ANI Pharmaceuticals - Earnings Call - Q1 2025

Executive Summary

• Record Q1 revenue of $197.1M (+43.4% YoY) and adjusted EPS of $1.70; GAAP diluted EPS was $0.69. Management raised FY25 revenue, EBITDA and adjusted EPS guidance, signaling confidence in full-year trajectory.
• Cortrophin Gel delivered $52.9M (+43.1% YoY) on record new patient starts and prescriber expansion; Generics hit $98.7M (+40.5% YoY), aided by first-to-market prucalopride exclusivity. ILUVIEN/YUTIQ posted $16.1M amid Medicare Part B co-pay foundation funding headwinds and sales force turnover.
• Gross margin mixed: GAAP 62.9% (down ~130 bps YoY), non-GAAP 63.1% (down ~130 bps YoY) on mix/royalty-bearing products; SG&A up with Alimera integration and rare disease investment.
• Catalysts: FDA label expansion for ILUVIEN to include NIU-PS, royalty obligation buyout on ILUVIEN/YUTIQ, launch of Cortrophin prefilled syringe; FY25 guidance raised across revenue/EBITDA/EPS. Near-term watch: Medicare access dynamics and prucalopride exclusivity phasing.

What Went Well and What Went Wrong

What Went Well

• Cortrophin Gel momentum: “record number of prescriptions and new patient starts” with 40% of prescribers naïve to ACTH; ophthalmology volume up ~50% QoQ.
• Generics execution: $98.7M (+40.5% YoY) driven by new launches including first-to-market prucalopride (180-day exclusivity) and strong base business.
• Strategic retina moves: FDA approved expanded ILUVIEN label to add NIU-PS; buyout of 3.125% perpetual royalty on ILUVIEN/YUTIQ enhances economics and flexibility.

What Went Wrong

• Retina headwinds: U.S. ILUVIEN/YUTIQ demand impacted by reduced co-pay foundation funding under Medicare Part B, sales force turnover and seasonality; management is shifting to specialty pharmacy/Part D pathways and expects improvement in Q2.
• Gross margin compression YoY (GAAP 62.9%, non-GAAP 63.1%) from mix with higher royalty-bearing products (including Cortrophin).
• SG&A elevated (+59.4% GAAP; +56.5% non-GAAP) on Alimera integration, expanded ophthalmology team, and increased commercial investment.

Transcript

Operator (participant)

Welcome to today's ANI Pharmaceuticals First Quarter 2025 Earnings Results Call. Please note this call is being recorded. After the speaker's opening remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press the star, then the number one on your telephone keypad. If you would like to withdraw your question, please press the star key, then number two on your telephone keypad. It is now my pleasure to turn the conference over to Lisa Wilson.

Lisa Wilson (Head of Investor Relations)

Thank you, operator. Welcome to ANI Pharmaceuticals 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; Steven Carey, Chief Financial Officer; and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease business. You can also access the webcast of this call through the 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 9th, 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. With that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani (President and 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, Purified 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 Purified Cortrophin Gel, and increased demand for our brands portfolio. The top line upside was partially offset by near-term factors impacting our retina products that I will expand on in a minute. We were pleased with the strength across our overall company.

Based on our first quarter performance and favorable demand trends across generics, Purified 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-$793 million, which represents growth of 25%-29% over 2024 versus our prior guidance of $756 million-$776 million. We expect adjusted non-GAAP EBITDA of $195 million-$205 million, which reflects growth of 25%-31% over 2024 versus our prior guidance of $190 million-$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 million, $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 Purified Cortrophin Gel, and continued demand for our brand's portfolio. Adjusted non-GAAP EBITDA was $50.7 million, and adjusted non-GAAP EPS was $1.70. Purified 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 Purified Cortrophin Gel remains on a strong multi-year growth trajectory.

Based on reported sales of Purified 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 room for headroom for expansion. It is worth noting that approximately 40% of Purified 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 Purified Cortrophin Gel revenues to increase 34%-38% to $265 million-$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, but 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, such as Good Days, did not receive sufficient funding in the first quarter of 2024, affecting their ability to assist patients with copay support. This change broadly impacted products reimbursed under Medicare Part B, and has been particularly important for ILUVIEN's indication for diabetic macular edema, or DME, as also reflected by other players with therapeutics in DME.

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 a specialty pharmacy and Medicare Part D. We have also had some turnover in our U.S. ophthalmology sales force as we took steps to optimize and elevate the quality of our team. We are adding best-in-class 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 2023 end-user demand levels. Given the recent promising trends we've seen, we are maintaining our 2024 outlook for ILUVIEN and YUTIQ revenues of $97 million-$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 an 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 previously been our highest quarter ever for generics. The robust growth was driven by contribution from new product launches, including our first-to-market launch of prucalopride tablets with 180 days of exclusivity that runs to late June, coupled with strong execution in the base business. With a 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 brand's 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, 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 carry 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 Purified 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, and in particular in ophthalmology, we saw the highest growth driven by the efforts of our expanded dedicated ophthalmology sales team. Notably, the number of new initiated cases and new patient starts for Purified Cortrophin Gel reached record levels in the first quarter, which is not typically a seasonally strong quarter for Purified 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 adds and patient starts in their sales territories.

The indication for acute gouty arthritis flares, which is unique to Purified Cortrophin Gel among ACTH therapies, remained a strong driver, contributing to growth in the prescriber base and patients on therapy. We are also beginning to see improved access from the new affordability options under the Medicare Part D redesign under the Inflation Reduction Act, or IRA. As Nikhil noted, we continue to see Purified Cortrophin Gel on a strong multi-year growth trajectory. 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. 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 Purified Cortrophin Gel franchise.

Part of these efforts include improving patient and physician convenience. In March, we announced FDA approval of our prefilled syringe and recently launched the new presentation. The prefilled 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 Purified Cortrophin Gel. Earlier this week, at the Association for Research in Vision and Ophthalmology, or ARVO, annual meeting, we presented preclinical data on the use of Purified Cortrophin Gel for uveitis. We are also excited to announce that we plan to initiate a phase four clinical trial for the treatment of acute gouty arthritis flares later this year. 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 Purified 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 Purified Cortrophin Gel and could ultimately support inclusion in the American College of Rheumatology treatment guidelines. Overall, we're pleased to see the growing recognition of Purified 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 and practice while keeping patients first always.

The impact of these market access changes has varied across regions, and how HCPs have responded to these changes has also varied. It is important to note that prescribing for NIU-PS has been impacted to a much lesser degree relative to prescribing for DME. Our team has spent time understanding HCP responses and the granular impact to their workflows. With that understanding, we are exploring alternative paths to improve access for the impacted DME population. For example, Medicare patients with a pharmacy benefit can avail 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 bespoke commercial approach customized 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 responses to these materials have been very positive. The multi-pronged commercial approach I described earlier is yielding 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. We've also made significant progress over the last few months to enhance supply security for our retina franchise. In March, we received FDA approval for an expanded label for ILUVIEN that includes an indication for the treatment of chronic NIU-PS, which is the indication for YUTIQ.

We plan to begin marketing ILUVIEN for both chronic NIU-PS and DME under the new combined label this quarter. We expect the transition to be relatively seamless for physicians who have prescribed both ILUVIEN and YUTIQ in the past. These physicians who have prescribed both products account for approximately 90% of prescriptions for ILUVIEN and YUTIQ. We are engaged in discussions with commercial payers to expand coverage of ILUVIEN for the new indication of chronic NIU-PS. We believe this process will be relatively straightforward for plans that cover YUTIQ, as we're simply transitioning patients to ILUVIEN and discontinuing YUTIQ. As a reminder, ILUVIEN is already approved for both DME and chronic NIU-PS outside the U.S., including in 17 European countries.

Moving to the New Day and Synchronicity clinical trials, we are in the process of analyzing the data from the completed New Day study and the Synchronicity study at the six-month time point. We look forward to updating you on the results of both studies in the near term. Overall, we continue to expect our rare disease business to be our largest revenue growth driver in 2025. With that, I'll turn the call over to Steve for the financial update. Steve?

Steven 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 Purified 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 and similar to prior year levels of revenue achievement. Revenues for our generics and other segment 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. Please refer to Table 3 for a reconciliation to our GAAP expenditures. 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 was 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 Purified 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 and 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. At the end of the first quarter, 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-$793 million, up from our prior guidance of $756 million-$776 million, representing year-over-year growth of approximately 25%-29%. Purified Cortrophin Gel net revenue of $265 million-$274 million, representing growth of 34%-38%, and in line with our prior estimate. We continue to expect quarterly sequential growth of Purified Cortrophin Gel revenues throughout the year. Combined ILUVIEN and YUTIQ net revenue of $97 million-$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-$205 million, up from our prior guidance of $190 million-$200 million, representing growth of approximately 25%-31%. From a quarterly perspective, we anticipate second quarter adjusted EBITDA to be lower as compared to the first quarter, followed by a return to sequential growth in the third and fourth quarters. Adjusted non-GAAP earnings per share 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%, and consistent with prior quarters, we will tax-effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26%. We 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. As a reminder, on March 4th, 2024, ANI commenced a civil action against CG Oncology in the Superior Court of the State of Delaware.

ANI's complaint alleges that under an assignment and technology transfer agreement dated as of November 15th, 2010, CG Oncology is liable to pay ANI a running royalty on 5% of the worldwide net sales of their lead product candidate, CREDIS Imaging, and that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to ANI. The jury trial is set to commence on July 21st, 2025, and ANI intends to pursue this matter vigorously. With that, I'll turn the call back to Nikhil.

Nikhil Lalwani (President and 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, improving lives. With that, Operator, I turn it over to you for questions.

Operator (participant)

At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. We'll take our first question from Gary Nachman with Raymond James. Please go ahead.

Gary Nachman (Managing Director)

Thanks, and congrats on the strong quarter. First on Cortrophin, how much should the prefilled syringe help you? Do you think it could open up use a lot more because of the convenience? What sort of benefit are you seeing from the additional 20 reps across the indications? Are you considering adding some more for any indications? Mallinckrodt announced a good quarter for Acthar. It seems like there's good market growth. What else can you do to try and differentiate Cortrophin? I thought the phase four study for acute gouty flares is really interesting. Are there other studies that you're considering to potentially do with either the existing indications or maybe some others down the road? I have a follow-up.

Nikhil Lalwani (President and CEO)

Good morning, and thank you, Gary, for your question. First on the prefilled syringe, as Chris mentioned in the prepared remarks, the early response from HCPs is positive as this reduces one step in the administration process for Purified Cortrophin Gel, and we look forward to updating you on the progress. We have just launched the product in the market. While we got the approval or announced the approval in March, we just launched the product a couple of weeks ago. Look forward to updating you on the progress. Your next question was on the 20 reps and how that's going. They are doing well. They have started getting traction with getting both new patient starts and new prescribers and enrollments, and we'll continue to build momentum as the year progresses. We keep evaluating higher ROI efforts from the commercial side.

With regards to adding more, there's no intent to do that this year at this time. We will keep, again, keep evaluating high ROI commercial initiatives to keep growing Cortrophin, which we believe is on a strong multi-year growth franchise as we've talked about several times. You're right that the third point was on the competitor. You're right, 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 at high single digits, if you take that at 7.5%, the combined market will grow at about 16%. We think that that's great for patients and for prescribers because the number of patients on therapy today are 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 six to eight times higher than the number of patients that were even being treated at its peak. It is 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 have launched the prefilled syringe to increase convenience, enhance convenience for patients and prescribers. We continue to evaluate additional steps that we can take to enhance the convenience for patients and for physicians, and we look forward to updating you on that progress. Chris detailed some of the efforts on the evidence generation area, right, and the gout clinical study that we are initiating later this year.

Those are, as well as the data that we presented at ARVO on uveitis, I think that those are indications of the multiple different steps across commercial, evidence generation, and bringing new presentations to the market that we're investing in to continue strengthening and growing the Purified Cortrophin Gel franchise that we believe is on a strong multi-year growth trajectory.

Gary Nachman (Managing Director)

Okay, great. And then just regarding ILUVIEN and YUTIQ, just given some of the challenges in the first quarter, just 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 for those to really take hold over the course of the year? Also, talk about the turnover in the OPTO sales team. It actually didn't seem to impact Cortrophin in that segment, which you said was really strong in OPTO, and I'm curious why that wasn't the case. Going forward, your outlook for OPTO. Thanks.

Nikhil Lalwani (President and CEO)

Right. Thank you again for your question, Gary. So first, ILUVIEN and YUTIQ guidance for this year is $97 million-$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. Just to dimensionalize that, and that's with the different topics, the factors we spoke about. When it comes to the guidance, our confidence in reiterating the guidance for ILUVIEN and YUTIQ at $97 million-$103 million is based on five factors. First, the performance outside the U.S., which is roughly 30%, is largely on track across the markets with direct, the four markets with direct commercial operation and the 17 markets where we work with partners. Next, the factors driving our confidence related to U.S. performance for the rest of the year.

First quarter results were low due to seasonality seen for most branded drugs. The remaining three quarters will not have this. In fact, it'll reverse in the fourth quarter. That's one. 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 bespoke commercial approach by region that we deployed, given the Medicare dynamics. Last, we expect to see positive impact from a combination of our efforts exploring alternatives for Medicare patients to the Part D pathway and restart in the back half of the year of some level of foundation support for Medicare patients.

I think you also asked more about turnover. Look, we believe we have a high-performance culture, and in the initial integration timeframe, it is typical to have a cross-calibration leading to organizational changes. We are adding best-in-class talent from top ophthalmology and retinal organizations as the approach we followed in Cortrophin. We expect our sales team to be back to full strength during the second quarter. That is the sales force turnover dynamic that we had in our combined ophthalmology sales force. You asked about impact on PCG and ophthalmology. While on a smaller base, Q1 volume for PCG for Cortrophin in ophthalmology was 50% higher than in Q4, and we believe that the momentum will continue, right, as we have our full strength combined ophthalmology, rare disease ophthalmology, sales force in action.

We feel confident about the continued growth and the outlook for Purified Cortrophin Gel in ophthalmology.

Gary Nachman (Managing Director)

All right, great. Thanks for all that color, Nikhil. Appreciate it.

Nikhil Lalwani (President and CEO)

Thank you, Gary.

Operator (participant)

We'll go next to Faisal Khurshid with Leerink Partners.

Faisal Khurshid (Equity Research Analyst)

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

Nikhil Lalwani (President and CEO)

Sure. Thank you for your question, and good morning, Faisal. The challenge is that there's a subset of patients that are on Medicare that require copay support to get therapy under Part B, as in boy. Due to lack of funding, they get the support from foundations. Due to lack of funding, these foundations have not been able to provide copay support, right? This is a dynamic that emerged in Q1. ACPs, 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 and practice while keeping patients first always. Their response has varied across regions, and we've spent the time to understand how they're responding.

One other thing to clarify is that this dynamic impacts ILUVIEN and the DME market more and therapeutics in the DME market more and as has been laid out by other therapeutics in the DME market, and to a much lesser degree, NIU-PS or non-infectious uveitis in the posterior segment of the eye patients. Our team has spent the time understanding the ACP responses and granular impact to their workflows. With that understanding, we're exploring alternate paths to improve the access for the DME population. For example, the Medicare patients with pharmacy benefit, they can avail of the affordability options where there's a cap on the copay and smoothing offer that the Part D offers. Under that approach, we're exploring how to have retina physicians accessing ILUVIEN through a specialty pharmacy. Does that give sufficient color, Faisal?

Faisal Khurshid (Equity Research Analyst)

Yeah, that's helpful. I had one on Purified Cortrophin Gel. You've done well in this acute gouty arthritis niche and cool to see kind of exploring some additional evidence generation there. Are there other opportunities for you to kind of recreate this sort of carve-out success in other indications or disease segments?

Nikhil Lalwani (President and CEO)

Yes, absolutely. I think across it goes back to the epidemiology. Across disease, across indications, the number of patients that can benefit from the therapy are significantly higher than what are availing of this option or being treated today. As we have 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. Going back to your question, yes, there is an opportunity to bring more focused commercial efforts in other therapeutic areas as we have done in ophthalmology.

Faisal Khurshid (Equity Research Analyst)

Got it. Thank you for taking the questions.

Nikhil Lalwani (President and CEO)

Thank you, Faisal.

Operator (participant)

We'll go next to Vamil Divan with Guggenheim Securities.

Vamil Divan (Senior Research Analyst)

Great. Thanks for taking the questions. And congrats on the quarter. Maybe one question sticking to the ophthalmology side and then one on the generics. On ophthalmology, I appreciate all the colors you've provided. You did mention the New Day trials completed now in synchronicity as you said you finished six months. Maybe can you just share your perspectives on sort of 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? On the generic side, you mentioned the Prucalopride 180-day exclusivity. I'm just wondering if you can comment on how much of contribution that was to the generics performance in the first quarter so we have a sense for the second quarter as well. Thank you.

Nikhil Lalwani (President and CEO)

Got it. Thank you for your question. Good morning, and thank you for your question, Vamil. On New Day, we are in the process of analyzing the data from the completed New Day study. If successful, it will allow physicians to consider ILUVIEN earlier in the treatment of DME. As we have described before, epidemiologically, today we have fewer than 5,000 patients annually on ILUVIEN, whereas the addressable market even before New Day is at 53,000, which is patients for whom multiple rounds of anti-VEGFs are not showing optimal response. They show positive response to steroid trial and can be considered for, they are then being considered for ILUVIEN. That is the addressable market of 53,000 versus the 5,000 patients that are currently annually being treated on ILUVIEN. The opportunity as it currently stands, even before New Day, is pretty substantial.

What New Day will do is that much earlier in the treatment paradigm, right? Instead of 53,000, there are 400,000 additional patients that are being treated with multiple rounds of anti-VEGF. If New Day is successful, HCPs could consider using ILUVIEN earlier in the treatment paradigm. It would open up a broader patient population for ANI, sorry, for ILUVIEN. Next, your question on prucalopride, look, we do not comment on product-level net revenues for the generics business. What we can say is that our estimates show genericization levels significantly higher than the IQVIA reported TRX share of 62-63%. We are pleased with the execution of the ANI team on this product from R&D and regulatory to win the CGT approval against numerous competitors to the sales and marketing team's ability to launch this product and maximize the opportunity.

We anticipate that Q2 prucalopride revenues will be down as compared to the first quarter as the team will need to manage trade inventory levels down in advance of the end of 180 days of exclusivity on June 26th. Generics will be in Q2 will be slightly lower, as Steve pointed out, on the phasing perspective. It will be lower than the first quarter and then return to growth in the subsequent quarters from a total company perspective.

Vamil Divan (Senior Research Analyst)

Okay. All right. Thank you.

Nikhil Lalwani (President and CEO)

Thank you, Vamil Divan.

Operator (participant)

We'll go next to David Amsellem with Piper Sandler.

David Amsellem (Senior Research Analyst)

Thanks. Just a couple for me. First, on Purified 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 is number one. Number two is regarding ILUVIEN. I appreciate all the color on the headwinds, but I am just wondering out loud, how are you feeling about the underlying acquisition of Alimera? What has surprised you most in terms of the challenges that you faced with the asset? Thank you.

Nikhil Lalwani (President and CEO)

Thank you for your questions, and good morning, David. On Cortrophin payer landscape, remember this category had not seen competition for many, many decades. The payers and PBMs, they definitely see us as the, they appreciate the fact that we brought competition to this category, and we went to go and collaborate and partner with them from day one. They appreciate that. As the category has evolved and as we've grown, we've continued to collaborate with them and see that continuing. I mean, at the end of the day, we all put the patients first and ensure that we're bringing this therapeutic, this much-needed therapeutic to patients in need. That is on the payer landscape dynamics. Then on where do we, where is our head on the overall acquisition of ILUVIEN?

I think the simplest answer to that is we just bought out a royalty obligation from SWK on ILUVIEN. And so we believe in the continued long-term opportunity for ILUVIEN and YUTIQ. So actually both in DME as well as in NIU-PS, where the addressable markets are substantially higher. In DME, 5,000 out of 53,000. In NIU-PS, less than 5,000 out of 78,000-112,000. So large addressable markets. We're fully confident of our ability to solve problems. Even when we acquired Alimera, we had to work through certain challenges. And so you can see the value that the Alimera acquisition has brought to us. So this is a team that thrives on capturing opportunities and addressing challenges and has a very strong orientation towards problem-solving. Last quarter, when we were speaking, we were talking about the supply challenges related to the CMO for YUTIQ.

We have worked through that challenge, right? Where later this quarter, we are going to start selling the combined label. I think as an operating team, we have a strong orientation towards problem-solving. As I said at the beginning, our belief in ILUVIEN is best highlighted by our recent, I think weeks ago, buyout of the royalty obligation from SWK. Thank you for that question.

Operator (participant)

We'll go next to Ekaterina Knyazkova with JPMorgan.

Ekaterina Knyazkova (Equity Research Associate)

Thank you so much, and congrats again on the quarter. First question is just on Purified Cortrophin Gel. 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? Just any changes you're seeing from a competitive standpoint on an indication-by-indication basis. 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? How much spare capacity do you have that you could potentially leverage to capture additional market share? Thanks.

Nikhil Lalwani (President and CEO)

Thank you, Ekaterina, for your questions. Good morning. On the first question on the indications, we're fortunate. We see growth across all specialties. Our core specialties, the ones that we launched with, nephrology, rheumatology, and neurology, we see strong growth across those indications. We talked about the more than 15% of our usage, of our Cortrophin usage, is coming from gout. We see growth, significant growth there too. Obviously, we invested in the expansion of our field force that focuses on nephrology, rheumatology, and neurology. They do that together as a portfolio sales team. That team, that expansion is yielding results. Ophthalmology, while on a smaller base, showed the highest growth with almost 50% increase in volumes versus the fourth quarter. Pulmonology also continues to show growth. We have opportunities, growth across indications.

In terms of competitive dynamics, they've raised their guidance to high single digits, and they spoke about four therapeutic areas that they're focusing their efforts on. The category, the number of patients that can benefit is just much, much larger than what either competitor is treating at this time. I think both competitors can continue getting the ACTH therapeutics to more patients and continue to grow the market. Your second question on tariffs and do we have spare capacity? Absolutely. We do have spare capacity across our plants in East Windsor, New Jersey, as well as in Bayport, Minnesota. We are positively and relative to our peers well-positioned with over 90% of our revenues coming from finished goods manufactured in the U.S. and less than 5% direct reliance on China.

We will play our role, as we have done in the past, of if there are supply challenges that arise out of the tariff situation to provide therapeutics to patients in need. Thank you for your question, Ekaterina.

Ekaterina Knyazkova (Equity Research Associate)

Thank you.

Operator (participant)

As a reminder, ladies and gentlemen, if you'd like to ask a question, you may do so by pressing star one. We'll go next to Les Sulewski with Truist Securities. Please go ahead.

Les Sulewski (VP of Biotech Equity Research)

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 how those scripts for naive patients will have been trending over time? I guess at what point do you expect that figure to turn? As for the prefilled syringe, is this driven by switches or naive patients? What's the impact to margin profile from that product? More broadly, gross margin looked favorable in Q1. How do you expect that to trend throughout 2025? I have a follow-up.

Nikhil Lalwani (President and CEO)

Yeah. Good morning, and thank you for your questions, Les. So Purified Cortrophin Gel having 40% of prescribers that were naive to the category, that number keeps growing as we reach with a larger addressable market and reaching more ACTH. We'll keep you updated on the progress on that. On the prefilled syringe, we see the prefilled syringe as another alternative, right? As we had the 5 ml vial and the 1 ml vial. We're introducing the prefilled syringe, which comes in two presentations, 1 ml and 0.5 ml. It's really for patients that have a, that the reduction in the number of steps of administration will be helpful to them. It's for a subset of patients. It's early days in the launch of the prefilled syringe, so we'll update you regarding your question on switches and as a new patient or switches.

We see this as another option for patients by reducing one step, for enhancing patient convenience by reducing one step in the administration, in the steps for administration. In the near term, we see limited impact on the margin profile. It is priced at a slight premium to the 1 ml on a per ml basis, but limited impact. On gross margin evolution through the year, I will turn it over to Steve to take that question.

Steven Carey (CFO)

Yeah. Good morning, Les. And thanks, Nikhil. Yeah. As we cited on the call today, Les, we continue to anchor in overall company gross margin between 63%-64% throughout the course of the year. Obviously, there's numerous mixed elements as the year progresses. We expect, right, as rare disease becomes a bigger portion of the overall part of the total company revenues in the second half of the year. As the quarters progress, that'll be a favorable margin input as compared to in the first quarter, strong margins in generics driven by prucalopride, as well as the persistence of market share gains in the brand business, which helped margins in the first quarter.

Les Sulewski (VP of Biotech Equity Research)

Great. That's helpful. As a follow-up on the ILUVIEN, YUTIQ, Nikhil, do you have a sense of what portion of that subset is Medicare Part B? Is there a potential that cohort, I guess, of patients does not come back, given that it appears unlikely the third party will come back with funding, the assistance, and co-pays? I guess a second portion, the sales force turnover within ophthalmology, does that have any impact on Cortrophin? Or perhaps asked in another way, is there a potential for an increased opportunity for Cortrophin given the new team that's in place now? Thank you.

Nikhil Lalwani (President and CEO)

Yeah. Thank you for your questions, Les. I'll take your second question first, which is on the turnover. Yes, I think you framed it appropriately that if we had the full team staffed, you would have seen more growth in Cortrophin. Yes, we will see the impact of the top talent that we bring in on both ILUVIEN and Cortrophin going forward. That's the answer on the turnover and the positive impact on Cortrophin. Your question on Medicare, there's a subset of Medicare patients, right, that do not have co-pay support through various mechanisms that are available. That's the population that's impacted by the funding not being available.

Look, from our perspective, from everything that we've heard from major contributors to the relevant foundations in the public domain and the discussions with several stakeholders in Retina, we believe that some level of foundation support will return in the second half of the year. If the foundation support does not come back, we're likely to trend towards the lower end of our guidance range as far as ILUVIEN and YUTIQ is concerned. Remember, ILUVIEN and YUTIQ in the U.S. is about 70% of our total ILUVIEN and YUTIQ guidance, right? From a total company basis, again, just a reminder, it's less than 10% of total company 2025 revenues. Our guidance for total company and the raised guidance factors in the puts and takes across different business lines.

We have high confidence in the overall total company revenues and total company adjusted non-GAAP EBITDA and adjusted non-GAAP EPS guidance that we have given, and we continue to retain that confidence.

Les Sulewski (VP of Biotech Equity Research)

Thank you.

Nikhil Lalwani (President and CEO)

Thanks, Les.

Operator (participant)

Thank you. This does conclude 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 (President and CEO)

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

Operator (participant)

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