, as I mentioned, the clinical trials were both run on the 0.18 milligrams of fluocinolone acetonide. So the main difference is ILUVIEN has a newer manufacturing process that has a slightly different strength. Essentially, we will have one product, which is ILUVIEN, and that ILUVIEN product will have both indications on the label, including diabetic macular edema, as well as chronic non-infectious uveitis. Siegfried already manufactures ILUVIEN and will continue manufacturing ILUVIEN. Anticipating this potential label consolidation, we extended the Siegfried manufacturing agreement by five years to 2029 while upgrading the equipment and adding a second manufacturing line. All those initiatives are on track. We've known that this label consolidation is coming and have been building ILUVIEN inventory to facilitate the transition. As I said, EyePoint has committed to working with us to ensure supply continuity for patients. Having shared that, the agreement with them won't renew starting May 31, 2025. We've discussed the inventory transition and have been preparing for it. Regarding the timing, we've engaged with the FDA well in advance and have had ongoing dialogue with them. We expect to receive approval for this PAS in Q2, and we'll transition from selling both YUTIQ and ILUVIEN to only selling ILUVIEN. Your third question was on the physicians and their usage of the two implants. We believe there is significant value-add to customers with the consolidation to one injector, simplifying the ordering and processes. The physicians who buy and build this will have only one SKU to maintain, reducing complexity. So we see this as advantageous. To sum it up, when merging these two products by adding the uveitis label to ILUVIEN, we create a simpler approach and process for both the physician and the retina community.
Oren Livnat, Analyst
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 could there even be tailwinds with pricing differences?
Nikhil Lalwani, CEO
The pricing is reasonably close for both the listed price and we do not foresee market access to cause any issues from a coverage perspective.
Oren Livnat, Analyst
Okay. And lastly, I appreciate all the time. On Cortrophin, how important is that one-milliliter prefilled syringe launch assuming it's approved? Do you know what share Acthar's similar SelfJect product has achieved since launch? Assuming some new uptake or switching from the five-milliliter vial to your prefilled syringe, would there be any material impact on average net selling price per patient potentially?
Nikhil Lalwani, CEO
Yes, and thank you for your question. Look, we are introducing the prefilled syringe to enhance physician and patient convenience. The five-milliliter vial requires a multi-step administration, while the prefilled syringe reduces one step in the administration process for patients. This is helpful to them, so there is a subset of patients that could benefit from this simplification. We believe that this will continue, as we've done with the one-milliliter vial introduced for acute gouty arthritis flare; it's focused on that indication. We believe the prefilled syringe will offer new presentations and options for different patient segments, driving overall growth in the ACTH market. We're excited about the approval and launch of the prefilled syringe. We are also continuing to look into other ideas for improving patient and physician convenience, and we will share updates on these projects as we progress.
Oren Livnat, Analyst
All right. Thanks so much.
Nikhil Lalwani, CEO
Thank you, Oren. I hope you feel better.
Operator, Operator
We'll go next now to Les Sulewski at Truist Securities.
Jeevan Larson, Analyst
Hi, good morning. Thank you for taking my questions. This is Jeevan on for Les. Are there any developments that could potentially disrupt the Cortrophin market given its growth? And do you see potential for synthetic versions or other pipeline products potentially from overseas competitors?
Nikhil Lalwani, CEO
Yes. Thank you, Jeevan. And good morning. Yes, look, the ACTH market has returned to growth. If you add our guidance and that of the competitor last reported in November, this market is seeing north of around 25% growth to $660 million. We are talking about increasing awareness of ACTH therapy for the appropriate patients. A new data point shared today for the first time is that almost 40% of our prescribers are HCPs that were naive to ACTH. Our ability to get to newer physicians highlights our proven capability to reach the appropriate patients. Regarding competition, bringing a generic or a biosimilar to this product is challenging. We do see that the outlook for the ACTH category is one where it will be two competitors trying to build awareness and bring this therapy to patients in need.
Operator, Operator
Operator Instructions. We'll go next now to Glen Santangelo with Jefferies.
Glen Santangelo, Analyst
Hi, good morning. Thanks for taking my questions. Maybe I'll ask just a quick one on the Generics business; I'm kind of curious, I mean, we've seen an uptick in Form 483s and that's led to certain shortages. I'm just trying to reconcile some of your comments you made with respect to the outlook for fiscal '25 in terms of organic volumes and price versus new product launches, fully appreciating your comments on the timing of Prucalopride, the tablets that you just recently launched and how that may impact the first half versus the second half.
Nikhil Lalwani, CEO
Yes. Thank you, Glen, and thank you. Great to have you on our call for the first time, so I appreciate that. Regarding the generics business, it's a combination of two or three things that will help us drive low double-digit growth this year. First is the new product launch cadence we have. We launched multiple new products in 2024, and we will see the full-year impact of those launches. Second is the launches that we will do in 2025, including Prucalopride. With its 180 days of exclusivity, you will see generics business sales take a jump in Q1 and Q2. Besides that, the annualization of the previous launches along with taking additional share in products already in the market comes into play. The growth will largely come from volumes, whether it's from new product launches or taking share in existing products; there isn't any material positive benefit expected from warnings or competitor supply issues.
Glen Santangelo, Analyst
Okay, thanks a lot. Nikhil.
Nikhil Lalwani, CEO
Thank you, Glen. Thank you for joining.
Operator, Operator
And ladies and gentlemen, it appears we have no further questions this morning. Mr. Lalwani, I'll turn things back to you for any closing comments.
Nikhil Lalwani, CEO
Thank you, Bo. 2024 was a record year for our business, and we expect to continue building on this momentum in 2025. Both Cortrophin Gel and generics 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 Health Care Conference in Miami Beach. Thank you for joining us today. Thank you.
Operator, Operator
Thank you very much, Mr. Lalwani. Again, ladies and gentlemen, that will conclude today's ANI Pharmaceuticals fourth quarter 2024 earnings results call. Again, thanks so much for joining us, everyone, and we wish you all a great day. Goodbye.