Q4 2025 ANI Pharmaceuticals Inc Earnings Call

February 27, 2026

Operator: Please stand by. Your program is about to begin. Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. Q4 and Full Year 2025 Earnings Results Call. Please note this call is being recorded. After the speaker's prepared remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star 1 on your telephone keypad. If you would like to withdraw your question, please press star 2 on your telephone keypad. It is now my pleasure to turn the conference over to Courtney Mobergley. Please go ahead.

Speaker #2: Please stand by. Your program is about to begin. Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. fourth quarter and full year 2025 earnings results call.

Speaker #2: Please note, this call is being recorded. After the speakers' prepared remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad.

Speaker #2: If you would like to withdraw your question, please press the star key, then number two on your telephone keypad. It is now my pleasure to turn the conference over to Courtney Moberly.

Speaker #2: Please go ahead. Thank you, Erica. Welcome to ANI Pharmaceuticals' fourth quarter and full year 2025 earnings results call. This is Courtney Moberly, Investor Relations for ANI.

Courtney Mogerly: Thank you, Erica. Welcome to ANI Pharmaceuticals Q4 and full year 2025 earnings results call. This is Courtney Mogerly, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Stephen Carey, Senior Vice President and 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. This call is accompanied by a slide deck that can be accessed by going to the Events section of the Investors page of our website. You can turn to our forward-looking statements on slide two.

Speaker #2: With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Stephen Carey, Senior Vice President and Chief Financial Officer; and Chris Metz, Senior Vice President and Head of ANI's Rare Disease Business.

Speaker #2: You can also access the webcast of this call through the Investors section of the ANI website at anipharmaceuticals.com. This call is accompanied by a slide deck that can be accessed by going to the Events section of the Investors page of our website.

Speaker #2: You can turn to our forward-looking statements on Slide 2. Before we begin, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.

Courtney Mogerly: Before we begin, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI Pharmaceuticals' management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. During this call, we will also refer to certain non-GAAP financial measures.

Speaker #2: These forward-looking statements are based on information available to ANI's Pharmaceuticals Management as of today, and involve risks and uncertainties including those noted in our press release issued this morning and are filings with the SEC.

Speaker #2: 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.

Speaker #2: During this call, we will also refer to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered as an alternative to financial measures required by GAAP.

Courtney Mogerly: These non-GAAP financial measures should not be considered as an alternative to financial measures required by GAAP. The non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measures in a table available on the slide deck accompanying this call. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on 27 February 2026. Since then, ANI may have made announcements related to the topics discussed, please reference the company's most recent press releases and SEC filings. With that, I'll turn the call over to Nikhil Awani.

Speaker #2: The non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measures in a table available on the slide deck accompanying this call.

Speaker #2: The archived webcast will be available for 30 days on our website, anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 27, 2026.

Speaker #2: 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.

Speaker #3: Thank you, Courtney. Good morning, everyone, and thank you for joining us. 2025 was another year of outstanding execution and growth by the ANI team.

Nikhil Lalwani: Thank you, Courtney. Good morning, everyone. Thank you for joining us. 2025 was another year of outstanding execution and growth by the ANI team, highlighted by our remarkable results in Q4. At the core of everything we do is our purpose of serving patients, improving lives. With our progress in the last year, we are well-positioned to continue delivering on that purpose in 2026 and beyond. Starting with slide four. In 2025, the company delivered record revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS, driven by strong performance across our rare disease and genetics business units. For the full year, we grew total company revenues by 44% year-over-year and adjusted non-GAAP EBITDA by 47% year-over-year.

Speaker #3: Highlighted by our remarkable results in the fourth quarter. At the core of everything we do is our purpose of serving patients, improving lives. With our progress in the last year, we are well positioned to continue delivering on that purpose in 2026 and beyond.

Speaker #3: Starting with slide four, in 2025, the company delivered record revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP W to DPS, driven by strong performance across our Rare Disease and Genetics business units.

Speaker #3: For the full year, we grew total company revenues by 44% year over year and adjusted non-GAAP EBITDA by 47% year over year. In addition, we delivered exceptional growth for our lead rare disease asset, Cortrofin, with full-year revenues up 76% year over year as we meaningfully expanded our reach in under-penetrated specialty indications and served more patients.

Nikhil Lalwani: In addition, we delivered exceptional growth for our lead rare disease asset, Cortrophin, with full-year revenues up 76% year-over-year, as we meaningfully expanded our reach in under-penetrated specialty indications and served more patients. With our strong R&D and operational capabilities, our generics business continued to outperform, growing 28% year-over-year in 2025. Turning to slide 5. We believe the momentum we generated in 2025 positions us for continued growth in 2026. Our priorities for this year are threefold. First and foremost, ANI's transformation into a leading rare disease company. For our lead asset, Cortrophin Gel, we plan to maximize its multi-year growth opportunity by addressing the significant unmet need across indications. We will continue to build on our momentum in the key under-penetrated specialty indications in nephrology, neurology, rheumatology, ophthalmology, and pulmonology.

Speaker #3: With our strong R&D and operational capabilities, our Generics business continued to outperform, growing 28% year over year in 2025. Turning to slide five, we believe the momentum we generated in 2025 positions us for continued growth in 2026.

Speaker #3: Our priorities for this year are threefold. First and foremost, ANI's transformation into a leading rare disease company. For our lead asset, Cortrofin Gel, we plan to maximize its multi-year growth opportunity by addressing the significant unmet need across indications.

Speaker #3: We will continue to build on our momentum in the key under-penetrated specialty indications in nephrology, neurology, rheumatology, ophthalmology, and pulmonology. In addition, we're building and deploying a 90-person organization dedicated to acute gouty arthritis flares.

Nikhil Lalwani: In addition, we're building and deploying a 90-person organization dedicated to acute gouty arthritis flares. With this expansion, we plan to capture sizable and unique additional opportunity in gout through expanding awareness and adoption of Cortrophin for appropriate patients by newly identified physicians in podiatry and primary care. For ILUVIEN, we are focused on returning the product to growth by leveraging the commercial and patient access initiatives established in 2025. Importantly, we continue to believe in the long-term potential of ILUVIEN, as we believe the addressable patient populations across DME and NIU-PS are at least 10x the current number of patients treated with ILUVIEN today. Our second priority is continued execution in our generics business by leveraging our superior R&D capabilities, operational execution, US-based manufacturing and business development expertise, as well as maintaining our current cadence of 10 to 15 launches annually.

Speaker #3: With this expansion, we plan to capture sizable and unique additional opportunity in gout through expanding awareness and adoption of Cortrofin for appropriate patients by newly identified physicians in podiatry and primary care.

Speaker #3: For Illuvian, we are focused on returning the product to growth by leveraging the commercial and patient access initiatives established in 2025. Importantly, we continue to believe in the long-term potential of Illuvian, as we believe the addressable patient population across DME and NIUPS is at least 10x the current number of patients treated with Illuvian today.

Speaker #3: Our second priority is continued execution in our genetics business by leveraging our superior R&D capabilities, operational execution, U.S.-based manufacturers, and business development expertise, as well as maintaining our current cadence of 10 to 15 launches annually.

Speaker #3: We continue to make progress on this priority and anticipate another year of strong performance and cash generation from our genetics business, which will enable us to further invest in our rare disease business.

Nikhil Lalwani: We continue to make progress on this priority and anticipate another year of strong performance and cash generation from our generics business that will enable us to further invest in our rare disease business. Our third priority is executing a disciplined capital allocation strategy. We are focused on driving organic growth by investing in our dedicated organization for Cortrophin in acute gouty arthritis flares and investing a high single-digit percentage of generics revenue into generics R&D, and to drive inorganic growth by exploring opportunities to expand the scope and scale of our rare disease business. Turning to slide 6. We believe the 3 2026 strategic priorities will drive long-term growth and value creation for the company. In 2026, we expect to deliver over $1 billion in revenue, representing 23% growth over 2025 at the midpoint of our guidance range.

Speaker #3: Our third priority is executing a disciplined capital allocation strategy. We are focused on driving organic growth by investing in our dedicated organization for Cortrophin in acute gouty arthritis flares and investing a high single-digit percentage of genetics revenue into genetics R&D.

Speaker #3: And to drive inorganic growth by exploring opportunities to expand the scope and scale of our rare disease business. Turning to slide six, we believe the Q3 2026 strategic priorities will drive long-term growth and value creation for the company.

Speaker #3: In 2026, we expect to deliver over $1 billion in revenue, representing 23% growth over 2025 at the midpoint of our guidance range. Rare disease is expected to account for approximately 60% of our total revenues in 2026.

Nikhil Lalwani: Rare disease is expected to account for approximately 60% of our total revenues in 2026, with Cortrophin Gel growing 60% year-over-year. We also expect to expand the bottom line, with adjusted EBITDA forecasted to grow 23% year-over-year at the midpoint of our guidance range. Later in the call, Steve will provide more detail on our 2026 guidance. In summary, 2025 was a pivotal year for ANI as we delivered record performance and drove significant growth across the business lines. We are entering the year from a position of strength and are focused on executing on our three strategic priorities. We anticipate that our virtuous cycle of growth, in which our genetics and brands businesses generate meaningful cash flows to support our rare disease business, will drive our transformation into a leading rare disease company.

Speaker #3: With Cortrofin Gel growing 60% year over year. We also expect to expand the bottom line with adjusted EBITDA forecasted to grow 23% year over year.

Speaker #3: At the midpoint of our guidance range. Later in the call, Steve will provide more detail on our 2026 guidance. In summary, 2025 was a pivotal year for ANI, as we delivered record performance and drove significant growth across the business lines.

Speaker #3: We are entering the year from a position of strength and our focus on executing on our three strategic priorities. We anticipate that our virtuous cycle of growth, in which our genetics and brands businesses generate meaningful cash flows to support our rare disease business, will drive our transformation into a leading rare disease company.

Speaker #3: I'll now turn the call to Chris to discuss our Rare Disease business in more detail. Chris? Thank you, Nikhil, and good morning, everyone. Starting with slide seven—looking at 2025—I'm proud of our team as we closed out the year strong, delivering another excellent quarter.

Nikhil Lalwani: I'll now turn the call to Chris to discuss our rare disease business in more detail. Chris?

Christopher Mutz: Thank you, Nikhil. Good morning, everyone. Starting with slide 7. Looking at 2025, I'm proud of our team as we closed out the year strong, delivering another excellent quarter, marked by significant growth for Cortrophin Gel as we expanded our reach in under-penetrated specialty indications. During Q4, the number of cases initiated and new patient starts reached another record high. We saw broad growth across all of our targeted specialties: rheumatology, nephrology, neurology, pulmonology, and ophthalmology. Prescribing for Cortrophin Gel and acute gouty arthritis flares remained a key growth driver this quarter. This indication is unique to Cortrophin Gel among ACTH therapies and represented approximately 15% of total utilization. Notably, gouty arthritis has also been a strong catalyst for new prescriber additions, including many providers who were previously unfamiliar with ACTH.

Chris Mutz: Thank you, Nikhil. Good morning, everyone. Starting with slide 7. Looking at 2025, I'm proud of our team as we closed out the year strong, delivering another excellent quarter, marked by significant growth for Cortrophin Gel as we expanded our reach in under-penetrated specialty indications. During Q4, the number of cases initiated and new patient starts reached another record high. We saw broad growth across all of our targeted specialties: rheumatology, nephrology, neurology, pulmonology, and ophthalmology. Prescribing for Cortrophin Gel and acute gouty arthritis flares remained a key growth driver this quarter. This indication is unique to Cortrophin Gel among ACTH therapies and represented approximately 15% of total utilization. Notably, gouty arthritis has also been a strong catalyst for new prescriber additions, including many providers who were previously unfamiliar with ACTH.

Speaker #3: Marked by significant growth for Cortrofin Gel as we expanded our reach in under-penetrated specialty indications. During the fourth quarter, the number of cases initiated and new patient starts reached another record high.

Speaker #3: And we saw broad growth across all of our targeted specialties: rheumatology, nephrology, neurology, pulmonology, and ophthalmology. Prescribing for Cortrofin Gel in acute gouty arthritis flares remained a key growth driver this quarter.

Speaker #3: This indication is unique to Cortrophin Gel among ACTH therapies and represented approximately 15% of total utilization. Notably, gouty arthritis has also been a strong catalyst for new prescriber additions, including many providers who were previously unfamiliar with ACTH.

Speaker #3: We also continue to realize meaningful revenue synergies in ophthalmology. In the fourth quarter, Cortrofin Gel volumes in ophthalmology were over two times that of the same period a year ago.

Christopher Mutz: We also continued to realize meaningful revenue synergies in ophthalmology, with Q4 Cortrophin Gel volumes in ophthalmology over 2 times that of the same period a year ago. Ophthalmology remains a fast-growing, targeted specialty for Cortrophin Gel. We believe there is further upside as we expand awareness of Cortrophin Gel for patients with severe allergic and inflammatory eye conditions. Turning to Slide 8. Looking at the market more broadly, the ACTH space has returned to growth following the launch of Cortrophin Gel in 2022, approaching $1 billion in sales in 2025. We expect it to increase significantly in 2026, with Cortrophin Gel growing by 55% to 65%. Turning to Slide 9. We continue to believe that the addressable patient populations across our key indications remain significantly underpenetrated. For example, there are roughly 10 million patients in the US with gouty arthritis.

Chris Mutz: We also continued to realize meaningful revenue synergies in ophthalmology, with Q4 Cortrophin Gel volumes in ophthalmology over 2 times that of the same period a year ago. Ophthalmology remains a fast-growing, targeted specialty for Cortrophin Gel. We believe there is further upside as we expand awareness of Cortrophin Gel for patients with severe allergic and inflammatory eye conditions. Turning to Slide 8. Looking at the market more broadly, the ACTH space has returned to growth following the launch of Cortrophin Gel in 2022, approaching $1 billion in sales in 2025. We expect it to increase significantly in 2026, with Cortrophin Gel growing by 55% to 65%. Turning to Slide 9. We continue to believe that the addressable patient populations across our key indications remain significantly underpenetrated. For example, there are roughly 10 million patients in the US with gouty arthritis.

Speaker #3: Ophthalmology remains a fast-growing targeted specialty for Cortrofin Gel and we believe there is further upside as we expand awareness of Cortrofin Gel for patients with severe allergic and inflammatory eye conditions.

Speaker #3: Turning to slide eight, looking at the market more broadly, the ACTH space has returned to growth following the launch of Cortrofin Gel in 2022 and approached $1 billion in sales in 2025.

Speaker #3: We expect to increase significantly in 2026, with Cortrofin Gel growing by 55% to 65%. Turning to slide nine, we continue to believe that the addressable patient population across our key indications remains significantly under-penetrated.

Speaker #3: For example, there are roughly 10 million patients in the US with gouty arthritis, about 36% receive treatment annually, and they have 1.5 to 2 flares on average per year.

Christopher Mutz: About 36% receive treatment annually. They have 1.5 to 2 flares on average per year. About 8% of those patients with severe gouty arthritis, an injectable treatment for their flares. This group of 285,000 patients represents our addressable patient population. Importantly, prescribers who were previously naive to ACTH represent approximately half of our total Cortrophin Gel prescriber base. This cohort continues to expand. We believe the most significant opportunity for growth is through overall expansion of the ACTH market by addressing unmet needs of appropriate patients. To capture the multi-year growth potential of Cortrophin Gel, we continue to focus on three key strategic priorities outlined on Slide 10. We are investing in high ROI commercial initiatives.

Chris Mutz: About 36% receive treatment annually. They have 1.5 to 2 flares on average per year. About 8% of those patients with severe gouty arthritis, an injectable treatment for their flares. This group of 285,000 patients represents our addressable patient population. Importantly, prescribers who were previously naive to ACTH represent approximately half of our total Cortrophin Gel prescriber base. This cohort continues to expand. We believe the most significant opportunity for growth is through overall expansion of the ACTH market by addressing unmet needs of appropriate patients. To capture the multi-year growth potential of Cortrophin Gel, we continue to focus on three key strategic priorities outlined on Slide 10. We are investing in high ROI commercial initiatives.

Speaker #3: And about 8% of those patients have severe gouty arthritis and use injectable treatment for their flares. This group of 285,000 patients represents our addressable patient population.

Speaker #3: Importantly, prescribers who were previously naïve to ACTH represent approximately half of our total Cortrofin Gel prescriber base. And this cohort continues to expand. We believe the most significant opportunity for growth is through overall expansion of the ACTH market by addressing unmet needs of appropriate patients.

Speaker #3: To capture the multi-year growth potential of Cortrophin Gel, we continue to focus on three key strategic priorities outlined on slide 10. We are investing in high-ROI commercial initiatives.

Speaker #3: Building on the commercial expansion we executed in 2025, we are now taking the next step to capture the unique opportunity for Cortrophin Gel in acute gouty arthritis flares with our new 90-person dedicated organization.

Christopher Mutz: Building on the commercial expansion we executed in 2025, we are now taking the next step to capture the unique opportunity for Cortrophin Gel and acute gouty arthritis flares with our new 90-person dedicated organization. There are several reasons why we are confident about the opportunity in acute gouty arthritis flares. As I highlighted earlier, there's a large addressable patient population of 285,000 patients. Second, Cortrophin Gel is the only approved ACTH therapy for acute gouty arthritis flares. Third, we have a proven track record in this indication. Prescribing for acute gouty arthritis flares represented approximately 15% of Cortrophin Gel use in 2025. In addition, we ran successful pilots across 10 territories in primary care and podiatry. This gave us further confidence to expand our organization to capture the opportunity in acute gouty arthritis.

Chris Mutz: Building on the commercial expansion we executed in 2025, we are now taking the next step to capture the unique opportunity for Cortrophin Gel and acute gouty arthritis flares with our new 90-person dedicated organization. There are several reasons why we are confident about the opportunity in acute gouty arthritis flares. As I highlighted earlier, there's a large addressable patient population of 285,000 patients. Second, Cortrophin Gel is the only approved ACTH therapy for acute gouty arthritis flares. Third, we have a proven track record in this indication. Prescribing for acute gouty arthritis flares represented approximately 15% of Cortrophin Gel use in 2025. In addition, we ran successful pilots across 10 territories in primary care and podiatry. This gave us further confidence to expand our organization to capture the opportunity in acute gouty arthritis.

Speaker #3: There are several reasons why we are confident about the opportunity in acute gouty arthritis flares. As I highlighted earlier, there's a large addressable patient population of 285,000 patients.

Speaker #3: Second, Cortrophin Gel is the only approved ACTH therapy for acute gouty arthritis flares. And third, we have a proven track record in this indication.

Speaker #3: Prescribing for acute gouty arthritis flares represented approximately 15% of Cortrofin Gel use in 2025. In addition, we ran successful pilots across 10 territories in primary care and podiatry.

Speaker #3: This gave us further confidence to expand our organization to capture the opportunity in acute gouty arthritis. The hiring process is underway, and we expect to deploy this team by mid-year.

Christopher Mutz: The hiring process is underway, and we expect to deploy this team by mid-year. While we anticipate the expansion to be impacting Cortrophin Gel volumes in the second half of 2026, we expect a greater impact in 2027 as the team reaches full productivity. Additionally, we continue to focus on enhancing patient convenience. Our Cortrophin Gel prefilled syringe offering, which we launched in April of last year, simplifies administration and provides a more convenient option for patients. The launch of the prefilled syringe has been well received by both patients and prescribers and continues to support broader adoption and serve as an important growth driver for Cortrophin Gel. Finally, we continue to invest in generating robust clinical evidence to support physician decision-making and confidence in Cortrophin Gel.

Chris Mutz: The hiring process is underway, and we expect to deploy this team by mid-year. While we anticipate the expansion to be impacting Cortrophin Gel volumes in the second half of 2026, we expect a greater impact in 2027 as the team reaches full productivity. Additionally, we continue to focus on enhancing patient convenience. Our Cortrophin Gel prefilled syringe offering, which we launched in April of last year, simplifies administration and provides a more convenient option for patients. The launch of the prefilled syringe has been well received by both patients and prescribers and continues to support broader adoption and serve as an important growth driver for Cortrophin Gel. Finally, we continue to invest in generating robust clinical evidence to support physician decision-making and confidence in Cortrophin Gel.

Speaker #3: While we anticipate the expansion to begin impacting Cortrofin Gel volumes in the second half of 2026, we expect it reaches full productivity. Additionally, we continue to focus on enhancing patient convenience.

Speaker #3: Our Cortrofin Gel prefilled syringe offering, which we launched in April of last year, simplifies administration and provides a more convenient option for patients. The launch of the prefilled syringe has been well received by both patients and prescribers, and continues to support broader adoption and serve as an important growth driver for Cortrofin Gel.

Speaker #3: Finally, we continue to invest in generating robust clinical evidence to support physician decision-making and confidence in Cortrofin Gel. As part of this effort, we are advancing a 150-patient phase 4 study in acute gouty arthritis flares.

Christopher Mutz: As part of this effort, we are advancing a 150 patient Phase IV study in acute gouty arthritis flares. This trial, along with ongoing collection of preclinical and real-world data across core indications, is designed to reinforce Cortrophin Gel's differentiated nonsteroidal mechanism of action and provide insights that may support adoption and treatment guidelines. We also continue to generate robust preclinical data for our key stakeholders on Cortrophin Gel's differentiated mechanism of action across multiple disease states. This remains a critical growth initiative, as expanding the body of evidence supporting Cortrophin Gel's use across indications helps physicians make more informed treatment decisions. On Slide 11, turning to our retina franchise, we are continuing to advance several initiatives to support ILUVIEN sales.

Chris Mutz: As part of this effort, we are advancing a 150 patient Phase IV study in acute gouty arthritis flares. This trial, along with ongoing collection of preclinical and real-world data across core indications, is designed to reinforce Cortrophin Gel's differentiated nonsteroidal mechanism of action and provide insights that may support adoption and treatment guidelines. We also continue to generate robust preclinical data for our key stakeholders on Cortrophin Gel's differentiated mechanism of action across multiple disease states. This remains a critical growth initiative, as expanding the body of evidence supporting Cortrophin Gel's use across indications helps physicians make more informed treatment decisions. On Slide 11, turning to our retina franchise, we are continuing to advance several initiatives to support ILUVIEN sales.

Speaker #3: This trial, along with ongoing collection of preclinical and real-world data across core indications, is designed to reinforce Cortrofin Gel's differentiated non-steroidal mechanism of action and provide insights that may support adoption and treatment guidelines.

Speaker #3: We also continue to generate robust preclinical data for our key stakeholders on Cortrofin Gel's differentiated mechanism of action across multiple disease states. This remains a critical growth initiative.

Speaker #3: As expanding the body of evidence supporting Cortrofin Gel's use across indications helps physicians make more informed treatment decisions. On slide 11, turning to our retina franchise, we are continuing to advance several initiatives to support Eluvian sales.

Speaker #3: Our fully onboarded commercial team is focused on educating and engaging the retina community, and we are ramping up peer-to-peer educational programs and field activities with updated marketing materials to enhance physician understanding of Eluvian and its two indications.

Christopher Mutz: Our fully onboarded commercial team is focused on educating and engaging the retina community, and we are ramping up peer-to-peer educational programs and field activities with updated marketing materials to enhance physician understanding of Iluvien and its two indications. In June of last year, we began promoting Iluvien under the combined label for chronic NIUPF and DME. Our sales teams have been educating customers nationwide while our market access team worked with payers to establish coverage for the new chronic NIUPF indication. All seven Medicare administrative contractors, or MACs, have now updated their policies to cover Iluvien for NIUPF. Among the top 20 commercial payers, all those with Iluvien-specific policies have updated them to reflect both DME and NIUPF indications. We also implemented initiatives to help physician practices navigate ongoing Medicare market access challenges that have persisted since January 2025.

Chris Mutz: Our fully onboarded commercial team is focused on educating and engaging the retina community, and we are ramping up peer-to-peer educational programs and field activities with updated marketing materials to enhance physician understanding of Iluvien and its two indications. In June of last year, we began promoting Iluvien under the combined label for chronic NIUPF and DME. Our sales teams have been educating customers nationwide while our market access team worked with payers to establish coverage for the new chronic NIUPF indication. All seven Medicare administrative contractors, or MACs, have now updated their policies to cover Iluvien for NIUPF. Among the top 20 commercial payers, all those with Iluvien-specific policies have updated them to reflect both DME and NIUPF indications. We also implemented initiatives to help physician practices navigate ongoing Medicare market access challenges that have persisted since January 2025.

Speaker #3: In June of last year, we began promoting Eluvian under the combined label for chronic NIUPS and DME. Our sales teams have been educating customers nationwide while our market access team worked with parents to establish coverage for the new chronic NIUPS indication.

Speaker #3: All seven Medicare Administrative Contractors, or MACs, have now updated their policies to cover Eluvian for NIUPS. Among the top 20 commercial payers, all those with Eluvian-specific policies have updated them to reflect both DME and NIUPS indications.

Speaker #3: We also implemented initiatives to help physician practices navigate ongoing Medicare market access challenges that have persisted since January 2025. As a reminder, patient support foundations such as Good Days had limited funding in 2025, affecting their ability to assist Medicare patients with copay support across retina products.

Christopher Mutz: As a reminder, patient support foundations such as Good Days, had limited funding in 2025, affecting their ability to assist Medicare patients with co-pay support across retina products. Our team has gained traction with leading retina practices, helping them explore pathways to cure ILUVIEN for eligible patients under the Medicare Part D benefit, using a specialty pharmacy, the same approach used for Cortrophin Gel access. In addition, we continued to share results from our NEW DAY study of ILUVIEN in patients with DME, which were presented at prominent medical meetings, including most recently at the FLOREtina International Congress in December and the Hawaiian Eye and Retina Conference in January. With that, I'll turn the call over to Steve for the financial update. Steve?

Chris Mutz: As a reminder, patient support foundations such as Good Days, had limited funding in 2025, affecting their ability to assist Medicare patients with co-pay support across retina products. Our team has gained traction with leading retina practices, helping them explore pathways to cure ILUVIEN for eligible patients under the Medicare Part D benefit, using a specialty pharmacy, the same approach used for Cortrophin Gel access. In addition, we continued to share results from our NEW DAY study of ILUVIEN in patients with DME, which were presented at prominent medical meetings, including most recently at the FLOREtina International Congress in December and the Hawaiian Eye and Retina Conference in January. With that, I'll turn the call over to Steve for the financial update. Steve?

Speaker #3: Our team has gained traction with leading retina practices, helping them explore pathways to secure Eluvian for eligible patients under the Medicare Part D benefit using a specialty pharmacy—the same approach used for Cortrofin Gel access.

Speaker #3: In addition, we continue to share results from our New Day study of Eluvian in patients with DME, which were presented at prominent medical meetings, including most recently at the Flow Retina International Congress in December and the Hawaiian Eye and Retina Conference in January.

Speaker #3: With that, I'll turn the call over to Steve for the financial update. Steve.

Speaker #1: Thanks, Chris, and good morning to everyone on the call. I'll review our fourth quarter and full year 2025 results, and 2026 guidance in more detail.

Stephen Carey: Thanks, Chris, good morning to everyone on the call. I'll review our Q4 and full year 2025 results and 2026 guidance in more detail. In 2025, we delivered on our financial commitments, generating robust top and bottom line growth and significant cash flows. Starting on Slide 12. ANI recorded revenues of $247.1 million in Q4, up 30% over the prior year period. For the full year 2025, ANI generated record revenues of $883.4 million, up 44% versus 2024. Revenues from Cortrophin Gel in Q4 were a record $111.4 million, up 88% from the prior year period.

Speaker #1: In 2025, we delivered on our financial commitments, generating robust top- and bottom-line growth and significant cash flows. Starting on slide 12, ANI recorded revenues of $247.1 million in the fourth quarter, up 30% over the prior-year period.

Speaker #1: For the full year 2025, ANI generated record revenues of $883.4 million, up 44% versus 2024. Revenues from Cortrophin Gel in the fourth quarter were a record $111.4 million, up 88% from the prior year period.

Speaker #1: In 2025, Cortrofin Gel delivered $347.8 million of net revenue up 76% year over year driven by strong adoption across neurology, nephrology, rheumatology, pulmonology, and ophthalmology.

Stephen Carey: In 2025, Cortrophin Gel delivered $347.8 million of net revenue, up 76% year-over-year, driven by strong adoption across neurology, nephrology, rheumatology, pulmonology, and ophthalmology. Iluvien net revenues were $19.8 million in Q4 and $74.9 million for the full year 2025. Revenues for generics in Q4 were $100.8 million, an increase of 28% over the prior year. The outperformance for the quarter was driven by continued strength in the partnered generic launch that occurred in Q3 2025. Full year revenues in 2025 for generics were $384.1 million, an increase of 28% over the prior year, reflecting our strong R&D capabilities, execution, and steady cadence of new product launches.

Speaker #1: Eluvian net revenues were $19.8 million in the fourth quarter and $74.9 million for the full year 2025. Revenues for generics in the fourth quarter were $100.8 million, an increase of 28% over the prior year.

Speaker #1: The outperformance for the quarter was driven by continued strength in the partner generic launch that occurred in the third quarter of 2025. Full year revenues in 2025 for generics were $384.1 million, an increase of 28% over the prior year, reflecting our strong R&D capabilities, execution, and steady cadence of new product launches.

Speaker #1: Now moving down the P&L on slide 13. As a reminder, when I speak to our operating expenses, I will be referring to our non-gap expenses which are detailed in Table 3 in our press release.

Stephen Carey: Now moving down the P&L on Slide 13. As a reminder, when I speak to our operating expenses, I will be referring to our non-GAAP expenses, which are detailed in Table 3 in our press release. Generally, our non-GAAP operating expenses exclude depreciation and amortization, stock-based compensation, and certain costs related to litigation and M&A activity. Please refer to Table 3 for a full reconciliation to our GAAP expenditures. Non-GAAP cost of sales increased 43% to $99.8 million in Q4 2025 compared to the prior year period, primarily due to net growth in sales volumes and significant growth of royalty-bearing products.

Speaker #1: 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 full reconciliation to our GAAP expenditures.

Speaker #1: Non-GAAP cost of sales increased 43% to $99.8 million in the fourth quarter of 2025 compared to the prior year period, primarily due to net growth in sales volumes and significant growth of royalty-bearing products.

Speaker #1: Non-GAAP gross margin in the fourth quarter was 59.6%, a decrease of approximately 400 basis points from the prior-year period, principally due to product mix, including significant growth of royalty-bearing products such as Cortroin and a partner generic product that was launched in the third quarter, as well as lower brand revenues.

Stephen Carey: Non-GAAP gross margin in the Q4 was 59.6%, a decrease of approximately 400 basis points from the prior year period, principally due to product mix, including significant growth of royalty-bearing products, including Cortrophin and a partnered generic product that was launched in the Q3, as well as lower brand revenues. For the full year of 2025, non-GAAP cost of sales increased 44% to $339.5 million compared to the year before, and non-GAAP gross margin was 61.6%, down approximately 10 basis points from the prior year. Non-GAAP research and development expenses were $11.7 million in the Q4, a decrease of 27% from the prior year period, driven by timing of rare disease and generic programs.

Speaker #1: For the full year of 2025, non-GAAP cost of sales increased 44% to $339.5 million compared to the year before, and non-GAAP gross margin was 61.6%, down approximately 10 basis points from the prior year.

Speaker #1: Non-GAAP research and development expenses were $11.7 million in the fourth quarter, a decrease of 27% from the prior year period, driven by timing of rare disease and generic programs.

Speaker #1: For the full year of 2025, non-GAAP research and development expenses increased 18% to $49.5 million compared to the year before, due to higher investment to support future growth of our rare disease and generics businesses.

Stephen Carey: For the full year of 2025, non-GAAP research and development expenses increased 18% to $49.5 million compared to the year before, due to higher investment to support future growth of our rare disease and generics businesses. Non-GAAP selling, general and administrative expenses increased 28% to $70.2 million in the Q4, driven by spend for our new, larger ophthalmology sales team, promoting Cortrophin Gel and ILUVIEN, and continued investment in rare disease sales and marketing activities, including the expansion of the rare disease team in the Q1 2025. For the full year of 2025, non-GAAP selling, general and administrative expenses increased 46% to $264.6 million.

Speaker #1: Non-gap selling general and administrative expenses increased 28% to $70.2 million in the fourth quarter driven by spend for our new larger ophthalmology sales team promoting Cortrofin Gel and Eluvian and continued investment in rare disease sales and marketing activities.

Speaker #1: Including the expansion of the rare disease team in the first quarter of 2025. For the full year of 2025, non-GAAP selling, general, and administrative expenses increased 46% to $264.6 million.

Speaker #1: Adjusted non-GAAP diluted earnings per share was $2.33 for the fourth quarter, compared to $1.63 per share in the prior year period. For the full year of 2025, non-GAAP diluted earnings per share was $7.89, compared to $5.20 the year before.

Stephen Carey: Adjusted non-GAAP diluted earnings per share was $2.33 for Q4, compared to $1.63 per share in the prior year period. For the full year of 2025, non-GAAP diluted earnings per share was $7.89, compared to $5.20 the year before. Adjusted non-GAAP EBITDA for Q4 was $65.4 million, up 31% compared to the prior year period, and was $229.8 million for the full year, up 47% compared to the prior year. We ended Q4 with $285.6 million in unrestricted cash, up $140.7 million, as compared to $144.9 million as of 31 December of the prior year.

Speaker #1: Adjusted non-GAAP EBITDA for the fourth quarter was $65.4 million, up 31% compared to the prior year period, and was $229.8 million for the full year, up 47% compared to the prior year.

Speaker #1: We ended the fourth quarter with $285.6 million in unrestricted cash, up $140.7 million as compared to the $144.9 million as of December 31st of the prior year.

Speaker #1: Cash flow from operations was $30.4 million in the fourth quarter of this year and $185.2 million on a full year basis. As of December 31st, 2025, we had $629.1 million in principal value of outstanding debt inclusive of our senior convertible notes and term loan.

Stephen Carey: Cash flow from operations was $30.4 million in Q4 of this year and $185.2 million on a full-year basis. As of 31 December 2025, we had $629.1 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. At the end of Q4, our gross leverage was 2.7x, and our net leverage was 1.5x our full-year adjusted non-GAAP EBITDA of $229.8 million. This morning, we are pleased to reaffirm our 2026 financial guidance, which reflects significant top and bottom-line growth.

Speaker #1: At the end of the fourth quarter, our gross leverage was 2.7 times, and our net leverage was 1.5 times our full-year adjusted non-GAAP EBITDA of $229.8 million.

Speaker #1: This morning, we are pleased to reaffirm our 2026 financial guidance, which reflects significant top and bottom line growth. Our guidance outlined on slide 14 is as follows.

Stephen Carey: Our guidance outlined on slide 14 is as follows: 2026 net revenue of $1.055 billion to $1.115 billion, representing year-over-year growth of approximately 19% to 26%. Cortrophin Gel net revenue of $540 million to $575 million, representing year-over-year growth of 55% to 65%, driven by continued volume gains. Consistent with prior years and typical industry dynamics, we expect Q1 Cortrophin Gel revenues to be down sequentially from Q4 and to represent approximately 13% to 14% of total 2026 revenues, slightly lower than in 2025, when Q1 accounted for approximately 15% of full-year revenues. This effect is driven by two factors.

Speaker #1: $226, I'm sorry. 2026 net revenue of $1.055 billion to $1.115 billion, representing approximately 19 to 26 percent. Cortrofin Gel net revenue of $540 million to $575 million, representing year-over-year growth of 55 to 65 percent.

Speaker #1: Driven by continued volume gains. Consistent with prior years and typical industry dynamics, we expect first quarter Cortrophin Gel revenues to be down sequentially from the fourth quarter and to represent approximately 13 to 14 percent of total 2026 revenues.

Speaker #1: Slightly lower than in 2025, when the first quarter accounted for approximately 15% of full-year revenues. This effect is driven by two factors. First, we are experiencing typical seasonality related to the impact of insurance reverifications, which appear to be taking slightly longer compared to the prior year due to increased Cortrofin patient volume in physicians' offices, and, in some parts of the country, due to weather-related physician office closures that temporarily delayed the reverification process.

Stephen Carey: First, we are experiencing typical seasonality related to the impact of insurance reverifications, which appear to be taking slightly longer as compared to the prior year, due to increased Cortrophin patient volume in the physician's offices and in some parts of the country, due to weather-related physician office closures that temporarily delayed the reverification process. While these factors impacted January, we have since seen a 25% jump in volumes dispensed and acceleration in new patient starts in February. We are confident that the momentum will persist in March as physician offices complete work through the reverifications backlog. Second, our full-year Cortrophin guidance is inclusive of initial script volume expected to result from our 90-person organizational expansion to support our gouty arthritis flares indication. Revenues associated with this expansion will first occur in Q3 and are expected to build momentum throughout Q4.

Speaker #1: While these factors impacted January, we have since seen a 25% jump in volumes dispensed and acceleration in new patient starts in February. And our confident that the momentum will persist in March as physician offices complete work through the reverifications backlog.

Speaker #1: Second, our full-year Cortrofin guidance is inclusive of initial script volume expected to result from our 90-person organizational expansion to support our Gowdy-authorized flares indication.

Speaker #1: Revenues associated with this expansion will first occur in the third quarter and are expected to build momentum throughout the fourth quarter. As we look farther out into the year, we remain confident in our full-year guidance and the significant multi-year growth opportunity for Cortrophin Gel.

Stephen Carey: As we look farther out into the year, we remain confident in our full-year guidance and the significant multiyear growth opportunity for Cortrophin Gel. We expect very significant sequential growth in Q2 as typical Q1 dynamics subside. We expect further sequential gains in Q3 and Q4, driven by continued performance of our portfolio, pulmonology, and ophthalmology teams, in addition to the full deployment by the end of Q2 of our new 90-person organization focused on acute gouty arthritis flares. We expect ILUVIEN net revenue of $78 million to $83 million, representing year-over-year growth of approximately 4% to 11%. We expect adjusted non-GAAP EBITDA of $275 million to $290 million, representing year-over-year growth of approximately 20% to 26%.

Speaker #1: We expect very significant sequential growth in the second quarter as typical first-quarter dynamics subside. We then expect further sequential gains in the third and fourth quarters, driven by continued performance of our portfolio pulmonology and ophthalmology teams, in addition to the full deployment by the end of the second quarter of our new 90-person organization focused on acute Gowdy arthritis flares.

Speaker #1: We expect Eluvian net revenue of $78 million to $83 million representing year-over-year growth of approximately 4 to 11 percent. We expect adjusted non-gap EBITDA of $275 million to $290 million representing year-over-year growth of approximately 20 to 26 percent.

Speaker #1: And from a quarterly cadence perspective, we expect adjusted non-GAAP EBITDA to be down sequentially in the first quarter and modestly down as compared to the first quarter of the prior year, driven by quarterly revenue dynamics.

Stephen Carey: From a quarterly cadence perspective, we expect adjusted non-GAAP EBITDA to be down sequentially in Q1 and modestly down as compared to Q1 of prior year, driven by quarterly revenue dynamics. We expect sequential growth in the remaining quarters of the year, with Q4 representing the highest quarter by a significant amount, driven by incremental contribution from our gout-focused team expansion. We expect adjusted non-GAAP earnings per share between $8.83 and $9.34, representing year-over-year growth of approximately 12% to 18%.

Speaker #1: We then expect sequential growth in the remaining quarters of the year, with the fourth quarter representing the highest quarter by a significant amount, driven by incremental contribution from our gout-focused team expansion.

Speaker #1: We expect adjusted non-GAAP earnings per share between $8.83 and $9.34, representing year-over-year growth of approximately 12% to 18%. We expect adjusted gross margin to be 59.3% to 60.3% in 2026, which is down from 2025, driven by significantly higher forecast sales of royalty-bearing products, the non-recurrence of revenues from our first-half 2025 180-day exclusive launch of Procalipride, and the expectation of lower brand sales.

Stephen Carey: We expect adjusted gross margin to be 59.3% to 60.3% in 2026, which is down from 2025, driven by significantly higher forecast sales of royalty-bearing products, the non-recurrence of revenues from our first half 2025, 180-day exclusive launch of prucalopride, and the expectation of lower brand sales. We currently anticipate a full-year US GAAP effective tax rate of approximately 26% to 28%, and consistent with prior quarters, we will tax effect our non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share, utilizing our estimated statutory rate of 26%. We anticipate between 21.5 million and 21.8 million shares outstanding for the purpose of calculating full-year non-GAAP diluted EPS.

Speaker #1: We currently anticipate a full-year U.S. GAAP effective tax rate of approximately 26% to 28%. Consistent with prior quarters, we will tax effect our non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share utilizing our estimated statutory rate of 26%.

Speaker #1: We anticipate between 21.5 million and 21.8 million shares outstanding for the purpose of calculating full-year non-GAAP diluted EPS. And finally, please note that we will continue to exclude from our adjusted non-GAAP diluted EPS calculation the diluted shares included in GAAP diluted EPS, which are expected to be offset in full by the capped call transaction.

Stephen Carey: Finally, please note that we will continue to exclude from our adjusted non-GAAP diluted EPS calculation, the dilutive shares included in GAAP diluted EPS, which are expected to be offset in full by the capped call transaction. With that, I'll turn the call back to Nikhil.

Speaker #1: With that, I'll turn the call back to Nico. Thank you, Steve. Turning to slide 15, in closing, we delivered a remarkable 2025 characterized by significant growth across Cortrophin Gel and outperformance in our Genetics business.

Nikhil Lalwani: Thank you, Stephen. Turning to slide 15. In closing, we delivered a remarkable 2025, characterized by significant growth across Cortrophin Gel and outperformance in our generics business. We've entered 2026 in a position of strength and remain focused on achieving our strategic priorities, including accelerating our transformation into rare disease, continuing to execute in generics, and deploying capital in a disciplined manner. Overall, we expect to deliver over $1 billion in revenue in 2026, with rare disease representing approximately 60% of total revenues. With that, operator, please open the line for questions.

Speaker #1: We've had our 2026 in a position of strength and remain focused on achieving our strategic priorities, including accelerating our transformation into rare disease. We are continuing to execute in genetics and deploying capital in a disciplined manner.

Speaker #1: Overall, we expect to deliver over $1 billion in revenue in 2026, with rare disease representing approximately 60% of total revenues. With that, Operator, please open the line for questions.

Speaker #2: Certainly. Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two.

Operator: Certainly. Thank you. If you'd like to ask a question, press star and one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question, and we'll take our first question from the line of Glen Santangelo from Barclays. Please go ahead.

Speaker #2: Once again, that is star one to ask a question and we'll take our first question from the line of Glen Santangelo from Barclays. Please go ahead.

Glen Santangelo: Yeah, thanks for taking my question. Good morning, everyone. Hey, Nikhil, obviously, Cortrophin continues to surprise on the upside, and you sort of make the case that you believe there's a multi-year opportunity here as you expand into these under-penetrated indications. You know, you're obviously investing in the sales force to try to take advantage of that. Without giving us guidance beyond 2026, I don't know if there's any high-level commentary you can sort of give us to help us think about how meaningful this multiyear opportunity could be. I'm guessing, you know, you're starting to think about a peak sales number. Maybe it's a little bit premature, but how do you think about that? Then, you know, my follow-up for Stephen is going to be, you know, the royalty steps up this year.

Speaker #3: Yeah. Thanks for taking my question. Good morning, everyone. Hey, Nikhil, obviously Cortrophin continues to surprise on the upside, and you sort of make the case that you believe there's a multi-year opportunity here as you expand into these under-penetrated indications.

Speaker #3: And, you know, you're obviously investing in the Salesforce to try to take advantage of that. Without giving us guidance beyond 2026, I don't know if there's any high-level commentary you can sort of give us to help us think about how meaningful this multi-year opportunity could be.

Speaker #3: And I, I—I'm guessing, you know, you're starting to think about a peak sales number. Maybe it's a little bit premature, but how do you think about that?

Speaker #3: And then, you know, my follow-up for Stephen's gonna be, you know, the royalty steps up this year. You know, can you help us think about how that royalty is gonna step up so we can sort of better model our gross margins going forward?

Glen Santangelo: You know, can you help us think about how that royalty is going to step up so we can sort of better model, gross margins going forward? Thank you.

Speaker #3: Thank you.

Speaker #1: Yes, good morning, and thank you for your question, Glen. Look, I think we believe in the significant multi-year growth opportunity for Cortrophin, and I think the key really is slide nine in our deck from this morning.

Nikhil Lalwani: Yes, good morning, and thank thank you for your question, Glen. Look, I think, we believe in the significant multi-year growth opportunity for Cortrophin, and I think the key really is, slide 9 in our deck from this morning, where we highlight, you know, the addressable patient populations across indications. These are significantly under-penetrated, not just by us, but across the ACTH category. We believe that there is a much larger number of patients that are yet to that are appropriate for ACTH therapy, that are yet to benefit from this therapy. You know, we, you know, we see, you know, a significant multi-year growth runway for the category and also for Cortrophin. We're investing to build momentum in 2026 and beyond, right?

Speaker #1: Where we highlight, you know, the addressable patient populations across indications. And these are significantly under-penetrated, not just by us, but across the ACTH category.

Speaker #1: So we believe that there is a much larger number of patients that are appropriate for ACTH therapy that are yet to benefit from this therapy.

Speaker #1: So you know, we you know, we see the you know, a significant multi-year growth runway for the ca for the for the category. And also for Cortrofin.

Speaker #1: And we're investing to build momentum in 26 and beyond, right? So high ROI commercial initiatives like the 90-person organizational, expansion for gout, right? We did an expansion last year.

Nikhil Lalwani: High ROI commercial initiatives like the 90% organizational expansion for gout, right? We did an expansion last year. We're enhancing convenience. You know, we launched a prefilled syringe last year. We're continuing to evaluate opportunities to further enhance patient convenience. Importantly, we're generating both scientific and clinical evidence. We're advancing a Phase IV clinical trial for Cortrophin in gout, as well as a robust pipeline of investigator-initiated trials across disease states. We believe in the strong multi-year growth opportunity and are investing to ensure that we can, you know, capture that opportunity. B, again, we believe in the opportunity for the category as a whole to keep growing for several years. Your second question on the Merck royalty.

Speaker #1: We're enhancing convenience. You know, we launched a prefill syringe last year. We're continuing to evaluate opportunities to further enhance patient convenience. And importantly, we're generating both scientific and clinical evidence.

Speaker #1: So we've advanced a phase four clinical trial we're advancing a phase four clinical trial for Cortrofin and gout. As well as a robust pipeline of investigator-initiated trials across disease strains.

Speaker #1: So we believe in the strong multi-year growth opportunity. And in our investing, to ensure that we can you know, capture that opportunity. And we again, we believe in the opportunity for the category as a whole, to keep growing, for several years.

Speaker #1: And then your second question, on the Merck royalty—in 2025, annual revenues of Cortrophin Gel reached a level by which we surpassed the highest royalty tier for incremental net sales.

Nikhil Lalwani: In 2025, annual revenues of Cortrophin Gel reached a level by which we surpassed the highest royalty tier for incremental net sales. The way in 2025 itself, we were in the highest royalty tier for the royalty. We currently anticipate the blended royalty rate to be in the high twenties in 2026. Thank you, Glenn.

Speaker #1: So we in 2025 itself, we were in the highest royalty tier for, for the royalty. And then we currently anticipate the blended royalty rate to be in the high 20s in 2026.

Speaker #1: Thank you, Glen.

Speaker #3: Okay. Yeah. Thanks for the comments.

Glen Santangelo: Okay. Yeah, thanks for the comments.

Speaker #2: Thank you. And we'll take our next question from David Amsellem with Piper Sandler. Please go ahead.

Operator: Thank you. We'll take our next question from David Amsellem with Piper Sandler. Please go ahead.

David Amsellem: Thanks. I had two on Cortrophin. One, I'm trying to get a better sense of how you're thinking about operating leverage going forward. You're adding the 90 reps, you're calling on primary care, you're calling on podiatrists. I'm just wondering how promotion intensive you perceive the gout indication to be and what that means for potentially further expansion. Just help us understand that and how you're thinking about operating leverage. That's number 1. Number 2 is, you're thinking about indications like sarcoidosis and ophthalmic indications. Can you talk about the number of vials used or duration of treatment in those kind of indications versus gout? What I'm trying to get at is the, quote, unquote, "value" of a given patient across the different opportunities within the Cortrophin franchise.

Speaker #4: Thanks. So, I had two on Cortrophin. First, I'm trying to get a better sense of how you're thinking about operating leverage going forward.

Speaker #4: So you're adding the 90 reps. You're calling on primary care, you're calling on podiatrists. I'm just wondering how promotion-intensive you perceive the gout indication to be, and what that means for potentially further expansion.

Speaker #4: So just help us understand that and how you're thinking about operating leverage—that's number one. And then, number two is, you're thinking about indications like sarcoidosis and ophthalmic indications.

Speaker #4: Can you talk about the number of vials used, or the duration of treatment, and those kinds of indications versus gout? What I'm trying to get at is the, quote-unquote, "value" of a given patient across the different opportunities within the Cortrofin franchise.

David Amsellem: If you could help us provide color there, that would also be helpful. Thank you.

Speaker #4: so if you could help us provide color there, that would also be helpful. Thank you.

Speaker #1: Great. good morning and thank you for your question. Dave. So the first question on operating leverage, look, we're still in high-growth mode. And we continue to balance growth and profitability as we drive that growth, right?

Nikhil Lalwani: Great. Good morning, and thank you for your question, Dave. The first question on operating leverage. Look, we're still in high growth mode, and we continue to balance growth and profitability as we drive that growth, right? When you look at 2025, you know, our guidance implies EBITDA growth of 20% to 26%. And the EBITDA margin as a percentage of growth, sorry, as a percentage, has stayed in the same in our 2026 versus 2025, despite a year of very significant investment in this, 90-person organization for gout and then also related OpEx, right? The total implied OpEx increase at the midpoint of our guidance is about $50 million, majority of which is for the gout expansion.

Speaker #1: So when you look at 2025, you know, our guidance implies EBITDA growth of 20 to 26 percent. And the EBITDA margin as a percentage of growth or sorry, as a percentage, has stayed in the same in our 2026 versus 2025 despite a year of very significant investment in this 90-person organization for gout and then also related OPEX, right?

Speaker #1: So the total implied OPEX increase at the midpoint of our guidance is about $50 million, the majority of which is for the gout expansion. And despite that, we're, you know, we're keeping the EBITDA margin percentage the same in '26 versus '25.

Nikhil Lalwani: Despite that, we're, you know, we're keeping the EBITDA margin percentage the same in 2026 versus 2025. We strongly believe that, you know, as we have seen, even with the expansion last year of the sales force, that, you will see partial impact from the organization expansion for gout in 2026, and we'll see full impact in 2027, right? The full year impact and the, you know, because it takes the sales force, you know, we'll have them in place by midyear. They'll have impact in Q3 and Q4, and then you'll see full impact in 2027, obviously driving operating leverage. That's the question on operating leverage. Look, you know, I think the key is in terms of further expansions, the key is the addressable patient population, right?

Speaker #1: We strongly believe that, you know, as we had seen even with the expansion last year of this of the sales force, that the you will we will see partial impact from the organization expansion for gout in 2026.

Speaker #1: And we'll see full impact in 2027, right? So the full-year impact and the you know, 'cause it takes the sales force, you know, we'll have them in place by mid-year.

Speaker #1: They'll have impact in Q3 and Q4, and then you'll see full impact in 2027, obviously driving operating leverage. So that's the question on operating leverage.

Speaker #1: And look, you know, I think the key is, in terms of further expansions, the key is the addressable patient population, right? As you know, we currently have a combined team that details into nephrology, neurology, and rheumatology.

Nikhil Lalwani: As you know, we currently have a combined team that details into nephrology, neurology, and rheumatology. That's called our portfolio team. We expanded that team in 2025, right? We're still have a much larger addressable patient population that we can address, not just in these three test therapeutic areas, but across areas. With an ability to reach physicians and reach patients, there will be a benefit from further expansions, obviously, but that's down the field as we capture this multiple, multiyear growth opportunity. I mean, the key in terms of the current year investment, we're seeing impact in this year, retaining the EBITDA margin percentage and then going in 2027, we'll see, you know, a much bigger impact with the same level of SG&A as this year. Your second question was on the duration of treatment across indications.

Speaker #1: We expand that's called our portfolio team. We expanded that team in 2025, right? We're still have a much larger addressable patient population that we can address not just in these three test therapeutic areas but across areas.

Speaker #1: So with an ability to reach physicians and reach patients, there would be a benefit from further expansions. Obviously, but that's down the field as we capture this multiple multi-year growth opportunity.

Speaker #1: I mean, the key in terms of the, the, the current-year investment, we're seeing impact in this year, retaining the EBITDA, margin percentage, and then going for in 2027, we'll see you know, a much bigger impact with the same with the same level of SG&A as this year.

Speaker #1: Your second question was on the duration of treatment across indications. the duration of treatment does indeed vary. sarcoidosis has a much longer you know, use.

Nikhil Lalwani: The duration of treatment does indeed vary. Sarcoidosis has a much longer, you know, in use and more vials per patient, whereas, you know, acute gouty arthritis flares has a lower number of vials per patient, that is appropriate, right, at the time of the exacerbation or flare. You know, there is a variance across the variations that we, that we serve, with Cortrophin Gel. Thank you, David.

Speaker #1: And more vials per patient. Whereas, you know, acute gouty arthritis flares have a lower number of vials per patient. That is appropriate, right? At the time of the exacerbation or flare.

Speaker #1: So, you know, there is a variance across the indications that we serve with Cortrofin Gel. Thank you, David.

Speaker #2: Thank you. And we'll go next to Vamil Devon from Guggenheim Securities. Please go ahead.

Operator: Thank you. We'll go next to Vamil Divan from Guggenheim Securities. Please go ahead.

Speaker #5: Great. Thanks for, taking my questions. Maybe one more on Cortrofin. I could just start building on the earlier question. So this additional 90-person organization you're saying is you know, opportunity.

Vamil Divan: Great. Thanks for taking my question. Maybe one more on Cortrophin, I could just sort of building on the earlier question. This additional 90 person organization you're saying is dedicated to the gouty, you know, opportunity in targeting mainly primary care providers. I'm just trying to get a sense of, again, sort of the leverage or the opportunity for them to do other things beyond just gouty arthritis. Can, you know, will they be going to any other specialties, or are there other indications they'll be focusing on, or is it strictly just for gouty arthritis? Just trying to get a sense, again, of the ability to leverage that additional investment. Second question, I guess, more for Steve on the business development side.

Speaker #5: In targeting mainly primary care and podiatry, I'm just trying to get a sense of, again, sort of the leverage or the opportunity for them to do other things beyond just gouty arthritis.

Speaker #5: Can you know, will they be going to any other specialties, or are there other indications they'll be focusing on? Or is it strictly just for gouty arthritis?

Speaker #5: Just trying to get a sense again of the ability to leverage that additional investment. And then second, question I guess more for Steve on the business development side.

Vamil Divan: I've talked about sort of investing in kind of expanding the rare disease opportunities here. I'm just trying to get a sense of given where your leverage is now, what you're willing to do in terms of leverage versus using equity or kind of as you think about the size of potential deals, what you be mind in terms of options for financing those sorts of opportunities? Thanks.

Speaker #5: and I've talked about sort of investing in kind of expanding the out rider disease. opportunities here. I'm just trying to get a sense of given where your leverage is now.

Speaker #5: So what you're willing to do in terms of leverage versus using equity or kind of as you think about the size of potential deals, what, what you're thinking about in terms of options for, for financing those sorts of opportunities.

Speaker #5: Thanks.

Speaker #1: And good morning and thank you, Vamil. so on the 90-person organization that's for gout and as a clarification, you know, not I'm not all 90 are in sales.

Nikhil Lalwani: Good morning, and thank you, Vamil. On the 90 person organization, that's for gout, and as a clarification, you know, not all 90 are in sales. You know, majority of that 90 person group is sales expansion, but there are obviously patient support, operations and marketing and other support areas too. Yes, that organization can, and the sales organization and the rest of the organization can be leveraged both for other indications that they treat. Primary care and psychiatry do treat other indications that Cortrophin is indicated for. Our focus is primarily on gout, but there are other indications potentially that they can treat, which of course are for the appropriate patients, but can be leveraged for that.

Speaker #1: So you know, majority of that 90-person group is sales expansion. But there are obviously patient support, operations, and marketing, and other support areas too.

Speaker #1: But yes, that organization can and the sales organization and the rest of the organization can be leveraged both for other indications that they treat.

Speaker #1: So primary care and podiatry do treat other indications that Cortrofin is indicated for are focus is primarily on gout. But there are other indications potentially that they can treat, which are for gross or for the appropriate patients.

Speaker #1: So, it can be leveraged for that. But in addition, you know, that sales force can also be leveraged by adding another product in the basket, just like we did for ophthalmology.

Nikhil Lalwani: In addition, you know, that sales force can also be leveraged by adding another product in the basket, just like we did for ophthalmology. That option is available. Obviously, the opportunity in acute gouty arthritis flares is very significant. We've identified 7,000 HCPs that treat the most severe acute gouty arthritis flares patients, and that is the primary focus of this expansion, and that is what we focus on as we, you know, put this team in place by midyear. Look, we've made, you know, very good progress on the recruitment. We have our sales leadership and the Area Business Directors in place, and we're now moving to recruitment of the sales team members, and we will launch by midyear.

Speaker #1: So, so that option is available. Obviously, the opportunity in acute gouty arthritis flares is very significant. We've identified 7,000 HCPs that treat the most severe acute gouty arthritis flares patients.

Speaker #1: And that is our—that is the primary focus of this expansion. And that is what we will be focused on as we, you know, put this team in place by mid-year.

Speaker #1: And look, we've made you know, very good progress on the on the recruitment. We have our sales leadership and the area business directors in place.

Speaker #1: And we're now moving to recruitment of the sales team members. And we will launch by mid-year. So on the acute you know, on the acute gouty arthritis flares expansion.

Nikhil Lalwani: on the acute, you know, the acute gouty arthritis flares expansion. Then I'll turn it to Steve to answer your question on BD. Steve?

Speaker #1: And then I'll turn it to Steve to answer your question on BD. Steve?

Speaker #3: Yeah. Vamil. Good morning. And thanks for the question. we're incredibly pleased with the cash flow dynamics of the, the company in 2025. we're ending the year with 285 million dollars on the balance sheet.

Stephen Carey: Yeah, Balaji Prasad, good morning, and thanks for the question. We're incredibly pleased with the cash flow dynamics of the company in 2025. We're ending the year with $285 million on the balance sheet, and the business generated $185 million from operations in 2025. As you see in our full year guidance, right, we're, you know, projecting, you know, continued both revenue and profitability measures growth. We expect very healthy cash flows in 2026 as well.

Speaker #3: And the business generated $185 million from operations in 2025. And as you see in our full-year guidance, right, we're, you know, projecting, you know, continued both revenue and profitability measures growth.

Speaker #3: And so we expect very healthy cash flows in 2026 as well. And so at this point in time, right, given the strategic imperatives of the company to expand rare disease, you know, we anticipate accruing that cash to the balance sheet.

Stephen Carey: At this point in time, right, given the strategic imperatives of the company to expand rare disease, you know, we anticipate accruing that cash to the balance sheet to build that war chest for future business development and M&A activities. I think what you've seen us do consistently, you know, you can look back to when we purchased Novitium in 2021, when we purchased Alimera in 2024, right? We take a balanced approach to how we finance these types of activities. In terms of leverage ratio, right, we like to take a, you know, reasonably conservative approach there.

Speaker #3: to build that war chest for future business development and M&A activities. I think what you've seen us do, do consistently, you know, you can look back to when we purchased Navidium in 2021, when we purchased Alimera in 2024, right, we, we take a balanced approach to how we finance these types of activities.

Speaker #3: and in terms of leverage ratio, right, we, we like to take you know, reasonably conservative approach there. I think what we've done in the past is, you know, we'll take leverage up to, you know, the, the three-ish range, maybe a touch above three on net leverage.

Stephen Carey: I think what we've done in the past is, you know, we'll take leverage up to, you know, the three-ish range, maybe a touch above 3 on net leverage, but always with a clear line of sight in terms of organic de-levering. If you look back, right, to the close of Alimera, we were, you know, just right around 3 times net levered. Here, you know, just 5 quarters downstream, you know, we've cut that leverage in half, you know, really driving with organic growth in the business. I think you should expect, you know, similar moves in the future. Thank you.

Speaker #3: But always with a clear line of sight in terms of organic de-levering. And if you look back, right, to the close of Alimera, we were, you know, just right around three times net levered.

Speaker #3: And here you know, just five quarters downstream, you know, we've cut that leverage in half, you know, really driving with organic growth in the business.

Speaker #3: So I think you should expect, you know, similar moves in the future. Thank you.

Speaker #1: Okay. Thank you.

Nikhil Lalwani: Okay, thank you.

Vamil Divan: Okay, thank you.

Speaker #2: Thank you. And we'll take our next question from Dennis Ding with Jefferies. Please go ahead.

Operator: Thank you. We'll take our next question from Dennis Ding with Jefferies. Please go ahead.

Speaker #4: Hey, good morning. Thanks for taking our questions. We have two. So on Cortrofin, thanks for the color on Q1. Seems like the winter storms weren't an unexpected impact.

Dennis Ding: Hey, good morning. Thanks for taking our questions. We have two. On Cortrophin, thanks for the color on Q1. Seems like the winter storms were an unexpected impact, but glad things are recovering. I'm wondering, when you take a step back and think about the first versus second half split, seems like they'll be meaningfully second half-weighted, and that does put pressure on the gout expansion going as planned. How do you give investors confidence that that will go as planned and that PCPs will be okay with prescribing a very expensive product? Question number two is specifically on gross margins. The royalty to Merck, I believe, is capped around 30%, so we shouldn't really get any more incremental headwinds moving forward.

Speaker #4: But glad things are recovering. So I'm wondering, when you take a step back and think about the first versus second-half split, it seems like there'll be meaningful second-half weighting.

Speaker #4: And that does put pressure on the gout expansion going as planned. So, how do you give investors confidence that that will go as planned?

Speaker #4: And that PCPs will be okay with prescribing a very expensive product? And then question number two is specifically on gross margins. So the royalty to Merck, I believe, is capped around 30%.

Speaker #4: So, we shouldn't really get any more incremental headwinds moving forward. But how are you thinking about buying that royalty down, given how much cash flows you guys are generating?

Dennis Ding: How are you thinking about buying that royalty down, given how much cash flows you guys are generating? You know, is that a priority for you, and how do you also convince Merck to come to the table? Thank you very much.

Speaker #4: And you know, is that a priority for you? And how do you also convince Merck to come to the table? Thank you very much.

Speaker #1: All right. Good morning. And thank you for your questions. Dennis, look, our new dedicated sales force for, for acute gouty arthritis flares will be deployed by mid-mid-year.

Nikhil Lalwani: Good morning, and thank you for your questions, Dennis. Look, our new dedicated field force for acute gouty arthritis flares will be deployed by midyear. Our reasons to believe are, number one, the large underpenetrated market opportunity, and Cortrophin is the only approved ACTH product with this indication. Second is we have a successful track record in gout, 10% plus of our volumes in 2025 coming from gout in rheumatology and nephrology. Number three, our successful pilot programs across 10 plus territories in primary care and podiatry offices, which we ran in 2025, right, which see the most severe acute gouty arthritis flares patients.

Speaker #1: And our reasons to believe are, number one, the large under-penetrated market opportunity, and Cortrophin is the only approved ACTH product with this indication. Second is, we have a successful track record in gout.

Speaker #1: 18% plus of our volumes in 2025 coming from gout in rheumatology and nephrology. And number three, our successful pilot programs across 10-plus territories in primary care and podiatry offices, which we ran in 2025, right, would see the most severe acute gouty arthritis flares patients and so we saw success with those pilot programs.

Nikhil Lalwani: We saw success with those pilot programs, and that gave us the confidence to deploy this larger sales force and the larger organization in an indication where we have the indication and we are the only ACTH product available, right? With the field force deploying midyear, we expect to see in Q3 and Q4, like we saw in 2025 when we did the expansion for our portfolio sales force, and then we'll see the full realization in 2027, right? As we're expanding our field force, we're also investing in clinical evidence generation through a Phase IV trial to expand usage over time. That's on the gout expansion. Your second question on the Merck royalty. Right.

Speaker #1: And that gave us the confidence to deploy this larger sales force. And the and the larger organization in, in, in an indication where we have the indication and is and we are the only ACTH product available.

Speaker #1: Right? So with the field force deploying in the mid-year, we expect to see in Q3 and Q4, like we saw in 2025 when we did the expansion for our portfolio sales force, and then we'll see the full realization in 2027.

Speaker #1: Right? As we're expanding our field force, we're also investing in clinical evidence generation through a phase four trial to expand usage over time. So that's on the gout expansion.

Speaker #1: And then your second question on the Merck royalty, right? Look, I think we've, you know, we are always evaluating potential opportunities, but we do not comment on active or non-active business development initiatives.

Nikhil Lalwani: Look, I think we've, you know, we are always evaluating potential opportunities, but we do not comment on active or non-active business development initiatives, especially with our partners. Thank you for your question, Dennis.

Speaker #1: Especially with our partners. And thank you for your question, Dennis.

Speaker #4: Thank you.

Dennis Ding: Thank you.

Speaker #2: Thank you. And we'll move next to E. Catarina. K., please go ahead.

Operator: Thank you, and we'll move next to Ekaterina Knyazkova. Please go ahead.

Ekaterina Knyazkova: Thank you so much. Just one from me. Just on Cortrophin Gel, have you seen any recent changes on the patient access front? Just are you seeing any payers or plans giving more trouble or coverage, or reimbursement, or are you seeing kind of trends that are similar as you were seeing last year? Thank you.

Speaker #5: thank you so much. Just one from me. So just on Cortrofin gel, have you seen any recent changes on the patient access front? Just are you seeing any payers or plans giving more trouble or coverage?

Speaker #5: or reimbursement? Or are you seeing kind of trends that are similar, as you were seeing last year? Thank you.

Nikhil Lalwani: Good morning, thank you for your question, Ekaterina. Look, we try to find a balance between sharing information that is helpful to investors and that is competitively sensitive. Having said that, you know, at an overall level, we have not seen material changes from an access perspective. Again, we're targeting or we're reaching, trying to reach, the appropriate patients as a late line therapy with Cortrophin Gel. Yeah. Thank you for your question, Ekaterina.

Speaker #1: Good morning, and thank you for your question. And Katrina, look, we try to find a balance between sharing information that is helpful to investors and that is competitively sensitive.

Speaker #1: having said that, you know, at an overall level, we have not seen material changes from a from an access perspective. Again, we're targeting or we're reaching trying to reach the appropriate patients.

Speaker #1: As a late-line therapy for with Cortrofin gel. so yeah. But thank you for your question, Katrina.

Speaker #2: Thank you. And we'll go next to Thomas Smith with Leerink Partners.

Operator: Thank you. We'll go next to Thomas Smith with Leerink Partners.

Speaker #6: Hey, guys. Good morning. Thanks for taking the questions. Two on Cortrofin, if I could. You mentioned that about 15% of utilization came from acute gouty arthritis in '25.

Thomas Smith: Hey, guys. Good morning. Thanks for taking the questions. Two on Cortrophin, if I could. You mentioned that about 15% of utilization came from acute gouty arthritis in 2025. Could you just give us a sense of what your expectations are for where that number goes in 2026 and 2027, given the sales force expansion efforts? Could you give a little bit more color on the Cortrophin pilot programs executed in primary care and podiatry? Any details, I guess, on specific feedback from those prescribers versus your other specialty types and any specific learnings you're implementing to help better target those offices? Thanks so much.

Speaker #6: Could you just give us a sense of what your expectations are for where that number goes in '26 and '27 given the sales force expansion efforts?

Speaker #6: And then could you give a little bit more color on the Cortrofin pilot programs executed in primary care and podiatry? Any details I guess on specific feedback from those prescribers versus your other specialty types?

Speaker #6: And any specific learnings you're implementing to help better target those offices? Thanks so much.

Speaker #1: Yeah, good morning. And welcome to your first ANI conference call, Tom. Great to have you. So, the first question is on, you know, our current business in gout. About 15% of our volumes come from gout.

Nikhil Lalwani: Good morning, welcome to your first ANI conference call, Tom. Great to have you. The first question is on, you know, our current business in gout. About 15% of our volumes comes from gout. As we deploy this targeted sales force and broader organization, we do expect it to increase significantly. We're not putting a number to it at this time, but we'll keep you updated, obviously, on our progress. I think the important thing to highlight here is that if you look at the ANI Cortrophin story, a big part of that success has been being able to reach new physicians. Almost half of our physicians that have prescribed Cortrophin were naive to the category, naive to ACTH, prior to the entry of Cortrophin Gel.

Speaker #1: As we as we deploy this this targeted sales force, and broader organization, we do expect it to increase significantly. we're not putting a number to it at this time.

Speaker #1: But we'll keep you updated, obviously, on our progress. I think the important thing to highlight here is that, you know, if you look at the ANI Cortrofin story, a big part of that success has been being able to reach new physicians.

Speaker #1: Almost half of our physicians that have prescribed Cortrofin were naive to the category naive to ACTH. Prior to the entry of Cortrofin gel. And if you think about and this dovetails into your second question around the pilot programs.

Nikhil Lalwani: If you think about, this dovetails into your second question around the pilot programs, if you think about the HCPs that we're reaching through this expansion, you know, we're targeting, we're trying to reach about 7,000 HCPs that we've identified across territories, right? Majority of these, right, obviously, some were part of the pilot programs that we had across 10 territories, but most of these have not been. That will further expand, right? The success we've had in being able to reach new physicians, right, will continue. That has given us confidence and will continue as we reach these new primary care and podiatry care physicians, right?

Speaker #1: If you think about the HCPs that were reaching through this expansion, you know, we're targeting we're trying to reach about 7,000 HCPs that we've identified across territories.

Speaker #1: Right? Majority of these, right? Obviously, some were part of the pilot programs that we had across 10 territories, but most of these have not been.

Speaker #1: And so, that will further expand, right? And the success we've had in being able to reach new physicians, right, will continue. That has given us confidence and will continue as we reach these new primary care and podiatry care physicians.

Speaker #1: Right? So what we'll also expand is not just the gout volumes as a percentage of, you know, Cortrofin volumes, but also the number of physicians and number of new physicians that were naive to ACTH.

Nikhil Lalwani: What we'll also expand is not just the gout volumes as a percentage of, you know, Cortrophin volumes, but also the number of physicians and number of new physicians that were naive to ACTH. Going back to your second question regarding, or I guess, second part of your second question on the pilot programs, I think that we've had, you know, a lot of learnings in terms of, you know, the discussion to be had with the primary care and podiatry physicians in terms of identifying the appropriate patients, you know, how to work with their offices, right, to work through the enrollment to fulfillment process. Also, you know, learnings on, you know, primary care and podiatrists are very large sort of numbers of HCPs that are there in the country.

Speaker #1: And then, going back to your second question regarding, or I guess the second part of your second question, on the pilot programs. I think that we've had, you know, a lot of learnings in terms of, you know, the discussion to be had with the primary care and podiatry physicians in terms of identifying the appropriate patients.

Speaker #1: You know, how to work with their offices. Right? to to work through the enrollment to fulfillment process. And then also you know, learnings on you know, primary care and podiatrists are are very large sort of number of numbers of of HCPs that are there in the country.

Speaker #1: But really figuring out the 7,000 that treat the most severe acute gouty arthritis flares how do you identify them with the claims and other data that is available so that you're reaching the appropriate patients.

Nikhil Lalwani: Really figuring out the 7,000 that treat the most severe acute gouty arthritis flares, how do you identify them with the claims and other data that is available so that you're reaching the appropriate patients? That's been part of our learnings through the pilot programs through 2025. Thank you for your question, Tom.

Speaker #1: That's been part of our learnings through the through the pilot programs through 2025. And thank you for your question, Tom.

Speaker #2: Thank you. And we'll take our next question from Lee Sulweski from Truist Securities. Please go ahead.

Operator: Thank you. We'll take our next question from Les Sulewski from Truist Securities. Please go ahead.

Ekaterina Knyazkova: Good morning. Thank you for taking my questions. Congrats on the progress. Three from me. On Cortrophin first, you noted that 15% of utilization is coming from gout. How would you expect that trend to uptake once the new team is in place? Is this a good representation of the percentage of the total Cortrophin revenues? Will you have some of the results from Phase IV trial in time for the salesforce expansion? The second, on ILUVIEN, can you provide an update on the specialty pharmacy progress and perhaps just kind of your thoughts on the patient access? Lastly, on generics, how are you thinking about product cadence and erosion as we move through the year? Thank you.

Speaker #7: good morning. Thank you for taking my questions. congrats on the progress. three from me. Cortrofin first. you noted the that 15% of utilization is coming from gout.

Lee Sulewski: Good morning. Thank you for taking my questions. Congrats on the progress. Three from me. On Cortrophin first, you noted that 15% of utilization is coming from gout. How would you expect that trend to uptake once the new team is in place? Is this a good representation of the percentage of the total Cortrophin revenues? Will you have some of the results from Phase IV trial in time for the salesforce expansion? The second, on ILUVIEN, can you provide an update on the specialty pharmacy progress and perhaps just kind of your thoughts on the patient access? Lastly, on generics, how are you thinking about product cadence and erosion as we move through the year? Thank you.

Speaker #7: How would you expect that trend to uptake once the new team is in place? And is this a good representation of the percentage of the total Cortrofin revenues?

Speaker #7: And then will you have some of the results in phase four trial in time for the sales force can you provide an update on the specialty pharmacy progress and perhaps just kinda your your thoughts on the the patient access?

Speaker #7: And then lastly, on generics. how are you thinking about product cadence and erosion as we move through the year? Thank you.

Speaker #1: Yeah. Good morning. And thank you for your questions, Liz. I'll take them one by one. So the first question on the gout. we do believe that the 15% of volume of current volumes will expand right?

Nikhil Lalwani: Yeah, good morning, and thank you for your questions, Les. I'll take them one by one. The first question on the gout, we do believe that the 15% of volume, of current volumes will expand, right, as a percentage of total volumes, you know, with this investment. We will see a significant update. We will, you know, update you as we move along. On the trial, the Phase IV trial is progressing, and we will provide meaningful updates as that trial progresses. The organization expansion, right, we've already hired, as I said, the sales leadership and the ABDs, the Area Business Directors. The organization will launch in full by midyear.

Speaker #1: As a percentage of total volumes, you know, with this investment. So we will see a significant update. We will, you know, update you as we move along.

Speaker #1: on the trial, we are the trial the phase four trial is progressing. And we will provide meaningful updates as that trial progresses. If the the the organization expansion right?

Speaker #1: We've already hired, as I said, the sales leadership and the ABDs, the Area Business Directors. The organization will launch in full by mid-year.

Speaker #1: The results of the trial will not be in place by then. So that's you know, on the come later on. And we'll obviously provide updates on the trial.

Nikhil Lalwani: The results of the trial will not be in place by then, that's, you know, on the come later on, and we'll obviously provide updates on the trial. The second question was on ILUVIEN. On ILUVIEN, you know, we continue to make progress in the growing use of the alternative access channels to navigate the market access challenges for Medicare patients. We are seeing prominent practices adopting this alternate workflow and use of alternate channels. And, you know, it's basically patients that have access to the drug benefit, and, you know, that's the same procedure that or process that we use and workflow that we use for Cortrophin. We've seen prominent retina practices use it.

Speaker #1: The second question was on Iluvian. So, on Iluvian, you know, we continue to make progress in the growing use of the alternative access channels to navigate the market access challenges for Medicare patients.

Speaker #1: We are seeing prominent practices adopting this alternate workflow and use of alternate channels. And, you know, it's basically patients that have access to the drug benefit and, you know, that's the same procedure or process that we use and workflow that we use for Cortrofin.

Speaker #1: And so we've seen prominent retina practices use it. Now, what has happened with the foundation funding is we had seen some early contributions to the funding earlier this year.

Nikhil Lalwani: Now, what has happened with the foundation funding is, we had seen some early contributions to the funding earlier this year. Though, this hasn't had a meaningful impact on patient access to ILUVIEN, you know, it was open for a few days, then it was, you know, closed back. Our guidance for 2026 does not assume that the funding will return in any meaningful way. We will continue to closely monitor the situation and, of course, stay focused on growing the use of the alternative access channels to navigate the market access challenges, in addition to the strategic investments in marketing and medical affairs to support the increased awareness of the NEW DAY clinical data for DME, establishing the coverage for both DME and NIU-PS, and obviously the strengthened commercial team and further enhanced promotional efforts.

Speaker #1: And though this hasn't had a meaningful impact on patient access to Iluvian. You know, it was open for a few days, and then it was, you know, closed back.

Speaker #1: So, our guidance for 2026 does not assume that the funding will return in any meaningful way, and we will continue to closely monitor the situation.

Speaker #1: And, of course, stay focused on growing the use of the alternative access channels to navigate the market access challenges, in addition to the strategic investments in marketing and medical affairs to support the increased awareness of the New Day clinical data for DME, establishing the coverage for both DME and NIUPS, and then, obviously, the strengthened commercial team and further enhanced promotional efforts.

Speaker #1: So that's that on Iluvian. And then, finally, your question on the generics cadence. You know, we are continuing to have a strong cadence, driven by our R&D capabilities, of 10 to 15 launches.

Nikhil Lalwani: That's on ILUVIEN. Finally, your question on the generics cadence. You know, we are continuing to have a strong cadence from our, driven by our R&D capabilities of 10 to 15 launches that will help support growth of the generics business and, you know, cash flow generation that we are reinvesting into rare disease to accelerate the transformation of ANI into a leading rare disease company. Thank you for your questions, Les.

Speaker #1: That'll help support growth of the generics business. And, you know, cash flow generation that we are reinvesting into rare disease to accelerate the transformation of ANI into a leading rare disease company.

Speaker #1: And thank you for your questions, Liz.

Speaker #7: Thank you.

Brandon Folkes: Thank you.

Lee Sulewski: Thank you.

Speaker #2: Thank you. And we'll take our next question from Brandon Folks with HC Wainwright. Please go ahead.

Operator: Thank you. We'll take our next question from Brandon Folkes with H.C. Wainwright. Please go ahead.

Speaker #8: Hi. Thanks for taking my question and congrats on the progress. maybe just sort of following on from the line of questioning on Cortrofin. Outside of gout, is there any way you can just give us some color in terms of how you're seeing the ACTH market shape up?

Brandon Folkes: Hi, thanks for taking my question, and congrats on all the progress. Maybe just sort of following on from the line of questioning on Cortrophin. Outside of gout, is there any way you can just give us some color in terms of how you're seeing the ACTH market shape up? You know, are prescribers choosing one product over the other, or are prescribers using both where they can? You know, you talked about adding new prescribers. Can you just help us think through, when you convert these new prescribers, are you generally converting them to sort of be a Cortrophin prescriber or an ACTH believer and prescriber? What I'm trying to get to is: How competitive is the next script for a potential ACTH patient right now versus a continued market expansion?

Speaker #8: You know, our prescribers choosing one product over the other, or our prescribers using both where they can. You know, you talked about adding new prescribers.

Speaker #8: Can you just help us think through, when you're converting these new prescribers, are you generally converting them to sort of be a Cortrophin prescriber or ACTH?

Speaker #8: believer in prescriber? And what I'm trying to get to is how competitive is the next script for a potential ACTH patient right now versus a continued market expansion?

Speaker #8: How long do you see sort of the market expansion playing out versus market expansion as well as share capture between the two and within the category driving growth?

Brandon Folkes: How long do you see sort of the market expansion playing out versus market expansion, as well as share capture between the two and within the category driving growth? Thank you.

Speaker #8: Thank you.

Speaker #1: Yeah. Good morning. And thank you for your question. Brandon, so I think your first question was on the the ACTH market beyond gout. And I think that you know, we'll just point to a couple of a couple of points.

Nikhil Lalwani: Yeah, good morning, and thank you for your question, Brandon. I think your first question was on the ACTH market beyond gout. I think that, you know, we'll just point to a couple of points. Number one is that we see growth across indications, across the core indications that we launched with, which is in rheumatology, nephrology, and neurology, in addition to in pulmonology and ophthalmology. If you think about ANI's growth in Cortrophin in 2025, you know, the 75% to 76% growth in Cortrophin, you know, a significant portion of that came from just growth across all these specialties outside of gout. Now, gout also was a driver, but there was significant growth across these other specialties, too.

Speaker #1: Number one is that we see growth across indications, across the core indications that we launched with, which is in part in rheumatology, nephrology, and neurology.

Speaker #1: In addition to in Port in pulmonology and ophthalmology. If you think about the ANI's growth in Cortrofin in 2025, you know, the 75 to 76 percent growth in Cortrofin you know, a significant portion of that came from just growth across all these specialties outside of gout.

Speaker #1: Now gout also was a driver. But there was significant growth across these other specialties too. And it really the the thing that's underpinning and that really goes to your second question around the the competitive situation I mean, this is to us not about a you know, about share capture at all.

Nikhil Lalwani: Really, the thing that's underpinning, and that really goes to your second question around the competitive situation, I mean, this is, to us, not about, you know, about share capture at all. This is about market expansion, reaching the appropriate patients, and the addressable patient population is very significant and highly underpenetrated, right? It's significantly underpenetrated across indications. You know, the fact that two players are out there trying to address the appropriate patients, you know, ultimately supports the overall market growth. You know, ensures that the appropriate patients get the benefit of ACTH treatment, you know, for their indications.

Speaker #1: This is about market expansion, reaching the appropriate patients. And there are the addressable patient population is very significant and highly underpenetrated, right? So it's significantly underpenetrated across indications.

Speaker #1: And so, you know, the fact that two players are out there trying to address the appropriate patients, you know, ultimately supports the overall market growth.

Speaker #1: And and you know, ensures that the appropriate patients get get the the benefit of ACTH treatment you know, for for their for their indications.

Speaker #1: And then you know, maybe to your the last part of your question which was you know, we are our team is out there trying to convince and this is a little bit on a lighter note.

Nikhil Lalwani: You know, maybe to your, the last part of your question, which was, you know, our team is out there trying to convince, and this is a little bit on a lighter note, but our team is out there trying to convince patients, oh, sorry, trying to convince physicians of the appropriate patients for Cortrophin, right? You know, not the broader ACTH category. Thank you for your questions, Brandon.

Speaker #1: But our team is out there trying to convince patients or sorry, trying to convince physicians of the appropriate patients for Cortrofin, right? and you know, and not the broader ACTH category.

Speaker #1: So, thank you for your questions, Brandon.

Speaker #2: And I would now like to turn the call back over to Nikhil Lalwani for closing remarks.

Operator: I would like to now turn the call back over to Nikhil Lalwani for closing remarks.

Speaker #1: Thank you, everybody, for taking time to join the ANI discussion. we look forward to updating you on our progress and our looking forward to a strong 2026.

Nikhil Lalwani: Thank you, everybody, for taking time to join the ANI discussion. We look forward to updating you on our progress and are looking forward to a strong 2026. Thank you so much. We will remain focused on our purpose of serving patients, improving lives.

Speaker #1: Thank you so much. And we will remain focused on our purpose of serving patients improving lives.

Operator: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Q4 2025 ANI Pharmaceuticals Inc Earnings Call

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