ANI Pharmaceuticals, Inc.

Good morning, everyone. Welcome to today's A&I Pharmaceuticals fourth quarter 2024 earnings results call. Please note this call is being recorded. After the speaker's opening remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star one on your telephone. If you would like to withdraw your question, please press star two. Now at this time, it's my pleasure to turn the call over to Ms. Lisa Wilson, Investor Relations of A&I Pharmaceuticals. Please go ahead, ma'am.

Thank you. Welcome to ANI Pharmaceuticals Q4 2024 Earnings Results Call. This is Lisa Wilson of Insight Communications, Investor Relations for ANI. With me on today's call are Nikhil Lawani, 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 anifarmaceuticals.com. Before we get started, I would like to remind everyone that any statement made on today's conference call that expresses a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to anti-pharmaceuticals management as of today and involve risks and uncertainties included in those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website at anifarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 28, 2025. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani Thank you, Lisa. Good morning, everyone, and thank you for joining us. Today, I'll start by discussing our full year and fourth quarter performance and highlights and our 2025 guidance. First, we'll provide additional color on our rare disease business, including our lead asset, cortofan gel, and alluvian and utique, which we recently added to the acquisition of Alameda. Finally, we will review our fourth quarter results and 2025 guidance in more detail. Following our remarks, we'll take your questions. We're pleased to report record fourth quarter and full year 2024 results and are raising our 2025 guidance for total revenues and adjusted non-GAAP EBITDA. The upward revision of our guidance is based on further confidence in higher demand for cortofan gel, a strong start for generics with the launch of ProcaloPride with 180-day exclusivity, and increased demand in the first quarter, as we have seen in the past, for our established brands portfolio. which is now referred to as brand under our new segment reporting structure. We now expect 2025 revenue of $756 million to $776 million, which represents growth of 23 percent to 26 percent over 2024, versus our prior guidance of $739 million to $759 million. We expect adjusted non-GAAP EBITDA of $190 million to $200 million, which reflects growth of 22% to 28% over 2024, versus our prior guidance of $182 million to $192 million. Steve will provide more specifics on our financial guidance. 2024 was another year of strong execution for ANI, capped by a record fourth quarter with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS all coming in above our previously announced guidance for the full year. Rare disease was our primary driver of growth in 2024 with our lead rare disease asset, cortofan gel, generating close to $200 million of sales in just the third year since launch. And our genetics business delivered 12% revenue growth driven by operational excellence and new product launches, making 2024 the third straight year of achieving double-digit top-line growth for this business. In addition, we expanded our rare disease franchise in 2024 with the acquisition of Almera Sciences in September, in keeping with our longer-term strategy to broaden our presence in the rare disease space. We also successfully executed the refinancing of our prior debt and put in place a more efficient and effective capital structure. Turning now to our fourth quarter results, our financial performance in the fourth quarter was the strongest in our history. Total revenues were $190.6 million, representing a year-over-year increase of 45 percent on an as-reported basis and 24 percent on an organic basis. driven by accelerating demand for cortofan gel, continued strong growth for generics, a full quarter contribution from Illuvian and Utique, and higher demand for brands. Adjusted non-GAAP EBITDA was $50 million, and adjusted non-GAAP EPS was $1.63. Cortofan gel generated $59.4 million in revenues during the quarter, up 42% over the fourth quarter of 2023. The quarter reflected continued momentum with the highest number of both quarterly new patient starts and new cases initiated since we launched the product in January 2022. We saw increased demand across all targeted specialties, neurology, rheumatology, nephrology, pulmonology, and ophthalmology. Portrophine gel remains on a strong multi-year growth trajectory. The overall ACTH category returned to growth in 2024, while the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of headroom for expansion. We expect the strong momentum to continue in 2025 And our new guidance forecasts cortofan gel revenues to grow between 34% and 38% to $265 million to $274 million in 2025. Chris will talk more about our initiatives to increase awareness of the benefits of ACTH therapy for appropriate patients and further drive demand for cortofan gels. Our new ophthalmology products, Illuvian and Utique, generated revenues of $27.6 million in the fourth quarter, our first full quarter of ownership following the acquisition of Almera. Our expanded ophthalmology team also drove significant growth in new patient starts for cortofan gel in ophthalmology, which doubled in Q4 versus Q3. A core strategic rationale for acquiring Almera was to add assets that are synergistic with cortofan gel and leverage our rare disease infrastructure and proven commercial execution capabilities in order to unlock the potential of eluvian and utique, as well as accelerate the growth of cortofan gel in ophthalmology. We believe there is significant room for both Illuvian and Utique, given the novel, long-acting nature of the products and size of the addressable markets. We have taken steps and are continuing to execute on initiatives that will enable us to capture these growth initiatives. Let me lay these out for you. We expanded the U.S. ophthalmology sales team of approximately 30 representatives that we acquired from Almera to 46 sales reps who began promoting Illuvian, Utique, and Cortofengel in mid-October of 2024. We are continuing to invest to drive growth in international markets, both direct markets such as Germany and partner markets such as France and Spain. Clinically, We continue to invest behind the New Day clinical trial for Alluvian and Synchronicity clinical trial for UTiQ. For New Day, if the clinical trial results are positive, it could significantly expand the use of Alluvian earlier in the DME patient journey in combination with anti-VEGF therapies. We expect preliminary top-line data from both trials in the second quarter of 2025. Operationally, we have taken steps to increase supply security for both Illuvion and Utique. For Illuvion, we extended our partnership with our contract manufacturer, Siegfried, for five years until 2029. Siegfried has been a reliable partner for Illuvion for over 10 years. As a part of this extension, we agreed to partner with Siegfried to upgrade equipment on the existing manufacturing line in Irvine, California, and significantly expand capacity through the addition of a second manufacturing line. Both the equipment upgrade and capacity expansion initiatives are on track. We have also been executing a strategy to transition the manufacturing of Utique to Siegfried in 2025. We submitted a prior approval supplement, or PAS, to the FDA to add Utique's indication of chronic noninfectious uveitis affecting the posterior segment of the eye, or NIU-PS, to the Illuvian label. Note, both Illuvian and Utique are substantially similar ophthalmic implants with the same active ingredient, flucinolone acetonide, and almost identical strengths with Illuvian having 0.19 milligrams of flucinolone and UTIC having 0.18 milligrams of flucinolone. In fact, the clinical trials for both NIUPS and DME were run on implants with 0.18 milligrams of flucinolone acetonide. The newer manufacturing process used exclusively for Illuvian resulted in a strength of 0.19 milligrams per implant. We engaged with the FDA prior to the PA submission in order to understand the regulatory requirements and submitted an application aligned with FDA's guidance. Since submission, we have been engaged with the agency during the review period and expect action on the PAF in the second quarter. Following approval, we plan to transition commercialization efforts for both the DME and chronic NIU-PAF indications to a single product. Illuvian. As a reminder, Illuvian is already approved and marketed for both DME and NIUPS outside the U.S., including in seven European countries and the Middle East. Operationally, the above initiatives will significantly enhance supply security for both Illuvian and UT, positioning the franchise for a strong multi-year growth trajectory. In conjunction with these initiatives, ANI and I-Point have agreed to non-renewal of the current supply agreement for UTIC with an effective date of May 31st, 2025. Moving now to our 2025 guidance for Elluvian and UTIC. Our Q4 net sales for Elluvian and UTIC was $27.6 million. Typical Q4-Q1 impact driven by insurance resets and purchasing patterns for products such as Illuvian and UT causes Q1 to be lower than Q4 by levels that are similar to other products. In addition, Q1-2025 for Illuvian and UT will have the added impact of the change in U.S. market access dynamics since early January that has reduced access for Medicare patients. which is particularly important for Illuvian's DME indication. We are working with HCPs to understand their response to the market access changes and defining our commercial approach accordingly. Stepping back to the overall picture, There are currently fewer than 5,000 patients on therapy for each of Eluvian and UT, and we estimate that the addressable patient population for each drug is approximately 6 to 10 times higher based on epidemiological data. So while there are near-term topics to work through, we remain confident of the growth prospects for our products in both DME and NIUPS. As we strengthen the foundation of our ophthalmology business through these transitions and market dynamics in 2025, we expect to deliver $97 million to $103 million in sales for Illuvian and Nutique, and we remain enthusiastic about the product's long-term runway for growth. Chris will further detail our commercial and clinical initiatives that we expect will drive significant quarter-on-quarter growth through 2025 and beyond. Turning now to our generics business, we delivered another solid quarter with revenues of $78.6 million, an increase of 9% over the fourth quarter of 2023. The performance reflected strength in our base business, coupled with contribution from new product launches. We continue to leverage our U.S.-based manufacturing footprint to deliver over 1 billion doses to patients in the U.S., Our R&D team was highly productive in 2024, submitting multiple new ANDAs and securing 17 new product approvals, including two with competitive generic therapy or CGT designation. We are proud that we retained the number two ranking in CGT approvals in 2024. One of these approvals was Procaliprite tablets, which we launched in late December, early January into $168 million branded market with 180 days of exclusivity. Our ability to be first to market with this important generic product is a testament to the quality of our R&D team. We expect another year of low double-digit growth for our genetics business in 2025, supported by our high-performing R&D engine, operational excellence, and US-based manufacturing footprint. Our brands portfolio, which we previously referred to as established brands, continues to address patient needs with reliability of supply, a unique set of commercial capabilities, and opportunistic business development to expand the portfolio. Our overall portfolio of businesses is strengthened by this high gross margin, low working capital, and strong cash flow generation business. During the fourth quarter of 2024 and into the first quarter of 2025, we experienced an increase in demand for some of our brands portfolio as we have periodically seen in the past. Our new 2025 guidance reflects this increased demand in the first quarter, followed by a return to a more normalized run rate in the second quarter. As I reflect on our year of accomplishments and look forward to 2025, I would like to thank our customers suppliers, partners, investors, and the entire ENI team for their collaboration and significant contribution in delivering on our company's purpose of serving patients, improving lives. And now turn the call over to Chris Mutt, our head of rare disease.

Chris. Thank you, Nikhil. And good morning, everyone. Our rare disease team drove strong demand for cortofan gel in the fourth quarter. We were pleased to see demand growth across all targeted specialties, neurology, rheumatology, nephrology, pulmonology, and ophthalmology. Prescribing momentum continued across both existing and new prescribers, and the number of initiated cases and new patient starts reached record levels in the quarter. We saw particularly strong growth from our newer therapeutic areas. In ophthalmology, the number of new patient starts roughly doubled from the third quarter as our new, larger ophthalmology sales team expanded our promotional activities to a broader group of physicians. Prescribing for acute gouty arthritis flares, for which cortofan gel is the only approved ACTH therapy, also continues to ramp and now represents approximately 15% of cortofan gel use. Notably, gout is serving as a gateway indication for many physicians that are new to ACTH therapy. For approximately 15% of healthcare professionals prescribing cortofan gel for the first time, a gout patient is their first patient on therapy. We expect the gout indication to remain a key growth driver for cortofan gel in 2025. As Nikhil mentioned, we believe cortofan gel is on a strong multi-year growth trajectory. The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024 based on the reported sales for Cortofrin Gel and the guidance given for the other ACTH product by our competitor. We believe the growing recognition of Cortofrin Gel as a safe and effective treatment option for appropriate patients is reflected by the recent growth dynamics for the overall ACTH category. While the market is growing, ACTH prescribing is still well below historical levels. Based on our analysis of claims data, we believe the number of patients on ACTH therapy now is approximately half the level of patients on therapy when the category previously peaked in 2017. Treatment of flares and exacerbations continues to be a significant unmet need for autoimmune disorders and inflammatory diseases. We believe the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago. Our belief is anchored in the prevalence of and need for alternative treatment options for the autoimmune disorders that cortofrin is indicated for. It's worth noting that approximately 40% of cortofrin gel prescribers are new to the ACTH category, which illustrates the need for our therapy in certain patients and our ability to expand the market. Our messaging has resonated with physicians who see patients with severe autoimmune disorders who need alternative therapies for continued flares and exacerbations. We've also taken important steps to strengthen and grow the Cortofrin Gel franchise over the last several quarters. We launched dedicated sales teams in pulmonology and ophthalmology, and with the Almera acquisition, we now have a much larger ophthalmology sales team that is already driving greater prescribing in this important therapeutic area. We've also seen continued strong growth in our initially targeted therapeutic areas of rheumatology, neurology, and nephrology. Given our view on the unmet need in these areas and the utility of ACTH therapy, we recently increased the size of our sales team to help expand our promotional efforts to additional physicians. The larger sales team has already contributed to growing the number of cortofan gel prescribers in the first quarter, and the number of new cases initiated reached a new monthly all-time high in February, despite the quarter tending to be seasonally low for cortofan gel and other rare disease therapies due to insurance resets and market dynamics. We're also investing in initiatives to improve patient and physician convenience. We have a pre-filled syringe under FDA review that we expect to launch in the second quarter of 2025. The pre-filled syringe will provide benefits to patients and physicians by reducing the steps needed for self-administration. We're excited about the potential of this new presentation and look forward to making the cortofan gel pre-filled syringe available in the second quarter as we continue to advance our rare disease portfolio. We're also exploring other ideas to enhance convenience for patients starting on cortofan gel and the healthcare providers who treat them. And we look forward to sharing more details on these initiatives in the future. Overall, we believe in and are committed to investing in the cortofan gel franchise and continuing to deliver strong multi-year growth for the product. Turning now to our new ophthalmology products, Illuvian and Utique. As a reminder, Iluvian and Utique are both novel, long-acting, intervitreal implants. In the U.S., Iluvian is used to treat diabetic macular edema, or DME, the leading cause of vision loss in diabetic patients. And Utique is used to treat chronic, non-infectious uveitis affecting the posterior segment of the eye, or NIU-PS. Iluvian and Utique are the only long-term, durable therapies available that can reduce disease recurrence through extended disease control for up to three years. We believe there is significant room for growth for both products. As we move through 2025, we expect to increasingly deploy the same commercial acumen with the Luvian and Utique that has driven our success with Cortofan Jail. In sales, we have fully transitioned into the new larger footprint of 46 territories and key customer handoffs are now complete. We also are beginning to see meaningful increase in call activity, which we expect to drive performance in both the Luvian and Utique throughout the remainder of 2025. In marketing, we are making significant investments in increasing peer-to-peer education, as well as conference and Congress engagements, further amplifying awareness of ANI's commitment to the ophthalmology space. Additionally, in the coming weeks, we are launching new and enhanced marketing materials informed by a significant investment in market research to help physicians better identify appropriate patients for our long-acting implants. We've continued to make progress on the clinical trials New Day and Synchronicity. New Day is investigating the use of alluvian in combination with the current standard of care, anti-digest, for the treatment of DME. New Day is fully enrolled with 306 patients in approximately 42 sites. The last patient last visit occurred in early January, and we expect top-line results in the second quarter of this year. Synchronicity is designed to provide retina and uveitis specialists with a broader sense of the utility of UT across a variety of patients with chronic NIUPS. The clinical trials enrolled 110 patients in approximately 25 sites around the U.S. We expect preliminary top-line results also in the second quarter of this year. Looking across our overall rare disease business, we are pleased with the continued strong performance of cortofan gel. Furthermore, we remain excited about the long-term growth runway for Luvian and Utique, and we are laser-focused on optimizing our commercial strategy and increasing supply security for these products. Our new ophthalmology sales team has been promoting all three products since mid-October, and we expect the team to draw greater awareness of the products and the patients that can benefit from treatment. For 2025, we expect our rare disease business, which includes cortofan gel, eluvian, and utique, to be ANI's largest growth driver. With that, I'll turn the call over to Steve for the financial update. Steve?

Thanks, Chris, and good morning to everyone on the call. I'll review our fourth quarter results. and then discuss our 2025 guidance in detail. A&I generated fourth quarter revenues of $190.6 million, up 45% over the prior year period. Beginning with this reporting period, we have redefined our reporting segment. We continue to have two segments. However, they are now defined as rare disease and brands, and generics and other. This change reflects how we analyzed the business post the Alamara acquisition. The new segment presentation can be found in our earnings release, MD&A in our Form 10-K, and the footnotes to our financial statements filed this morning. Prior period disclosures have been recast to be consistent with the go-forward presentation. Revenues from rare disease and brands were $106.9 million in the fourth quarter, up 97% from the prior year period, as reported, and 24% on an organic basis, driven by gains in both rare disease and brands. Rare disease revenues more than doubled to $87 million. Revenues from Cortofengel were $59.4 million, up 42% from the prior year period, driven primarily by increased volume on a record number of new patient starts. Revenues from our new ophthalmology products, Oluvian and Utique, were $27.6 million. As a reminder, we completed the acquisition of the Almera on September 16th, and therefore the fourth quarter represents our first full quarter of owning these assets. Revenue for brands were $19.8 million in the quarter, an increase of 59% over the prior year period. The quarter benefited from higher demand related to changes in market dynamics for certain products, similar to what this portfolio has experienced in the past. Revenues for our generics and other segments were $83.7 million, an increase of 8% over the prior year period, driven by increased volumes on contributions from new product launches in 2024 and the full-year impact of products launched in 2023. Now to move down the P&L. As a reminder, when I speak to our operating expenses for the purposes of this earnings call, I will be referring to our non-GAAP expenses, which are detailed on Table 3 of our product release. Generally, our non-GAAP operating expenses exclude depreciation and amortization, stock-based compensation, and certain costs related to litigation and M&A activity. please refer to Table 3 for a reconciliation to our GAAP expenditures. Non-GAAP cost of sales, excluding depreciation and amortization, increased 31% compared to the prior year period to $69.5 million in the fourth quarter of 2024, primarily due to net growth in sales volumes of pharmaceutical products significant growth of royalty-bearing products, and a full quarter of alluvian and utique sales. Non-GAAP gross margin was 63.5%, an increase of approximately 3.9 percentage points from the prior year period, primarily driven by favorable product mix due to higher revenues from cortofan gel and brands, and a full quarter of alluvian and utique sales. Non-GAAP research and development expenses increased 68% to $16.2 million in the fourth quarter due to the inclusion of costs related to the New Day and synchronicity clinical trials, development of the cortofan gel pre-filled syringe, and ongoing investments in generic R&D programs. Non-GAAP selling, general, and administrative expenses increased 42% to $54.8 million in the fourth quarter, driven by a full quarter of spend for our new, larger ophthalmology sales force, promoting Cortofengel, Alluvian, and Utique, continued investment in rare disease sales and marketing activities, increased employment-related costs, including incentive-based compensation tied to our record financial performance in 2024, and an overall increase in activities required to support the ongoing growth of our business. Adjusted non-GAAP diluted earnings per share was $1.63 for the quarter compared to $1 per share in the prior year period. adjusted non-GAAP EBITDA for the fourth quarter was $50 million compared to $30.2 million in the prior year period. We ended the quarter with $494.3 million of debt debt comprised of $144.9 million in non-restricted cash and $639.2 million in principal value of outstanding debt, inclusive of our senior convertible notes and our term loan. Utilizing the midpoint of our revised 2025 adjusted non-GAAP EBITDA guidance, at the end of the fourth quarter, our net leverage is approximately 2.5 times on a forward basis. Turning to our 2025 financial guidance, as Nikhil previewed, we are raising our guidance for total revenue and adjusted non-GAAP EBITDA from the preliminary targets that we announced on January 13th, based on recent strong trends for Couture Au Fin Gel, the continued evolution of our generics business, and higher first quarter demand for our brand's portfolio. we now expect total revenue of $756 million to $776 million, which represents growth of 23% to 26% over 2024. For Cortofengel, we expect revenue of $265 million to $274 million, representing growth of 34% to 38%. We anticipate continued adoption of portrophine gel in the therapeutic areas of rheumatology, neurology, and nephrology, helped in part by our expanded commercial team, and strong growth in ophthalmology as well as for the gout indication. We also expect continued growth for the overall ACTH market in 2025. As you consider the quarterly progression for cortofan gel, please note that the general pattern of revenue in 2025 is expected to be similar to that reported in 2024, with a quarter-over-quarter decline in the first quarter due to prescription reauthorizations, followed by strong sequential growth in the second quarter. This pattern is generally consistent with other rare disease drugs. We expect combined alluvian and utique net revenues of $97 million to $103 million, which reflects the impact of the first quarter dynamics outlined by Nikhil and Chris early in the call, as well as the commercial and operational transitions they discussed. First quarter net revenues of alluvian and utique are expected to be impacted by both the typical Q4 to Q1 drop seen in rare disease products, as well as the added impact of the change in U.S. market access dynamics since early January. We expect this franchise to return to sequential growth in the second quarter of 2025. For generics, We anticipate low double-digit revenue growth driven by strength in our base business and contribution from new launches, including the full launch of Procalipride in early January with 180 days exclusivity. For brands, we saw increased demand in the fourth quarter for certain products, as we have periodically experienced over the past two years. This increased demand has persisted in the first two months of 2025. Our guidance assumes that this increased demand does not persist beyond the first quarter, and thus we assume normalized performance in quarters two through four. Moving down the P&L, we expect total company non-GAAP gross margin to be between 63% and 64%, which reflects modest growth relative to 2024, driven primarily by higher sales for our rare disease franchise. We expect adjusted non-GAAP operating expenses of $293 million to $302 million, which reflects sales and marketing investments to drive rare disease growth and a full year of SG&A and R&D associated with Alluvia and then Utique. Taking all of these factors into account, we expect 2025 adjusted non-GAAP EBITDA of $190 million to $200 million, which reflects 22% to 28% growth over 2024, and adjusted non-GAAP earnings per share between $6.12 and $6.49. We currently expect our U.S. GAAP effective tax rate to be approximately 25%. And consistent with the prior year, we will tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26% unless the item being adjusted is non-tax deductible in whole or part. We anticipate between 20.1 million and 20.4 million shares outstanding for purpose of calculating diluted EPS. With that, I'll turn the call back to Nikhil.

Thank you, Steve. We'll open it up for questions. Operator, Bo, could you please help us with the questions?

Certainly, Mr. Lewany. Ladies and gentlemen, at this time, if you would like to ask a question, please press star 1. Just a reminder, if you find your question has been addressed, you may remove yourself from the queue by pressing star 2. Once again, star 1 for questions. We go first this morning to David Amselem at Piper Sandler.

Thanks. So just got a couple. First, just on business development and M&A, and obviously you've built out the rare disease business and brand business overall. Can you just talk about your deal capacity right now and how high would you take pro forma net leverage up to to execute on a deal? And then also, how are you thinking about the sizing of the brand business or maybe the mix over time? I mean, right now it's sort of, you know, it has been, you know, kind of near, you know, 60-40, 50-50 brand generics. But ultimately, where are you looking to take the company, you know, longer term in terms of the brand presence? So that's number one. And then secondly, on Quartrofen, just want to drill down a little more deeply on the the mix here, how much of gout is in the mix? You cited that as a higher growth opportunity. I'm just wondering how we should think about that particular opportunity and how much it could drive the business in 25 and beyond. Thanks.

Good morning, David, and thank you for your questions. So your first question on BD and M&A, you know, As we have shared before, in terms of the areas, we would focus our BDM and ASR on rare disease. And then your second part of the question was, you know, what is the deal capacity and, you know, where are we willing to take pro forma leverage? So, look, if you look at ENI's history, and as we've built the company and done two acquisitions, as well as launched our lead rare disease product, you will see that this management team is very thoughtful about, you know, the leverage ratio, the net leverage ratio, and what we're willing to extend that to. And historically, it has, you know, it has always been kept under three. And at some points, you know, for short periods of time, such as during the launch of Cortrop, and it went, you know, slightly above, but then, you know, quickly de-levered. And as you look at you know, how we did the Almera acquisition and, you know, refinancing of the loan and putting in place a more efficient capital structure. I think that it, you know, our intent and we believe it gives us the ability to pursue additional BD and M&A while not straining the balance sheet. So that's how I would answer the question on, you know, BD, M&A. Your second question on where are we taking this company? You know, ANI has two very strong – has a strong portfolio of businesses. Both the rare disease business as well as the generics business are growing. And the brands business, what we used to refer to as established brands, plays a role in terms of being high margin, strong cash flow generation, and low working capital. But in terms of focus area and capital allocation, rare disease will be the primary driver of growth and the area in which we will continue to build, right, through BD, through M&A. We will invest in R&D to fuel high single-digit, low double-digit growth for the genetics business. But if you look over a period of time and just, you know, natural evolution, the center of gravity will will shift with greater percentage coming from rare disease and brands. So that's point number two. And then the third question on gout, I think there's two data points to share. 15% of the volume of cortofan currently is coming from gouts. And then as Chris talked about, gout is ending up being a gateway in some ways with 15% of prescribers. writing their first, they were naive to ACTH, writing their first prescription in gout and then moving on to consider it for other types of patients. Thank you, David. Thank you.

Thank you. We go next now to Vamil Devan at Guggenheim Securities.

Great. Thanks for taking the question. So a couple that I have. One just on the comments around the Alamira and some of the access issues. since January. Maybe you can just provide a little more insight on how that, I guess, your plans are there in terms of what we should look for in terms of time to resolution. The guidance this year suggests sort of, you know, the $100 million or so in the midpoint. It is not really much year-over-year growth from where you left in the fourth quarter. So how should we think about the longer-term impact of this access issue and year-over-year growth? Maybe look at a 2026 and 2027, for example. And then the other question more on Cortropins, you talked a lot about the seasonality, obviously, with the LMR assets. For Cortropin, how should we think about that, given it sounds like the growth has been very good? It looks like your initial trends are good for the year of your raising your guidance, partially based on that. So should we think about any sort of seasonality impact in one queue? And maybe you can just comment on how should we think about quarter-to-quarter growth for that franchise as well? Thanks.

Yeah, good morning, Maman, and thank you for your question. So your first question on the Illuvian-UTIC access issues. So in the past, patients with Medicare and Medicare Advantage plans had access to programs that assisted with offsetting the cost of the patient responsibility based on financial need. And some of these programs have not received adequate funding yet in 2025. In terms of what ANI is doing about it, well, first and foremost, ANI has in place a patient's assistance program that provides access for patients in financial need with free Illuvian and Utique as needed. And then secondly, we're spending time with our ACPs to understand their response to these market access changes and refining our commercial approach accordingly. And, you know, you asked a great question about what's the outlook and, you know, as we've, uh, talked about, there are currently, and stepping back, looking at the overall picture, there are currently fewer than 5,000 patients on therapy for each of Eluvian and Juteq. And we estimate that the addressable patient population for each drug is approximately six to 10 times higher based on epidemiological data. So while, you know, this is a near-term topic to work through, we remain confident of the growth prospects for our products in both DME and NIUPS. The second question was around seasonality in PCG. You know, you will see typical Q4 to Q1 dynamic in PCG also. It's typical for all rare disease drugs driven by purchasing patterns as well as insurance resets. What we do have is that, as we shared in February, we've had the highest number of new cases initiated. So we built momentum early and is one of the reasons why we raised our guidance that we had shared a few weeks ago. And you will see a drop, and then there will be sequential growth building on from there. Just again, typical Q4 to Q1 type dynamic in terms of sales for BCG. Thank you all.

Okay, thank you.

Thank you. We go next now to Gary Nachman at Raymond James.

Hey, thanks, and good morning. So, yeah, back to Alluvian and UT. I'm also trying to better understand the guidance. of the 97 to 103 million, given a lot of different moving parts that you have that you're working through in the near term. So are you anticipating any issues or hiccups as you transition supply from iPoint to Siegfried? Is that factored in there at all? And then I guess, how much do you think adding the uveitis indication for UT will help And also with those additional data sets coming, how much could those help? And how soon do you think those could benefit the overall franchise? And then I have one for Cortofa.

Got it. Thank you, Gary. Thank you for your question. Yeah, I think your first question is on the guidance. And, you know, as we've talked about, that there are – several commercial, clinical, and operational initiatives that will drive the significant quarter-on-quarter ramp for the rest of 2025 and beyond as we work through the access issues that we're seeing in early January as well as the transitions. Commercially, as you would expect with an acquisition and integration like this, we've made positive changes to, and Chris spoke a little bit about this, and strengthened the peer-to-peer education programs for further increasing awareness of Illuvian Utique and amplifying ANI's commitment to ophthalmology and retina, marketing materials to help physicians identify appropriate patients, and also continuing to refine our approach to selling free products across the U.S. And in the international markets, we're investing in higher ROI activities, such as expansion of the team in Germany and providing increased support for our partner products. You then asked about New Day. So on the clinical front, we've continued to push forward with the key programs, New Day and Synchronicity, and we're pleased that both programs will read out preliminary top-line data in the second quarter of 2025. If the New Day results are positive, it could significantly expand the use of Alluvian earlier in the DME patient journey. We have in place a robust plan for publishing and awareness building of the clinical results amongst the retina community who are eagerly awaiting these results. Having said that, we've been measured in our full year guidance and not resumed a tailwind from New Day results in our 2025 guidance. And then, you know, I'll just come back to the earlier question you also asked about the label combination and how that will work commercially. Look, we'll look to, I think, a couple of things. First is iPoint is committed to working with us to support the transition and ensure patients ensure continued supply security. So that's from a supply perspective and transition. Obviously, We submitted the PAS a while ago. We knew this transition was coming, so we were building up Elluvian inventory to do that, and we talked a lot about Siegfried and the capacity expansion there. But from a commercial perspective, we'll drive fast and broad awareness of the label consolidation during the UTIC and Elluvian transition period. We'll introduce the new consolidated label while gradually transitioning accounts from UTIC. to Illuvian for NIUPS. And we'll do this through the field team marketing initiatives and distributor communication to the accounts. And we'll deliver succinct messaging on value-added customers and the retina community. I mean, look, when you add the uveitis label to Illuvian, you consolidate to one injector, right, which is the only real difference between the two implants. And it also simplifies the ordering and processes for the office. So there's value-add to the customers, which we will reinforce. Your next question was on – I think you also had a question around the data set and new day, and hopefully I answered that as I was talking about the guidance and what's factored in and what's not factored in. Thank you, Gary.

Yeah. Yeah, no, that's great. And then I just had a follow-up on Quartrofen. I mean, you're seeing a nice benefit in ophthalmology and acceleration in gout. Maybe just talk about how much did you add to the sales force, you know, across what indications, and, you know, how you evaluate that ROI if you think the market should really grow that much, at what point you could add to that even further. Thank you.

Yeah, thank you. Thank you for that question, Gary. So, um, the, the, the increase in the courtroom, uh, Salesforce, we've added about 15 to 20 ish, uh, you know, between reps and, uh, area business directors, these are, uh, largely focused on the, uh, core indications that we initially launched with, uh, rheumatology, nephrology, neurology, um, and, you know, in terms of ROI, I think, you know, as we've grown this product from, you know, over three years from zero to 200 million, and we've driven growth across both the specialties we targeted at launch, as well as the, which is rheumatology, neurology, and nephrology, as well as the newer specialties of pulmonology and ophthalmology, I think we've developed, you know, and under Krista's leadership, developed a good understanding of, you know, the how to drive sort of high ROI commercial investments, right, leveraging the rare disease infrastructure that we also have in place, and also an understanding of, you know, the type of sales profile that succeeds, you know, with a product like Cortofin. I think all of those come together and help us to continue sort of driving growth here. Now, having said that, there's a number of other things that we're also doing to support the growth of this franchise, right? And we're investing in R&D project span for improving patient and physician convenience. We'll share updates on these projects as we progress them. We've obviously talked about the free cell syringe and launching that in, you know, getting approval for that and launching that in the second quarter. We're investing in research to provide additional support for the use of cortrophin. And then, obviously, what we already talked about, which is the high ROI commercial spend, such as expansion of our cortrophin sales team to drive in the growth of the core specialties targeted at launch.

Thank you, Gary. Great. Thanks, Nikhil.

Thank you. We go next now to Faisal Khurshid at Lear Inc. Partners.

Hey, good morning, guys. Thanks for taking me on the call. I just want to ask, you spoke a little bit about the reimbursement changes with Medicare. Can you talk a little bit more about that and the impact? Is that just the kind of Medicare Part D redesign, and how does that affect the product? And then are there other kind of product-specific kind of factors at play with regards to reimbursement that we should be considering?

Yeah. Good morning, Cecil, and thank you for your question. This is not a redesign. What it is is patients with Medicare and Medicare Advantage plans that had access to programs that assisted with the offsetting the cost of the patient responsibility or the copay based on financial need. And some of these programs have not received adequate funding yet in 2025. Now, you know, In terms of what we're doing about this, you know, Medicare, look, the number of patients for the addressable market is six to ten times higher than what is being treated right now, right? Less than 5,000 patients, as we've discussed with you, on either Illuvian or UT. And so the addressable market is much, much higher. And so while we're working through this in the short term, and we're trying to understand, you know, how Prescribers are thinking of this, too. But while this is a near-term issue to work through, we, you know, remain confident of the growth prospects for our products in both DME and NIUPS.

Got it. And is this dynamic specific to uvenutique, or does this impact cortofen as well?

No, this does not impact cortofen because it's, you know, it's for Part B. And then, you know, the Part B has, you know, has some of the positive tailwinds from IRA changes, such as, you know, maximizing the copay at $2,000 and then allowing for smoothing. So that's, you know, those changes are impacting the Part B of Medicare. However, this is to your question. These programs, you know, provide, assist with the cost setting, the cost of patient responsibilities, also for other products, not just a little bit of a new team.

Got it.

That's helpful. Thank you. Thank you. We go next now to Oren Livnat at HC Wainwright.

Thanks. Apologies in advance. I have a really bad cough now, so might have to use the mute button if I drop off periodically. I want to talk about you taking Olivia to get I'm just a little confused, so hopefully you can help me understand this transition. You mentioned transitioning UTIC manufacturing to Siegfried, which we had expected, but also planning to stop promoting the product. So I'm just trying to understand, is this just supporting an ongoing supply as you transition, or do you intend to continue long-term manufacturing UTIC at Siegfried? Also, how close are you threading the needle regarding this supply agreement and with iPoint and then this new indication and switch. And sorry, a third part, if I may. How disruptive could this be in terms of training and technique? Is there any difference with these new applicators and new training required? And do these have different costs or access, which maybe would cause some insurance transition trade to happen as well? And then I have a question.

Thank you for your question and thank you for joining despite being under the weather. So I think the first question was on, you know, the transfer of manufacturing to Siegfried. The way we are transferring the manufacturing to Siegfried is by adding the label, the indication of uveitis, or sorry, chronic noninfectious uveitis affecting posterior segment of the eye to the alluvial label. That is possible because these two products are extremely similar. In fact, as I mentioned, the clinical trials were both run on the 0.18 milligram of flucinolone aspartanide. And so the only real difference between the two is the Eluvian has a newer manufacturing process that has a slightly different strength. So essentially, we'll have one product, which is Eluvian. That alluvium product will have both indications on the label, diabetic macular edema as well as chronic non-infectious uveitis affecting posterior segment of the eye. Siegfried already manufactures alluvium and will continue manufacturing alluvium. Anticipating this potential label consolidation, we extended the Siegfried manufacturing agreement by five years to 2029, upgraded the equipment on the existing manufacturing line, as well as are adding a second manufacturing line. And all those initiatives are on track. We've known that this label consolidation is coming, and so we've been building up Illuvian inventory, right, to allow for the transition. And as I said to you, iPoint has committed to continue to work with us to ensure supply continuity for patients, right, and work with us through these changes. Having said that, the agreement with them, you know, we've agreed for both iPoint and A&I have agreed for non-renewal starting May 31, 2025. So we've talked through the inventory transition and have been preparing for it. And regarding the timing, also, right, look, we've engaged with the FDA. We knew exactly what they wanted to support the indication edition, right, even before we submitted the PAS. And then we've been having ongoing dialogue with them to ensure that, you know, do we understand what they're asking for? And look, you know, you can read the tea leaves and we've been satisfactorily answering the questions that they've been asking on the label. So that's why, you know, Q2, we expect approval of this PAS, and we'll transition, you know, from Utique to from selling both Utique and Alluvian to only selling Alluvian. And then your third question was on, you know, physicians and what they actually use and the fact that there are two implanters. Look, we believe that there is significant value add to customers and simplicity because there's consolidation to one injector for the retina community. And for the offices who buy and build this, you know, they can, it simplifies the ordering and processes. They don't have two SKUs to maintain. They can only maintain one. So we think that this is actually a value add to our customers and the retina community. Thank you, Warren.

Okay, and just so I can get some clarity on that last point, aside from the simplicity of having one product instead of two, is the procedure the same for each relative indication across different, I guess, injectors? Is there any reason, would doctors who are already using UTIC now for NIU switching to Alluvian have to do anything differently?

and not in any material. I mean, there's quite difference, but nothing material. And a lot of the retina physicians, you know, have, you know, have, you know, the ability to use different kinds of inserts, right? This is not the only, they do use different kinds of inserts for products. So the ability to, and these are substantially similar So the ability to sort of, you know, learn the slight tweak or change, we don't think that that's material. And obviously, you know, look, again, to be clear, Alamira contemplated this even well before our acquisition. If ANI had never acquired Alamira, this is exactly what they would have done. And they obviously, you know, and we've just picked up from where they left off, right, in terms of, you know, the consolidation of the two labels. Yep.

And again, to clarify, is the insurance coverage and cost similar or identical for these products, so the transition shouldn't be disruptive on that front? Or in theory, could there even be tailwinds with pricing differences?

The pricing is reasonably close for both the listed price, and we do not foresee market access to cause any issues from a coverage perspective. Yeah.

Okay. And lastly, I appreciate all the time on cortrophin. How important is that one milliliter pre-filled syringe launch, assuming it's approved? Do you know what share AXAR, a similar self-check product, has achieved since launch? And assuming some new uptake or switching from the five milliliter vial to your pre-filled syringe, would there be any material impact on average net selling price per patient potentially?

Yeah. Thank you for your question. Look, we are introducing the pre-fill syringe to enhance patient position and patient convenience. The 5 ml vial requires a multi-step administration. And so what the pre-fill syringe does is reduce one step in the administration process for the patients. And so that's helpful to them. And so there's a subset of patients that have you know, for whom it is helpful to have one less step in the administration process. And that's, you know, that's a new presentation that we're bringing to the market. We believe that this will continue as we had done with the 1ml vial that we launched for acute gaudy arthritis flares or focus on acute gaudy arthritis flares. We believe that this will continue to, you know, present, offer new presentations and options for different segments of patients and will drive you know, overall growth of the ACTH market. And that's how we see the launch of the approval and launch of the pre-filter engine. As we said, that we're continuing to look into other, explore other ideas for improving patient and physician convenience. And we'll look forward to sharing updates on these projects as we progress them.

All right. Thanks so much.

Thank you, Oren. I hope you feel better.

Thank you. We'll go next now to Les Zalewski at Chura Securities.

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

Yeah. No, thank you, Jeevan, and good morning. Yeah, look, the ACTH market has returned to growth. The, you know, if you add our, if you take our actuals and add the competitors' guidance that they last reported in November, this market is seeing north of, you know, around 25% growth to $660 million. You know, you hear their rhetoric and what we're saying, and, you know, essentially we're all talking about, we're both talking about increasing awareness of the ACTH therapy for the appropriate patients. And then, you know, the data point that we shared, which is when you look at number of patients on therapy today, it's about half the number of patients of therapy that were at the peak and from an epidemiological perspective were much lower than than what the addressable market was, right? So, again, the opportunity is very substantial. And I think a new data point that we shared for the first time today is that almost 40 percent of our prescribers are ACPs that were naive to ACTH. So, our ability to get to, you know, when you talk about the epidemiological addressable market and our ability to get to newer physicians and to reach the appropriate patients, I think it's proven over the last three years. So I think that tells you about sort of why we continue to believe and continue to invest behind the long-term multi-year growth trajectory of the ACTH market. And regarding competition, look, I would say that for both products, uh the competitor and ours we've continued to see this over time that uh it is uh you know just tough to bring a a generic or a biosimilar to this product um i think that path to genericization and both the competitor and us have added uh ip to strengthen uh and so you know obviously we keep tracking this from a competitive standpoint we just we do see the outlook for the ACTH category is one where, you know, it'll be the two competitors trying to continue to build awareness and bring this therapy to patients in need. Thank you, Jeevan.

Thank you. And just a quick reminder, ladies and gentlemen, star one for further questions this morning. We'll go next now to Glenn Santangelo with Jefferies.

Oh, yeah, good morning. Thanks for taking my question. Hey, maybe I'll ask just a quick one on the generics business since nobody's touched on that. I'm kind of curious. I mean, we've seen an uptick in Form 483s, and that's led to certain shortages. And I'm just trying to reconcile some of your comments that you made with respect to the outlook for fiscal 25 in terms of assuming continued double-digit growth. And what I was really hoping that you could do is maybe just sort of unpack that growth algorithm for me And give us a sense for maybe how much of that you expect to come from, you know, maybe organic volumes in price versus new product launches, maybe fully appreciating, you know, the comments you made on the timing on Procalipride, the tablets that you just recently launched and how that may impact the first half versus the second half. Thanks.

Yeah. Thank you, Glenn, and thank you. You know, great to have you on our call for the first time, so appreciate that. Regarding the generics business, look, I think it's a combination of two or three things that's helping us drive low double-digit growth this year. I think first and foremost is the new product launch cadence that we have. You know, we launched 17 new products in 2024. We'll obviously see the full year impact of those launches because we launched them at different points in the year. Back end is the launches that we'll do this year, right, including CoCal Pride, right, which gives us a, you know, with 180 days of exclusivity. What you will see is that, you know, the genetics business sales because of the 180 days of exclusivity will see a, you know, a jump in Q1 and Q2. But there are other launches through the year, so I think it's a combination of the annualization of the 2017-2024 launches, the new launches from 2025, and you balance the erosion that we'll see in what I call the class of 2023 and before products from additional competition, and I think that's typical generic pricing, as you're well aware of. Now, to your question, all of our growth will largely come from volumes, new volumes either from new product launches or from taking additional share in products that we're already in the market for. But there is, in the guidance that we have shared of low double-digit There isn't any material, you know, positive benefit from warning letters or 483, whatever the, any supply-related issues that competitors may have.

Okay. Thanks for having me, Phil.

Thank you, Glenn. Thank you for joining.

And ladies and gentlemen, it appears we have no further questions this morning. Mr. Lawani, I'll turn things back to you for any closing comments.

Thank you, Bo. 2024 was a record year for our business, and we expect to continue building on this momentum in 2025. Both Cortropin Gel and Generics and our ophthalmology franchise are already off to a good start and are leading us to raise our 2025 outlook. I'm confident that ANI is well-positioned to deliver another year of strong revenue growth and profitability in 2025. We look forward to seeing many of you in person next month at the Raymond James Annual Institutional Investor Conference in Orlando and the Learing Global Healthcare Conference in Miami Beach. Thank you for joining us today. Thank you.

Thank you very much, Mr. Lewany. Again, ladies and gentlemen, that will conclude today's A&I Pharmaceuticals fourth quarter 2024 earnings results call. Again, thanks so much for joining us, everyone, and we wish you all a great day. Goodbye.