Q4 2025 Amneal Pharmaceuticals Inc Earnings Call
Speaker #1: Good morning and welcome to the Anneal Pharmaceuticals for Quarter and Full Year 2025 earnings call. I'll now hand the call over to Anneal's head of investor relations, Tony DiMeo.
Operator: Good morning, and welcome to the Amneal Pharmaceuticals Q4 and full year 2025 earnings call. I'll now hand the call over to Amneal's Head of Investor Relations, Tony DeMaio. Go ahead, please, sir.
Operator: Good morning, and welcome to the Amneal Pharmaceuticals Q4 and full year 2025 earnings call. I'll now hand the call over to Amneal's Head of Investor Relations, Tony DeMaio. Go ahead, please, sir.
Speaker #1: Go ahead, please, sir.
Speaker #2: Good morning. And thank you for joining Anneal Pharmaceuticals' fourth quarter 2025 earnings call. Today, we issued a press release reporting Q4 results. The earnings press release and presentation are available at anneal.com.
Anthony DiMeo: Good morning, and thank you for joining Amneal Pharmaceuticals' Q4 2025 earnings call. Today, we issued a press release reporting Q4 results. The earnings press release and presentation are available at amneal.com. Certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discuss non-GAAP measures. Information and use of these measures and reconciliations to GAAP are in the earnings release and presentation. On the call today are Chirag Patel and Chintu Patel, Co-Founders and Co-CEOs, Tasos Konidaris, CFO, our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer.
Tony DiMeo: Good morning, and thank you for joining Amneal Pharmaceuticals' Q4 2025 earnings call. Today, we issued a press release reporting Q4 results. The earnings press release and presentation are available at amneal.com. Certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discuss non-GAAP measures. Information and use of these measures and reconciliations to GAAP are in the earnings release and presentation. On the call today are Chirag Patel and Chintu Patel, Co-Founders and Co-CEOs, Tasos Konidaris, CFO, our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer.
Speaker #2: Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions, are forward-looking statements.
Speaker #2: They are based solely on information that is now available to us. Please see the section entitled 'Cautionary Statements on Forward-Looking Statements' for factors that may impact future performance.
Speaker #2: We also discuss non-gap measures. Information on use of these measures and threat conciliations to gap are in the earnings release and presentation. On the call today are Chirag and Chintu Patel, co-founders and co-CEOs.
Speaker #2: Tasos Konidaris, CFO; our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty; and Jason Daley, Chief Legal Officer. I will now hand the call over to Chirag.
Anthony DiMeo: I will now hand the call over to Chirag.
Tony DiMeo: I will now hand the call over to Chirag.
Speaker #3: Thank you, Tony. And good morning, everyone. 2025 was a defining year of excellence, excellent execution, and portfolio expansion at Amneal. As a diversified biopharmaceutical company—across specialty, complex products, injectables, and biosimilars—we’re building category leadership positions in large and growing markets.
Chirag Patel: Thank you, Tony. Good morning, everyone. 2025 was a defining year of excellence, excellent execution and portfolio expansion at Amneal. As a diversified biopharmaceutical company across specialty, complex products, injectables, and biosimilars, we're building category leadership positions in large and growing markets. In 2025, revenue grew 8%, adjusted EBITDA increased 10%, adjusted EPS rose 43%. 2025 marks our sixth consecutive year of growth. In our industry, that consistency of growth stands out. What's most exciting is not only what we have achieved so far, which we are truly proud of, but the even greater opportunity that lies ahead. We enter 2026 with a strong foundation and exciting strategic growth opportunities.
Chirag Patel: Thank you, Tony. Good morning, everyone. 2025 was a defining year of excellence, excellent execution and portfolio expansion at Amneal. As a diversified biopharmaceutical company across specialty, complex products, injectables, and biosimilars, we're building category leadership positions in large and growing markets. In 2025, revenue grew 8%, adjusted EBITDA increased 10%, adjusted EPS rose 43%. 2025 marks our sixth consecutive year of growth. In our industry, that consistency of growth stands out. What's most exciting is not only what we have achieved so far, which we are truly proud of, but the even greater opportunity that lies ahead. We enter 2026 with a strong foundation and exciting strategic growth opportunities.
Speaker #3: In 2025, revenue grew 8%, adjusted EBITDA increased 10%, and adjusted EPS rose 43%. 2025 marks our sixth consecutive year of growth. In our industry, that consistency of growth stands out.
Speaker #3: What's most exciting is not only what we have achieved so far, which we are truly proud of, but the even greater opportunity that lies ahead.
Speaker #3: We entered 2026 with a strong foundation and exciting strategic growth opportunities. Whether we are advancing the standard of care with innovative therapies like Crexon or expanding access to affordable complex medicines, our mission is clear: to become America's number one affordable medicines company.
Chirag Patel: Whether we are advancing the standard of care with innovative therapies like Trexall, or expanding access to affordable, complex medicines, our mission is clear: to become America's number one affordable medicines company. Since our founding over 20 years ago, Amneal has always been driven by the deep passion and responsibility to serve the millions of patients who rely on our medicines every day. We're just getting started. Let me begin with our largest segment, affordable medicines. The business continues to grow year after year, driven by an expanding portfolio of complex, differentiated, and durable products. 2025 was an exceptional year for approvals and launches, particularly in complex generics and injectables. These launches are not one-time events. They are multi-year value drivers. As a result, we expect meaningful acceleration in our affordable medicine segment revenue growth in 2026 and 2027.
Chirag Patel: Whether we are advancing the standard of care with innovative therapies like Trexall, or expanding access to affordable, complex medicines, our mission is clear: to become America's number one affordable medicines company. Since our founding over 20 years ago, Amneal has always been driven by the deep passion and responsibility to serve the millions of patients who rely on our medicines every day. We're just getting started. Let me begin with our largest segment, affordable medicines. The business continues to grow year after year, driven by an expanding portfolio of complex, differentiated, and durable products. 2025 was an exceptional year for approvals and launches, particularly in complex generics and injectables. These launches are not one-time events. They are multi-year value drivers. As a result, we expect meaningful acceleration in our affordable medicine segment revenue growth in 2026 and 2027.
Speaker #3: Since our founding over 20 years ago, Amneal has always been driven by the deep passion and responsibility to serve the millions of patients who rely on our medicines every day.
Speaker #3: And we're just getting started. Let me begin with our largest segment, affordable medicines. The business continues to grow year after year, driven by an expanding portfolio of complex, differentiated, and durable products. 2025 was an exceptional year for approvals and launches.
Speaker #3: Particularly in complex generics and injectables. These launches are not one-time events. They are multi-year value drivers. As a result, we expect meaningful acceleration in our affordable medicines segment, revenue growth in 2026 and '27.
Speaker #3: In injectables, we're executing with a clear ambition to become a top five player in the US institutional market. Over the years, we have significantly expanded our R&D and manufacturing capabilities.
Chirag Patel: In injectables, we are executing with a clear ambition to become a top five player in the US institutional market. Over the years, we have significantly expanded our R&D and manufacturing capabilities, adding the technical capabilities required for long-term leadership. Our strategy focuses on providing differentiated offerings for hospitals, including ready-to-use specialty injectables. With over 40 products and a pipeline of differentiated launches, we expect this business to scale substantially over time. In biosimilars, we're building a long-term growth engine. We begin with in-licensing and creating a strong commercial platform. In December, we received approval for our neratuzumab biosimilars, our fourth and fifth products. With biosimilar Xolair in the review, we remain on track to have six biosimilars in the US market by 2027. Strategically, our goal remains to be vertically integrated in biosimilars across development, manufacturing, and commercialization, which we believe is essential for long-term success.
Chirag Patel: In injectables, we are executing with a clear ambition to become a top five player in the US institutional market. Over the years, we have significantly expanded our R&D and manufacturing capabilities, adding the technical capabilities required for long-term leadership. Our strategy focuses on providing differentiated offerings for hospitals, including ready-to-use specialty injectables. With over 40 products and a pipeline of differentiated launches, we expect this business to scale substantially over time. In biosimilars, we're building a long-term growth engine. We begin with in-licensing and creating a strong commercial platform. In December, we received approval for our neratuzumab biosimilars, our fourth and fifth products. With biosimilar Xolair in the review, we remain on track to have six biosimilars in the US market by 2027. Strategically, our goal remains to be vertically integrated in biosimilars across development, manufacturing, and commercialization, which we believe is essential for long-term success.
Speaker #3: Adding the technical capabilities required for long-term leadership. Our strategy focuses on providing differentiated offerings for hospitals, including ready-to-use specialty injectables. With over 40 products and a pipeline of differentiated launches, we expect this business to scale substantially over time.
Speaker #3: In biosimilars, we're building a long-term growth engine. We begin with in-licensing and creating a strong commercial platform. In December, we received approval for our denosumab biosimilars—our fourth and fifth products.
Speaker #3: With biosimilars Zoled under review, we remain on track to have six biosimilars in the US market by 2027. Strategically, our goal remains to be vertically integrated in biosimilar across development, manufacturing, and commercialization.
Speaker #3: Which we believe is essential for long-term success. From a macro perspective, the opportunity is remarkable. Over the next decade, about 234 billion of biologic cells will lose exclusivity, more than double the prior 10 years.
Chirag Patel: From a micro perspective, the opportunity is remarkable. Over the next decade, about 234 millions of biologic cells will lose exclusivity, more than double the prior 10 years, and only about 10% of those products have biosimilars in development. This creates a significant long-term opportunity to dramatically expand patient access and drive very meaningful growth for our company. Next, in GLP-1s, our collaboration with Pfizer is progressing well, and both teams are working together. We are here to assist Pfizer in a meaningful way. This initiative builds on what we do best: develop, manufacture, and commercialize complex medicines at scale, and position us to play a meaningful long-term role in one of the largest and fastest-growing therapeutic categories in healthcare. Now, let's turn to the specialty segment. We're very pleased with the uptake of Rexulti.
Chirag Patel: From a micro perspective, the opportunity is remarkable. Over the next decade, about 234 millions of biologic cells will lose exclusivity, more than double the prior 10 years, and only about 10% of those products have biosimilars in development. This creates a significant long-term opportunity to dramatically expand patient access and drive very meaningful growth for our company. Next, in GLP-1s, our collaboration with Pfizer is progressing well, and both teams are working together. We are here to assist Pfizer in a meaningful way. This initiative builds on what we do best: develop, manufacture, and commercialize complex medicines at scale, and position us to play a meaningful long-term role in one of the largest and fastest-growing therapeutic categories in healthcare. Now, let's turn to the specialty segment. We're very pleased with the uptake of Rexulti.
Speaker #3: And only about 10% of those products have biosimilars in development. These create a significant long-term opportunity to dramatically expand patient access and drive very meaningful growth for our company.
Speaker #3: Next, in GLP-1s, our collaboration with Pfizer is progressing well, and both teams are working together. We are here to assist Pfizer in a meaningful way.
Speaker #3: This initiative builds on what we do best: develop, manufacture, and commercialize complex medicines at scale. And position us to play a meaningful long-term role in one of the largest and fastest-growing therapeutic categories in healthcare.
Speaker #3: Now, let's turn to the specialty segment. We're very pleased with the uptake of Crexon. At the end of 2025, about 23,000 patients were on therapy.
Chirag Patel: At the end of 2025, about 23,000 patients were on therapy, reflecting over 3% market share one year post-launch. For context, RYTARY reached roughly 42,000 patients and 6% market share 10 years after launch. In December, interim Phase IV data reinforced that what physicians and patients are already seeing, Rexulti delivers more good on time than other therapies. We remain confident in peak US sales of $300 to 500 million for Rexulti, which we believe is setting a new standard of care for Parkinson's patient. In Q4, we launched Vyepti, a first and only auto-injector for severe migraine and cluster headache patients. For many of these patients, the prior option was an emergency room visit. Vyepti gives them control, delivering the same hospital medication in a ready-to-use auto-injector.
Chirag Patel: At the end of 2025, about 23,000 patients were on therapy, reflecting over 3% market share one year post-launch. For context, RYTARY reached roughly 42,000 patients and 6% market share 10 years after launch. In December, interim Phase IV data reinforced that what physicians and patients are already seeing, Rexulti delivers more good on time than other therapies. We remain confident in peak US sales of $300 to 500 million for Rexulti, which we believe is setting a new standard of care for Parkinson's patient. In Q4, we launched Vyepti, a first and only auto-injector for severe migraine and cluster headache patients. For many of these patients, the prior option was an emergency room visit. Vyepti gives them control, delivering the same hospital medication in a ready-to-use auto-injector.
Speaker #3: Reflecting over 3% market share one year post-launch. For context, Rytary reached roughly 42,000 patients and 6% market share 10 years after launch. In December, interim phase four data reinforced what physicians and patients are already seeing: Crexon delivers more good-on-time than other therapies.
Speaker #3: We remain confident in peak U.S. sales of $300 million to $500 million for Crexon, which we believe is setting a new standard of care for Parkinson's patients.
Speaker #3: In the fourth quarter, we launched Brekia, the first and only autoinjector for severe migraine and cluster headache patients. For many of these patients, the prior option was enemas or an emergency room visit.
Speaker #3: Brekia gives them control, delivering the same hospital medication in a ready-to-use autoinjector. Brekia is our next growth catalyst in specialty. With expected peak cells of 50 to 100 million dollars.
Chirag Patel: Vyepti is our next growth catalyst in specialty, with expected peak sales of $50 to $100 million. Lastly, AvKARE continues to provide diversification and strategic advantage. Through government and distribution channels, AvKARE strengthens our direct access to key end markets and provides an efficient path for new launches, including biosimilars, complex generics, and specialty products. Overall, we are building a diversified biopharmaceutical company that expands access and provides new therapies for patients, and delivers consistent growth for investors. With that, I'll turn it over to Chintan.
Chirag Patel: Vyepti is our next growth catalyst in specialty, with expected peak sales of $50 to $100 million. Lastly, AvKARE continues to provide diversification and strategic advantage. Through government and distribution channels, AvKARE strengthens our direct access to key end markets and provides an efficient path for new launches, including biosimilars, complex generics, and specialty products. Overall, we are building a diversified biopharmaceutical company that expands access and provides new therapies for patients, and delivers consistent growth for investors. With that, I'll turn it over to Chintan.
Speaker #3: Lastly, healthcare continues to provide diversification and strategic advantage. Through government and distribution channels, healthcare strengthens our direct access to key end markets and provides an efficient path for new launches, including biosimilars, complex generics, and specialty products.
Speaker #3: Overall, we are building a diversified biopharmaceutical company that expands access and provides new therapies for patients, and delivers consistent growth for investors. With that, I'll turn it over to Chintu.
Speaker #1: Thank you, Chirag, and good morning. I will begin with gratitude and thank the global Amneal team for their dedication and hard work, which continue to drive our company's success.
Chintu Patel: Thank you, Chirag. Good morning. I will begin with gratitude and thank the global Amneal team for their dedication and hard work, which continue to drive our company's success. The formula for strong execution remains the same: operational excellence, robust innovation, and a differentiated portfolio. First, on operations, our global manufacturing network and leading technical capabilities remain a core strategic advantage. We continually enhance efficiency through digitization, automation, and AI, which will drive cost efficiencies. In GLP-1s, our collaboration with Pfizer is progressing very well. Our manufacturing build-out of two new GLP-1 facilities remain on target, one for large-scale peptide production and one for advanced sterile fill finish manufacturing, designed to support all dosage forms. We are well-positioned to participate meaningfully in the long-term GLP-1 market with this scalable and flexible manufacturing platform. In affordable medicine, we look to launch 20 to 30 new products each year.
Chintu Patel: Thank you, Chirag. Good morning. I will begin with gratitude and thank the global Amneal team for their dedication and hard work, which continue to drive our company's success. The formula for strong execution remains the same: operational excellence, robust innovation, and a differentiated portfolio. First, on operations, our global manufacturing network and leading technical capabilities remain a core strategic advantage. We continually enhance efficiency through digitization, automation, and AI, which will drive cost efficiencies. In GLP-1s, our collaboration with Pfizer is progressing very well. Our manufacturing build-out of two new GLP-1 facilities remain on target, one for large-scale peptide production and one for advanced sterile fill finish manufacturing, designed to support all dosage forms. We are well-positioned to participate meaningfully in the long-term GLP-1 market with this scalable and flexible manufacturing platform. In affordable medicine, we look to launch 20 to 30 new products each year.
Speaker #1: The formula for strong execution remains the same. Operational excellence, robust innovation, and a differentiated portfolio. First on operations, our global manufacturing network and leading technical capabilities remain a core strategic advantage.
Speaker #1: We continually enhance efficiency through digitization, automation, and AI, which will drive cost efficiencies. In GLP-1s, our collaboration with Pfizer is progressing very well. Our manufacturing buildout of two new GLP-1 facilities remains on target.
Speaker #1: One for large-scale peptide production, and one for advanced sterile fill-finish manufacturing. Designed to support all dosage forms. We are well positioned to participate meaningfully in the long-term GLP-1 market with the scalable and flexible manufacturing platform.
Speaker #1: In Affordable Medicine, we look to launch 20 to 30 new products each year. Importantly, it is not just the number of launches, but the value and complexity of these products that matter.
Chintu Patel: Importantly, it is not just the number of launches, but the value and complexity of these products that matter. In that regard, 2025 was an exceptionally strong year. For years, we have strategically prioritized the development of complex generics, including injectables, ophthalmics, inhalation products, and other advanced drug device combinations. As a result, we are now in the midst of one of the most concentrated and impactful waves of high-value, affordable medicine launches in Amneal's history. During Q4, we meaningfully expanded our portfolio with a series of important late 2025 approvals and launches across multiple areas. Highlights included Risperidone extended release, our first long-acting injectable, Sodium Oxybate, Bimatoprost, and Cyclosporine in ophthalmics. The first generic for Iohexol and multiple other injectables for hospitals, including several Epinephrine products. Notably, we also announced approval and now launching our first two inhalation products, Beclomethasone dipropionate and Albuterol sulfate.
Chintu Patel: Importantly, it is not just the number of launches, but the value and complexity of these products that matter. In that regard, 2025 was an exceptionally strong year. For years, we have strategically prioritized the development of complex generics, including injectables, ophthalmics, inhalation products, and other advanced drug device combinations. As a result, we are now in the midst of one of the most concentrated and impactful waves of high-value, affordable medicine launches in Amneal's history. During Q4, we meaningfully expanded our portfolio with a series of important late 2025 approvals and launches across multiple areas. Highlights included Risperidone extended release, our first long-acting injectable, Sodium Oxybate, Bimatoprost, and Cyclosporine in ophthalmics. The first generic for Iohexol and multiple other injectables for hospitals, including several Epinephrine products. Notably, we also announced approval and now launching our first two inhalation products, Beclomethasone dipropionate and Albuterol sulfate.
Speaker #1: In that regard, in 2025 was an exceptionally strong year. For years, we have strategically prioritized the development of complex generics including injectables, ophthalmics, inhalation products, and other advanced drug-device combinations.
Speaker #1: As a result, we are now in the midst of one of the most concentrated and impactful waves of high-value, affordable medicine launches in Amneal's history.
Speaker #1: During the fourth quarter, we meaningfully expanded our portfolio with a series of important late 2025 approvals and launches across multiple areas. Highlights included risperidone extended release, our first long-acting injectable, sodium oxalate, bimatoprost, and cyclosporine in ophthalmics.
Speaker #1: The first generic for iohexol and multiple other injectables for hospitals, including several epinephrine products. Notably, we also announced approval and now launching our first two inhalation products.
Speaker #1: Beclomethasone dipropionate and albuterol sulfate. This reflects a decade of hard work by the team and marks our new entry into inhalation, which is a new growth platform starting this year.
Chintu Patel: This reflects a decade of hard work by the team and marks our new entry into inhalation, which is new growth platform starting this year. With this level of activity, we are reaching an inflection point in complex innovation. Today, we have 59 ANDAs pending, with 64% classified as complex products and 52 more products in development with 94% complex. We look to file 10 to 15 key complex programs in 2026, including several more injectables and inhalation programs. This complex portfolio evolution positions us very well for sustainable growth. In biosimilars, we continue to build our business deliberately over time. Our next major milestone is biosimilar Xolair, which represents our sixth potential biosimilar and our largest opportunity to date.
Chintu Patel: This reflects a decade of hard work by the team and marks our new entry into inhalation, which is new growth platform starting this year. With this level of activity, we are reaching an inflection point in complex innovation. Today, we have 59 ANDAs pending, with 64% classified as complex products and 52 more products in development with 94% complex. We look to file 10 to 15 key complex programs in 2026, including several more injectables and inhalation programs. This complex portfolio evolution positions us very well for sustainable growth. In biosimilars, we continue to build our business deliberately over time. Our next major milestone is biosimilar Xolair, which represents our sixth potential biosimilar and our largest opportunity to date.
Speaker #1: With this level of activity, we are reaching an inflection point in complex innovation. Today, we have 59 ANDAs pending, with 64% classified as complex.
Speaker #1: Products and 52 more products in development with 94% complex. We look to file 10 to 15 key complex programs in 2026, including several more injectables and inhalation programs.
Speaker #1: These complex portfolio evolutions position us very well for sustainable growth. In biosimilars, we continue to build our business deliberately over time. Our next major milestone is biosimilar Xolair, which represents our sixth potential biosimilar and our largest opportunity to date.
Speaker #1: Xolair was one of the first blockbuster allergy biologics, and we expect to be among the first biosimilars in these over 4 billion US markets next year.
Chintu Patel: Xolair was one of the first blockbuster allergy biologics. We expect to be among the first biosimilars in this over $4 billion US market next year. We are very proud of the progress we have made in building a biosimilar business. As Chirag noted, we see a very significant opportunity ahead with the upcoming wave of biologics LOEs. Success in this space will require vertical integration from cell line development and R&D to manufacturing and commercial capabilities. That is what will be needed to be a long-term leader in biosimilar. In specialty, CREXONT continues to perform exceptionally well and believe it has the potential to become the standard of care for all people living with Parkinson's disease. For decades, the foundation of treatment has been immediate-release carbidopa/levodopa, a therapy that dates back to 1970s.
Chintu Patel: Xolair was one of the first blockbuster allergy biologics. We expect to be among the first biosimilars in this over $4 billion US market next year. We are very proud of the progress we have made in building a biosimilar business. As Chirag noted, we see a very significant opportunity ahead with the upcoming wave of biologics LOEs. Success in this space will require vertical integration from cell line development and R&D to manufacturing and commercial capabilities. That is what will be needed to be a long-term leader in biosimilar. In specialty, CREXONT continues to perform exceptionally well and believe it has the potential to become the standard of care for all people living with Parkinson's disease. For decades, the foundation of treatment has been immediate-release carbidopa/levodopa, a therapy that dates back to 1970s.
Speaker #1: We are very proud of the progress we have made in building a biosimilar business. As Chirag noted, we see a very significant opportunity ahead with the upcoming wave of biologics LOEs.
Speaker #1: Success in this space will require vertical integration from cell line development and R&D to manufacturing, and commercial capabilities. That is what will be needed to be a long-term leader in biosimilar.
Speaker #1: In specialty, Kynmobi continues to perform exceptionally well and we believe it has the potential to become the standard of care for all people living with Parkinson's disease.
Speaker #1: For decades, the foundation of treatment has been immediate-release carbidopa-levodopa, a therapy that dates back to the 1970s. IR CD-LD is limited by fluctuating symptom control, frequent dosing, and significant off-time as the disease progresses.
Chintu Patel: IR CD/LD is limited by fluctuating symptom control, frequent dosing, and significant off time as the disease progresses. CREXONT represents a meaningful advancement in therapy designed to address these long-lasting limitations by delivering more consistent symptom control with fewer daily doses. In 2024, we initiated a phase four real-world study of approximately 225 patients, converting them from RYTARY, IR CD/LD, and IR CD/LD with comp inhibitors to CREXONT. In December, we shared the first interim results from this open-label study, which demonstrated clear and clinically meaningful differentiation. Patients treated with CREXONT experienced substantially more good on time, less off time, and longer intervals of continuous good on time. Importantly, patients converted from IR to CREXONT showed over 3 hours more good on time per day, a result that is highly meaningful for Parkinson's patients.
Chintu Patel: IR CD/LD is limited by fluctuating symptom control, frequent dosing, and significant off time as the disease progresses. CREXONT represents a meaningful advancement in therapy designed to address these long-lasting limitations by delivering more consistent symptom control with fewer daily doses. In 2024, we initiated a phase four real-world study of approximately 225 patients, converting them from RYTARY, IR CD/LD, and IR CD/LD with comp inhibitors to CREXONT. In December, we shared the first interim results from this open-label study, which demonstrated clear and clinically meaningful differentiation. Patients treated with CREXONT experienced substantially more good on time, less off time, and longer intervals of continuous good on time. Importantly, patients converted from IR to CREXONT showed over 3 hours more good on time per day, a result that is highly meaningful for Parkinson's patients.
Speaker #1: Craxont represents a meaningful advancement in therapy designed to address these long-lasting limitations by delivering more consistent symptom control with fewer daily doses. In 2024, we initiated a Phase 4 real-world study of approximately 225 patients.
Speaker #1: Converting them from wirtery IRCD-LD and IRCD-LD with COMT inhibitors to Craxont. In December, we shared the first interim result from these open-label studies, which demonstrated clear and clinically meaningful differentiation: patients treated with Craxont experienced substantially more good on-time, less off-time, and longer intervals of continuous good on-time.
Speaker #1: Importantly, patients converted from IR to Craxont showed over three hours more good on-time per day. A result that is highly meaningful for Parkinson's patients.
Speaker #1: We look to generate further evidence to demonstrate Craxont's effectiveness and expect to share more data over 2026 and 2027. In addition, internationally, we have filed the products in a number of key countries including India, Canada, and in Europe.
Chintu Patel: We look to generate further evidence to demonstrate CREXONT's effectiveness and expect to share more data over 2026 and 2027. In addition, internationally, we have filed the products in a number of key countries, including India, Canada, and Europe. Beyond CREXONT, we plan to expand our specialty portfolio over time with products in areas like CNS and others, where differentiated delivery, real-world performance, and patient convenience matter. Brekiya auto-injector is a clear example, combining a proven therapy with differentiated drug delivery system that improves how patients receive care. Specialty represents a multiproduct growth engine for Amneal, and we'll share more on our pipeline as it evolves. In summary, we are executing well, driving operational excellence, advancing innovation, and expanding a differentiated portfolio across affordable medicines, specialty, and biosimilar. The progress we made in Q4 reinforces our confidence in the path ahead.
Chintu Patel: We look to generate further evidence to demonstrate CREXONT's effectiveness and expect to share more data over 2026 and 2027. In addition, internationally, we have filed the products in a number of key countries, including India, Canada, and Europe. Beyond CREXONT, we plan to expand our specialty portfolio over time with products in areas like CNS and others, where differentiated delivery, real-world performance, and patient convenience matter. Brekiya auto-injector is a clear example, combining a proven therapy with differentiated drug delivery system that improves how patients receive care. Specialty represents a multiproduct growth engine for Amneal, and we'll share more on our pipeline as it evolves. In summary, we are executing well, driving operational excellence, advancing innovation, and expanding a differentiated portfolio across affordable medicines, specialty, and biosimilar. The progress we made in Q4 reinforces our confidence in the path ahead.
Speaker #1: Beyond Craxont, we plan to expand our specialty portfolio over time with products in areas like CNS and others, where differentiated delivery real-world performance and patient convenience matter.
Speaker #1: Brachia autoinjector is a clear example: combining a proven therapy with a differentiated drug delivery system that improves how patients receive care. Specialty represents a multi-product growth engine for Amneal, and we will share more on our pipeline as it evolves.
Speaker #1: In summary, we are executing well, driving operational excellence, advancing innovation, and expanding a differentiated portfolio across affordable medicines, specialty, and biosimilars. The progress we made in Q4 reinforces our confidence in the path ahead.
Speaker #1: With that, I will turn it over to Tasos.
Chintu Patel: With that, I will turn it over to Tasos.
Chintu Patel: With that, I will turn it over to Tasos.
Speaker #2: Thank you. Chin, doing good morning, everyone. The fourth quarter completed another terrific year for Anneal. With strong top and bottom line growth, as Q4 revenues grew 11%, adjusted EBITDA grew 13%, and adjusted EPS grew 75%.
Tasos Konidaris: Thank you, Chintu, and good morning, everyone. The Q4 completed another terrific year for Amneal, with strong top and bottom line growth, as Q4 revenues grew 11%, adjusted EBITDA grew 13%, and adjusted EPS grew 75%. Our consistent performance reflects our strategic choices, relevancy of our broad portfolio, prudent capital allocation, and strong execution. In addition to strong top and bottom line growth, we also delivered strong full-year operating cash flow of $340 million, reduced net leverage to 3.5x, and our successful refinancing extended maturities to 2032, and substantially reduced interest costs. All in all, an excellent finish to the year. Over the next few minutes, I'll cover in more detail our Q4 and full year 2025 results and move on to our 2026 guidance.
Tasos Konidaris: Thank you, Chintu, and good morning, everyone. The Q4 completed another terrific year for Amneal, with strong top and bottom line growth, as Q4 revenues grew 11%, adjusted EBITDA grew 13%, and adjusted EPS grew 75%. Our consistent performance reflects our strategic choices, relevancy of our broad portfolio, prudent capital allocation, and strong execution. In addition to strong top and bottom line growth, we also delivered strong full-year operating cash flow of $340 million, reduced net leverage to 3.5x, and our successful refinancing extended maturities to 2032, and substantially reduced interest costs. All in all, an excellent finish to the year. Over the next few minutes, I'll cover in more detail our Q4 and full year 2025 results and move on to our 2026 guidance.
Speaker #2: Our consistent performance reflects our strategic choices: relevancy of our broad portfolio, prudent capital allocation, and strong execution. In addition to strong top and bottom line growth, we also delivered strong full-year operating cash flow of $340 million, reduced net leverage to 3.5 times, and our successful refinancing extended maturities to 2032 and substantially reduced interest costs.
Speaker #2: So, all in all, an excellent finish to the year. Over the next few minutes, I'll cover in more detail our fourth quarter and full-year 2025 results, and then move on to our 2026 guidance.
Speaker #2: Starting with the fourth quarter, total company revenues grew 11% to a record $814 million. First, our Affordable Medicines segment was essentially flat at $437 million, reflecting the timing of key products and new launches.
Tasos Konidaris: Starting with Q4, total company revenues grew 11% to a record $814 million. First, our affordable medicines segment was essentially flat to $437 million, reflecting the timing of key products and new launches. Second, specialty revenues were very strong again in Q4, up 38% year-over-year to $167 million, due to strong demand across our key brands such as CREXONT, RYTARY, UNITHROID, and some small initial sales of our newest branded product, Brekiya autoinjector for cluster headaches. Third, AvKARE revenues grew 24% to $211 million, driven by strong growth in the government channel. Our Q4 revenues continued to benefit by approximately $50 million associated with one significant new product launch, which accounted for approximately $100 million in new revenue for the full year 2025.
Tasos Konidaris: Starting with Q4, total company revenues grew 11% to a record $814 million. First, our affordable medicines segment was essentially flat to $437 million, reflecting the timing of key products and new launches. Second, specialty revenues were very strong again in Q4, up 38% year-over-year to $167 million, due to strong demand across our key brands such as CREXONT, RYTARY, UNITHROID, and some small initial sales of our newest branded product, Brekiya autoinjector for cluster headaches. Third, AvKARE revenues grew 24% to $211 million, driven by strong growth in the government channel. Our Q4 revenues continued to benefit by approximately $50 million associated with one significant new product launch, which accounted for approximately $100 million in new revenue for the full year 2025.
Speaker #2: Second, specialty revenues were very strong again in Q4, up 38% year over year to $167 million, due to strong demand across our key brands such as Craxont, Writery, Unithroid, and some small initial sales of our newest branded product, Brachia autoinjector, for cluster headaches.
Speaker #2: Third, healthcare revenues grew 24% to $211 million, driven by strong growth in the government channel. Our Q4 revenues continued to benefit by approximately $15 million associated with one significant new product launch which accounted for approximately $100 million in new revenue for the full year 2025.
Tasos Konidaris: Q4 adjusted EBITDA over $175 million grew 13%, driven by top-line growth and limited OpEx growth. Q4 earnings per share of $0.21 grew 75% due to adjusted EBITDA growth and lower interest expense due to our favorable refinancing earlier in 2025. Let me now shift to our full year 2025 performance, where we exceeded all our financial guidance metrics. The company revenue of $3 billion increased 8%, driven by growth across all of our business segments as affordable medicines grew 4%, specialty grew 19%, and AvKARE grew 12%. We're also very pleased by the growth of our adjusted gross margin, which expanded by 50 basis points to approximately 43%. It's worth noting that AvKARE's 2025 adjusted gross margin increased in excess of 400 basis points due to our concerted efforts to prioritize profitability.
Tasos Konidaris: Q4 adjusted EBITDA over $175 million grew 13%, driven by top-line growth and limited OpEx growth. Q4 earnings per share of $0.21 grew 75% due to adjusted EBITDA growth and lower interest expense due to our favorable refinancing earlier in 2025. Let me now shift to our full year 2025 performance, where we exceeded all our financial guidance metrics. The company revenue of $3 billion increased 8%, driven by growth across all of our business segments as affordable medicines grew 4%, specialty grew 19%, and AvKARE grew 12%. We're also very pleased by the growth of our adjusted gross margin, which expanded by 50 basis points to approximately 43%. It's worth noting that AvKARE's 2025 adjusted gross margin increased in excess of 400 basis points due to our concerted efforts to prioritize profitability.
Speaker #2: Fourth quarter adjusted EBITDA of $175 million grew 13%, driven by top line growth and limited operating expense growth. Q4 earnings per share of $21 cents grew 75% due to adjusted EBITDA growth and lower interest expense due to our favorable refinancing earlier in 2025.
Speaker #2: Let me now shift to our full-year 2025 performance, where we exceeded all our financial guidance metrics. Total company revenue of $3 billion increased 8%, driven by growth across all of our business segments, as Affordable Medicines grew 4%, Specialty grew 19%, and Healthcare grew 12%.
Speaker #2: We're also very pleased by the growth of our adjusted gross margin, which expanded by 50 basis points to approximately 43%. It's worth noting that healthcare's 2025 adjusted gross margin increased in excess of 400 basis points due to our concerted efforts to prioritize profitability.
Speaker #2: On the bottom line, full-year 2025 adjusted EBITDA grew 10% to $688 million, and adjusted EPS grew 43% to $83 cents. In addition to our strong financial performance in 2025, we feel great about the actions we have taken to strengthen our balance sheet.
Tasos Konidaris: On the bottom line, full year 2025 adjusted EBITDA grew 10% to $688 million, and adjusted EPS grew 43% to $0.83. In addition to our strong financial performance in 2025, we feel great about the actions we have taken to strengthen our balance sheet. First, we have reduced net leverage from 7.4x in 2019 to 3.9x at the end of 2024, and finally to 3.5x at the end of 2025. Second, we fully refinanced our debt last summer. In January of this year, we repriced our Term Loan B to further lower interest rate expense.
Tasos Konidaris: On the bottom line, full year 2025 adjusted EBITDA grew 10% to $688 million, and adjusted EPS grew 43% to $0.83. In addition to our strong financial performance in 2025, we feel great about the actions we have taken to strengthen our balance sheet. First, we have reduced net leverage from 7.4x in 2019 to 3.9x at the end of 2024, and finally to 3.5x at the end of 2025. Second, we fully refinanced our debt last summer. In January of this year, we repriced our Term Loan B to further lower interest rate expense.
Speaker #2: First, we have reduced net leverage from 7.4 times in 2019 to 3.9 times at the end of 2024, and finally to 3.5 times at the end of 2025.
Speaker #2: Second, we fully refinanced our dead last summer and in January of this year, we repriced our term loan B to further lower interest rate expense.
Speaker #2: As a result, our weighted average cost of debt is down from 10% in 2024 to about 6.8% in 2026, and maturities have been extended out to 2032.
Tasos Konidaris: As a result, our weighted average cost of debt is down from 10% in 2024 to about 6.8% in 2026, and maturities have been extended out to 2032. Accordingly, interest expense in 2025 was $217 million, compared to $256 million in 2024, and as importantly, we expect a further reduction in 2026. I'll now turn to our full year 2026 guidance, which in summary, reflects another year of growth across all financial metrics. In summary, we expect top line growth between 1% and 4%, adjusted EBITDA growth between 5% and 10%, and adjusted EPS growth between 12% and 24%.
Tasos Konidaris: As a result, our weighted average cost of debt is down from 10% in 2024 to about 6.8% in 2026, and maturities have been extended out to 2032. Accordingly, interest expense in 2025 was $217 million, compared to $256 million in 2024, and as importantly, we expect a further reduction in 2026. I'll now turn to our full year 2026 guidance, which in summary, reflects another year of growth across all financial metrics. In summary, we expect top line growth between 1% and 4%, adjusted EBITDA growth between 5% and 10%, and adjusted EPS growth between 12% and 24%.
Speaker #2: Accordingly, interest expense in 2025 was $217 million, compared to $256 million in 2024, and, as importantly, we expect a further reduction in 2026. I'll now turn to our full-year 2026 guidance, which in summary reflects another year of growth across all financial metrics.
Speaker #2: In summary, we expect top-line growth between 1% and 4%, adjusted EBITDA growth between 5% and 10%, and adjusted EPS growth between 12% and 24%.
Speaker #2: Let me provide a bit more detail on each of our guidance metrics. Starting with total company revenue of $3.05 billion to $3.15 billion.
Tasos Konidaris: Let me provide a bit more detail on each of our guidance metrics, starting with total company revenue of $3.05 billion to $3.15 billion, up 1% to 4%, as I mentioned. We expect the growth to be driven by our largest business segment, affordable medicines, where we expect growth between 7% and 8%. This is an acceleration from 4% growth in 2025, but in line with our prior 3-year average. Our growth expectation is rooted in the robust cadence of new product launches we received from the FDA in the last couple of months. As a result, we're entering 2026 with the highest number of product approvals, which de-risks our growth expectations. In our specialty segment, we expect 2026 revenues to be about flat to 2025.
Tasos Konidaris: Let me provide a bit more detail on each of our guidance metrics, starting with total company revenue of $3.05 billion to $3.15 billion, up 1% to 4%, as I mentioned. We expect the growth to be driven by our largest business segment, affordable medicines, where we expect growth between 7% and 8%. This is an acceleration from 4% growth in 2025, but in line with our prior 3-year average. Our growth expectation is rooted in the robust cadence of new product launches we received from the FDA in the last couple of months. As a result, we're entering 2026 with the highest number of product approvals, which de-risks our growth expectations. In our specialty segment, we expect 2026 revenues to be about flat to 2025.
Speaker #2: Up 1 to 4 percent, as I mentioned. We expect the growth to be driven by our largest business segment, affordable medicines, where we expect growth between 7 and 8 percent.
Speaker #2: This is an acceleration from 2025, but in line with our prior three-year average. Our growth expectation is rooted in the robust cadence of new product launches we receive from the FDA the last couple of months.
Speaker #2: As a result, we're entering 2026 with the highest number of product approvals, which derisks our growth expectations. In our Specialty segment, we expect 2026 revenues to be about flat to 2025.
Speaker #2: This temporary pause in growth simply reflects the continued growth of Craxont and our other brands being offset by the expected generic erosion of Writery.
Tasos Konidaris: This temporary pause in growth simply reflects the continued growth of CREXONT and our other brands being offset by the expected generic erosion of RYTARY. As we look forward to 2027 and beyond, we expect our specialty business to resume its strong growth trajectory as the growth of CREXONT and our multiple other branded products overcome the loss of exclusivity of RYTARY. In our AvKARE segment, we expect revenue between $625 million to 700 million in 2026, compared to $745 million in 2025, and $663 million in 2024. While the year-over-year revenues will be down in 2026, our expected profitability is flat year over year, as we continue our successful efforts to focus on the more profitable segments of the business.
Tasos Konidaris: This temporary pause in growth simply reflects the continued growth of CREXONT and our other brands being offset by the expected generic erosion of RYTARY. As we look forward to 2027 and beyond, we expect our specialty business to resume its strong growth trajectory as the growth of CREXONT and our multiple other branded products overcome the loss of exclusivity of RYTARY. In our AvKARE segment, we expect revenue between $625 million to 700 million in 2026, compared to $745 million in 2025, and $663 million in 2024. While the year-over-year revenues will be down in 2026, our expected profitability is flat year over year, as we continue our successful efforts to focus on the more profitable segments of the business.
Speaker #2: As we look forward to 2027 and beyond, we expect our specialty business to resume its strong growth trajectory as the growth of Craxont and our multiple other branded products overcome the loss of exclusivity of Writery.
Speaker #2: In our healthcare segment, we expect revenue between $625 million and $700 million in 2026, compared to $745 million in 2025 and $663 million in 2024.
Speaker #2: While the year-over-year revenues will be down in 2026, our expected profitability is flat year-over-year, as we continue our successful efforts to focus on the more profitable segments of the business.
Speaker #2: For some of the newer audience on our call, it's worth noting that it has been about six years since we acquired 65% of Healthcare, and over that time, top and bottom line have increased by over three times.
Tasos Konidaris: For some of the newer audience on our call, it's worth noting that it has been about 6 years since we acquired 65% of AvKARE. Over that time, top and bottom line have increased by over 3 times. We're very excited about AvKARE's growth potential, given the strong fundamentals of expanding population of more than 20 million veterans and federal government workers, as well as the growing portfolio of new launches such as biosimilars, complex generics, and specialty products. Overall, AvKARE remains a highly strategic direct platform for Amneal, and we expect it to continue generating substantial profits and cash flow over time.
Tasos Konidaris: For some of the newer audience on our call, it's worth noting that it has been about 6 years since we acquired 65% of AvKARE. Over that time, top and bottom line have increased by over 3 times. We're very excited about AvKARE's growth potential, given the strong fundamentals of expanding population of more than 20 million veterans and federal government workers, as well as the growing portfolio of new launches such as biosimilars, complex generics, and specialty products. Overall, AvKARE remains a highly strategic direct platform for Amneal, and we expect it to continue generating substantial profits and cash flow over time.
Speaker #2: We're very excited about healthcare's growth potential given the strong fundamentals of expanding populations of more than 20 million veterans and federal government workers, as well as the growing portfolio of new launches such as biosimilars, complex generics, and specialty products.
Speaker #2: Overall, healthcare remains a highly strategic direct platform for Amneal, and we expect it to continue generating substantial profits and cash flow over time. Moving down the P&L, we expect 2026 adjusted gross margins of over 44%, which reflects approximately 100 basis points of gross margin expansion driven by the continued mix shift in our business as the higher-margin parts of our business are growing faster.
Tasos Konidaris: Moving down the P&L, we expect 2026 adjusted gross margins of over 44%, which reflects approximately 100 basis points of gross margin expansion, driven by the continued mix shift in our business, as the higher margin parts of our business are growing faster. As a result, we expect 2026 adjusted EBITDA between $720 and $760 million, up between 5% and 10%. From an EPS perspective, we expect 2026 adjusted EPS between $0.93 and $1.03, which reflects 12% to 20% earnings growth, driven by strong adjusted EBITDA growth and lower interest expense. In terms of quarterly phasing for 2026, we expect a gradual build over the year for a couple reasons. First, the revenue associated with many new affordable medicines launches, as well as correction, will build throughout the year.
Tasos Konidaris: Moving down the P&L, we expect 2026 adjusted gross margins of over 44%, which reflects approximately 100 basis points of gross margin expansion, driven by the continued mix shift in our business, as the higher margin parts of our business are growing faster. As a result, we expect 2026 adjusted EBITDA between $720 and $760 million, up between 5% and 10%. From an EPS perspective, we expect 2026 adjusted EPS between $0.93 and $1.03, which reflects 12% to 20% earnings growth, driven by strong adjusted EBITDA growth and lower interest expense. In terms of quarterly phasing for 2026, we expect a gradual build over the year for a couple reasons. First, the revenue associated with many new affordable medicines launches, as well as correction, will build throughout the year.
Speaker #2: As a result, we expect 2026 adjusted EBITDA between $720 and $760 million, up between 5 and 10 percent from an EPS perspective we expect 2026 adjusted EPS between 93 cents and $1.03, which reflects 12 to 20 percent earnings growth driven by strong adjusted EBITDA growth and lower interest expense.
Speaker #2: Now, in terms of quarterly phases for 2026, we expect a gradual build over the year for a couple of reasons. First, the revenue associated with many new affordable medicines launches as well as Craxont will build throughout the year.
Tasos Konidaris: Second, some launch-related investments are more front-end loaded to support key launches, such as Brekiya auto-injector. Moving on to cash. We expect robust 2026 operating cash flow between $325 million to 375 million, compared to approximately $340 million in 2025, and CapEx of approximately $110 million or 3% of revenue. Lastly, we're pleased to be added to the S&P SmallCap 600 index a month ago, which reinforces the consistency of our operating and financial performance over time. We believe this inclusion enhances our visibility with the investment community and continued expansion of our institutional investor base. In summary, we enter 2026 in our strongest position yet, and with a wind in our backs.
Speaker #2: And second, some launch-related investments are more front-end loaded to support key launches such as Abrequia, photo injector. Moving on to CAS, we expect robust 2026 operating cash flow between $325 million to $375 million, compared to approximately $340 million in 2025.
Tasos Konidaris: Second, some launch-related investments are more front-end loaded to support key launches, such as Brekiya auto-injector. Moving on to cash. We expect robust 2026 operating cash flow between $325 million to 375 million, compared to approximately $340 million in 2025, and CapEx of approximately $110 million or 3% of revenue. Lastly, we're pleased to be added to the S&P SmallCap 600 index a month ago, which reinforces the consistency of our operating and financial performance over time. We believe this inclusion enhances our visibility with the investment community and continued expansion of our institutional investor base. In summary, we enter 2026 in our strongest position yet, and with a wind in our backs.
Speaker #2: And CapEx of approximately $110 million or 3% of revenue. Lastly, we're pleased to be added to the S&P Small Cap 600 Index a month ago which reinforces the consistency of our operating and financial performance over time.
Speaker #2: We believe this inclusion enhances our visibility with investment community and continued expansion of our institutional investor base. In summary, we enter 2026 in our strongest position yet and with a wind in our back.
Speaker #2: We expect sustained top and bottom line growth supported by our diversified portfolio in multiple growth drivers including new branded launches such as Craxont and Abrequia, new biosimilar launches, and a very strong wave of new affordable medicines.
Tasos Konidaris: We expect sustained top and bottom line growth, supported by our diversified portfolio and multiple growth drivers, including new branded launches such as CREXONT and Brekiya, new biosimilar launches, and a very strong wave of new affordable medicines. Combined with our disciplined focus on profitable growth, operating efficiencies, and strong balances, we see a clear path for substantial value creation. With that, I'll turn the call back to Chirag.
Tasos Konidaris: We expect sustained top and bottom line growth, supported by our diversified portfolio and multiple growth drivers, including new branded launches such as CREXONT and Brekiya, new biosimilar launches, and a very strong wave of new affordable medicines. Combined with our disciplined focus on profitable growth, operating efficiencies, and strong balances, we see a clear path for substantial value creation. With that, I'll turn the call back to Chirag.
Speaker #2: Combined with our disciplined focus on profitable growth, operating efficiencies, and strong balance sheet, we see a clear path for substantial value creation. With that, I'll turn the call back to Chirag.
Speaker #1: Thank you, Tassos. Our strong 2025 results and 2026 guidance reflect the momentum across our diversified business. We remain focused on the disciplined execution of our strategy as we progress towards becoming America's leading affordable medicines company.
Chirag Patel: Thank you, Tasos. Our strong 2025 results and 2026 guidance reflect the momentum across our diversified business. We remain focused on the disciplined execution of our strategy as we progress towards becoming America's leading affordable medicines company. Let's now open the call for Q&A.
Chirag Patel: Thank you, Tasos. Our strong 2025 results and 2026 guidance reflect the momentum across our diversified business. We remain focused on the disciplined execution of our strategy as we progress towards becoming America's leading affordable medicines company. Let's now open the call for Q&A.
Speaker #1: Let's now open the call for Q&A.
Operator: Thank you. As a reminder for our audience, if you would like to ask a question, you may do so by pressing star, followed by the number one on your telephone keypads. Again, that is star followed by the number one on your telephone keypads, please. We now have our first question here from Chris Schott from J.P. Morgan. Go ahead, please. Your line is now open.
Operator: Thank you. As a reminder for our audience, if you would like to ask a question, you may do so by pressing star, followed by the number one on your telephone keypads. Again, that is star followed by the number one on your telephone keypads, please. We now have our first question here from Chris Schott from J.P. Morgan. Go ahead, please. Your line is now open.
Speaker #3: Thank you. As a reminder for our audience, if you would like to ask a question, you may do so by pressing star followed by the number one on your telephone keypads.
Speaker #3: Again, that is star followed by the number one on your telephone keypads, please. And we now have our first question here from Chris Schott from JPMorgan.
Speaker #3: Go ahead, please. Your line is now open.
Chris Schott: Great. Thanks so much for the questions, and congrats on all the progress. Maybe just to start out on CREXONT. Post the Phase IV data for the product, can you just elaborate a little bit more on the response you're seeing in the market from these results? Maybe as part of that, as we think about 2026, how should we think about either revenue or market share targets for the product? Just have one follow-up after that.
Speaker #4: Great, thanks so much for the questions and congrats on all the progress. Maybe just to start out on Craxont—post the phase four data for the product, can you just elaborate a little bit more on the response you're seeing in the market from these results?
Chris Schott: Great. Thanks so much for the questions, and congrats on all the progress. Maybe just to start out on CREXONT. Post the Phase IV data for the product, can you just elaborate a little bit more on the response you're seeing in the market from these results? Maybe as part of that, as we think about 2026, how should we think about either revenue or market share targets for the product? Just have one follow-up after that.
Speaker #4: And maybe as part of that, as we think about 2026, how should we think about either revenue or market share targets for the product?
Speaker #4: And I just had one follow-up after that.
Speaker #1: Excellent. Well, I'll start, and have my brother add onto this as well. So, the Phase Four interim results are showing 3.13 hours of good 'on' time, which is what we've been hearing from physicians and the experience of patients.
Chirag Patel: Well, I'll start and have my brother added on to this as well. The Phase IV, its interim result, showing 3.13 hours of good on time, which is what we've been hearing from physicians and the experience of patient. It's a huge uptake. 80% of the IR patient are converting to CREXONT. The Phase IV continues. Chintu will give more details on it, and we also have another study which he will share as well. Market share, we would double it in 2026, more than double the revenue. As we march towards, the first goal is to reach 100,000 patient, and second goal post will be to reach 200,000 patient. Reminding you, total is 700,000 patient on CDLD treatment.
Chirag Patel: Well, I'll start and have my brother added on to this as well. The Phase IV, its interim result, showing 3.13 hours of good on time, which is what we've been hearing from physicians and the experience of patient. It's a huge uptake. 80% of the IR patient are converting to CREXONT. The Phase IV continues. Chintu will give more details on it, and we also have another study which he will share as well. Market share, we would double it in 2026, more than double the revenue. As we march towards, the first goal is to reach 100,000 patient, and second goal post will be to reach 200,000 patient. Reminding you, total is 700,000 patient on CDLD treatment. Chintu, why don't you add more on the clinical studies, please?
Speaker #1: So it's a huge uptake, 80% of the IR patient are converting to Craxont. And the phase four continues. Chintu will give more details on it.
Speaker #1: And we also have another study which he will share as well. Market share, we would double it in '26, more than double the revenue.
Speaker #1: And as we march towards the first goal, which is to reach 100,000 patients, the second goal post would be to reach 200,000 patients. Reminding you, the total is 700,000 patients on CDLD treatment.
Chirag Patel: Chintu, why don't you add more on the clinical studies, please?
Speaker #1: Chintu, why don't you add more on a clinical studies, please?
Speaker #4: Yeah. Hi, Chris. Good morning. So we are very excited about our interim results, which we shared for 50 patients. Throughout '26 and early '27, we will be sharing the remainder, which is the total study—about 225 patients.
Chintu Patel: Yeah. Hi, Chris. Good morning. we are very excited about our interim results, which we will share for 50 patients. Throughout 2026 and early 2027, we will be sharing remainder, which is the total study was about 225 patients, and the data is looking pretty promising. we have done, as I mentioned, converting patients first time from, you know, different therapy, not on just the IR CD/LD. We have done conversion from the Rituxan, from IR with continuator, and CREXONT is clearly showing benefits, substantial benefits of good on time compared to all those therapies. we are very excited. We have a lot more data coming, and I think that will further enhance CREXONT's position in the market. Plus, we are looking at another Phase IV.
Chintu Patel: Yeah. Hi, Chris. Good morning. we are very excited about our interim results, which we will share for 50 patients. Throughout 2026 and early 2027, we will be sharing remainder, which is the total study was about 225 patients, and the data is looking pretty promising. we have done, as I mentioned, converting patients first time from, you know, different therapy, not on just the IR CD/LD. We have done conversion from the Rituxan, from IR with continuator, and CREXONT is clearly showing benefits, substantial benefits of good on time compared to all those therapies. we are very excited. We have a lot more data coming, and I think that will further enhance CREXONT's position in the market. Plus, we are looking at another Phase IV.
Speaker #4: And the data is looking pretty promising. And we have done, as I mentioned, converting patients for the first time from different therapy, not just on the IR CDLD.
Speaker #4: We have done conversion from the Riteri, from IR with Compton inhibitor, and Craxont is clearly showing benefits—substantial benefits of good on-time compared to all those therapies.
Speaker #4: So we are very excited. We have a lot more data coming. And I think that will further enhance Craxont's position in the market. Plus, we are looking at another phase four at the right time.
Chintu Patel: At the right time, we will also disclose that Phase IV, which continue to generate the data. What we are excited about is the difference it's making in patient lives.
Chintu Patel: At the right time, we will also disclose that Phase IV, which continue to generate the data. What we are excited about is the difference it's making in patient lives.Please, we have so many testimonials from the patient and the doctors. I think when the product is doing well, obviously, it will reflect in the sales and the revenue and uptake. We are very pleased, and a lot more coming in 2026 and 2027 with new data.
Speaker #4: We will also disclose that phase four, which continue to generate the data. And what we are excited about is the difference is making in patient lives.
Speaker #4: And that's things we have so many testimonials from the patient and the doctors. So I think when the product is doing well, obviously it will reflect in the sales and the revenue and uptake.
Tasos Konidaris: ... Please, we have so many testimonials from the patient and the doctors. I think when the product is doing well, obviously, it will reflect in the sales and the revenue and uptake. We are very pleased, and a lot more coming in 2026 and 2027 with new data.
Speaker #4: So, we are very pleased. And a lot more coming in '26 and '27 with new data. Great, thanks so much. And just one maybe quick follow-up, just on healthcare.
Chris Schott: Great. Thanks so much. I just want maybe a quick follow-up on AvKare. Can you I just want to make sure I'm understanding the 2026 guidance relative to 2025. Can you just talk a little bit more about the growth you're expecting in that kind of higher margin government channel versus the distribution business? Just, like, roughly what type of gross margins we can think about, kind of, for that franchise for the year. Thank you.
Chris Schott: Great. Thanks so much. I just want maybe a quick follow-up on AvKare. Can you I just want to make sure I'm understanding the 2026 guidance relative to 2025. Can you just talk a little bit more about the growth you're expecting in that kind of higher margin government channel versus the distribution business? Just, like, roughly what type of gross margins we can think about, kind of, for that franchise for the year. Thank you.
Speaker #4: Can you—just, I just want to make sure I'm understanding the 2026 guidance relative to 2025. So, can you just talk a little bit more about the growth you're expecting in that kind of higher-margin government channel versus the distribution business? And just roughly, what type of gross margins can we think about for that franchise for the year?
Speaker #4: Thank you.
Speaker #1: Yeah, I can take that, Chris. Good morning, this is Tassos. Yeah, as I mentioned before, kind of stepping back, right, this business—when we acquired 65% of Abcare—since then, we have more than tripled the revenue, gross margins, and EBITDA.
Tasos Konidaris: Yeah, I can take that, Chris. Good morning, this is Tasos. Yeah, as I mentioned before, kind of stepping back, right? This business, when we acquired 65% of AvKare, since then, we have more than tripled the revenue, gross margins and EBITDA. It's great because we were able to leverage both the unique assets Emil brought to the transaction, as well as the inherent growth in that business. As we talked about, when you look at 2025 versus 2024, right? In 2025, the total revenue of AvKare was about $745 million, and in 2024, the revenue was $663 million. That grew about total, about 12%.
Tasos Konidaris: Yeah, I can take that, Chris. Good morning, this is Tasos. Yeah, as I mentioned before, kind of stepping back, right? This business, when we acquired 65% of AvKare, since then, we have more than tripled the revenue, gross margins and EBITDA. It's great because we were able to leverage both the unique assets Emil brought to the transaction, as well as the inherent growth in that business. As we talked about, when you look at 2025 versus 2024, right? In 2025, the total revenue of AvKare was about $745 million, and in 2024, the revenue was $663 million. That grew about total, about 12%.
Speaker #1: So, it's great because we were able to leverage both the unique assets MEL brought to the transaction, as well as the inherent growth in that business.
Speaker #1: So, as we talked about, when you look at 2025 versus 2024, in 2025 the total revenue of Abcare was about $745 million.
Speaker #1: And in 2024, the revenue was $663 million. So that grew about total about 12%. About 50% of the revenue is between about 40% of the revenue kind of goes into the government channel; 60% of the revenue goes in the distribution channel.
Tasos Konidaris: About 50% of the revenue is about 40% of the revenue kind of goes into the government channel, 60% of the revenue goes in the distribution channel. When you think about this 12% growth, 2025 versus 2024, distribution, the distribution part of the business declined, okay, while the government business grew. Okay? The distribution decline, it was purposefully done because that's what we talked about it, because we decided to not chase businesses with one or two gross margin, okay? As a result of that, kind of, what I would say is pivoting, right, into the kind of leaning hard into the government channel, the gross margin of our AvKare business grew over 400 basis points.
Tasos Konidaris: About 50% of the revenue is about 40% of the revenue kind of goes into the government channel, 60% of the revenue goes in the distribution channel. When you think about this 12% growth, 2025 versus 2024, distribution, the distribution part of the business declined, okay, while the government business grew. Okay? The distribution decline, it was purposefully done because that's what we talked about it, because we decided to not chase businesses with one or two gross margin, okay? As a result of that, kind of, what I would say is pivoting, right, into the kind of leaning hard into the government channel, the gross margin of our AvKare business grew over 400 basis points.
Speaker #1: So, when you think about this 12% growth—2025 versus 2024—the distribution part of the business declined, okay? While the government business grew.
Speaker #1: Okay? And the distribution declined, it was purposefully done, because that's what we talked about, because we decided to not chase businesses with one or two percent gross margins.
Speaker #1: Okay? So as a result of that kind of what I would say is pivoting, right, into the kind of leaning hard into the government channel, the gross margin of our Abcare business grew over 400 basis points.
Speaker #1: So, the gross margin in 2025 of Abcare was $147 million, compared to about $100 million in 2024. And the operating income in 2025 was $94 million, compared to $57 million.
Tasos Konidaris: The gross margin in 2025 of AvKare was $147 million, compared to about $100 million in 2024. The operating income in 2025 was $94 million, compared to $57 million. Essentially, 2025 versus 2024, revenue up 12%, gross margin up 41%, operating income up 65%. Great, great performance. Now as we look into 2026, there's two things that are happening. We continue to expect the distribution business to be declining, but because it's such a low profitability part of the business, it doesn't hurt the bottom line. The government business is gonna be down slightly, not because of anything fundamental that is happening, but in 2025 was such an extraordinary growth because we had this one generic product, essentially generic Entresto, that we essentially were the only ones in the market.
Tasos Konidaris: The gross margin in 2025 of AvKare was $147 million, compared to about $100 million in 2024. The operating income in 2025 was $94 million, compared to $57 million. Essentially, 2025 versus 2024, revenue up 12%, gross margin up 41%, operating income up 65%. Great, great performance. Now as we look into 2026, there's two things that are happening. We continue to expect the distribution business to be declining, but because it's such a low profitability part of the business, it doesn't hurt the bottom line. The government business is gonna be down slightly, not because of anything fundamental that is happening, but in 2025 was such an extraordinary growth because we had this one generic product, essentially generic Entresto, that we essentially were the only ones in the market.
Speaker #1: So essentially, '25 versus '24, revenue up 12, gross margin up 41, operating income up 65. So great performance. So now as we look into 2026, there are two things that are happening.
Speaker #1: We continue to expect the distribution business to be declining. But because it's such a low profitable such a low profitability part of the business, it doesn't hurt the bottom line.
Speaker #1: The government business is going to be down slightly. Not because of anything fundamental that is happening, but in 2025, with such extraordinary growth because we had this one generic product.
Speaker #1: Essentially, generic Entresto. But we essentially were the only ones in the market. That product had $100 million worth of revenue, as I mentioned before, in 2025.
Tasos Konidaris: That product had $100 million worth of revenue, as I mentioned before, in 2025. In 2026, as it always happens, it will have some additional competition. That's why in 2026, revenue is declining, is down because of our pivot away from distribution, number one, and not having kind of that exclusivity, if you want to call that, of generic Entresto impacting the government business as well. That's what's gonna drive the decline and what we like to call it, almost like a reset level for 2026. The bottom line is not gonna be impacted because for a couple reasons. A, there is other more profitable parts of the business who will be allocating resources, who will also be leaning on some of the operating expenses.
Tasos Konidaris: That product had $100 million worth of revenue, as I mentioned before, in 2025. In 2026, as it always happens, it will have some additional competition. That's why in 2026, revenue is declining, is down because of our pivot away from distribution, number one, and not having kind of that exclusivity, if you want to call that, of generic Entresto impacting the government business as well. That's what's gonna drive the decline and what we like to call it, almost like a reset level for 2026. The bottom line is not gonna be impacted because for a couple reasons. A, there is other more profitable parts of the business who will be allocating resources, who will also be leaning on some of the operating expenses.
Speaker #1: In 2026, as it always happens, it will have some additional competition. So that's why in 2026, revenue is declining, is down because of our pivot, away from distribution.
Speaker #1: Number one. And not having and not having kind of that exclusivity, if you want to call that, of generic Entresto impacting the government business as well.
Speaker #1: So that's what I was going to drive the decline. And what we like to call it almost like a reset level. Reset level for 2026.
Speaker #1: But the bottom line is not going to be impacted. Because for a couple of reasons. A, there are other more profitable parts of the business who will be allocating resources, who will also be leaning on some of the operating expenses.
Tasos Konidaris: These are the dynamics that are happening in AvKare, which essentially creates this reset revenue in 2026 before we resume top line and bottom line growth in 2027 and beyond. I know I said a lot, Chris, let me know if that was helpful.
Speaker #1: So these are the dynamics that are happening in Abcare. Which essentially creates this reset revenue in 2026 before we resume top line and bottom line growth in 2027 and beyond.
Tasos Konidaris: These are the dynamics that are happening in AvKare, which essentially creates this reset revenue in 2026 before we resume top line and bottom line growth in 2027 and beyond. I know I said a lot, Chris, let me know if that was helpful.
Speaker #1: So I know I said a lot, Chris. Let me know if that was helpful.
Speaker #4: That was perfect. Thank you so much. Appreciate it.
Chris Schott: That was perfect. Thank you so much. Appreciate it.
Chris Schott: That was perfect. Thank you so much. Appreciate it.
Tasos Konidaris: Sure.
Tasos Konidaris: Sure.
Speaker #3: Thank you for that question, Chris. Moving on, we now have Matt Bellatorre from Goldman Sachs. Go ahead, please. Your line is now open.
Operator: Thank you for that question, Chris. Moving on, we now have Matthew Dellatorre from Goldman Sachs. Go ahead, please. Your line is now open.
Operator: Thank you for that question, Chris. Moving on, we now have Matthew Dellatorre from Goldman Sachs. Go ahead, please. Your line is now open.
Speaker #5: Great. Good morning, guys. And thanks for the question. Maybe on the Pfizer Glip1 obesity partnership, could you just share your latest update on the status of that partnership?
Matthew Dellatorre: Great. Good morning, guys, and thanks for the question. Maybe on the Pfizer GLP-1 obesity partnership, could you just share your latest update on the status of that partnership? How should we think about potential outcomes? You know, for example, if they do end up buying you out, would that be a complete return of all rights and economics, or are there other scenarios where, you know, for instance, maybe you don't manufacture for developed market, but you keep emerging market rights? If it is a complete buyout, what would be the plan for the new facilities in India, and the cash you would receive? I had one follow-up. Thank you.
Matthew Dellatorre: Great. Good morning, guys, and thanks for the question. Maybe on the Pfizer GLP-1 obesity partnership, could you just share your latest update on the status of that partnership? How should we think about potential outcomes? You know, for example, if they do end up buying you out, would that be a complete return of all rights and economics, or are there other scenarios where, you know, for instance, maybe you don't manufacture for developed market, but you keep emerging market rights? If it is a complete buyout, what would be the plan for the new facilities in India, and the cash you would receive? I had one follow-up. Thank you.
Speaker #5: And then, how should we think about potential outcomes? For example, what if they do end up buying you out—would that be a complete return of all rights and economics?
Speaker #5: Or are there other scenarios where for instance, maybe you don't manufacture for developed market, but you keep emerging market rights? And then if it is a complete buyout, what would be the plan for the new facilities in India, and the cash you would receive that I had one follow-up?
Speaker #5: Thank you.
Speaker #1: So good morning, Nick. With Pfizer, our collaboration continues such as we had it with MedSera. Both teams are working together, facilities actually accelerated in manufacturing.
Tasos Konidaris: Good morning, Nick. With Pfizer, our collaborations continues, such as we had it with Metsera. Both teams are working together. Our facilities are actually accelerated in manufacturing, and several levels of C levels meetings have been already conducted with Pfizer. We expect nothing much to change. Right now, it's all waiting for the starting the Phase III and getting the products, and, you know, the demand is global.
Chirag Patel: Good morning, Nick. With Pfizer, our collaborations continues, such as we had it with Metsera. Both teams are working together. Our facilities are actually accelerated in manufacturing, and several levels of C levels meetings have been already conducted with Pfizer. We expect nothing much to change. Right now, it's all waiting for the starting the Phase III and getting the products, and, you know, the demand is global.
Speaker #1: And we several levels of C levels meetings have been already conducted with Pfizer. So we expect nothing much to change. Right now, it's all waiting for the starting the phase three.
Speaker #1: And getting the products, and the demand is global. And we have built such a remarkable, highly automated fill-and-finish facility with the latest and greatest equipment.
Chirag Patel: We have built, building such a remarkable, highly automated fill and finish facility, with latest and greatest equipment. Pfizer is very excited about that. Also, we are making great progress on our peptide manufacturing, which, you know, is in shortages with solid phase technology, and we're also introducing hybrid in the future. We, our teams are working with Pfizer on those aspects as well. We continue to have the marketing rights for 18 countries, including India and Southeast Asia. We're excited about the entire partnership, and there are no plans to think about right now. It's moving great.
Chirag Patel: We have built, building such a remarkable, highly automated fill and finish facility, with latest and greatest equipment. Pfizer is very excited about that. Also, we are making great progress on our peptide manufacturing, which, you know, is in shortages with solid phase technology, and we're also introducing hybrid in the future. We, our teams are working with Pfizer on those aspects as well. We continue to have the marketing rights for 18 countries, including India and Southeast Asia. We're excited about the entire partnership, and there are no plans to think about right now. It's moving great.
Speaker #1: So Pfizer is very excited about that. And also, we are making great progress on our peptide manufacturing, which you know is in shortages, with solid phase technology.
Speaker #1: And we are also introducing hybrid in the future. So our teams are working with Pfizer on those aspects as well. And we continue to have the marketing rights for 18 countries, including India and Southeast Asia.
Speaker #1: So we're excited about the entire partnership. And there are no plans to think about right now. It's moving great.
Speaker #5: Okay. Awesome. That's exciting. And then maybe just on business development, could you share your latest thoughts on the strategy areas of interest and capacity?
Chintu Patel: Okay, awesome. That's exciting. Maybe just on business development, could you share your latest thoughts on strategy, areas of interest, and capacity, and then how you're thinking about the potential vertical integration of biosimilars? Thank you.
Matthew Dellatorre: Okay, awesome. That's exciting. Maybe just on business development, could you share your latest thoughts on strategy, areas of interest, and capacity, and then how you're thinking about the potential vertical integration of biosimilars? Thank you.
Speaker #5: And then how you're thinking about the potential vertical integration of biosimilars? Thank you.
Speaker #1: Yeah. So as we've been saying for the last couple of years, the time is now to do the vertical integration. Biosimilar opportunities are awesome. Regulatory is streamlined.
Chirag Patel: Yeah. As we've been saying it since last couple of years, time is now to do the vertical integration. Biosimilar opportunities are awesome, regulatory is streamlined, and we are very familiar with the market. Very excited. That's where the capital allocation will go first. Then, as I said previously, 2027 and onward, we'll be more focused on specialty assets and keep building our pipeline there. Remember, organically, we are very strong in our R&D pipeline, so we keep our pipeline full. More complex products, a great team in-house we have, so we'll continue to invest in our own R&D, our own CapEx, which is strategically, we've been investing. Very excited about the future.
Chirag Patel: Yeah. As we've been saying it since last couple of years, time is now to do the vertical integration. Biosimilar opportunities are awesome, regulatory is streamlined, and we are very familiar with the market. Very excited. That's where the capital allocation will go first. Then, as I said previously, 2027 and onward, we'll be more focused on specialty assets and keep building our pipeline there. Remember, organically, we are very strong in our R&D pipeline, so we keep our pipeline full. More complex products, a great team in-house we have, so we'll continue to invest in our own R&D, our own CapEx, which is strategically, we've been investing. Very excited about the future. Next 5 years is going to be tremendous growth than what we have even witnessed in last 5 years.
Speaker #1: And we are very familiar with the market. So very excited that's where the capital allocation will go first. And then as I said previously, 2027 and onward will be more focused on specialty assets.
Speaker #1: And keep building our pipeline there. And remember, the organically we are very strong in our R&D pipeline. So we keep our pipeline full. More complex products, great team in-house.
Speaker #1: We have. So we'll continue to invest in our own R&D, our own CapEx, which is strategically we've been investing. And very excited about the future.
Chirag Patel: Next 5 years is going to be tremendous growth than what we have even witnessed in last 5 years.
Speaker #1: And next five years, going to be tremendous growth. Then what we have even witnessed in last five years.
Speaker #5: Great. Thank you.
Chintu Patel: Great. Thank you.
Matthew Dellatorre: Great. Thank you.
Speaker #3: Thank you, Matt. Thank you for that. Thank you for that question, Matt. Moving on, we now have David Amsalon from Piper Sandler. Go ahead, please.
Anthony DiMeo: Thank you, Matt.
Chirag Patel: Thank you, Matt.
Operator: Thank you for that. Thank you for that question, Matt. Moving on, we now have David Amsellem from Piper Sandler. Go ahead, please. Your line is now open.
Operator: Thank you for that. Thank you for that question, Matt. Moving on, we now have David Amsellem from Piper Sandler. Go ahead, please. Your line is now open.
Speaker #3: Your line is now open.
David Amsellem: Hey, thanks. Just a few for me. Wanted to get your thoughts on the generic Omnipaq opportunity, and what has been built into your 2026 expectations regarding that opportunity. Talk about barriers to competition, potential approval of additional strengths, and the extent to which you think that's going to be a limited competition product for the foreseeable future. I know that's a bunch, but that's number 1. Secondly, I had a question on Xolair. Kind of similar set of questions, wanted to get your thoughts on the extent to which that could be a limited competition market. I believe there's only 2 or 3 others. Talk about how big of an opportunity that could be in 2027 and beyond. Thank you.
Speaker #6: Hey, thanks. So just a few for me. I wanted to get your thoughts on the generic Omnipack opportunity. And what has been built into your 26 expectations regarding that opportunity?
David Amsellem: Hey, thanks. Just a few for me. Wanted to get your thoughts on the generic Omnipaq opportunity, and what has been built into your 2026 expectations regarding that opportunity. Talk about barriers to competition, potential approval of additional strengths, and the extent to which you think that's going to be a limited competition product for the foreseeable future. I know that's a bunch, but that's number 1. Secondly, I had a question on Xolair. Kind of similar set of questions, wanted to get your thoughts on the extent to which that could be a limited competition market. I believe there's only 2 or 3 others. Talk about how big of an opportunity that could be in 2027 and beyond. Thank you.
Speaker #6: Talk about barriers to competition, potential approval of additional strengths, and the extent to which you think that's going to be a limited competition product for the foreseeable future.
Speaker #6: So I know that's a bunch, but that's number one. And then secondly, I had a question on Xolair. Kind of similar set of questions, but wanted to get your thoughts on the extent to which that could be a limited competition market.
Speaker #6: I believe there's only two or three others. So talk about how big of an opportunity that could be in 27 and beyond. Thank you.
Chirag Patel: Great. Thank you, David. On Iohexol, you know, the supply chain is complicated. They will be entering the market. GE has the huge market share, so we'll be making inroads. The hospitals we have spoken to, they're very excited. Expect that as a ramp-up because of the difficulty in the supply chain. Over the years, as we introduce more strength, it will pick up. Great achievement from our R&D team and complexity of manufacturing, both we have achieved. Excited over time on Iohexol. On Xolair, very excited right now. It's Celltrion and us in 26. Large market, growing market, very well set about.
Chirag Patel: Great. Thank you, David. On Iohexol, you know, the supply chain is complicated. They will be entering the market. GE has the huge market share, so we'll be making inroads. The hospitals we have spoken to, they're very excited. Expect that as a ramp-up because of the difficulty in the supply chain. Over the years, as we introduce more strength, it will pick up. Great achievement from our R&D team and complexity of manufacturing, both we have achieved. Excited over time on Iohexol. On Xolair, very excited right now. It's Celltrion and us in 26. Large market, growing market, very well set about.
Speaker #1: Great. Thank you, David. On BioHexol, the supply chain is complicated. There will be entering the market. G has the huge market share. So we'll be making inroads.
Speaker #1: The hospitals we have spoken to, they're very excited. But expect that as a ramp-up because of the difficulty in the supply chain. So over the years, as we introduce more strength, it will pick up.
Speaker #1: So, great achievement from our R&D team. And complexity of manufacturing—both we have achieved. So excited over time on BioHexol. On Xolair, very excited.
Speaker #1: Right now, it's Celtron and us in 26. Large market, growing market. Very well set about we expect 65 to 70 percent to go through the private label.
Chirag Patel: We expect 65% to 70% to go through the private label, which, you know, gives us immediate bump in the sales rather than ramp up our market share over 1, 2, 3 years. Exciting opportunity. As you know, Amneal is well positioned to do business with these large buying groups, as we have been doing business with them over 20 years. Great relationship, number 1 pipeline in the country for them, and they appreciate our high integrity, the quality standards we have. We expect tremendous partnership with these private label side of the business, which I expect about going forward would be almost 70% would go through private label, which would make the biosimilar penetration very effective.
Chirag Patel: We expect 65% to 70% to go through the private label, which, you know, gives us immediate bump in the sales rather than ramp up our market share over 1, 2, 3 years. Exciting opportunity. As you know, Amneal is well positioned to do business with these large buying groups, as we have been doing business with them over 20 years. Great relationship, number 1 pipeline in the country for them, and they appreciate our high integrity, the quality standards we have. We expect tremendous partnership with these private label side of the business, which I expect about going forward would be almost 70% would go through private label, which would make the biosimilar penetration very effective.
Speaker #1: Which gives us immediate bump in the sales rather than ramp-up over market share over one, two, three years. So exciting opportunity. And as you know, Amneal is well positioned to do business with these large buying groups as we have been doing business with them over 20 years.
Speaker #1: Great relationship. Number one pipeline in the country for them. And they appreciate our high integrity, the quality standards we have. So we expect tremendous partnership with these private label side of the business, which I expect, going forward, would be almost 70% would go through private label.
Speaker #1: Which would make the biosimilar penetration very effective. It would not have to wait for three, four years to get to 30, 40 percent market share.
Chirag Patel: It would not have to wait for three, four years to get to 30%, 40% market share. It would jump to higher market share immediately in year one. 20%, 30% will continue on a buy and build, which we are well positioned as well. Very excited on Xolair as well. Chintu, you wanted to add anything on Iohexol?
Chirag Patel: It would not have to wait for three, four years to get to 30%, 40% market share. It would jump to higher market share immediately in year one. 20%, 30% will continue on a buy and build, which we are well positioned as well. Very excited on Xolair as well. Chintu, you wanted to add anything on Iohexol?
Speaker #1: It would jump to higher market share immediately in year one. And 20, 30 percent will continue on a buy and bill, which we are well positioned as well.
Speaker #1: So very excited on Xolair as well. Chinto, you wanted to add anything on BioHexol?
Speaker #5: Yeah, David. So, on BioHexol, you had a question on additional strengths. So, by the end of the year, we will have approval for the missing strengths.
Chintu Patel: Yeah, David. On Iohexol, you had a question on additional strength. By end of the year, we will have approval for the missing strength. By end of the year, we'll have the entire Omnipaq, all the strength. It's a very large opportunity for us. We have been working on strengthening our supply chain and increasing our capacity. 2026, we will start, but 2027 onward, it would be a meaningful revenue contribution. For competition perspective, it is a tough product.
Chintu Patel: Yeah, David. On Iohexol, you had a question on additional strength. By end of the year, we will have approval for the missing strength. By end of the year, we'll have the entire Omnipaq, all the strength. It's a very large opportunity for us. We have been working on strengthening our supply chain and increasing our capacity. 2026, we will start, but 2027 onward, it would be a meaningful revenue contribution. For competition perspective, it is a tough product. Supply chain perspective, manufacturing, it's a unique bottle, you know. All those things put together, I think, we don't foresee a lot of competition and multiple strengths. We are very excited, and by end of the year, we'll have all the strength approved.
Speaker #5: So by end of the year, we'll have the entire Omnipack, all the strengths. It's a very large opportunity for us. We have been working on strengthening our supply chain and increasing our capacity.
Speaker #5: So '26, we will start, but '27 onward, it would be a meaningful revenue contribution. And from a competition perspective, it is a tough product. From a supply chain perspective, manufacturing, it's a unique bottle.
Chirag Patel: ... supply chain perspective, manufacturing, it's a unique bottle, you know. All those things put together, I think, we don't foresee a lot of competition and multiple strengths. We are very excited, and by end of the year, we'll have all the strength approved.
Speaker #5: So all those things put together, I think we don't foresee a lot of competition. And multiple strengths. So we are very excited. And by end of the year, we'll have all the strengths approved.
Speaker #6: Okay. Great. That's very helpful. Thank you.
David Amsellem: Okay, great. That's very helpful. Thank you.
David Amsellem: Okay, great. That's very helpful. Thank you.
Speaker #3: Thank you, David. Moving on, we now have Less Soluci from Tourist Securities. Go ahead, please. Your line is now open.
Operator: Thank you, David. Moving on, we now have Les Sulewski from TD Cowen. Go ahead, please. Your line is now open.
Operator: Thank you, David. Moving on, we now have Les Sulewski from TD Cowen. Go ahead, please. Your line is now open.
Les Sulewski: Good morning. Thank you for taking my questions. First one, on CREXONT. Can you quantify the persistence at perhaps month 3 or 6 versus your internal expectations and versus RYTARY? Any sort of signal around discontinuation? How should we think about the gross-to-net evolving as you brought in access and what's kind of a steady state gross-to-net you're expecting at peak? Second, on a Brekiya autoinjector, what's the early patient profile? Is it migraine versus clusters and the switches from prior Brekiya exposure versus naive? Thank you.
Speaker #7: Good morning. Thank you for taking my questions. First one on Crexon. Can you quantify the persistence at, perhaps, month three or six versus your internal expectations and versus Rightary?
Les Sulewski: Good morning. Thank you for taking my questions. First one, on CREXONT. Can you quantify the persistence at perhaps month 3 or 6 versus your internal expectations and versus RYTARY? Any sort of signal around discontinuation? How should we think about the gross-to-net evolving as you brought in access and what's kind of a steady state gross-to-net you're expecting at peak? Second, on a Brekiya autoinjector, what's the early patient profile? Is it migraine versus clusters and the switches from prior Brekiya exposure versus naive? Thank you.
Speaker #7: Any sort of signal around this continuation? And how should we think about the growth-to-net evolving as you brought in Access? And what's kind of a steady-state growth-to-net you're expecting at peak?
Speaker #7: And then, second, on a DHE autoinjector, what's the early patient profile? Is it migraine versus clusters? And is it switches from prior DHE exposure versus naïve?
Speaker #7: Thank you.
Speaker #1: Oh, thank you, Leslie. Good morning. Crexon versus Rightary, obviously, Crexon is performing much better as Rightary took almost 10 years to get to 6% market share.
Chirag Patel: Thank you, Les. Good morning. CREXONT versus RYTARY, obviously, CREXONT is performing much better as RYTARY took 10 years to get to 6% market share. First year, we have 3% market share, 23,000 patients on it. Testimonials are amazing, and we get letters at our office, literally written letters from patients. Physicians are so excited about the product as well. Our aim is to make that a first-line therapy over time, so no patient has to take the old Sinemet, which is giving them a lot of fluctuations every hour and half, 2 hours. This is clearly a 7, 8 hours, a good on time every day. Amazing stories. No comparison with RYTARY.
Chirag Patel: Thank you, Les. Good morning. CREXONT versus RYTARY, obviously, CREXONT is performing much better as RYTARY took 10 years to get to 6% market share. First year, we have 3% market share, 23,000 patients on it. Testimonials are amazing, and we get letters at our office, literally written letters from patients. Physicians are so excited about the product as well. Our aim is to make that a first-line therapy over time, so no patient has to take the old Sinemet, which is giving them a lot of fluctuations every hour and half, 2 hours. This is clearly a 7, 8 hours, a good on time every day. Amazing stories. No comparison with RYTARY.
Speaker #1: First year, we have 3% market share. 23,000 patients on it. Testimonials are amazing. And we get letters at our office literally written letters from patients providers are so excited.
Speaker #1: Physicians are so excited about the product as well. And now our aim is to make that a first-line therapy over time, so no patient has to take the old Sinemet, which is giving them a lot of fluctuations every hour and a half, two hours.
Speaker #1: So this is clearly a 7, 8, 8 hours a good on time every day. So amazing stories. No comparison with Rightary. It is we're doubling or more than doubling market share this year.
Chirag Patel: We're doubling or more than doubling market share this year, so we'll reach 6%+ this year, which would be above RYTARY. We learned, on the pricing side, we learned everything. We had about 35% of patients could not fill that prescription due to the pricing on RYTARY. We have really worked on it and have put the pricing out there. That number has been reduced now, our gross-to-net runs typical in this category, about 40% to 45%. We're very excited about CREXONT. Brekiya, Joe, you want to... Brekiya is for cluster headache as well as severe migraine. We're treating two segments, all the excitement is amazing. Joe Renda is here. He just came back from our national sales meeting.
Chirag Patel: We're doubling or more than doubling market share this year, so we'll reach 6%+ this year, which would be above RYTARY. We learned, on the pricing side, we learned everything. We had about 35% of patients could not fill that prescription due to the pricing on RYTARY. We have really worked on it and have put the pricing out there. That number has been reduced now, our gross-to-net runs typical in this category, about 40% to 45%. We're very excited about CREXONT. Brekiya, Joe, you want to... Brekiya is for cluster headache as well as severe migraine. We're treating two segments, all the excitement is amazing. Joe Renda is here. He just came back from our national sales meeting.Would you like to shed some light on this?
Speaker #1: So we'll reach 6-plus percent this year, which would be about Rytary. And we learned on the pricing side, we learned everything we had—about 35% of patients could not fill that prescription due to the pricing on Rytary.
Speaker #1: We have really worked on it and have put the pricing out there that that number has been reduced now. And our growth-to-net runs a typical in this category about 40 to 45 percent.
Speaker #1: But very excited about Crexon. Brekia, Joe, you want to it is also the Brekia is for cluster headache as well as severe migraine. So we're treating two segments.
Speaker #1: And only excitement is amazing. Jorenda is here. He just came back from our national sales meeting. Would you like to shed some light on that?
Chirag Patel: Would you like to shed some light on this?
Speaker #8: Sure. Yeah. Thanks so much for the question. And yeah, the response from the field team so far has been fantastic on both Crexon and Brekia auto injector because what we're seeing in the market from the key KOLs has been very favorable.
Joe Renda [Senior Vice President and Chief Commercial Officer: Sure. Thanks so much for the question, the response from the field team so far has been fantastic on both CREXONT and Brekiya autoinjector, because what we're seeing in the market from the key KOLs has been very favorable. I would say with regards to your question about CREXONT with persistence and adherence, it continues to improve as we continue to see more and more patients on the product. Right now it's surpassing that of RYTARY, we anticipate to see that continue to go up, 'cause we're seeing patients return to therapy at a, on a higher rate with CREXONT than they did with RYTARY. That's been very favorable.
Joe Renda: Sure. Thanks so much for the question, the response from the field team so far has been fantastic on both CREXONT and Brekiya autoinjector, because what we're seeing in the market from the key KOLs has been very favorable. I would say with regards to your question about CREXONT with persistence and adherence, it continues to improve as we continue to see more and more patients on the product. Right now it's surpassing that of RYTARY, we anticipate to see that continue to go up, 'cause we're seeing patients return to therapy at a, on a higher rate with CREXONT than they did with RYTARY. That's been very favorable.
Speaker #8: I would say with regards to your question about Crexon with persistence and adherence, it continues to improve as we continue to see more and more patients on the product.
Speaker #8: And right now, it's surpassing that of Rightary, and we continue to—we anticipate to see that continue to go up because we're seeing patients return to therapy.
Speaker #8: And on a higher rate, with Crexon than they did with Rightary. So that's been very favorable. With Brekia auto injector, our strategy has been to focus on the key migraine treatment centers across the United States.
Joe Renda [Senior Vice President and Chief Commercial Officer: With Brekiya autoinjector, our strategy has been to focus on the key migraine treatment centers across the United States and key KOLs. The response has been beyond our expectations so far. We've been very pleased. We're about 90 days into the launch. Having come back now from our sales and marketing meeting, our national meeting this week, I'm maybe even more further convinced that we're going to continue to drive growth for both of those products. The team is trained and ready, and we're going to be executing this year. Excited about that.
Joe Renda: With Brekiya autoinjector, our strategy has been to focus on the key migraine treatment centers across the United States and key KOLs. The response has been beyond our expectations so far. We've been very pleased. We're about 90 days into the launch. Having come back now from our sales and marketing meeting, our national meeting this week, I'm maybe even more further convinced that we're going to continue to drive growth for both of those products. The team is trained and ready, and we're going to be executing this year. Excited about that.
Speaker #8: And key KOLs. And the response has been beyond our expectations so far, so we've been very pleased. We're about 90 days into the launch.
Speaker #8: And having come back now from our sales and marketing meeting, our national meeting this week, I'm even more further convinced that we're going to continue to drive growth for both of those products.
Speaker #8: The team is trained and ready, and we're going to be executing this year. So excited about that.
Speaker #7: Thank you.
Les Sulewski: Thank you.
Les Sulewski: Thank you.
Speaker #3: Thank you, Les. And checking the Q&A list now. And we are now all clear. And with that, I'll go ahead and hand it back to Shirak Patel for some final remarks.
Operator: Thank you, Les. Checking the Q&A list now, and we are now all clear. With that, I'll go ahead and hand it back to Chirag Patel for some final remarks. Go ahead, please.
Operator: Thank you, Les. Checking the Q&A list now, and we are now all clear. With that, I'll go ahead and hand it back to Chirag Patel for some final remarks. Go ahead, please.
Speaker #3: Go ahead, please.
Speaker #1: Well, thank you, everyone, for joining the call today. Have a great Friday and weekend. Thank you.
Chirag Patel: Well, thank you everyone for joining the call today. Have a great Friday and weekend. Thank you.
Chirag Patel: Well, thank you everyone for joining the call today. Have a great Friday and weekend. Thank you.
Speaker #8: Thanks, everyone.
Joe Renda [Senior Vice President and Chief Commercial Officer: Thanks, everyone.
Joe Renda: Thanks, everyone.
Speaker #5: Thank you. Thanks, everyone.
Chirag Patel: Thank you. Thanks, everyone.
Chirag Patel: Thank you. Thanks, everyone.
Operator: Thank you, gentlemen. This concludes today's call. Thank you all for joining. You may now disconnect your lines and have a great weekend.
Operator: Thank you, gentlemen. This concludes today's call. Thank you all for joining. You may now disconnect your lines and have a great weekend.