Earnings Call Transcript - ANIP Q1 2025

Operator, Operator

Please stand by. Your program is about to begin. Good day everyone and welcome to today's ANI Pharmaceuticals, Inc. First Quarter 2025 Earnings Results Call. Please note this call is being recorded. After the speakers' opening remarks, there will be a question-and-answer session. It is now my pleasure to turn the conference over to Lisa Wilson.

Lisa Wilson, Investor Relations

Thank you, operator. Welcome to ANI Pharmaceutical's Q1 2025 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 Investor section of the ANI website at anipharmaceuticals.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI Pharmaceuticals Management, as of today and involve risks and uncertainties including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 9, 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. I'll start by discussing our first quarter performance and highlights, along with our updated 2025 guidance. Chris will provide additional color on our rare disease business, including our lead asset, Cortrophin Gel, and our retina assets, ILUVIEN and YUTIQ. Finally, Steve will review our first quarter results and updated 2025 guidance in more detail. Following our remarks, we'll take your questions. We had a very strong start to the year with record revenue, adjusted EBITDA, and adjusted EPS. The first quarter reflected particularly strong performance for our generics business, continued solid demand for Cortrophin Gel, and increased demand for our brand's portfolio. The top-line upside was partially offset by near-term factors impacting our retina products that I will expand on in a moment. We were pleased with the strength across our overall company. Based on our first quarter performance and favorable demand trends across generics, Cortrophin Gel, and brands, we are raising our 2025 guidance for total revenues and adjusted non-GAAP EBITDA. We now expect 2025 revenues of $768 million to $793 million, which represents growth of 25% to 29% over 2024 versus our prior guidance of $756 million to $776 million. We expect adjusted non-GAAP EBITDA of $195 million to $205 million, which reflects growth of 25% to 31% over 2024 versus our prior guidance of $190 million to $200 million. Steve will provide more specifics on our updated guidance later in the call. Turning now to our first quarter results. Total revenues were $197.1 million, representing a year-over-year increase of 43% on an as-reported basis and 32% on an organic basis, driven by exceptional performance for generics, continued strong growth for Cortrophin Gel, and continued demand for our Brands portfolio. Adjusted non-GAAP EBITDA was $50.7 million, and adjusted non-GAAP EPS was $1.70. Cortrophin Gel generated $52.9 million in revenues during the quarter, up 43% over the first quarter of 2024. We continue to see growth across our targeted specialties—urology, nephrology, rheumatology, ophthalmology, and pulmonology. Notably, we had a record number of new patient starts and new cases initiated despite the insurance resets that typically impact branded drugs in the first quarter. We continue to believe that Cortrophin Gel remains on a strong multi-year growth trajectory. Based on reported sales of Cortrophin Gel and the other ACTH product on the market, the overall ACTH category grew 27% to approximately $684 million in 2024. While the overall ACTH category returned to strong growth in 2024, the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of headroom for expansion. It is worth noting that approximately 40% of Cortrophin Gel prescribers are new to the ACTH category, which illustrates the need for our therapy and our ability to expand the market. We expect 2025 Cortrophin Gel revenues to increase 34% to 38% to $265 million to $274 million for the year. Our retina products, ILUVIEN and YUTIQ, generated revenues of $16.1 million in the first quarter. Performance of our retina assets outside the U.S. was in line with our expectations. Our performance in the U.S. was impacted by several factors, including market access challenges for Medicare patients, typical first quarter dynamics for branded drugs, and turnover in our sales force as we optimized our field team to sell our complete rare disease ophthalmology portfolio. As we discussed on our fourth quarter call at the end of February, we saw an impact in the first quarter due to reduced access for Medicare patients. Patient support foundations did not receive sufficient funding in the first quarter of 2025, affecting their ability to assist patients with co-pay support. This change broadly impacted products reimbursed under Medicaid Part B and has been particularly important for ILUVIEN syndication for diabetic macular edema, as also reflected by other players with therapeutics in diabetic macular edema. After working with HCPs to understand their response to the market access challenges, we've refined our commercial approach. We're also exploring pathways to improve access for appropriate patients through specialty pharmacy and Medicare Part D. We've also had some turnover in our U.S. Ophthalmology Salesforce as we took steps to optimize and elevate the quality of our team. We are adding top-tier talent to our sales team and expect to be back to full strength during the second quarter. Our plans to address the near-term challenges in retina are yielding positive results. In April, end-user demand was higher than any month in the first quarter and almost back to fourth quarter 2024 end-user demand levels. Given the recent promising trends we've seen, we are maintaining our 2025 outlook for ILUVIEN and YUTIQ revenues of $97 million to $103 million. Our commitment and confidence in the value of our retina portfolio is further reflected in our recent buyout of our royalty obligation on ILUVIEN and YUTIQ. Turning next to our generics business, we delivered exceptionally strong first quarter revenues of $98.7 million, an increase of 41% over the first quarter of 2024 and 26% over the fourth quarter of 2024, which had been our highest quarter ever for generics. The robust growth was driven by contributions from new product launches, including our first-to-market launch of Prucalopride Tablet, with 180 days of exclusivity that runs to late June, coupled with strong execution in the base business. With this strong start, we now expect mid-double-digit growth from our generics business for the full year, up from our prior estimate of low double-digit growth. Our Brands portfolio continued to perform well. As discussed on our last earnings call, we were able to identify and capture increased demand in the first quarter for certain products, just as we have done periodically for three consecutive years. Our revised full-year guidance reflects a return to a more normalized level of demand during the second quarter. Finally, I would say a few words on the evolving tariff situation. While we await the administration's pharmaceutical industry-specific framework, it is worth highlighting ANI's long-standing commitment to the U.S. pharmaceutical industry and our positive and unique positioning relative to our peers. We are a U.S. Domiciled pharmaceutical company, with over 90% of total company revenues coming from finished goods manufactured in the U.S. Less than 5% of our total company revenues has a direct reliance on China. In addition, we have a strong balance sheet that enables us to maintain healthy levels of finished goods and raw material inventories, and we look forward to maintaining our strong commitment to the U.S. pharmaceutical industry. I'll now turn the call over to Chris Mutz to discuss our rare disease business in more detail. Chris?

Christopher Mutz, SVP and Head of Rare Disease Business

Thank you, Nikhil, and good morning, everyone. As Nikhil mentioned, we were pleased with the strong demand trends for Cortrophin Gel during the first quarter, which included continued momentum in adding new prescribers and robust growth among existing prescribers. We saw demand growth across all of our targeted specialties. In particular in ophthalmology, we saw the highest growth attributable to the efforts of our expanded dedicated ophthalmology sales team. Notably, the number of new initiated cases and new patient starts for Cortrophin Gel reached record levels in the first quarter, which is not typically a seasonally strong quarter for Cortrophin Gel or rare disease drugs in general. We completed the expansion of our portfolio sales team, which covers indications across neurology, nephrology, and rheumatology. Our new team members are quickly building momentum in both new prescriber ads and patient starts in their sales territories. The indications for acute gouty arthritis flares, which is unique to Cortrophin Gel among ACTH therapies, remained a strong driver contributing to growth in the prescriber base and patients on therapy. There were also new affordability options under the Medicare Part D redesign under the Inflation Reduction Act. As Nikhil noted, we continue to see Cortrophin Gel on a strong multi-year growth trajectory. We believe the number of patients on ACTH therapy is now approximately half the level of patients on therapy when the category previously peaked in 2017. We also believe the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago. Keeping this significant unmet medical need in mind, we continue to invest in and make progress on initiatives to strengthen and grow the Cortrophin Gel franchise. Part of these efforts include improving patient and physician convenience. In March, we announced the approval of our pre-filled syringe and recently launched the new presentation. The pre-filled syringe will benefit patients and physicians by reducing the steps needed for self-administration. So far, we've been pleased with early feedback on this important new offering. We're also continuing to invest in evidence generation for Cortrophin Gel. Earlier this week at the Association for Research and Vision in Ophthalmology annual meeting, we presented preclinical data on the use of Cortrophin Gel for uveitis. We are also excited to announce that we plan to initiate a Phase IV clinical trial for the treatment of acute gouty arthritis flares. The study is planned to enroll approximately 150 patients, and we expect to complete the study in approximately one year following initial patient initiation. While Cortrophin Gel has seen significant use in gout, results of this study will provide physicians with valuable insight into the treatment of acute gouty arthritis flares with Cortrophin Gel and could ultimately support inclusion in the relevant treatment guidelines. Overall, we're pleased to see the growing recognition of Cortrophin Gel as a safe and effective treatment option for appropriate patients and look forward to delivering strong multi-year growth for the product. Turning now to our retina products, ILUVIEN and YUTIQ. As Nikhil mentioned, during the first quarter, there was a significant change in market access dynamics for Medicare patients. HCPs took some time to understand the change, whether it would persist, and how they needed to modify their approach while keeping patients first. The impact of these market access changes has varied across regions, and how HCPs have responded to these changes has also varied. It's important to note that prescribing for NIU-PS has been impacted to a much lesser degree relative to prescribing for diabetic macular edema. Our team has spent time understanding HCP responses and the granular impact on their workflows. Without this understanding, we are focused on the impacted diabetic macular edema population. For example, Medicare patients with a pharmacy benefit can avail themselves of the affordability options that Part D offers. Under this approach, retina physicians can access ILUVIEN through a specialty pharmacy. Taking all the above into account, our team has deployed a customized commercial approach by region and territory, which is already paying off, as we've seen in our April results. We've taken several additional steps to enhance our commercial effectiveness. We're strengthening our sales team with top talent from leading retina and ophthalmology organizations, an approach that served us well when we built the Cortrophin team. To drive greater awareness and adoption of ILUVIEN and YUTIQ, we are launching new peer-to-peer educational programming and new refreshed marketing materials. Early response to these materials has been very positive. Overall, we continue to expect our rare disease business to be our largest revenue growth driver in 2025.

Stephen Carey, CFO

Thanks, Chris, and good morning to everyone on the call. I'll review our first quarter results and then discuss our updated 2025 guidance. ANI had a very strong start to the year, and our first quarter results form a strong foundation for the achievement of our increased full-year financial goals. We generated first quarter revenues of $197.1 million, up 43% over the prior year period. Revenues from Rare Disease and Brands were $94.1 million in the first quarter, up 50% from the prior year period as reported and 25% on an organic basis, driven by growth in our Rare Disease franchise. Rare disease revenues were $69 million, up 87% from the prior year period. Revenues from Cortrophin Gel were $52.9 million, up 43% from the prior year period, driven primarily by increased volume on a record number of new patient starts. Revenues from ILUVIEN and YUTIQ were $16.1 million for the reasons that Nikhil and Chris just discussed. Revenues for Brands were $25.1 million in the quarter, a decrease of 2% from the prior year period. The first quarter benefited from continued elevated demand, consistent with what we have periodically achieved with this portfolio in the past, similar to prior year levels of revenue achievement. Revenues for our generics and other segments were $103 million, an increase of 38% over the prior year period. Revenues for generics were $98.7 million, an increase of 41% over the prior year period and 26% over the fourth quarter of 2024 due to increased volumes from new product launches, such as Prucalopride, and the impact of 2024 product launches. Now moving 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 in 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. Non-GAAP cost of sales, excluding depreciation and amortization, increased 49% to $72.7 million in the first quarter of 2025 compared to the prior year period, primarily due to net growth in sales volumes of pharmaceutical products and significant growth of royalty-bearing products. Non-GAAP gross margin was 63.1%, a decrease of approximately 130 basis points from the prior year period, principally driven by mix and significant growth of royalty-bearing products. Non-GAAP research and development expenses of $10 million in the first quarter were relatively in-line with the prior year period. Non-GAAP selling, general, and administrative expenses increased 56.5% to $63.7 million in the first quarter, driven by costs related to our acquisition of Alimera in the form of spend for our new larger ophthalmology sales team promoting Cortrophin Gel, ILUVIEN, and YUTIQ, and continued investment in rare disease sales and marketing activities, including the new purified Cortrophin Gel sales representatives that we added in the quarter. Adjusted non-GAAP diluted earnings per share was $1.70 for the first quarter compared to $1.21 per share in the prior year period. Adjusted non-GAAP EBITDA for the quarter was $50.7 million compared to $37.6 million in the prior year period. We ended the quarter with $149.8 million in non-restricted cash, reflective of $35 million of cash flow from operations, net of $17.3 million of cash used during the quarter to buy out our royalty obligation to SWK on net revenues of ILUVIEN and YUTIQ, and the payout of annual 2024 incentive compensation. As of March 31, we have $637.2 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. Our gross leverage was 3.5 times and our net leverage was 2.7 times. Our trailing 12-month adjusted non-GAAP EBITDA of $181.4 million, which is pro forma for the Alimera acquisition. Utilizing the midpoint of our revised 2025 Adjusted non-GAAP EBITDA guidance, our net leverage is approximately 2.4 times on a forward basis. Turning to our updated 2025 financial guidance, we are raising our guidance for total revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS based upon higher estimates for our generics business and higher first quarter demand for our Brands portfolio. Updated guidance is as follows: Full year 2025 net revenue of $768 million to $793 million up from our prior guidance of $756 million to $776 million, representing year-over-year growth of approximately 25% to 29%. Cortrophin Gel net revenues of $265 million to $274 million, representing growth of 34% to 38%, and in line with our prior estimate. We continue to expect quarterly sequential growth of Cortrophin revenues throughout the year. Combined ILUVIEN and YUTIQ net revenue of $97 million to $103 million, in line with our prior estimate, and we continue to expect quarterly sequential growth throughout the year. Generics revenue growth in the mid-double digits driven by strength in our base business and contributions from new product launches versus our prior assumption of low double-digit growth. Note that in terms of phasing, we expect the first quarter to be our highest revenue quarter for this year for generics and the first half of the year to be higher than the second half of the year due to our late December 2024 first-to-market launch of Prucalopride and its corresponding six months of exclusivity. For Brands, we expect a return to more normalized performance during the second quarter as compared to a full quarter's worth of incremental market share achieved in the first quarter. Putting all the revenue elements together, we expect our second quarter revenues to be lower by a modest amount as compared to the first quarter, followed by a return to sequential revenue growth in the third and fourth quarters. Adjusted non-GAAP EBITDA of $195 million to $205 million, up from our prior guidance of $190 million to $200 million, representing growth of approximately 25% to 31%. From a quarterly perspective, we anticipate second quarter adjusted EBITDA to be lower compared to the first quarter, followed by a return to sequential growth in the third and fourth quarters. Adjusted non-GAAP earnings per share will be between $6.27 and $6.62 up from our prior guidance of $6.12 and $6.49. We continue to anticipate a U.S. GAAP effective tax rate of approximately 25%. We will tax-effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26%. We also continue to anticipate between 20.1 million and 20.4 million shares outstanding for the purpose of calculating diluted EPS. Finally, I will highlight that the company continues to prepare for its upcoming trial with CG Oncology. ANI commenced a civil action against CG Oncology in the Superior Court of the State of Delaware on March 4, 2024. ANI's complaint alleges that under an assignment and technology transfer agreement dated as of November 15, 2010, CG Oncology is liable to pay ANI a running royalty on 5% of the worldwide net sales of their lead product candidate, and that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to ANI. The jury trial is set to commence on July 21, 2025, and ANI intends to pursue this matter vigorously. With that, I'll turn the call back to Nikhil.

Nikhil Lalwani, CEO

Thank you, Steve. We're pleased with the strong start to 2025 and would like to thank you, our customers, suppliers, partners, investors, and the entire ANI team for their collaboration and significant contributions in delivering on our company's purpose of serving patients and improving lives. With that, operator, I turn it over to you for questions.

Operator, Operator

We'll take our first question from Gary Nachman with Raymond James. Please go ahead.

Gary Nachman, Analyst

Thanks and congratulations on the strong quarter. First, regarding Cortrophin, how much do you think the pre-filled syringe will help? Do you believe it could significantly increase usage due to its convenience? What kind of benefits are you seeing from the additional 20 representatives across the indications? Are you thinking about adding more for any indications? I noticed that Axar reported a good quarter, suggesting strong market growth. What additional steps can you take to differentiate Cortrophin? I found the base-four study for acute gouty flares very interesting; are there other studies you are considering for either the existing indications or potentially new ones in the future? I also have a follow-up.

Nikhil Lalwani, CEO

Good morning, and thank you, Gary, for your question. So first on the pre-filled syringe, as Chris mentioned in the prepared remarks, the early response from caregivers is positive, as this reduces one step in the administration process for Cortrophin Gel. We look forward to updating you on the progress. We have just launched the product in the market. While we announced the approval in March, we just launched the product a couple of weeks ago, so we look forward to updating you on the progress. The next question was on the 20 representatives and how they're doing. They are performing well. They have started gaining traction with both new patient starts and new prescribers, and we'll continue to build momentum as the year progresses. We keep evaluating high ROI efforts from the commercial side. Regarding adding more, there's no intent to do that this year at this time. We will again keep evaluating high ROI commercial initiatives to keep growing Cortrophin, which we believe is on a strong multi-year growth trajectory, as we've talked about several times. You're right, the third point was on the competitor. The competitor did announce a strong quarter as well as increased their guidance to high single digits. If you add their guidance and our guidance, the combined market is growing approximately 16%. If you take this as high single digits at 7.5%, the combined market will grow at about 16%. We think that's great for patients and for prescribers because the number of patients on therapy today is, you know, still half of what it was at its peak. From an epidemiological perspective, the number of patients that can benefit or the addressable market is 6 to 8 times higher than the number of patients that were even being treated at its peak. It's good for the category to have two players bringing options for patients and for prescribers. You then asked about differentiation. We continue to invest to strengthen the franchise. You will remember that we launched the 1 ml vial. Now, we've launched the pre-filled syringe to increase convenience, enhance convenience for patients and prescribers. We continue to evaluate additional steps to enhance convenience for patients and for physicians, and we'll look forward to updating you on that progress. Additionally, Chris details some of the efforts on the evidence generation area, and the clinical study that we're initiating later this year, as well as the data that we presented at ARVO on uveitis. I believe these are indications of the multiple different steps across commercial evidence generation and bringing new presentations to the market that we are investing in to continue strengthening and growing the Cortrophin Gel franchise that we believe is on a strong multi-year growth trajectory.

Gary Nachman, Analyst

Okay, great. And then just regarding ILUVIEN and YUTIQ, just given some of the challenges in the first quarter, what gives you confidence you can accelerate the sales to get up into the guidance range for the full year? That's a pretty big step up. I appreciate the steps that you're taking, but how long do you think those will really take hold over the course of the year? And then just talk about the turnover in the ophthalmology sales team. It actually didn't seem to Cortrophin in that segment, which you said was really strong in ophthalmology, and I'm curious why that wasn't the case. And just, you know, going forward, your outlook for ophthalmology. Thanks.

Nikhil Lalwani, CEO

Thank you again for your question, Gary. First, the guidance for ILUVIEN and YUTIQ this year is $97 million to $103 million, of which 30% is outside the U.S. Therefore, ILUVIEN and YUTIQ in the U.S. accounts for, under 10% of total company 2025 revenue guidance. So just to dimensionalize that. As for the factors driving our confidence related to U.S. performance for the rest of the year, the first quarter results were low due to seasonality, as seen for most branded drugs. The remaining three quarters will not have this impact. In fact, it will reverse in the fourth quarter. So that's one factor. Second, we made significant strides in working through the turnover and strengthening our sales force with best-in-class talent. As of today, only four vacancies remain, and we'll be back to full strength during the second quarter, which will create additional momentum. Third, we're already seeing positive impact in April results from the customized commercial approach by region that we deployed, given the Medicare dynamics. Lastly, we expect to see a positive impact from a combination of our efforts to explore alternatives for Medicare patients through the Part D pathway and restarting some level of foundation support for Medicare patients in the second half of the year. Additionally, you asked more about turnover. We believe we have a high-performance culture, and, in the initial integration timeframe, it's typical to have a calibration leading to organizational changes. We're adding top-tier talent from leading ophthalmology and retina organizations. As we approach, we followed in Cortrophin and expect our sales team to be back to full strength during the second quarter. That's the Salesforce turnover dynamic we had in our combined ophthalmology Salesforce, and then you asked about the impact on Cortrophin in ophthalmology. While on a smaller base, Q1 volume for Cortrophin in ophthalmology was 50% higher than in Q4, and we believe the momentum will continue as we have our full strength combined ophthalmology, rare disease ophthalmology Salesforce in action. We feel confident about the continued growth and the outlook for Cortrophin in ophthalmology.

Faisal Khurshid, Analyst

Hey, Nikhil. Thanks so much for taking my questions. I just want to ask, can you kind of drill in a little bit more to the details on the commercial and access challenges that impacted ILUVIEN in the first quarter? And can you just explain a little bit about how you're thinking about working around that with getting the specialty pharmacy and Part D over Part B? If you could help us understand that a little bit. Thank you.

Nikhil Lalwani, CEO

Thank you for your question and good morning, Faisal. The challenges are that there's a subset of patients on Medicare that require co-pay support to get therapy under Part B as an example. Due to a lack of funding from patient support foundations, they have not been able to provide that support. This is a dynamic that emerged in Q1. Physicians took some time, and retina practices took some time, to understand the change, whether it would persist, and how they would need to modify their approach while keeping patients first always. Their response has varied across regions, and we've spent time understanding how they're responding. It's important to clarify that this dynamic impacts ILUVIEN and the diabetic macular edema market more and is affected to a much lesser degree for non-infectious uveitis or posterior segment of the eye patients. Our team has spent time understanding the HCP responses and the granular impact on their workflows. With that understanding, we are focusing on improving access for the diabetic macular edema population. Medicare patients with pharmacy benefits can avail themselves of the affordability options where there's a cap on the co-pay Part D offers. Under that approach, we're exploring how to have retina physicians accessing ILUVIEN through a specialty pharmacy.

Faisal Khurshid, Analyst

That's helpful. And then I had one on Cortrophin Gel. So, you've done well in acute gouty arthritis, and I'm curious if there are other opportunities for you to recreate this sort of carve-out success in other indications or disease segments.

Nikhil Lalwani, CEO

Yes, absolutely. I think across, you know, it goes back to the epidemiology, across disease, across indications. The number of patients that can benefit from the therapy are significantly higher than those availing the option or being treated today. As we've shared, 40% of our prescribers on Cortrophin were naive to ACTH and had never prescribed ACTH before. We have confidence in our ability to get this treatment and this treatment option to more patients and prescribers. To your question, yes, there is an opportunity to bring more focused commercial efforts in other therapeutic areas as we have done in ophthalmology.

Vamil Divan, Analyst

Great. Thanks for taking the questions. So maybe one question was sticking to the ophthalmology side and then one on the generics. On ophthalmology, I appreciate all the color you provided. You mentioned the New Day trials completed now and SYNCHRONICITY, as you said you finished six months. Can you just share your perspectives on what you're hoping to see from those trials as we wait for the results here, and then what sort of impact could those have commercially on that business? And then on the generic side, you mentioned the Prucalopride 180-day facility. I'm just wondering if you can comment on how much of a contribution that was to the generic performance in the first quarter, so we have a sense for the second quarter as well. Thank you.

Nikhil Lalwani, CEO

Thank you for your question. Good morning, and thank you for your question, Vamil. As for NEW DAY, we are currently analyzing the data from the completed NEW DAY study. If successful, it will allow physicians to consider ILUVIEN earlier in the treatment of DME. Currently, we have less than 5,000 patients annually on ILUVIEN, whereas the addressable market, even before NEW DAY, is at about 53,000, which includes patients who have not shown an optimal response from multiple rounds of anti-VEGFs and can be considered for ILUVIEN after a positive response to a steroid trial. The opportunity, as it currently stands, is substantial. If NEW DAY is successful, HCPs could consider using ILUVIEN earlier in the treatment paradigm, which would open up a broader patient population for ILUVIEN. Regarding Prucalopride, we don't comment on product-level net revenues for the generics business. However, our estimates indicate that generalization levels are significantly higher than the IQVIA reported TRx share of 62% to 63%. We're pleased with the execution of the ANI team on this product from R&D and regulatory to win the CGT approval against numerous competitors, and to the sales and marketing team's efforts to launch this product and maximize the opportunity. We anticipate that Q2 for Prucalopride revenues will be down compared to the first quarter, as the team will need to manage trade inventory levels down in advance of the end of the 180 days of exclusivity on June 26th. Therefore, generics will be slightly lower in Q2 than in Q1, but will return to growth in subsequent quarters from a total company perspective.

David Amsellem, Analyst

Thanks. So just a couple for me. First, on Cortrophin Gel, as the category returns to growth, do you anticipate the payer landscape becoming more challenging over time compared to where it is now? Just talk about payer dynamics and what you're anticipating with the category returning to growth. That's number one. And number two is regarding ILUVIEN, I appreciate all the color on the headwinds, but I'm just wondering out loud how you're feeling about the overall acquisition of Alimera and what has surprised you most in terms of the challenges that you've faced with the asset. Thank you.

Nikhil Lalwani, CEO

Thank you for your questions and good morning, David. Regarding Cortrophin, keep in mind that this category had not seen competition for many decades. The payers and PBMs see us as an important player. They appreciate that we brought competition to this category and have collaborated and partnered with them from day one. We've continued to collaborate with them, and we see that dynamic continuing. We prioritize putting patients first and ensuring that we are delivering this much-needed therapeutic to patients in need. Regarding the acquisition of Alimera, we believe in the continued long-term opportunity for ILUVIEN and YUTIQ. We recently bought out a royalty obligation from SWK on ILUVIEN. We see large addressable markets in DME and NIU-PS, where the numbers of patients being treated currently are significantly lower than those who could benefit. Our team is strong at capturing opportunities and addressing challenges, as reflected in our past performance, including with Novitium. We faced certain challenges there and have done well to overcome them. Last quarter, we discussed supply challenges related to the CMO for YUTIQ. We have already worked through that challenge. So as an operating team, we excel at problem-solving, and our confidence in ILUVIEN is reflected in our recent actions.

Ekaterina Knyazkova, Analyst

Thank you so much and congrats again on the quarter. The first question is just on Cortrophin. Can you elaborate a bit about which indications are driving most of the growth at this point? How much of the growth is coming from neuro versus rheumatology, versus nephrology, versus some of the new areas like ophthalmology? And just any changes you're seeing from a competitive standpoint on an indication-by-indication basis. The second question is just around tariffs. Do you think there's an opportunity for you to leverage your U.S. manufacturing footprint if we do see these pharma tariffs enacted? And just how much spare capacity do you have that you could potentially leverage to capture additional market share? Thanks.

Nikhil Lalwani, CEO

Thank you, Ekaterina, for your questions, and good morning. Regarding indications, we're fortunate to see growth across all specialties. Our core specialties—nephrology, rheumatology, and neurology—are exhibiting strong growth. More than 15% of our Cortrophin usage is coming from gout, which has seen significant growth too. We have invested in expanding our field force focusing on nephrology, rheumatology, and neurology. That expansion is yielding results. In ophthalmology, while on a smaller base, we have experienced the highest growth, with almost a 50% increase in volumes versus the fourth quarter. Pulmonology is also continuing to show growth. As for competitive dynamics, competitors have raised their guidance to high single digits and spoke about four therapeutic areas they are focusing on. The number of patients that can benefit is much larger than either competitor is currently treating. Regarding tariffs, absolutely, we do have spare capacity across our plants in East Windsor, New Jersey, and Baudette, Minnesota. We are well-positioned relative to our peers. Over 90% of our revenues are coming from finished goods manufactured in the U.S., and less than 5% has a direct reliance on China. We will play our role in addressing any supply challenges that may arise from a tariff situation to provide therapeutics to those in need. Thank you for your questions, Ekaterina.

Les Sulewski, Analyst

Good morning. Thank you for taking my questions. Nikhil, perhaps I'll start on Cortrophin. You mentioned the 40% naive patient adoption. Do you have a sense of how those scripts for naive patients will have been trending over time? At what point do you expect that figure to turn? As for the pre-filled syringe, is this driven by switches or naive patients? What's the impact on the margin profile from that product? More broadly, gross margin looks favorable in Q1. How do you expect that to trend throughout 2025? I have a follow-up.

Nikhil Lalwani, CEO

Good morning, and thank you for your questions, Les. On Cortrophin, having 40% of prescribers that were naive to the category, that number keeps growing as we reach more healthcare providers. We will keep you updated on that. Regarding the pre-filled syringe, we see it as another alternative. It comes in two presentations, and it's for patients that having the reduction in the number of steps for administration will be helpful. It's too early to specify whether this is about switches or naive patients, but we see it as another option for patients. We expect limited impact on the margin profile; it's priced at a slight premium to the 1 ml vial on a per ml basis, but with a limited impact. For gross margin evolution, I'll turn it over to Steve.

Stephen Carey, CFO

Good morning, Les, and thanks, Nikhil. As we indicated on the call today, we continue to anchor our overall company gross margin between 63% and 64% throughout the year. There are numerous mixed elements as the year progresses, and we expect favorably due to rare disease becoming a bigger portion of total company revenues in the second half of the year. As the quarters progress, this will positively impact margins compared to Q1, which saw strong margins in generics driven by Prucalopride, as well as continued market share gains in the brand business, which helped margins in Q1.

Les Sulewski, Analyst

Great. That's helpful. As a follow-up on the ILUVIEN and YUTIQ, Nikhil, do you have a sensible portion of that subset as Medicare Part B? Is there a potential that cohort of patients does not come back, given that it appears unlikely the third party will come back with funding for the assistance and co-pays? Additionally, the turnover within Ophthalmology, does that have any impact on Cortrophin or is there potential for an increased opportunity for Cortrophin, given the new team that's in place now? Thank you.

Nikhil Lalwani, CEO

Thank you for your questions, Les. I'll address the turnover first. Yes, if we had the full team staff, you would have seen more growth in Cortrophin. We will experience the impact of the top talent that we bring in on both ILUVIEN and Cortrophin going forward. Regarding Medicare patients, there's a subset that require co-pay support, and with the lack of funding affecting those dynamics, we believe some level of foundation support will return in the second half of the year. If that support does not materialize, we might trend toward the lower end of our guidance for ILUVIEN and YUTIQ. Remember, ILUVIEN and YUTIQ in the U.S. represents about 70% of our total ILUVIEN and YUTIQ guidance.

Operator, Operator

Thank you. This concludes today's question-and-answer session. I will now turn the program back over to Nikhil Lalwani for any additional or closing remarks.

Nikhil Lalwani, CEO

Thank you everybody for joining our call this morning. We look forward to updating you on further progress as the year unfolds and we look forward to seeing many of you at the Jefferies Conference in New York in June. Thank you.

Operator, Operator

This does conclude today's program. Thank you for your participation. You may disconnect at any time.