ANI Pharmaceuticals - Earnings Call - Q4 2024

Executive Summary

• Record quarter: total net revenues $190.6M (+44.8% YoY), adjusted non-GAAP EBITDA $50.0M (+65.7% YoY), and adjusted diluted EPS $1.63; GAAP diluted loss per share $(0.55) as mix and Alimera inventory step-up weighed on GAAP gross margins.
• Rare Disease momentum: Cortrophin Gel $59.4M (+42.3% YoY), first full quarter of ILUVIEN/YUTIQ $27.6M; Generics $78.6M (+9.4% YoY); Brands $19.8M (+58.9% YoY).
• Guidance raised for FY2025: total net revenue to $756–$776M, adjusted EBITDA to $190–$200M, and new adjusted EPS $6.12–$6.49; Rare Disease revenue to 48–49% of company, with Cortrophin Gel $265–$274M and ILUVIEN/YUTIQ $97–$103M.
• Near-term watch items: Q1 seasonal downtick in Rare Disease; Medicare access program funding changes affecting ILUVIEN/YUTIQ in Q1; PAS to add NIU-PS to ILUVIEN label targeted for Q2 2025; NEW DAY and SYNCHRONICITY top-line in Q2 2025.

What Went Well and What Went Wrong

What Went Well

• Rare Disease growth and mix: Cortrophin Gel revenue up 42.3% YoY to $59.4M, with record new patient starts and broad specialty uptake; ILUVIEN/YUTIQ $27.6M in first full quarter post-Alimera acquisition.
• Margin improvement on non-GAAP basis: non-GAAP gross margin rose to 63.5% (from 59.6%), driven by favorable product mix (Cortrophin Gel, Brands, and full-quarter ILUVIEN/YUTIQ).
• Strategic execution: Expanded ophthalmology sales force to 46 reps; manufacturing capacity expansion with Siegfried to secure ILUVIEN supply; PAS filed to consolidate YUTIQ indication onto ILUVIEN label, expected Q2 2025.

Management quotes:

• “We’re thrilled to report another year of strong execution... capped by our record fourth quarter results... we are raising our 2025 guidance...” — Nikhil Lalwani, CEO.
• “We expect preliminary top-line data from both [NEW DAY and SYNCHRONICITY] in the second quarter of 2025.” — Management on clinical catalysts.

What Went Wrong

• GAAP pressure: GAAP gross margin fell to 57.9% (from 59.4%) due to royalty-bearing products and Alimera inventory fair-value step up; GAAP diluted loss per share $(0.55) as SG&A rose with expanded sales and integration.
• ILUVIEN/YUTIQ Q1 headwinds: Medicare program funding changes reduce access for Medicare patients in early 2025; management expects Q1 to be below Q4 before sequential improvement in Q2.
• Elevated operating expenses: Non-GAAP SG&A +41.8% to $54.8M and non-GAAP R&D +68.1% to $16.2M from clinical spend and commercial build-out; GAAP SG&A +56.8% to $69.7M.

Transcript

Operator (participant)

Good morning, everyone. Welcome to today's ANI 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 ANI Pharmaceuticals. Please go ahead, ma'am.

Lisa Wilson (Founder and CEO)

Thank you. Welcome to ANI Pharmaceuticals Q4 2024 earnings results call. This is Lisa Wilson of In-Site Communications, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Stephen Carey, Chief Financial Officer; and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business. You can also access the webcast of this call through the investor section of the ANI website at anipharmaceuticals.com. Before we get started, I would like to remind everyone that any statement made on today's conference call that expresses a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.

These forward-looking statements are based on information available to ANI Pharmaceuticals Management as of today and involve risks and uncertainties included in those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website at anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 28th, 2025. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. With that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani (President and CEO)

Thank you, Lisa. Good morning, everyone, and thank you for joining us. 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, Cortrophin Gel, and ILUVIEN and YUTIQ, which we recently added through the acquisition of Alimera. Finally, Stephen 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 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-$776 million, which represents growth of 23%-26% over 2024 versus our prior guidance of $739 million-$759 million. We expect adjusted non-GAAP EBITDA of $190 million-$200 million, which reflects growth of 22%-28% over 2024 versus our prior guidance of $182 million-$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. 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, a 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 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 Cortrophin Gel revenues to grow between 34% and 38% to $265 million-$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 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. 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 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 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 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 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 mg of fluocinolone and YUTIQ having 0.18 mg of fluocinolone.

In fact, the clinical trials for both NIU-PS and DME were run on implants with 0.18 mg of fluocinolone acetonide. The newer manufacturing process used exclusively for ILUVIEN results in a strength of 0.19 mg per implant. We engaged with the FDA prior to the PAS submission in order to understand the regulatory requirements and submit 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 multi-year growth trajectory. In conjunction with these initiatives, ANI and EyePoint have agreed to non-renewal 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 six to 10x higher based on epidemiological data. 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-$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 number two 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 would 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 now turn the call over to Chris Mutz, our Head of Rare Disease. Chris?

Chris Mutz (SVP and Head of Rare Disease)

Thank you, Nikhil, and good morning, everyone. Our rare disease team drove strong demand for Cortrophin Gel in the fourth quarter. We 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 Cortrophin Gel is the only approved ACTH therapy, also continued to ramp and now represents approximately 15% of Cortrophin Gel use. Notably, gout is serving as a gateway indication for many physicians that are new to ACTH therapy. For approximately 15% of healthcare professionals prescribing Cortrophin Gel for the first time, a gout patient is their first patient on therapy. We expect the gout indication to remain a key growth driver for Cortrophin Gel in 2025. As Nikhil mentioned, we believe Cortrophin Gel is on a strong 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 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 larger 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're also investing in initiatives to improve patient and physician convenience. We have a prefilled syringe under FDA review that we expect to launch in the second quarter of 2025. The prefilled syringe will provide benefits to patients and physicians by reducing the steps needed for self-administration. We're excited about the potential of this new presentation and look forward to making the Cortrophin Gel prefilled syringe available in the second quarter as we continue to advance our rare disease portfolio. We're also exploring other ideas to enhance convenience for patients starting on Cortrophin Gel and the healthcare providers who treat them, and we look forward to sharing more details on these initiatives in the future. Overall, we believe in and are committed to investing in the Cortrophin Gel franchise and continuing to deliver strong multi-year 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. 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 a 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 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 (CFO)

Thanks, Chris, and good morning to everyone on the call. I'll review our fourth quarter results and then discuss our 2025 guidance in detail. ANI generated fourth quarter revenues of $190.6 million, up 45% over the prior year period. Beginning with this reporting period, we have redefined our reporting segments. 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 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 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 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, significant growth 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 ophthalmology sales force promoting 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 $1.00 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 2.5x 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 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-$776 million, which represents growth of 23%-26% over 2024. For Cortrophin Gel, we expect revenue of $265 million-$274 million, representing growth of 34%-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-$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 ILUVIEN and YUTIQ are expected to be impacted by both the typical Q4 to Q1 drop seen in rare disease products, as well as the added impact of the change in U.S. market access dynamics since early January. We expect this franchise to return to sequential growth in the second quarter of 2025. For generics, we anticipate low double-digit revenue growth driven by strength in our base business and contribution from new launches, including the full launch of prucalopride in early January with 180-day 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-$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-$200 million, which reflects 22%-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-affect 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.

Nikhil Lalwani (President and CEO)

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

Operator (participant)

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

David Amsellem (Managing Director and Senior Research Analyst)

Thanks. 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? 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, it has been kind of near 60/40, 50/50 brands generics, but ultimately, where are you looking to take the company longer term in terms of the brand presence? That's number one. Secondly, on Cortrophin, 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 we should think about that particular opportunity and how much it could drive the business in 2025 and beyond. Thanks.

Nikhil Lalwani (President and CEO)

Good morning, David, and thank you for your questions. Your first question on BD and M&A, as we have shared before, in terms of the areas, we would focus our BD M&A efforts on rare disease. Your second part of the question was, what is the deal capacity and where are we willing to take pro forma leverage? If you look at ANI's history and as we built the company and done two acquisitions as well as launched our lead rare disease product, you will see that this management team is very thoughtful about the leverage ratio, the net leverage ratio, and what we're willing to extend that to. Historically, it has always been kept under three.

At some points, for short periods of time, such as during the launch of Cortrophin Gel, it went slightly above, but then quickly de-levered. As you look at how we did the Alimera Sciences acquisition and refinancing of the loan and putting in place a more efficient capital structure, I think that our intent, and we believe it gives us the ability to pursue additional BD and M&A while not straining the balance sheet. That is 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. 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.

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 generics business. 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. That is point number two. The third question on gout, I think just two data points to share. 15% of the volume of Cortrophin currently is coming from gout.

As Chris talked about, gout is ending up being a gateway in some ways with 15% of prescribers writing their first that 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.

David Amsellem (Managing Director and Senior Research Analyst)

Thank you.

Operator (participant)

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

Vamil Divan (Senior Biopharmaceuticals Research Analyst)

Great. Thanks for taking the question. 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 on kind of 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 the $100 million or so in the midpoint is not really much year-over-year growth from where you left in the fourth quarter. How should we think about the longer-term impact of this access issue and kind of the year-over-year growth? Maybe looking at 2026 and 2027, for example. 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? Looks like your initial trends are good for the year. If you're raising your guidance partially based on that, should we think about any sort of seasonality impact in Q1? Maybe you can just comment on how should we think about quarter-to-quarter growth for that franchise as well. Thanks.

Nikhil Lalwani (President and CEO)

Yeah.

Good morning, [audio distortion]. Thank you for your question. Your first question on the ILUVIEN YUTIQ access issues. In the past, patients with Medicare and Medicare Advantage plans had access to programs that assisted with offsetting the cost of the patient responsibility based on financial need. Some of these programs have not received adequate funding yet in 2025. In terms of what ANI is doing about it, first and foremost, ANI has in place a patient assistance program that provides access for patients in financial need with free ILUVIEN and YUTIQ as needed. Secondly, we're spending time with our ACPs to understand their response to these market access changes and refining our commercial approach accordingly. You asked a great question about what's the outlook.

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. We estimate that the addressable patient population for each drug is approximately six to 10x higher based on epidemiological data. 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. 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, right?

We built momentum early and is one of the reasons why we raised our guidance that we had shared a few weeks ago. You will see a drop, but then there will be sequential growth building on from there. Just again, typical Q4 to Q1 type dynamic in terms of sales for PCG. Thank you, Vamil.

Vamil Divan (Senior Biopharmaceuticals Research Analyst)

Okay. Thank you.

Operator (participant)

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

Gary Nachman (Managing Director and Biopharma or Biotech Equity Research Analyst)

Hey, thanks. Good morning. Yeah, back to ILUVIEN and YUTIQ. I'm also trying to better understand the guidance of the $97 million-$103 million given a lot of different moving parts that you have that you're working through in the near term. Are you anticipating any issues or hiccups as you transition supply from EyePoint to Siegfried? Is that factored in there at all?

I guess, how much do you think adding the uveitis indication for YUTIQ will help? Also, with those additional data sets coming, how much could those help? How soon do you think those could benefit the overall franchise? I have one for Cortrophin.

Nikhil Lalwani (President and CEO)

Got it. Thank you, Gary. Thank you for your question. Yeah. Your first question is on the guidance. As we've talked about, there are several commercial, clinical, and operational initiatives that will drive the significant quarter-on-quarter ramp for the rest of 2025 and beyond as we work through the access issues that we're seeing in early January as well as the transitions.

Commercially, as you would expect with an acquisition and integration like this, we've made positive changes to, and Chris spoke a little bit about this, and strengthened the peer-to-peer education programs for further increasing awareness of ILUVIEN, 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. In the international markets, we're investing in high ROI activities such as expansion of the team in Germany and providing increased support for our partner products. You then asked about New Day. 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 ILUVIEN 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 assumed a tailwind from New Day results in our 2025 guidance. I'll just come back to the earlier question you also asked about the label combination and how that'll 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 ensure continued supply security. 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 ILUVIEN inventory to do that. We talked a lot about Siegfried and the capacity expansion there. From a commercial perspective, we will drive fast and broad awareness of the label consolidation during the YUTIQ and ILUVIEN transition period. We will introduce the new consolidated label while gradually transitioning accounts from YUTIQ to ILUVIEN for NIU-PS. We will do this through the TLT marketing initiatives and distributor communication to the accounts. We will deliver succinct messaging on value at the 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. It also simplifies the ordering and processes for the office. 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 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.

Gary Nachman (Managing Director and Biopharma or Biotech Equity Research Analyst)

Yeah. Yeah. No, that's great. 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 (President and CEO)

Thank you for that question, Gary. The increase in the Cortrophin sales force, we've added about 15-20-ish between reps and area business directors.

These are largely focused on the core indications that we initially launched with: rheumatology, nephrology, neurology. In terms of ROI, I think as we've grown this product from over three years from 0 to $200 million, and we've driven growth across both the specialties we targeted at launch, which is rheumatology, neurology, and nephrology, as well as the newer specialties of pulmonology and ophthalmology, I think we've developed, and under Chris's leadership, developed a good understanding of 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 the type of sales profile that succeeds with a product like Cortrophin. 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? 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, 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. What we already talked about, which is the high ROI commercial spend, such as expansion of our Cortrophin sales team to drive the growth of the core specialties targeted at launch. Thank you, Gary.

Gary Nachman (Managing Director and Biopharma or Biotech Equity Research Analyst)

Great. Thanks, Nikhil.

Operator (participant)

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

Faisal Khurshid (Equity Research Analyst)

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? Are there other kind of product-specific kind of factors at play with regards to reimbursement that we should be considering?

Nikhil Lalwani (President and CEO)

Yeah. Good morning, Faisal, and thank you for your question. Look, this is not a redesign. What it is, is patients with Medicare and Medicare Advantage plans that had access to programs that assisted with offsetting the cost of the patient responsibility or the copay based on financial need. 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 for the addressable market is six to 10x 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. The addressable market is much, much higher. While we're working through this in the short term, we're trying to understand how prescribers are thinking of this too. 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 (Equity Research Analyst)

Got it. Is this dynamic specific to ILUVIEN and YUTIQ or does this impact Cortrophin as well?

Nikhil Lalwani (President and CEO)

No, this does not impact Cortrophin because it's for Part B.

Part B has some of the positive tailwinds from IRA changes, such as maximizing the copay at $2,000 and allowing for smoothing. Those changes are impacting the Part B of Medicare. However, this is 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.

Faisal Khurshid (Equity Research Analyst)

Got it. That's helpful. Thanks.

Nikhil Lalwani (President and CEO)

Thank you, Faisal.

Operator (participant)

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

Oren Livnat (Managing Director and Senior Equity Research Analyst)

Thanks. Apologies in advance. I have a really bad cough now, so I 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. I'm just trying to understand, is this just supporting its 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 end with EyePoint and then this new indication and switch? 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? Do these have different costs or access, which maybe would cause some insurance transition period to happen as well? I have a Cortrophin follow-up.

Nikhil Lalwani (President and CEO)

Got it. Good morning, Oren, and thank you for your question, and thank you for joining despite being under the weather.

I think the first question was on the transfer of manufacturing to Siegfried. The way we are transferring the manufacturing to Siegfried is by adding the label of the indication of uveitis or, 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 mg of fluocinolone acetonide. The only real difference between the two is the ILUVIEN has a newer manufacturing process that has a slightly different strength. Essentially, 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 uveitis affecting posterior segment of the eye. Siegfried already manufactures ILUVIEN and will continue manufacturing ILUVIEN.

Anticipating this potential label consolidation, we extended the Siegfried manufacturing agreement by five years to 2029, upgraded the equipment on the existing manufacturing line, as well as are adding a second manufacturing line. All those initiatives are on track. We've known that this label consolidation is coming, and we've been building up ILUVIEN inventory, right, to allow for the transition. 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. We've talked through the inventory transition and have been preparing for it. 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. We have been having ongoing dialogue with them to ensure that we understand what they're asking for. Look, you can read the tea leaves, and we've been satisfactorily answering the questions that they've been asking on the label. That is why Q2, we expect approval of this PAS, and we will transition from selling both YUTIQ and ILUVIEN to only selling ILUVIEN. Your third question was on 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 is consolidation to one injector for the retina community. For the offices who buy and bill this, it simplifies the ordering and processes. They do not have two SKUs to maintain.

They can only maintain one. We think that this is actually a value add to our customers and the retina community. Thank you, Oren.

Oren Livnat (Managing Director and Senior Equity Research Analyst)

Okay. 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 YUTIQ now for NIU switching to ILUVIEN have to do anything differently?

Nikhil Lalwani (President and CEO)

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

The ability to—and these are substantially similar—the ability to sort of learn the slight tweak or change, we do not think that is material. Obviously, look, again, to be clear, Alimera contemplated this well before our acquisition. If ANI had never acquired Alimera, this is exactly what they would have done. They obviously—and we have just picked up from where they left off, right, in terms of the consolidation of the two labels. Yep.

Oren Livnat (Managing Director and Senior Equity Research Analyst)

Again, to clarify, is the insurance coverage and cost similar or identical for these products? The transition should not be disruptive on that front, or in theory, could there even be tailwinds with pricing differences?

Nikhil Lalwani (President and CEO)

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

Oren Livnat (Managing Director and Senior Equity Research Analyst)

Yeah. Okay. Lastly, I appreciate all the time on Cortrophin.

How important is that 1 mL prefilled syringe launch, assuming it's approved? Do you know what share Acthar Similar Self-Ject product has achieved since launch? And assuming some new uptake or switching from the 5 mL vial to your prefilled syringe, would there be any material impact on average net selling price per patient, potentially?

Nikhil Lalwani (President and CEO)

Yeah. Thank you for your question. Look, we are introducing the prefilled syringe to enhance physician and patient convenience. The 5 mL vial requires a multi-step administration. What the prefilled syringe does is reduce one step in the administration process for the patients. That is helpful to them. There is a subset of patients for whom it is helpful to have one less step in the administration process. That is a 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 flares. We're 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. That's how we see the approval and launch of the prefilled syringe. As we said, we're continuing to look into 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 (Managing Director and Senior Equity Research Analyst)

All right. Thanks so much.

Nikhil Lalwani (President and CEO)

Thank you, Oren. I hope you feel better.

Operator (participant)

Thank you. We'll go next now to Les Salusky at Truist Securities.

Jeevan Larson (Equity Research Associate)

Hey, 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 (President and CEO)

Yeah. No, thank you, Jeevan. And good morning. Yeah. Look, the ACTH market has returned to growth. 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 around 25% growth to $660 million. You hear their rhetoric and what we're saying. Essentially, we're all talking about—we're both talking about increasing awareness of the ACTH therapy for the appropriate patients. The data point that we shared, which is when you look at the number of patients on therapy today, it's about half the number of patients on therapy that were at the peak.

From an epidemiological perspective, we're much lower than what the addressable market was, right? The opportunity is very substantial. I think a new data point that we shared for the first time today is that almost 40% of our prescribers are ACPs that were naive to ACPH. 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 over the last three years. 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 ACPH market.

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. I think that path to genericization and both the competitor and us have added IP to strengthen. Obviously, we keep tracking this from a competitive standpoint. We do see that the outlook for the ACTH category is one where it'll be two of the two competitors trying to continue to build awareness and bring this therapy to patients in need. Thank you, Jeevan.

Operator (participant)

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

Glen Santangelo (Managing Director)

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. I'm just trying to reconcile some of your comments that you made with respect to the outlook for fiscal 2025 in terms of assuming continued double-digit growth. 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. Thanks.

Nikhil Lalwani (President and CEO)

Yeah. Thank you, Glen. And thank you.

Great to have you on our call for the first time. 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. 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. Second is the launches that we'll do this year, right, including prucalopride, right, which gives us with 180 days of exclusivity. What you will see is that the generics business sales, because of the 180 days of exclusivity, will see a jump in Q1 and Q2. There are other launches through the year.

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. 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. In the guidance that we have shared of low double-digit, there isn't any material positive benefit from warning letters or 483s, whatever any supply-related issues that competitors may have.

Glen Santangelo (Managing Director)

Okay. Thanks a lot, Nikhil.

Nikhil Lalwani (President and CEO)

Thank you, Glenn. Thank you for joining.

Operator (participant)

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 (President and CEO)

Thank you both. 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 Healthcare Conference in Miami Beach. Thank you for joining us today. Thank you.

Operator (participant)

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.