ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q4 2024 Earnings Conference Call February 28, 2025 8:00 AM ET

Company Participants

Lisa Wilson - IR, Insight Communications
Nikhil Lalwani - President, CEO & Director
Christopher Mutz - SVP, Head, Rare Diseases
Stephen Carey - CFO & SVP

Conference Call Participants

David Amsellem - Piper Sandler
Vamil Divan - Guggenheim Securities
Gary Nachman - Raymond James
Faisal Khurshid - Leerink Partners
Oren Livnat - H.C. Wainwright
Jeevan Larson - Truist Securities
Glen Santangelo - Jefferies

Operator

Good morning, everyone. Welcome to today's ANI Pharmaceuticals Fourth Quarter 2024 Earnings Results Call. Please note, this call is being recorded.

After speakers’ remarks there will be a question-and-answer session. [Operator Instructions] Now at this time, it's my pleasure to turn the call over to Ms. . Lisa Wilson, Investor Relations of ANI Pharmaceuticals.

Please go ahead, ma'am.

Lisa Wilson

Thank you. Welcome to ANI Pharmaceuticals Q4 2024 earnings results call. This is , Investor Relations for ANI.

With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Stephen Carey, Chief Financial Officer; and Chris Mutz, Senior Vice-President and Head of ANI's Rare Disease business. You can also access the webcast of this call through the Investors section of the ANI website at anipharmaceuticals. com.

Before we get started, I would like to remind everyone that any statement made on today's conference call that expresses a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI Pharmaceutical's 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 [Technical Difficulty] site at anipharmaceuticals.

com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 28, 2025. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings.

And with that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani

Thank you, Lisa. Good morning, everyone, and thank you for joining us. Today, I'll start by discussing our full year and fourth quarter performance and highlights and our 2025 guidance.

Chris will provide additional color on our Rare Disease business, including our lead asset, Cortrophin Gel and ILUVIEN, and YUTIQ, which we recently added through the acquisition of Alimera. Finally, Steve will review our fourth quarter results and 2025 guidance in more detail. Following our remarks, we'll take your questions.

We are pleased to report record fourth quarter and full year 2024 results and are raising our 2025 guidance for total revenues and adjusted non-GAAP EBITDA. The upward revision in our guidance is based on further confidence in higher demand for Cortrophin Gel, a strong start for generics with the launch of Prucalopride with 180-day exclusivity, and increased demand in the first quarter as we have seen in the past for our established brands portfolio, which is now referred to as brands under our new segment reporting structure. We now expect 2025 revenue of $756 million to $776 million, which represents growth of 23% to 26% over 2024 versus our prior guidance of $739 million to $759 million. We expect adjusted non-GAAP EBITDA of $190 million to $200 million, which reflects growth of 22% to 28% over 2024 versus our prior guidance of $182 million to $192 million.

Steve will provide more specifics on our financial guidance. 2024 was another year of strong execution for ANI capped by our record fourth quarter with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS, all coming in above our previously announced guidance for the full-year. Rare Disease was our primary driver of growth in 2024 with our lead rare disease asset, Cortrophin Gel, generating close to $200 million of sales in just the third year since launch.

And our Generics business delivered 12% revenue growth, driven by operational excellence and new product launches, making 2024 the third straight year of achieving double-digit top-line growth for this business. In addition, we expanded our rare disease franchise in 2024 with the acquisition of Alimera Sciences in September in keeping with our longer-term strategy to broaden our presence in the rare disease space. We also successfully executed the refinancing of our prior debt and put in place a more efficient and effective capital structure.

Turning now to our fourth quarter results. Our financial performance in the fourth quarter was the strongest in our history. Total revenues were $190.6% million, representing a year-over-year increase of 45% on an as-reported basis and 24% on an organic basis, driven by accelerating demand for Cortrophin Gel, continued strong growth for generics, our full quarter contribution from ILUVIEN and YUTIQ and higher demand for brands.

Adjusted non-GAAP EBITDA was $50 million, and adjusted non-GAAP EPS was $1.63%. Cortrophin Gel generated $59.4% million in revenues during the quarter, up 42% over the fourth quarter of 2023. The quarter reflected continued momentum with the highest number of both quarterly new patient starts and new cases initiated since we launched the product in January 2022.

We saw increased demand across all targeted specialties, neurology, rheumatology, nephrology, pulmonology and ophthalmology. Cortrophin Gel remains on a strong multiyear growth trajectory. The overall ACTH category returned to growth in 2024, while the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of headroom for expansion.

We expect the strong momentum to continue in 2025 and our new guidance forecasts Cortrophin Gel revenues to grow between 34% and 38% to $265 million to $274 million in 2025. Chris will talk more about our initiatives to increase awareness of the benefits of ACTH therapy for appropriate patients and further drive demand for Cortrophin Gel. Our new ophthalmology products, ILUVIEN and YUTIQ, generated revenues of $27.6% million in the fourth quarter.

Our first full quarter of ownership following the acquisition of Alimera. Our expanded ophthalmology team also drove significant growth in new patient starts for Cortrophin Gel in ophthalmology, which doubled in Q4 versus Q3. A core strategic rationale for acquiring Alimera was to add assets that are synergistic with Cortrophin Gel and leverage our rare disease infrastructure, and proven commercial execution capabilities in order to unlock the potential of ILUVIEN and YUTIQ, as well as accelerate the growth of Cortrophin -- sorry, as well as accelerate the growth of Cortrophin Gel in ophthalmology.

We believe there is significant room for both ILUVIEN and YUTIQ, given the novel long-acting nature of the products and size of the addressable market. We have taken steps and are continuing to execute on initiatives that will enable us to capture these growth initiatives. Let me lay these out for you.

Commercially, we expanded the U.S. ophthalmology sales team of approximately 30 representatives that we acquired from Alimera to 46 sales reps, who began promoting ILUVIEN, YUTIQ, and Cortrophin Gel in mid-October of 2024. We are continuing to invest to drive growth in international markets, both direct markets such as Germany and partner markets such as France and Spain. Clinically, we continue to invest behind the NEW DAY clinical trial for ILUVIEN and SYNCHRONICITY clinical trial for YUTIQ.

For NEW DAY, if the clinical trial results are positive, it could significantly expand the use of ILUVIEN earlier in the DME patient journey in combination with anti-VEGF therapy. 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 ILUVIEN and YUTIQ.

For ILUVIEN, we extended our partnership with our contract manufacturer Siegfried for five years until 2029. Siegfried has been a reliable partner for ILUVIEN for over 10 years. As a part of this expansion, 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 YUTIQ to Siegfried in 2025. We submitted a prior approval supplement or PAS to the FDA to add YUTIQ's indication of chronic non-infectious uveitis affecting the posterior segment of the eye or NIU-PS to the ILUVIEN label. Note, both ILUVIEN and YUTIQ are substantially similar ophthalmic implants with the same active ingredient, fluocinolone acetonide.

And almost identical strengths with ILUVIEN having 0.19% milligram of fluocinolone and YUTIQ having 0.18% milligrams of fluocinolone. In fact, the clinical trials for both NIU-PS and DME were run on implants with 0.18% milligrams of fluocinolone acetonide. The newer manufacturing process used exclusively for ILUVIEN results in a strength of 0.19% milligrams per implant.

We engaged with the FDA prior to the PAS 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 PAS in the second quarter. Following approval, we plan to transition commercialization efforts for both the DME and chronic NIU-PS indications to a single product, ILUVIEN. As a reminder, ILUVIEN is already approved and marketed for both DME and NIU-PS outside the U.S., including in seven European countries and the Middle East.

Operationally, the above initiatives will significantly enhance supply security for both ILUVIEN and YUTIQ, positioning the franchise for a strong multiyear growth trajectory. In conjunction with these initiatives, ANI and EyePoint have agreed to nonrenewal of the current supply agreement for YUTIQ with an effective date of May 31st, 2025. Moving now to our 2025 guidance for ILUVIEN and YUTIQ. Our Q4 net sales for ILUVIEN and YUTIQ was $27.6% million.

Typical Q4, Q1 impact driven by insurance resets and purchasing patterns for products such as ILUVIEN and YUTIQ causes Q1 to be lower than Q4 by levels that are similar to other products. In addition, Q1 2025 for ILUVIEN and YUTIQ will have the added impact of the change in U.S. market access dynamics since early January that has reduced access for Medicare patients, which is particularly important for ILUVIEN's DME indication. We are working with HCPs to understand their response to the market access changes and refining our commercial approach accordingly.

Stepping back to the overall picture, there are currently fewer than 5,000 patients on therapy for each of ILUVIEN and YUTIQ and we estimate that the addressable patient population for each drug is approximately 6 times 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 NIU-PS. 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 ILUVIEN and YUTIQ.

And we remain enthusiastic about the product's long-term runway for growth. Chris will further detail our commercial and clinical initiatives that we expect will drive significant quarter-on-quarter growth through 2025 and beyond. Turning now to our Generics business.

We delivered another solid quarter with revenues of $78.6% 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 #2 ranking in CGT approvals in 2024. One of these approvals was Prucalopride tablets, which we launched in late December, early January into a $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 generics business in 2025, supported by our high-performing R&D engine, operational excellence, and U.S.-based manufacturing footprint. Our brands portfolio, which we previously referred to as established brands, continues to address patient needs with reliability of supply, a unique set of commercial capabilities, and opportunistic business development to expand the portfolio. Our overall portfolio of businesses is strengthened by this high gross margin, low working capital and strong cash flow generation business.

During the fourth quarter of 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’d like to thank our customers, suppliers, partners, investors, and the entire ANI team for their collaboration and significant contribution in delivering on our company's purpose of serving patients, improving lives.

I'll now turn the call over to Chris Mutz, our Head of Rare Disease. Chris.

Christopher Mutz

Thank you, Nikhil, and good morning everyone. Our rare disease team drove strong demand for Cortrophin Gel in the fourth quarter. We are pleased to see demand growth across all targeted specialties, 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, [Technical Difficulty] from the third quarter as our new larger ophthalmology sales team expanded our promotional activities to a broader group of physicians.

Prescribing for acute gouty arthritis flares for which Cortrophin Gel is the only approved ACTH therapy also continued to ramp and now represents approximately 15% of Cortrophin Gel use. Notably, gout is serving as a gateway indication for many physicians that are new to ACTH therapy. For approximately 15% of health care professionals prescribing Cortrophin Gel for the first time, a gout patient is their first patient on therapy. We expect the gout indication to remain a key growth driver for Cortrophin Gel in 2025. As Nikhil mentioned, we believe Cortrophin Gel is on a strong multiyear growth trajectory.

The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024 based on the reported sales for Cortrophin Gel and the guidance given for the other ACTH product by our competitor. We believe the growing recognition of Cortrophin Gel as a safe and effective treatment option for appropriate patients is reflected by the recent growth dynamics for the overall ACTH category. While the market is growing, ACTH prescribing is still well below historical levels.

Based on our analysis of claims data, we believe the number of patients on ACTH therapy now is approximately half the level of patients on therapy when the category previously peaked in 2017. Treatment of flares and exacerbations continues to be a significant unmet need for autoimmune disorders and inflammatory diseases. We believe the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago.

Our belief is anchored in the prevalence of and need for alternative treatment options for the autoimmune disorders that Cortrophin is indicated for. It's worth noting that approximately 40% of Cortrophin Gel prescribers are new to the ACTH category, which illustrates the need for our therapy in certain patients and our ability to expand the market. Our messaging has resonated with physicians who see patients with severe autoimmune disorders who need alternative therapies for continued flares and exacerbations.

We've also taken important steps to strengthen and grow the Cortrophin Gel franchise over the last several quarters. We launched dedicated sales teams in pulmonology and ophthalmology. And with the Alimera acquisition, we now have a much larger ophthalmology sales team that is already driving greater prescribing in this important therapeutic area.

We've also seen continued strong growth in our initially targeted therapeutic areas of rheumatology, neurology, and nephrology. Given our view on the unmet need in these areas and the utility of ACTH therapy, we recently increased the size of our sales team to help expand our promotional efforts to additional physicians. The largest sales team has already contributed to growing the number of Cortrophin Gel prescribers in the first quarter, and the number of new cases initiated reached a new monthly all-time high in February despite the quarter tending to be seasonally low for Cortrophin Gel and other rare disease therapies due to insurance resets and market dynamics.

We are also investing in initiatives to improve patient and physician convenience. We have a prefilled syringe under FDA review that we expect to launch in the second quarter of 2025. The prefilled syringe will provide benefits to patients and physicians by reducing the steps needed for self-administration.

We're excited about the potential of this new presentation and look forward to making the Cortrophin Gel prefilled syringe available in the second quarter, as we continue to advance our rare disease portfolio. We're also exploring other ideas to enhance convenience for patients starting on Cortrophin Gel and the health care providers who treat them, and we look forward to sharing more details on these initiatives in the future. Overall, we believe in and are committed to investing in the Cortrophin Gel franchise and continuing to deliver strong multiyear growth for the product.

Turning now to our new ophthalmology products, ILUVIEN and YUTIQ. As a reminder, ILUVIEN and YUTIQ are both novel long-acting intravitreal implants. In the U.S., ILUVIEN is used to treat diabetic macular edema or DME, the leading cause of vision loss in diabetic patients. And YUTIQ is used to treat chronic non-infectious uveitis affecting the posterior segment of the eye or NIU-PS.

ILUVIEN and YUTIQ are the only long-term durable therapies available that can reduce disease recurrence through extended disease control for up to three years. We believe there is significant room for growth for both products. As we move through 2025, we expect to increasingly deploy the same commercial acumen with ILUVIEN and YUTIQ that has driven our success with Cortrophin Gel.

In sales, we have fully transitioned into the new larger footprint of 46 territories and key customer handoffs are now complete. We also are beginning to see meaningful increase in call activity, which we expect to drive performance in both ILUVIEN and YUTIQ throughout the remainder of 2025. In marketing, we are making significant investments in increasing peer-to-peer education, as well as conference and Congress engagements, further amplifying awareness of ANI's commitment to the ophthalmology space.

Additionally, in the coming weeks, we are launching new and enhanced marketing materials informed by a significant investment in market research to help physicians better identify appropriate patients for our long-acting implants. We've continued to make progress on the clinical trials NEW DAY and SYNCHRONICITY. NEW DAY Is investigating the use of ILUVIEN in combination with the current standard of care anti-VEGF for the treatment of DME.

NEW DAY is fully enrolled with 306 patients in approximately 42 sites. The last patient's last visit occurred in early January, and we expect top-line results in the second-quarter of this year. SYNCHRONICITY is designed to provide retina and uveitis specialists with a broader sense of the utility of YUTIQ across a variety of patients with chronic NIU-PS.

The clinical trial has enrolled 110 patients in approximately 25 sites around the U.S. We expect preliminary top-line results also in the second quarter of this year. Looking across our overall Rare Disease business, we are pleased with the continued strong performance of Cortrophin Gel. Furthermore, we remain excited about the long-term growth runway for ILUVIEN and YUTIQ, and we are laser-focused on optimizing our commercial strategy and increasing supply security for these products.

Our new ophthalmology sales team has been promoting all three products since mid-October, and we expect the team to drive greater awareness of the products and the patients that can benefit from treatment. For 2025, we expect our rare disease business, which includes Cortrophin Gel, ILUVIEN and YUTIQ to be ANI's largest growth driver. With that, I'll turn the call over to Steve for the financial update.

Steve.

Stephen Carey

Thanks, Chris, and good morning to everyone on the call. I'll review our fourth quarter results and then discuss our 2025 guidance in detail. ANI generated fourth quarter revenues of [$190.6%] (ph) million, up 45% over the prior year period.

Beginning with this reporting period, we have redefined our reporting segment. We continue to have two segments. However, they are now defined as Rare Disease and Brands and Generics and other.

This change reflects how we analyze the business post the Alimera acquisition. The new segment presentation can be found in our earnings release, MD&A in our Form 10-K, and the footnotes to our financial statements filed this morning. Prior period disclosures have been recast to be consistent with the go-forward presentation.

Revenues from Rare Disease and Brands were $106.9% million in the fourth quarter, up 97% from the prior year period as reported and 24% on an organic basis, driven by gains in both Rare Disease and Brands. Rare disease revenues more than doubled to $87 million. Revenues from Cortrophin Gel were $59.4% million, up 42% from the prior year period, driven primarily by increased volume on a record number of new patient starts.

Revenues from our new ophthalmology products, ILUVIEN and YUTIQ were $27.6% million. As a reminder, we completed the acquisition of Alimera on September 16, and therefore, the fourth quarter represents our first full quarter of owning these assets. Revenue for brands were $19.8% million in the quarter, an increase of 59% over the prior year period.

The quarter benefited from higher demand related to changes in market dynamics for certain products, similar to what this portfolio has experienced in the past. Revenues for our Generics and Other segment were $83.7% million, an increase of 8% over the prior year period, driven by increased volumes on contributions from new product launches in 2024 and the full year impact of products launched in 2023. Now to move down the P&L.

As a reminder, when I speak to our operating expenses for the purposes of this earnings call, I will be referring to our non-GAAP expenses, which are detailed on Table 3 of our press release. Generally, our non-GAAP operating expenses exclude depreciation and amortization, stock based compensation, and certain costs related to litigation and M&A activity. Please refer to Table 3 for a reconciliation to our GAAP expenditures.

Non-GAAP cost-of-sales, excluding depreciation and amortization increased 31% compared to the prior year period to $69.5% million in the fourth quarter of 2024 primarily due to net growth in sales volumes of pharmaceutical products of royalty-bearing products and a full quarter of ILUVIEN and YUTIQ sales. Non-GAAP gross margin was 63.5%, an increase of approximately 3.9% percentage points from the prior year period primarily driven by favorable product mix, due to higher revenues from Cortrophin Gel and brands, and a full-quarter of ILUVIEN and YUTIQ sales. Non-GAAP research and development expenses increased 68% to $16.2% million in the fourth quarter due to the inclusion of costs related to the NEW DAY and SYNCHRONICITY clinical trials, development of the Cortrophin Gel prefilled syringe and ongoing investments in generic R&D programs. Non-GAAP selling, general and administrative expenses increased 42% to $54.8% million in the fourth quarter, driven by a full quarter of spend for our new larger Cortrophin Gel, ILUVIEN and YUTIQ, continued investment in rare disease sales and marketing activities, increased employment-related costs including incentive-based compensation tied to our record financial performance in 2024 and an overall increase in activities required to support the ongoing growth of our business.

Adjusted non-GAAP diluted earnings per share was $1.63% for the quarter compared to $1 per share in the prior year period. Adjusted non-GAAP EBITDA for the fourth quarter was $50 million, compared to $30.2% million in the prior year period. We ended the quarter with $494.3% million of net debt, comprised of $144.9% million in unrestricted cash and $639.2% million in principal value of outstanding debt, inclusive of our senior convertible notes and our term loan.

Utilizing the midpoint of our revised 2025 adjusted non-GAAP EBITDA guidance. At the end of the fourth quarter, our net leverage is approximately 2.5% times on a forward basis. Turning to our 2025 financial guidance.

As Nikhil previewed, we are raising our guidance for total revenue and adjusted non-GAAP EBITDA from the preliminary targets that we announced on January 13, based on recent strong trends for Cortrophin Gel, the continued evolution of our generics business and higher first quarter demand for our Brands portfolio. We now expect total revenue of $756 million to $776 million, which represents growth of 23% to 26% over 2024. For Cortrophin Gel, we expect revenue of $265 million to $274 million, representing growth of 34% to 38%.

We anticipate continued adoption of Cortrophin Gel in the therapeutic areas of rheumatology, neurology, and nephrology, helped in part by our expanded commercial team and strong growth in ophthalmology, as well as for the gout indication. We also expect continued growth for the overall ACTH market in 2025. As you consider the quarterly progression for Cortrophin Gel, please note that the general pattern of revenue in 2025 is expected to be similar to that reported in 2024 with a quarter-over-quarter decline in the first quarter due to prescription reauthorizations followed by strong sequential growth in the second quarter.

This pattern is generally consistent with other rare disease drugs. We expect combined ILUVIEN and YUTIQ net revenues of $97 million to $103 million, which reflects the impact of the first quarter dynamics outlined by Nikhil and Chris earlier in the call, as well as the commercial and operational transitions they discussed. First quarter net revenues of ILUVIEN and YUTIQ are expected to be impacted both -- by both the typical Q4 to Q1 drop seen in rare disease products, as well as the added impact of the change in U.S. market access dynamics since early January.

We expect this franchise to return to sequential growth in the second quarter of [2025] (ph). For generics, we anticipate low double-digit revenue growth driven by strength in our base business and contribution from new launches, including the full launch of Prucalopride in early January with 180 days exclusivity. For Brands, we saw increased demand in the fourth quarter for certain products as we have periodically experienced over the past 2 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 ILUVIEN and YUTIQ. 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, [Technical Difficulty].

Nikhil Lalwani

Thank you, Steve. We'll open it up for questions.

Operator

[Operator Instructions] We go first this morning to David Amsellem at Piper Sandler.

David Amsellem

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 execute on a deal. And then also how you're thinking about the sizing of the brand business or maybe the mix over time.

I mean, right now, it is sort of -- it has been kind of mere 60-40, 50-50 Brand, Generics, but ultimately, where are you looking to take the company longer-term in terms of its -- in terms of the brand presence. So that's number one. And then secondly, on Cortrophin, I just want to drill down a little more deeply on the mix here.

How much of gout is in the mix. You cited that as a higher growth opportunity. I'm just wondering how you -- we should think about that particular opportunity and how much it could drive the business in '25 and beyond.

Thanks.

Nikhil Lalwani

David, thank you for your questions. So your first question on BD and M&A, as we have shared before, in terms of the areas we would focus on rare disease. And then your second part of the question was, what is the deal capacity and where are we willing to take pro forma leverage.

So look, if you look at ANI's history and as we've built the company and done two acquisitions as well as launched our lead rare disease product, you will see that this management team is very thoughtful about the leverage ratio, the net leverage ratio and what we're willing to extend that to. And historically, it has always been kept under three. And at some points for short periods of time, such as during the launch of Cortrophin, it went slightly above, but then quickly de-levered.

And as you look at how we did the Alimera acquisition and refinancing of the loan and putting in place a more efficient capital structure, I think that it is our intent and we believe it gives us the ability to pursue additional BD and M&A, while not straining the balance sheet. So that's how I would answer the question on BD, M&A. Your second question on where are we taking this company, ANI has 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 rights through BD, through M&A.

We will invest in R&D to fuel high single-digit, low double-digit growth for the Generics business. But if you look over a period of time and just natural evolution, the center of gravity will shift with greater percentage coming from Rare Disease and Brands. So that's point number two.

And then the third question on gout. I think just two data points to share, 15% of the volume of Cortrophin currently is coming from gout. And then as Chris talked about, gout is ending up being a gateway in some ways with 15% of prescribers writing their first – they were naïve to ACTH, writing their first prescription in gout and then moving on to consider it for other types of patients.

Thank you, David.

David Amsellem

Thank you.

Operator

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

Vamil Divan

Great. Thanks for taking my question. So a couple that I have.

One, just on the comments around the Alimera assets and the access issues since January. Maybe you can just provide a little more insight kind of how that -- I guess your plans are there in terms of what we should look for in terms of time to resolution and the guidance this year suggests sort of the $100 million or so in the midpoint is not really much year-over-year growth from where you left in the fourth quarter. So how should we think about the longer-term impact of this access issue and kind of year-over-year growth, maybe looking at 2026 and 2027, for example.

And then the other question more on Cortrophin, you talked a lot about the seasonality obviously, with the Alimera assets, for Cortrophin, 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, if you're raising your guidance, partially based on that. So should we think about any sort of seasonality impact in 1Q. And maybe you can just comment on sort of how should we think about quarter-over-quarter growth for that franchise as well.

Thanks.

Nikhil Lalwani

Yeah, good morning Vamil and thank you for your question. So your first question on the ILUVIEN, YUTIQ access issues, so in the past, patients with Medicare and Medicare Advantage plans had access to programs that assisted with offsetting the cost of the -- based on the responsibility, based on financial need, and some of these programs have not received adequate funding yet in 2025. In terms of what ANI is doing about it.

Look, first and foremost, ANI has in place a patient assistance program that provides access for patients in financial need with free ILUVIEN and YUTIQ as needed. And then secondly, we are spending time with our HCPs to understand their response to these market access changes and refining our commercial approach accordingly. And you asked a great question about what's the outlook.

And as we've 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 ILUVIEN and YUTIQ and we estimate that the addressable patient population for each drug is approximately 6 times to 10 times higher based on epidemiological data. So while this is a near-term topic to work through, we remain confident of the growth prospects for our products in both DME and NIU-PS. The second question was around seasonality in PCG, you will see typical Q4 to Q1 dynamic in PCG also is typical for all rare disease drugs driven by purchasing patterns, as well as insurance resets.

What we do have is that, as we shared in February, right, we've had the highest number of new cases initiated, right. So we built momentum early and is one of the reasons why we raised our guidance that we had shared a few weeks ago. And you will see a drop, but -- and then there'll be sequential growth building on from there.

Just again typical Q4 to Q1 type dynamic for -- in terms of sales for PCG. Thank you, Vamil.

Vamil Divan

Okay, thank you.

Operator

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

Gary Nachman

Hi, thanks and good morning. So yes, back to ILUVIEN and YUTIQ. I'm also trying to better understand the guidance of the $97 million to $103 million given a lot of different moving parts that you have that you're working through in the near-term.

So are you anticipating any issues or hiccups as you transition supply from EyePoint to Siegfried. Is that factored in there at all. And then I guess, how much do you think adding the uveitis indication for YUTIQ will help.

And also with those additional data sets coming [Technical Difficulty]. And how soon do you think those could benefit the overall franchise. And then I have one for Cortrophin.

Nikhil Lalwani

Got it. Thank you, Gary. Thank you for your question.

Yes, your first question is on the guidance. And 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 ILUVIEN and YUTIQ, and amplifying ANI's commitment to ophthalmology and retina.

Marketing materials to help physicians identify appropriate patients and also continuing to refine our approach to selling three products across the U.S. 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 are pleased that both programs will read-out preliminary top-line data in the second quarter of 2025.

If the NEW DAY results are positive, it could significantly expand the use of ILUVIEN earlier in the DME patient journey. And we have in place a robust plan for publishing and awareness building of the clinical results amongst the retina community, who are eagerly awaiting these results. 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 I'll just come back to the earlier question, you also asked about the label combination and how that will work commercially. Look, we'll look to -- I think a couple of things. First is, EyePoint is committed to working with us to support the transition and ensure patients -- and ensure continued supply security.

So that's from a supply perspective and transition. And obviously, we submitted the PAS a while ago. We knew this transition was coming.

So we are building up ILUVIEN inventory to do that, 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 YUTIQ and label -- YUTIQ and ILUVIEN transition period. We will introduce the new consolidated label whilst gradually transitioning accounts from YUTIQ to ILUVIEN for NIU-PS, and we'll do this through the sales team, marketing initiatives, and distributor communication to the accounts.

And will deliver succinct messaging on value-added customers and the retina community. I mean, look, when you merge these -- when you add the uveitis label to ILUVIEN, you consolidate to one injector right, which is the only real difference between the two implants. And it also simplifies the ordering and processes for the office.

So there is value-add to the customers, which we will reinforce. Your next question was on, sorry, I think you also had a question around the data sets in 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.

Gary Nachman

Yes. And then I just had a follow-up on Cortrophin. I mean, you're seeing a nice benefit in ophthalmology and acceleration in gout.

Just maybe just talk about how much did you add to the sales force across what indications. And how you evaluate that ROI if you think the market should really grow that much at what point you could add to that even further. Thank you.

Nikhil Lalwani

Yes, thank you. Thank you for that question, Gary. So the increase in the Cortrophin sales force, we've added about 15 to 20-ish between reps and area business directors, these are largely focused on the core indications that we initially launched with rheumatology, nephrology, neurology.

And in terms of ROI, I think as we've grown this product from over three years from [0 to $200 million] (ph) 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 -- and under Chris' leadership developed a good understanding of the -- how to drive sort of high ROI of commercial investments, right, leveraging the rare disease infrastructure that we also have in place. And also an understanding of the type of sales profile that succeeds with a product like Cortrophin.

So I think all of those come together and help us to continue sort of driving growth here. Now having said that, there is 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 spend for improving patient and physician convenience, we'll share updates on these projects as we progress them.

We've obviously talked about the prefilled syringe and launching that in getting approval for that and launching that in the second quarter. We are 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.

Gary Nachman

Great. Thanks again.

Operator

Thank you. We'll go next now to Faisal Khurshid at Leerink Partners.

Faisal Khurshid

Hi, good morning guys. Thanks for taking me on the call. I just wanted to ask, you spoke a little bit about the reimbursement changes with Medicare. Can you talk a little bit more about that and the impact.

Like, is that just the kind of Medicare Part D redesign. And how does that affect the products. And then are there other kind of product-specific kind of factors at play with regards to reimbursement that we should be considering.

Nikhil Lalwani

Yes. Good morning Faisal and thank you for your question. So this is not a redesign.

What it is to patients with Medicare and Medicare Advantage plans that had access to programs that assisted in with the offsetting the cost of the patient responsibility or the co-pay based on financial need. And these -- some of these programs have not received adequate funding yet in 2025. Now, in terms of what we're doing about this, Medicare -- look, the number of patients or the addressable market is 6 times to 10 times higher than what is being treated right now, right, less than 5,000 patients as we've discussed with you on either ILUVIEN or YUTIQ.

And so the addressable market is much, much higher. And so while we are working through this in the short-term -- and we're trying to understand how prescribers are thinking of this too. But while this is a near-term issue to work through, we remain confident of the growth prospects for our products in both DME and NIU-PS.

Faisal Khurshid

Got it. And is this dynamic specific to ILUVIEN and YUTIQ. Or does this impact Cortrophin as well.

Nikhil Lalwani

This does not impact Cortrophin because it's for Part B, and then the Part D has some of the positive tailwinds from IRA changes such as maximizing the co-pay at $2,000 and then allowing for smoothing. So that's -- those changes are impacting the Part D of Medicare. However, this is pure to your question, these programs provide assist with the cost setting, the cost of patient responsibilities also for other products, not just ILUVIEN and YUTIQ.

Operator

We go next now to Oren Livnat at H. C. Wainwright.

Oren Livnat

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 YUTIQ and ILUVIEN again.

I'm just a little confused. So hopefully you can help me understand this transition. You mentioned transitioning YUTIQ 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 – ongoing supply as you transition. Or do you intend to continue long-term manufacturing YUTIQ at Siegfried. Also, how close are you threading the needle regarding this supply agreement and -- with EyePoint 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 period to happen as well. And then I have a follow-up.

Nikhil Lalwani

Hi, Oren, thank you for your question and thank you for joining despite being under the weather. So I think the first question was on the transfer of manufacturing to Siegfried. The way we are transferring the manufacturing to Siegfried is by adding the label, the indication of uveitis -- sorry, chronic non-infectious uveitis affecting posterior segment of the eye to the ILUVIEN 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% milligrams of fluocinolone acetonide. And so the only real difference between the two is ILUVIEN has a newer manufacturing process that has a slightly different strength.

So essentially that we will have one product, which is ILUVIEN. That ILUVIEN product will have both indications on the label, diabetic macular edema as well as chronic non-infectious affecting posterior segment of the eye. Siegfried already manufactures ILUVIEN and we'll continue manufacturing ILUVIEN.

Anticipating this potential label consolidation, we extended the Siegfried manufacturing agreement by 5 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 ILUVIEN inventory, right, to allow for the transition.

And as I said to you, EyePoint 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 -- we've agreed for -- both EyePoint and ANI 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 addition, right, even before we submitted the PAS. And then we've been having ongoing dialogue with them to ensure that -- we understand what they're asking for. And look, you can read the tea leaves and we've been satisfactory answering the questions that they've been asking on the label.

So that's why -- Q2, we expect approval of this PAS, and we'll transition from YUTIQ to -- from selling both YUTIQ and ILUVIEN to only selling ILUVIEN. And then your third question was on physicians and what they actually use and the fact that there are two implanters. But we believe that there is significant value-add to customers and simplicity because there is consolidation to one injector into for the retina community.

And for the offices, who buy and build this, they can -- it simplifies the ordering and processes. They don't have two SKUs to maintain, they can only maintain one. So we think that this is actually a value-add to our customers and the retina community.

Thank you, Oren.

Oren Livnat

Okay. And just so I can get some clarity on that last point, aside from the simplicity of having 1 product instead of 2, is the procedure the same for each relative indication across different, I guess injectors. Is there any reason -- would doctors who are already using YUTIQ now for NIU switching to ILUVIEN have to do anything differently.

Nikhil Lalwani

Not in any material way. I mean, there's slight difference, but nothing material. And lot of the retina physicians have the ability to use different kind of inserts, right. This is not the only -- so they do use different kinds of inserts for products.

So the ability to -- and these are substantially similar. So the ability to sort of learn to slight tweak or change, we don't think that that's material. And obviously, look again, to be clear Alimera contemplated this even well before our acquisition.

If ANI had never acquired Alimera, this is exactly what they would have done. And they obviously as -- and we've just picked up from where they left off, right in terms of merge -- the consolidation of the two labels.

Oren Livnat

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.

Nikhil Lalwani

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

Oren Livnat

Okay. And lastly, I appreciate all the time. On Cortrophin, how important is that one-milliliter prefilled syringe launch assuming it's approved.

Do you know what share Acthar's similar SelfJect product has achieved since launch. And assuming some new uptake or switching from the 5 milliliter vial, to your prefilled syringe, would there be any material impact on average net selling price per patient potentially.

Nikhil Lalwani

Yes. And thank you for your question. Look, we are introducing the prefilled syringe to enhance physician and patient convenience.

But no, the five ml vial is a -- requires a multi-step administration. And so what the prefilled syringe does is reduces one step in the administration process for the patients. And so that's helpful to them. And so there is a subset of patients that have -- for whom it is helpful to have one less step in the administration process.

And that's the new presentation that we're bringing to the market. We believe that this will continue as we had done with the 1 ml vial that we launched for acute gouty arthritis flare, where it was focused on acute gouty arthritis flares. We believe that this will continue to present -- offer new presentations and options for different segments of patients and will drive overall growth of the ACTH market.

And that's how we see the launch of the approval and launch of the prefilled syringe. And as we said, that we're continuing to look into other -- explore other ideas for improving patient and physician convenience, and we'll look forward to sharing updates on these projects as we progress them.

Oren Livnat

All right. Thanks so much.

Nikhil Lalwani

Thank you Oren. I hope you feel better.

Operator

We'll go next now to Les Sulewski at Truist Securities.

Jeevan Larson

Hi, good morning thank you for taking my questions. This is Jeevan on for Les. Are there any developments that could potentially disrupt the Cortrophin market given its growth.

And do you see potential for synthetic versions or other pipeline products potentially from overseas competitors. Thank you.

Nikhil Lalwani

Yes. Thank you, Jeevan. And good morning.

Yes. Look, the ACTH market has returned to growth. The -- if you add our guide -- if you take our actuals and add the competitor's guidance that they last reported in November, this market is seeing north of around 25% growth to $660 million.

And you hear their rhetoric and what we are seeing, and essentially, we're all talking about -- we're both talking about increasing awareness of the ACTH therapy for the appropriate patients. And then the data point that we shared, which is when you look at number of patients on therapy today, it's about half, the number of patients on therapy that were at the peak. And from an epidemiological perspective, we are much lower than the addressable -- than what the addressable market was, right.

So the -- again, the opportunity is very substantial. And I think a data point -- a new data point that we shared for the first time today is that almost 40% of our prescribers are HCPs that were naive to ACTH. So our ability to get to -- 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 as -- over the last three years. So I think that tells you about sort of the -- why we continue to believe and continue to invest behind the long-term multiyear growth trajectory of the ACTH market.

And regarding competition, look, I would say that for both products, the competitor and ours, we've continued to see this over time that it is just tough to bring a generic or a biosimilar to this product. So I think that path to genericization and both the competitor and us have added IP to strengthen, and so obviously, we keep tracking this from a competitive standpoint. We just -- we do see that the outlook for the ACTH category is one where -- it will be two of our -- the 2 competitors trying to continue to build awareness and bring this therapy to patients in need.

Thank you, Jeevan.

Operator

[Operator Instructions] We'll go next now to Glen Santangelo with Jefferies.

Glen Santangelo

Hi, good morning. Thanks for taking my questions. Maybe I'll ask just a quick one on the Generics business, you probably 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 [Technical Difficulty]. And what I was really hoping that you could do is maybe just sort of unpack that growth algorithm for me and give us a sense for maybe how much of that you expect to come from maybe organic volumes and price versus new product launches, maybe fully appreciating the comments you made on the timing on Prucalopride, the tablets that you just recently launched and how that may impact the first half versus the second half.

Thank you.

Nikhil Lalwani

Yes. Thank you, Glen, and thank you. Great to have you on our call for the first time.

So appreciate that. Regarding the generics business, look, I think it is a combination of 2 or 3 things that's helping us drive low double-digit growth this year. I think first and foremost is the new product launch cadence that we have.

We launched 17 new products in 2024, we'll obviously see the full year impact of those launches. We launched them at different points in the year. Second is the launches that we'll do this year, right, including Prucalopride, right, which gives us a -- with 180 days of exclusivity. What you will see is that the generics business sales because of the 180 days of exclusivity, we'll see a jump in Q1 and Q2.

And so -- but there are other launches through the year. So I think it's a combination of the annualization of the [17, 2024] (ph) launches, the new launches from 2025 and you balance the erosion that we'll see in the, what I call, the class of 2023 and before products from additional competition. And that's -- I think that's typical generic pricing as you're well aware of.

Now to your question, all of our growth will largely come from volumes, rather -- sort of new volumes either from new product launches or from taking additional share in products that were already in the market for. But there is -- in the guidance that we've shared of low double-digit, there isn't any material positive benefit from warning letters or whatever the -- any supply related issues that competitors may have.

Glen Santangelo

Okay, thanks a lot. Nikhil.

Nikhil Lalwani

Thank you Glen. Thank you for joining.

Operator

Thank you. And ladies and gentlemen, it appears we have no further questions this morning. Mr.

. Lalwani, I'll turn things back to you for any closing comments.

Nikhil Lalwani

Thank you, Bo. 2024 was a record year for our business and we expect to continue building on this momentum in 2025. Both Cortrophin Gel and generics and our ophthalmology franchise are already off to a good start and are leading us to raise our 2025 outlook.

I'm confident that ANI is well-positioned to deliver another year of strong revenue growth and profitability in 2025. We look forward to seeing many of you in-person next month at the Raymond James Annual Institutional Investor Conference in Orlando and the Leerink Global Health care Conference in Miami Beach. Thank you for joining us today. Thank you.

Operator

Thank you very much, Mr. . Lalwani. Again, ladies and gentlemen, that will conclude today's ANI Pharmaceuticals fourth quarter 2024 earnings results call.

Again, thanks so much for joining us, everyone, and we wish you all a great day. Goodbye.