Q4 2023 Amneal Pharmaceuticals Inc Earnings Call

March 1, 2024

Operator: Ladies and gentlemen, the Amneal Pharmaceuticals fourth quarter and full year 2023 earnings call will begin shortly. If you would like to submit a question at any time, please press star one on your telephone keypad. Thank you.

Ladies and gentlemen, thank you for standing by email Pharmaceuticals fourth quarter and full year 2023 earnings call will begin shortly if you'd like to register a question at any time. Please press star one on your telephone keypad. Thank you.

Unnamed Speaker: [inaudible] Good morning, and welcome to Amneal Pharmaceuticals' fourth quarter and full year 2023 earnings call. I'll now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo. Good morning, and thank you for joining Amneal Pharmaceuticals' fourth quarter 2023 earnings call. Today, we issued a press release reporting Q4 and full year 2023 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 in the Earnings Presentation and SEC filings for factors that may impact future performance. We also discussed non-gap measures.

[music].

Okay.

Operator: Good morning and welcome to Amneal Pharmaceuticals Q4 and full year 2023 Earnings Call. I'll now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Speaker Change: Good morning, and welcome to unveil Pharmaceuticals fourth quarter and full year 2023 earnings call.

Speaker Change: I'll now turn the call over to M&A also head of Investor Relations turning to me.

Speaker Change: Okay.

Tony DiMeo: Good morning and thank you for joining Amneal Pharmaceuticals Q4 2023 earnings call. Today, we issued a press release reporting Q4 and full year 2023 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 in the earnings presentation and SEC filings for factors that may impact future performance. We also discuss non-GAAP measures. Information on use of these measures and reconciliation to US GAAP are in the earnings presentation. On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs. Tasos Konidaris, CFO.

M&A: Good morning.

M&A: Thank you for joining Ann Neale Pharmaceuticals fourth quarter 2023 earnings call.

M&A: We issued a press release reporting Q4, and full year 2023 results.

M&A: The earnings press release and presentation are available at <unk> Dot com.

M&A: 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.

M&A: That are based solely on information that is now available to us.

M&A: Please see the section entitled cautionary statement on forward looking statements in the earnings presentation.

M&A: <unk> SEC filings for factors that may impact future performance.

M&A: We also discuss non-GAAP measures.

Anthony DiMeo: Information on the use of these measures in reconciliation to U.S. gaps is in the earnings presentation. On the call today are Chirag and Chintu Patel, co-founders and co-CEOs. Tatos Konidaris, CFO, our commercial leaders, Andy Boyer for generics, Joe Renda for specialty, Harsher Singh for biosciences, and Jason Daly, chief legal officer. I will now hand the call over to Chirag. Thank you, Tony.

M&A: Information on use of these measures and reconciliations to U S. GAAP in the earnings presentation.

M&A: On the call today are <unk> <unk> co founders and co Ceos, Todd just Tony Garrett CFO, our commercial leaders, Andy Boyer for generics, Joe render for specialty harsher seeing for Biosciences, and Jason Daly Chief Legal officer.

Tony DiMeo: Our commercial leaders, Andy Boyer for generics, Joe Renda for specialty, Harsha Singh for biosciences, and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

M&A: I will now hand, the call over to Sharon.

Chirag Patel: Thank you, Tony. Good morning to everyone on the call. Amneal delivered solid financial performance in 2023 as revenues grew 8% and adjusted EBITDA grew 9%. We raised our guidance twice during the year and delivered on it. Driven by strong execution and the robust performance across our diversified business, we expect our momentum will continue in 2024 and beyond. Amneal's core strengths lie in our broad-based business platform and our team, both of which are dedicated to providing access to high quality, affordable, essential medicines. Since Chintu and I returned to the company in 2019, we have been implementing a thoughtful and deliberate strategy to transform Amneal into a leading global diversified pharmaceutical company. With a global aging population and ongoing supply challenges and shortages, our capabilities have never been more important and more in need.

Sharon: Thank you Tony good morning to everyone on the call.

Chirag K. Patel: Good morning to everyone on the call. Amneal delivered solid financial performance in 2023 as revenues grew 8% and adjusted EBITDA grew 9%. We raised our guidance twice during the year and delivered on it, driven by strong execution and robust performance across our diversified business. We expect our momentum will continue in 2024 and beyond. Amneal's core strengths lie in our broad-based business platform and our team, both of which are dedicated to providing access to high-quality, affordable, essential medicine. Since Chintu and I returned to the company in 2019, we have been implementing a thoughtful and deliberate strategy to transform Amneal into a leading, global, diversified pharmaceutical company. With a global aging population and ongoing supply challenges and shortages, our capabilities have never been more important or needed.

Speaker Change: <unk> delivered solid financial performance in 2023 as revenues grew 8% and adjusted EBITDA grew 9%.

Sharon: We raised our guidance twice during the year and delivered on it.

Sharon: Driven by strong execution and the robust performance across our diversified business. We expect our momentum will continue in 2024 and beyond.

Sharon: <unk> core strengths lie in our broad based business platform and our team.

Sharon: Both of which are dedicated to providing access to high quality affordable essential medicines.

Since Jim and I returned to the company in 2019.

Sharon: We have been implementing a thoughtful and deliberate strategy to transforming <unk> into a leading global diversified pharmaceutical company.

Sharon: With a global aging population and ongoing supply challenges and shortages.

Sharon: Capabilities have never been more important and more in need.

Chirag Patel: In our affordable medicines business, which is our generic segment, we have been building our leadership position since Amneal's inception. We have decades-long reputation for industry-leading innovation, quality, and customer service levels. Our strategy focuses on expanding our portfolio and driving growth with complex high-value products across retail, injectables, and biosimilars. Our affordable medicines business has consistently grown each year since 2019, and we have launched more complex retail and injectable innovations in the United States than anyone else since then. In 2023, we set a new record number of 39 new retail and injectable products launched. In retail market, our commercial portfolio of over 230 medicines is complex and diversified with less price erosion and more stability.

Chirag K. Patel: In our Affordable Medicines business, which is our generic segment, we have been building our leadership position since Amneal's inception. We have a decades-long reputation for industry-leading innovation, quality, and customer service levels. Our strategy focuses on expanding our portfolio and driving growth with complex, high-value products across retail, injectables, and biosimilars. Our affordable medicines business has consistently grown each year since 2019, and we have launched more complex retail and injectable innovations in the United States than anyone else since then. In 2023, we set a new record number of 39 new retail and injectable products launched. In the retail market, our commercial portfolio of over 230 medicines is complex and diversified, with less price erosion and more stability.

Sharon: You know what affordable medicines business, which is our generics segment, we have been building our leadership position since <unk>.

Sharon: Inception.

Sharon: We have decades long reputation for industry, leading innovation quality and customer service levels or strategy focuses on expanding our portfolio and driving growth with complex high value products across retail injectables and biosimilars.

Our affordable medicines business has consistently grown each year since 2019, and we have launched more complex retail and injectable innovations in the United States than anyone else since then.

Sharon: In 2023, we set a new record.

Sharon: Number of 39, new retail and injectable products launched.

Sharon: In retail market, our commercial portfolio of over 230 medicines is complex and diversified with less price erosion and more stability.

Chirag Patel: Overall, the US generics industry appears to have turned the corner after years of higher price erosion, as many recognize the importance of the sector responsible for over 90% of US medicines. In injectables, we have an expanding portfolio, significant capacity, and the capabilities needed to scale this business. We are helping address chronic shortages across hospitals and clinics, and are providing ready-to-use injectables that reduce errors and improve the efficiency of care. The next wave of affordable medicines is biosimilars, which has an estimated $141 billion in branded products facing loss of exclusivity between 2023 and 2027. We successfully entered this new market with our three oncology biosimilars. Their performance exceeded our revenue expectations in 2023, driven by an exceptional co-commercial execution in their first year.

Chirag K. Patel: Overall, the U.S. generics industry appears to have turned the corner after years of higher price erosion, as many recognize the importance of the sector responsible for over 90 percent of U.S. medicine. For injectables, we have an expanding portfolio, significant capacity, and the capabilities needed to scale this business. We are helping address chronic shortages across hospitals and clinics and are providing ready-to-use injectables that reduce errors and improve the efficiency of care.

Sharon: But all the U S. Generics industry appears to have turned the corner after years of higher price erosion as many recognize the importance of this sector responsible for over 90% of U S medicines.

In Injectables, we have an expanding portfolio significant capacity and the capabilities needed to scale this business.

We are helping address chronic shortages across hospitals and clinics.

Sharon: And are providing ready to use injectables that reduce errors and improve the efficiency of care.

Chirag K. Patel: The next wave of affordable medicines is biosimilars, which have an estimated 141 billion in branded products facing loss of exclusivity between 2023 and 2027. We successfully entered this new market with our three oncology biosimilars. Their performance exceeded our revenue expectations in 2023, driven by exceptional commercial execution in their first year. In Q4, we also expanded our biosimiles portfolio by adding two more oncology molecules to our pipeline. Given the market growth and importance of biosimilars, this is a key area of strategic focus and investment for Amneal. We look to further build out our biosimilars pipeline over time. Internationally, we are expanding our reach. In India, we are building a customized portfolio focused on key local needs.

Sharon: The next wave of affordable medicines as Biosimilars.

Sharon: Which has an estimated $141 billion in branded products facing loss of exclusivity between 2023 and 2007.

We successfully entered this new market with our three oncology biosimilars.

Sharon: Their performance has exceeded our revenue expectations in 2023, driven by an exceptional.

Sharon: Initial execution in their first year.

Chirag Patel: In Q4, we also expanded our biosimilars portfolio by adding two more oncology molecules to our pipeline. Given the market growth and importance of biosimilars, this is a key area of strategic focus and investment for Amneal. We look to further build out biosimilars pipeline over time. Internationally, we are expanding our reach. In India, we're building a customized portfolio focused on key local needs. In other geographies, we are actively working with partners to register and commercialize Amneal products. In our specialty branded business, we continue to provide differentiated medicines. We are focused primarily on neurology and endocrinology with our key branded products. In Q4, we expanded with the addition of Ongentys, an adjunctive therapy for Parkinson's. Next, we are so excited about the potential approval and launch of IPX-203 this year, which we believe meaningfully advances the standard of care for all Parkinson's patients.

Sharon: In Q4, we also expanded our biosimilars portfolio by adding two more oncology molecules to our pipeline.

Given the market growth and importance of Biosimilars. This is a key area of strategic focus and investment for them Neil.

Sharon: We look to further build out biosimilar pipeline over time.

Internationally, we are expanding our reach in India. We are building a customized portfolio focused on key local needs.

Chirag K. Patel: In other geographies, we are actively working with partners to register and commercialize Amneal products in our specialty branded business. We continue to provide differentiated medicines. We are focused primarily on neurology and endocrinology with our key branded products. In Q4, we expanded with the addition of Ongentis, an adjunctive therapy for Parkinson's.

Sharon: Other geographies, we are actively working with partners to register and commercialize amnio products.

Sharon: Specialty branded business, we continue to provide differentiated medicines.

Sharon: We're focused primarily on neurology and endocrinology with our key branded products in Q4, we expanded with the addition of <unk>, an adjunctive therapy for Parkinson's.

Chirag K. Patel: Next, we are so excited about the potential approval and launch of IPX203 this year, which we believe meaningfully advances the standard of care for all Parkinson's patients. In our healthcare distribution business, which we acquired in 2020, the business has almost doubled in size in four years. We're launching new products across three channels: distribution, government, and unit dose. In short, we are starting 2024 with remarkable momentum. We believe our durable, broad-based, top and bottom line growth profile is sustainable and accelerating. As Amnealians, we wake up every day thinking about what we can accomplish next.

Sharon: Next we are so excited about the potential approval and launch of IPX, two or three this year, which we believe meaningfully advances the standard of care for all Parkinson's patients.

Chirag Patel: In our AvKARE distribution business, which we acquired in 2020, the business has about doubled in size in four years. We're launching new products across three channels, distribution, government, and unit dose. In short, we're starting 2024 with remarkable momentum. We believe our durable broad-based top and bottom-line growth profile is sustainable and accelerating. As Amnealians, we wake up every day thinking about what we can accomplish next. We have more shots on goal than ever before. This includes key medicines and new markets where success represents $100 million or more in potential revenues each. Amneal is on an upward trajectory, and we are so excited for what's ahead. I'll now hand it over to my younger brother, Chintu.

Sharon: You know what I would get a distribution business, which we acquired in 2020. The business is about double in size in four years, we are launching new products across three channels distribution government and unit dose.

Sharon: In short, we're starting 2024 with remarkable momentum we believe our durable broad based top and bottom line growth profile is sustainable and accelerating.

Sharon: As there are millions, we wake up every day thinking about what we can accomplish next we have more shots on goal than ever before this includes key medicines in new markets, where success represents 100 million or more in potential revenues each.

Chirag K. Patel: We have more shots on goal than ever before, including key medicines and new markets where success represents 100 million or more in potential revenues each. Amneal is on an upward trajectory, and we are so excited for what's ahead. I'll now hand it over to my younger brother, Chintu.

Sharon: Neil is on an upward trajectory and we are so excited for what's ahead.

Speaker Change: I'll now hand, it over to my younger brother agenda.

Chintu Patel: Thank you. Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who work hard every day to help make healthy possible. As Chirag mentioned, we are executing well on our strategy to be an innovative global pharmaceuticals company capable of driving sustainable growth in the key areas of medicine. I will touch on how our core competencies in operations and R&D continue to drive our company's success. First, Amneal has one of the best service levels in the industry, with quality at the center of everything we do. Our success is driven by our operational excellence, robust supply chain, and great commercial team. We are driving operational efficiencies to lower costs and expand our margins.

Chintu Patel: Thank you. Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who work hard every day to help make health possible. As Chirag mentioned, we are executing well on our strategy to be an innovative global pharmaceutical company capable of driving sustainable growth in the key areas of medicine. I will touch on how our core competencies in operations and R&D continue to drive our company's success. First, Amneal has one of the best service levels in the industry, with quality at the center of everything we do.

Agenda: Thank you good morning, everyone. Thank you Doug and thank you to the global revenues, primarily who work hard every day to help make healthy possible.

As Doug mentioned, we are executing well on our strategy strategy to be an innovative global pharmaceuticals company capable of driving sustainable growth in the key areas of medicine, I will touch on how our core competencies in operations and R&D.

Agenda: To drive our company's success first and Neil has one of the best service levels in the industry with quality at the center of everything we do our success is driven by our operational excellence robust supply chain and great commercial team, we are driving operational efficiencies.

Chintu Patel: Our success is driven by our operational excellence, robust supply chain, and great commercial team. We are driving operational efficiencies to lower costs and expand our margins. At Amneal, we have long been focused on global supply chain security and resilience as we work proactively to meet market needs, given the dynamic and ever-changing nature of our business.

Agenda: Two lower cost and expand our margins at our mill, we have long been focused on global supply chain security and resilience as we work proactively to meet market needs, given the dynamic and ever changing nature of our business over the last few years.

Chintu Patel: At Amneal, we have long been focused on global supply chain security and resilience as we work proactively to meet market needs given the dynamic and ever-changing nature of our business. Over the last few years, we have invested substantial resources to triple our injectables capacity to scale our business and help address market shortages. As you know, the US pharmaceutical market is plagued by chronic drug shortages, including critical oncology therapies. There are several contributing factors, including market price being generally too low for some products to be produced and contract commitment being too short-term in the retail market. As of February, the US FDA listed 121 products in shortages, including 78 injectables. About 20 of our commercial and pipeline injectables products are on the US FDA shortage list. We continue to work closely with the FDA to help alleviate drug shortages in the US.

Chintu Patel: Over the last few years, we have invested substantial resources to triple our injectable capacity, to scale our business, and to help address market shortages. As you know, the U.S. pharmaceutical market is plagued by chronic drug shortages, including critical oncology therapy. There are several contributing factors, including the market price being generally too low for some products to be produced and contract commitment being too short-term in the retail market.

Agenda: We have invested substantial resources to triple our injectables capacity to scale, our business and help address market shortages as you know the U S. Pharmaceutical market is plagued by chronic drug shortages, including critical oncology therapies.

Agenda: There are several contributing factors, including market price being generally too low for some products to be produced and contract commitment being too short term in the retail market as of February the U S. FDA listed 121 products in shortages.

Chintu Patel: As of February, the U.S. FDA listed 121 products in shortage, including 78 injectables. About 20 of our commercial and pipeline injectable products are on the FDA shortage list. We continue to work closely with the FDA to help alleviate drug shortages in the U.S. We also remain committed to maintaining our stellar quality track record. Since 2005, the FDA has conducted over 100 successful inspections with either no or only minor observations.

Agenda: <unk> 78 Injectables.

Agenda: 20 of our commercial and pipeline Injectables products are on the U S. FDA shortage list. We continue to work closely with the FDA to help alleviate drug shortages in the U S will.

Chintu Patel: We also remain committed to maintaining our stellar quality track record. Since 2005, the US FDA has conducted over 100 successful inspections with either no or only minor observations. Now, all of our manufacturing locations are FDA-approved for commercial products, including our inhalation plant in Ireland. As the standards of quality continue to increase, we continue to invest in quality and infrastructure. Our high-quality global operations are at scale to support sustainable long-term growth. Second, innovation is the lifeblood of any growing pharmaceuticals company, and that's certainly the case for Amneal. In 2023, we launched a record 39 new retail and injectables products. Looking forward, the pipeline is deep, with 160 products pending approval or in development. We have 88 ANDAs pending, of which 64% are non-oral solids, primarily injectables, ophthalmics, and inhalation products.

Agenda: We also remain committed to maintaining our risk tailored quality track record since 2005. The U S. FDA has conducted over 100 successful inspections with either no or only minor observations.

Chintu Patel: Now, all of our manufacturing locations are FDA-approved for commercial products, including our inhalation plant in Ireland. As the standards of quality continue to increase, we continue to invest in quality and infrastructure. Our high-quality global operations are at scale to support sustainable long-term growth. Second, innovation is the lifeblood of any growing pharmaceutical company, and that's certainly the case for Amneal.

Agenda: Now all of our manufacturing locations are FDA approved for commercial products, including our insulation plant in Ireland.

Agenda: As the standards of quality continue to increase we continue to invest in quality.

Agenda: And infrastructure.

Agenda: Our high quality global operations at scale to support sustainable long term growth.

Second innovation is the life blood of any growing Pharmaceuticals company and that's certainly the case for EMEA in 2023, we launched a record 39, new retail and Injectables products looking forward. The pipeline is deep with 160 <unk>.

Chintu Patel: In 2023, we launched a record 39 new retail and injectable products. Looking forward, the pipeline is deep with 160 products pending approval or in development. We have 88 ANDs pending, of which 64% are non-oral solids, primarily injectables, ophthalmics, and inhalation products. Additionally, we have 72 pipeline products, of which 94% are now non-oral solids.

Agenda: Our expanding approval or in development.

Agenda: <unk> spending of which 64% non oral solids, primarily injectables ophthalmic <unk> and inhalation products. Further we have 72 pipeline products of three each now 94% are non oral solids.

Chintu Patel: Further, we have 72 pipeline products, of which now 94% are non-oral solids. Accordingly, we expect over 13 launches in 2024. Also, approximately 45% of pending ANDAs and over 60% of our pipeline are expected to be first to market, first to file, or 505(b)(2) products. As we shift towards complex innovations, we have also been very disciplined by doing more with less spend and have improved the efficiency of our R&D operations. This also allows us to allocate more investment towards external R&D over time. Our key area of R&D focus remains injectables. In 2023, we launched 14 new injectables, which sets up well for revenue acceleration in 2024 and beyond. We are increasingly focusing our R&D on oncology, ready-to-use bag, and long-acting injectables.

Chintu Patel: Accordingly, we expect over 30 new launches in 2024. Also, approximately 45% of pending ANDAs and over 60% of our pipeline are expected to be first-to-market, first-to-file, or 505b2 products. As we shift towards complex innovations, we have also been very disciplined by doing more with less spend and have improved the efficiency of our R&D operations.

Agenda: Accordingly, we expect over 30, new launches in 2024.

Agenda: Also approximately 45% of our pending andas and over 60% of our pipeline are expected to be first to market first to file our 500 <unk> two products as we shift towards complex innovations.

Agenda: <unk> also been very disciplined by doing more with less spend and have improved the efficiency of our R&D operations.

Chintu Patel: This also allows us to allocate more investment towards external R&D over time. Our key area of R&D focus remains injectables. In 2023, we launched 14 new injectables, which sets up well for revenue acceleration in 2024 and beyond. We are increasingly focusing our R&D on oncology, ready-to-use bags, and log-acting injectables.

Agenda: This also allows us to allocate more investment towards towards external R&D over time.

Agenda: Our key areas of R&D focus remains injectables.

Agenda: In 2020, we launched 14, new Injectables, which sets up well for revenue acceleration in 'twenty 'twenty four and beyond.

Agenda: Increasingly focusing our R&D on oncology.

Agenda: To use bag and long acting Injectables, we look to launch two to three.

Chintu Patel: We look to launch 2 to 3 high-value 505(b)(2) injectables each year going forward, starting with the upcoming launch of PEMRYDI RTU in April. In addition, our filing for risperidone was recently accepted by the FDA. This microsphere product reflects our leading complex R&D and manufacturing capabilities. We have more products like this in the advanced stage of development. Outside injectables, another complex area we are focusing our R&D effort is inhalation. We are advancing a number of inhalation drug delivery devices, including metered dose inhalers and Respimat products, which we believe will drive sustainable long-term growth. The next key catalyst is naloxone nasal spray, which is an essential life-saving drug. Our facility in Branchburg, New Jersey, has been repurposed for making this product. Our goal date is soon, and we are ready to go.

Chintu Patel: We look to launch two to three High Value 552 injectables each year going forward, starting with the upcoming launch of PAM-Ready RTU in April. In addition, our filing for Respiridone was recently accepted by the FDA.

Agenda: High value fiber to inject it was each year going forward, starting with the upcoming launch of <unk> <unk> in April in.

Agenda: In addition, our filing for <unk> was recently accepted by the FDA. These microspheres product reflects our leading complex R&D and manufacturing capabilities.

Chintu Patel: These microsphere products reflect our leading complex R&D and manufacturing capabilities. We have more products like these in the advanced stage of development outside injectables. Another complex area we are focusing our R&D effort on is inhalation. We are advancing a number of inhalation drug delivery devices, including meter dose inhalers and recipe-made products, which we believe will drive sustainable long-term growth. The next key catalyst is naloxone nasal spray, which is an essential life-saving drug. Our facility in Branchburg, New Jersey, has been repurposed for making this product.

Agenda: Have more products like this in the advanced stage of development our.

Agenda: Outside Injectables and other complex area, we are focusing our R&D effort is inflation.

Agenda: Our advancing a number of inhalation drug delivery devices, including metered dose inhalers and recipe made products.

Agenda: Which we believe will drive sustainable long term growth.

Agenda: Next key catalyst is naloxone nasal spray, which is an essential life saving drugs or.

Our facility in Branchburg, New Jersey has been repurposed for making this product. Our goal date is soon and we are ready to go this product will be available over the counter and two states and counties around the U S to help improve access to these critical.

Chintu Patel: Our goal date is soon, and we are ready to go. This product will be available over the counter and in states and counties around the U.S. to help improve access to this critical overdose rescue therapy. Next, we are very excited about the future of biosimilars and pleased with the commercial success of our first three products. This is a key area of growth for us, and to build on that initial success, we added two more biosimilars to our pipeline in 2023, and we look to add 2 to 3 more to our pipeline in 2024. In international, we filed about 60 dossiers in emerging markets in 2023, and we plan to file 150 to 200 more in Europe and the rest of the world in 2024.

Chintu Patel: This product will be available over the counter and to states and counties around the US to help improve access to this critical overdose rescue therapy. Next, we are very excited about the future of biosimilars and pleased with the commercial success of our first three products. This is a key area of growth for us, and to build on that initial success, we added two more biosimilars to our pipeline in 2023, and we look to add 2 to 3 more to our pipeline in 2024. In international, we filed about 60 dossiers in emerging markets in 2023, and we plan to file 150 to 200 more in Europe and the rest of the world in 2024. In specialty, we are continuously evolving our R&D efforts to move up the value chain, just like in generics.

Agenda: Overdose rescue therapy.

Agenda: Next we are very excited about the future of Biosimilars and pleased with the commercial success of our first three products.

Agenda: This is a key area of growth for us and to build on that initial success. We added two more.

Biosimilars two of our pipeline in 2023, and we look to add two to three more towards pipeline in 2024.

Agenda: In International we filed about 60 of those years in emerging markets in 2023, and we plan to file 150 to 200 more in Europe, and the rest of the world in 2024.

Chintu Patel: In specialty, we are continuously evolving our R&D effort to move up the value chain, just like in generics. For IPX203, we have completed one additional study with very good results and made our complete response resubmission in early February. We look forward to launching IPX203 in Q3, pending FDA approval. We seek to provide access to IPX203 for the over 10 million global Parkinson's patients and are pleased to have recently signed licensing agreements to bring IPX203 to Europe, Canada, and Latin America. Next, our DHE auto-injector for migraine and cluster headache is set for Q1 2025 launch as site transfer to MD manufacturing is underway now.

Agenda: In specialty we are continuously evolving our R&D effort to move up the value chain just like in genetics.

Chintu Patel: On IPX-203, we have completed one additional study with very good results and made our complete response resubmission in early February. We look forward to launching IPX-203 in Q3, pending FDA approval. We seek to provide access to IPX-203 for the over 10 million global Parkinson's patients and are pleased to recently sign licensing agreements to bring IPX-203 to Europe, Canada, and Latin America. Next, our DHE autoinjector for migraine and cluster headache is set for Q1 2025 launch as site transfer to Amneal manufacturing is underway now. We continue to look to add to our specialty pipeline, particularly in new key areas of neurology and endocrinology. As Chirag mentioned, our hard work continues in 2024 as we build on the success of 2023 to bring Amneal to new heights.

Agenda: An IPX two or three we have completed one additional study with very good results and made our complete response resubmission in early February.

Agenda: I look forward to launching IPX, two or three in Q3 pending FDA approval, we seek to grow provide access to IPX towards fee for the over 10 million global Parkinson's patients and are pleased to recently signed licensing agreements to bring IPX two or three.

Two Euro, Canada, and Latin America.

Agenda: Next our <unk> auto injector for migraine and cluster headache is set for Q1 'twenty quantify launch as site transferred to EM lean manufacturing is underway now we continue to look to add to our specialty pipeline, particularly in new key areas of neurology and.

Chintu Patel: We continue to look to add to our specialty pipeline, particularly in new key areas of neurology and endocrinology. As Chirag mentioned, our hard work will continue in 2024 as we build on the success of 2023 to bring Amneal to new heights. As founders and CEOs, we are extremely passionate about our company's mission and the shared value we can create for all our stakeholders. I will now pass this over to Tasos. Thank you, Chintu, and good morning, everyone.

Agenda: Endocrinology.

Agenda: As Jack mentioned, our hardware continues in 2024 as we build on the success of 'twenty two 'twenty three to bring <unk> to new heights as founders and Ceos, we are extremely passionate about our company's mission and the shared value we can create for all our stakeholders.

Chintu Patel: As founders and CEOs, we are extremely passionate about our company's mission and the shared value we can create for all our stakeholders. I will now pass it over to Tasos.

Speaker Change: I will now pass it over to <unk>. Thank you Jim and good morning, everyone. As a reminder, the four pillars of value creation at Emil our diversification financial growth cash generation and deleveraging.

Tasos Konidaris: Thank you, Chintu, and good morning, everyone. As a reminder, the four pillars of value creation at Amneal are diversification, financial growth, cash generation, and deleveraging. I'm extremely pleased with our performance across all four pillars in 2023 and excited about 2024 and beyond. Let me first start with diversification, where Amneal has made remarkable progress driven by AvKARE, strong cadence of new, more complex products, growth of our specialty brands, and expanding in new areas such as biosimilars. As a tangible result, our oral solid generics now account for 25% of total revenues, compared to 53% in 2019. Also, our generics account for 61% of total revenue, compared to 80% in 2019. We expect our diversification to grow over time, which bodes well for consistent financial performance.

Anastasios G. Konidaris: As a reminder, the four pillars of value creation at Amneal are diversification, financial growth, cash generation, and leverage. I'm extremely pleased with our performance across all four pillars in 2023 and excited about 2024 and beyond. Let me first start with diversification, where Amneal has made remarkable progress driven by Adcare. A strong cycle of new, more complex products, growth of our specialty branch, and expanding in new areas such as biosimilars. As a tangible result, our oral solid generics now account for 25% of total revenues, compared to 53% in 2019.

Speaker Change: I am extremely pleased with our performance across all four pillars in 2023 and excited about 2024 and beyond.

Let me first start with diversification, where Emil has made remarkable progress driven by our care.

Speaker Change: Strong cadence of new more complex products.

Speaker Change: Of our specialty brands and expanding in new areas such as Biosimilars.

Speaker Change: As a tangible result.

Speaker Change: Oral solid generics now account for 25% of total revenues compared to 53% in 2019.

Anastasios G. Konidaris: Also, our generics account for 61% of total revenue compared to 80% in 2019. We expect our diversification to grow over time, which bodes well for consistent financial performance. Let me now discuss our second and third pillars of value creation, where financial performance and cash generation were undoubtedly exceptional in 2023. All business units grew their respective businesses to deliver record levels of financial results and substantially exceeded every guidance metric we shared with you over the course of last year. Let me first start with our Q4 results, where we recorded strong revenue of $617 million. Generics net revenue was $363 million, down 9% due to year-end timing of orders.

Speaker Change: Also our generics account for 61% of total revenue compared to 80% in 2019.

Speaker Change: We expect our diversification to grow over time, which bodes well for consistent financial performance.

Tasos Konidaris: Let me now discuss our second and third pillars of value creation, where financial performance and cash generation was undoubtedly exceptional in 2023. All business units grew their respective businesses to deliver record levels of financial results and substantially exceeded every guidance metric we shared with you over the course of last year. Let me first start with our Q4 results, where we recorded strong revenue of $617 million. Generics net revenue was $363 million, down 9% due to year-end timing of orders. Products launched in 2022, 2023, and biosimilars continued to perform very well and added $34 million in Q4.

Speaker Change: Let me now discuss our second and third pillars of value creation.

Speaker Change: Financial performance and cash generation was adopted <unk> exceptional in 2023.

Speaker Change: All business units grew their respective businesses to deliver record levels of financial results substantially exceeded every guidance metric we shared with you over the course of last year.

Speaker Change: Let me first start with our Q4 results when we reported strong revenue of $617 million.

Speaker Change: Generics net revenue was $363 million down 9% due to year end timing of orders.

Anastasios G. Konidaris: Products launched in 2022-2023 and biosimilars continue to perform very well and added $34 million in Q4. Q4 specialty net revenue of $104 million grew 2% driven by key brand products, while after net revenues of $149 million grew 38%, reflecting strong growth across all of their three customer channels. Q4 Adjusted EBITDA of $142 million compares to $154 million in the prior year quarter driven by investments in R&D and commercial to drive future growth. Adjusted EBITDA in Q4 was ahead of our average quarterly 2023 level as well as our expectations, which is why we exceeded our annual adjusted EBITDA guidance. Q4 EPS of $0.14 compares to $0.23 in the prior year quarter, mostly driven by higher interest. From an operating cash flow perspective, in the fourth quarter of 2023, we generated $136 million compared to negative $23 million in the prior year quarter.

Speaker Change: Products launched in 2000, 22023, and Biosimilars continue to perform very well and added $34 million in Q4.

Tasos Konidaris: Q4 specialty net revenue of $104 million grew 2% driven by key brand products, while AvKARE net revenues of $149 million grew 38%, reflecting strong growth across all of their three customer channels. Q4 adjusted EBITDA of $142 million compares to $154 million in the prior year quarter, driven by investments in R&D and commercial to drive future growth. Adjusted EBITDA in Q4 was ahead of our average quarterly 2023 level as well as our expectations, which is why we exceeded our annual adjusted EBITDA guidance. Q4 EPS of $0.14 compares to $0.23 in the prior year quarter, mostly driven by higher interest costs.

Speaker Change: Q4 specialty net revenue of $104 million grew 2% driven by key brand products, while <unk> net revenues of 149 million grew 38%, reflecting strong growth growth across all of the three customer channels.

Speaker Change: Q4, adjusted EBITDA of 142 million compares to $154 million in the prior year quarter, driven by investments in R&D and commercial to drive future growth.

Speaker Change: Adjusted EBITDA in Q4. It was ahead of our average quarterly 2023 level as well as our expectations, which is why we exceeded our annual adjusted EBITDA guidance.

Speaker Change: Q4, EPS of 14, <unk> compares to <unk> 23 cents in the prior year quarter, mostly driven by higher interest costs.

Tasos Konidaris: From an operating cash flow perspective, in Q4 2023, we generated $136 million compared to -$23 million in the prior year quarter. This strong growth was well ahead of our expectations and reflects both the strength of our underlying business as well as timing benefits related to collections of our accounts receivable. Let me now discuss our full year 2023 performance, where total net revenue grew to a record level of $2.4 billion, up $181 million or 8%. Generics net revenue of $1.471 billion grew 3%. Products launched in 2022, 2023, and biosimilars added $113 million or 9% of growth.

Speaker Change: And operating cash flow perspective in the fourth quarter of 2023, we generated $136 million compared to negative $23 million in the prior year quarter.

Anastasios G. Konidaris: This strong growth was well ahead of our expectations and reflects both the strength of our underlying business, as well as timing benefits related to collections of our accounts receivable. Let me now discuss our full year 2023 performance, where total net revenue grew to a record level of $2.4 billion, up 181 million, or 8%. Generic's net revenue of $1,471,000,000 grew 3%.

Speaker Change: This strong growth was well ahead of our expectations and reflects both the strength of our underlying business as well as us timing benefits related to collections of our accounts receivable.

Speaker Change: Let me now discuss our full year 2023 performance, where total net revenue grew to a record level of $2 4 billion up $181 million or 8%.

Speaker Change: Generics net revenue of $1 billion $471 million grew 3%.

Anastasios G. Konidaris: Photox lamps in 2022 and 2023, and biosimilars added 130 million, or 9% of growth. The remaining product portfolio continues to perform well due to the relevancy of our products, strong market demand, and Amneal's high quality supply chain. Specialty net revenue for the year was 390 million and grew 4%, driven by key branded products. Adcare net revenue for the year was $532 million and grew 31%, driven by new product launches and strong commercial execution across all its three customer channels.

Speaker Change: Products launched in 2020, due 2023 and Biosimilars.

Speaker Change: $130 million or 9% of growth.

Tasos Konidaris: The remaining product portfolio continues to perform well due to the relevancy of our products, strong market demand, and Amneal's high-quality supply chain. Specialty net revenue for the year was $390 million and grew 4% driven by key branded products. Healthcare net revenue for the year was $532 million and grew 31%, driven by new product launches and strong commercial execution across all its three customer channels. Full year adjusted EBITDA was $558 million and grew 9%, well ahead of our original 2023 guidance of $500 to $530 million, as well as the guidance we provided in November, which was between $450 and $550 million. Our growth was driven by strong operating leverage, favorable R&D spend, and growth in our commercial expenses.

Speaker Change: The remaining product portfolio continues to perform well due to the relevancy of our products.

Speaker Change: <unk> market demand and their meals high quality supply chain.

Speaker Change: Specialty net revenue for the year was $390 million and grew 4% driven by key branded products.

Speaker Change: <unk> net revenue for the year was $532 million and grew 31% driven by new product launches and strong commercial execution across all three customer channels.

Anastasios G. Konidaris: Full year adjusted EBITDA was $558 million and grew 9% well ahead of our original 2023 guidance of $500 to $530 million, as well as the guidance we provided in November, which was between $540 and $550 million. Our growth was driven by strong operating leverage, favorable R&D spend, and growth in our commercial expenses. Full year 2023 adjusted EPS of $0.64 declined 6% as higher interest expense offset adjusted EBITDA growth.

Speaker Change: Full year, adjusted EBITDA was 558 million and grew 9%.

Speaker Change: Well ahead of our original 2023 guidance of $500 million to $530 million as well as the guidance. We provided in November which was between 400 540 and $515 million.

Speaker Change: Our growth was driven by strong operating leverage favorable R&D spend and growth in our commercial expenses.

Tasos Konidaris: Full year 2023 adjusted EPS of $0.64 declined 6% as higher interest expense offset adjusted EBITDA growth. Nevertheless, our EPS performance again substantially exceeded all prior guidance we had provided. Operating cash flow in 2023 was $346 million compared to $65 million in 2022. Our 2023 performance was well ahead of our expectations and benefited from strong collections in December. It is worth noting that our 2023 operating cash flow of $346 million also includes $86 million in legal costs, mostly related to the settlement of the Opana ER case. At the end of 2023, we only had one last remaining payment related to Opana ER for approximately $52 million, which bodes well for future cash generation. Let me now turn to our 2024 guidance, where we expect another year of strong growth.

Speaker Change: Full year 2023, adjusted EPS of <unk> 64 cents declined 6%.

Speaker Change: Higher interest expense offset adjusted EBITDA growth.

Anastasios G. Konidaris: Nevertheless, our EPS performance again substantially exceeded all prior guidance we had provided. Operating cash flow in 2023 was $346 million compared to $65 million in 2022. Our 2023 performance was well ahead of our expectations and benefited from strong collections in December. It is worth noting that our 2023 operating cash flow of $346 million also includes $86 million in legal costs, mostly related to the settlement of the Opana ERK. At the end of 2023, we only had one last remaining payment related to Opana EER for approximately 52 million, which bodes well for future cash generation. Let me now turn to our 2024 guidance, where we expect another year of strong growth. On the top line, we expect a total company net revenue of $2,550,000,000.

Speaker Change: Nevertheless, our EPS performance again substantially exceeded our prior guidance we have provided.

Speaker Change: Operating cash flow in 2023 was 346 million compared to $65 million in 2022.

Speaker Change: Our 2023 performance was well ahead of our expectations and benefited from strong collections in December.

Speaker Change: It is worth noting that our 2023 operating cash flow of $346 million also includes $86 million in legal costs, mostly related to the settlement of the Opana ER case.

Speaker Change: At the end of 2023, who only had one last remaining payment related to a panel for approximately $52 million, which bodes well for future cash generation.

Let me now turn to our 2024 guidance, where we expect another year of strong growth.

Tasos Konidaris: On the top line, we expect total company net revenue of $2.55 billion to $2.65 billion, reflecting high single-digit growth driven by robust growth in all of our three segments. First, in generics, we expect high single-digit growth compared to 3% in 2023 due to three key dynamics. Number one, biosimilars should more than double to over $125 million in 2024 compared to $66 million in 2023. Our three oncology-focused products continue to drive substantial value to both payers and patients. Number two, new product launches, many of which have already been approved and launched, should add over $100 million. In addition, we're optimistic on the potential FDA approval of naloxone, which could add over $30 million in 2024.

Speaker Change: On the topline we expect total company net revenue of $2.550 billion.

Anastasios G. Konidaris: Q to 1,650,000,000, reflecting high single-digit growth driven by robust growth in all of our three segments. First, in generics, we expect high single-digit growth compared to three percent in 2023 due to three key dynamics. Number one, biosimilars should more than double to over 125 million in 2024 compared to 66 million in 2023. Our three oncology-focused products continue to drive substantial value to both payers and patients. Number two, new product launches, many of which have already been approved and launched, should add over 100 million. In addition, we're optimistic about the potential FDA approval of Naloxone, which could add over 30 million in 2024.

Speaker Change: $2.615 billion.

Speaker Change: Collecting high single digit growth driven by robust growth in all of our three segments.

Speaker Change: First in generics, we expect high single digit growth compared to 3% in 2023 due to three key dynamics.

Speaker Change: Number one biosimilars should more than double to over $125 million in 2024 compared to $66 million in 2023.

Speaker Change: Our free oncology focused products continued to drive substantial value to both payers and patients.

Speaker Change: Number two new product lines, many of which have already been approved in lumps show that over $100 million.

Speaker Change: We're optimistic on the potential FDA approval of naloxone, which could add over $30 million in 2024.

Tasos Konidaris: Three, as we always do, we expect the competitive nature of generics to persist and the strength of Amneal's R&D, superb quality, and reliable supply chain to be competitive advantages. Second, on the specialty business, we expect low double-digit growth compared to 4% in 2023, driven by our key branded products and, in addition, Ongentys in our Parkinson's franchise. We look forward to the potential approval of IPX-203, but we have not included any revenues at this point as to ensure proper conservatism. Finally, on AvKARE, we expect double-digit top-line growth, albeit some slowdown from the 31% growth in 2023, driven by continued broad-based strength across all channels and a number of new launches.

Anastasios G. Konidaris: Three, as we always do, we expect the competitive nature of generics to persist and the strength of Amneal's R&D, superb quality, and reliable supply chain to be a competitive advantage. Second, on the specialty business, we expect low double-digit growth compared to 4% in 2023, driven by key branded products and, in addition, Argentis, in our Parkinson's franchise. We look forward to the potential approval of IPX203, but we have not included any revenues at this point so as to ensure proper conservatism.

Speaker Change: Three as we always do we expect the competitive nature of generics to persist and the strength of MBS R&D superb quality and reliable supply chain to be competitive advantages.

Speaker Change: Second on the specialty business, we expect low double digit growth compared to 4% in 2023, driven by our key branded products.

Speaker Change: And in addition, <unk>.

Speaker Change: In our Parkinson's franchise, we look forward to the potential approval of IPX two three but we have not included any revenues at this point is to ensure proper conservatism.

Anastasios G. Konidaris: Finally, on healthcare, we expect double-digit top-line growth, albeit some slowdown from the 31 percent growth in 2023, driven by continued broad-based strength across all channels and a number of new lines. Moving down the P&L, we expect 2024 adjusted EBITDA of $580 million to $620 million, reflecting continued high single-digit growth and higher investments in R&D to drive the numerous projects in our pipeline. From an adjusted EPS perspective, we expect a range between $0.53 and $0.63 driven by higher interest costs partially offset by higher adjusted EBITDA. On the cash side, we expect operating cash flow, excluding legal settlements, between $260 million and $300 million. The strong caste generation reflects higher Ibida.

Speaker Change: Finally on healthcare, we expect double digit top line growth, albeit some slowdown from the 31% growth in 2023, driven by continued broad based strength across all channels and a number of new launches.

Tasos Konidaris: Moving down the P&L, we expect 2024 adjusted EBITDA of $580 million to $620 million, reflecting continued high single-digit growth and higher investments in R&D to drive the numerous projects in our pipeline. From an adjusted EPS perspective, we expect a range between $0.53 and $0.63, driven by higher interest costs, partially offset by higher adjusted EBITDA. On the cash side, we expect operating cash flow, excluding legal settlements, between $260 million and $300 million. The strong cash generation reflects higher EBITDA, typical accounts receivable collection patterns, and higher interest expense. From a capital expenditure perspective, we expect $60 to $70 million a year. Finally, we continue to make solid progress on our fourth pillar of value creation, deleveraging.

Speaker Change: Moving down the P&L, we expect 2024, adjusted EBITDA of $580 million to $620 million.

Speaker Change: Reflecting continued high single digit growth and higher investments in R&D to drive the numerous projects in our pipeline.

Speaker Change: From an adjusted EPS perspective, we.

Speaker Change: We expect a range between 53 and.

63 <unk>.

Speaker Change: Driven by higher interest costs, partially offset by higher adjusted EBITDA.

Speaker Change: On the cash side, we expect operating cash flow excluding legal settlements.

Speaker Change: Between $260 million and $300 million.

Speaker Change: The strong cash generation reflects higher EBITDA.

Anastasios G. Konidaris: Typical accounts receivable collection patterns and higher interest expense. From a capital expenditure perspective, we expect 60 to 70 million a year. Finally, we continue to make solid progress on our fourth pillar of value creation, leveraging. Net leverage has come down remarkably from 7.4 times in 2019 to 4.8 times at the end of 2023. For 2024, we expect to pay down between $100 and $200 million of gross debt and reduce net leverage closer to four times by the end of 2024, below four times in 2025, and then below three times thereafter. With that, let me turn the call over to Chirag. Thank you, Tassos.

Speaker Change: Typical accounts receivable collection patterns and higher interest expense.

From a capital expenditure perspective, we expect $60 million to $70 million a year.

Speaker Change: Finally, we continue to make solid progress on our fourth pillar of value creation deleveraging.

Tasos Konidaris: Net leverage has come down remarkably from 7.4x in 2019 to 4.8x at the end of 2023. For 2024, we expect to pay down between $100 and $200 million of gross debt and reduce net leverage closer to 4x by the end of 2024, below 4x in 2025, and then below 3x soon thereafter. With that, let me turn the call over to Chirag.

Speaker Change: Net leverage has come down markedly from seven four times in 2019 to four eight times at the end of 2023.

Speaker Change: For 2024, we expect to pay down between 100 and $200 million of gross debt.

Speaker Change: And reduced net leverage closer to four times by the end of 2024.

Speaker Change: Below four times in 2025.

Speaker Change: And then below three times soon thereafter.

Speaker Change: That let me turn the call over to Sheila. Thank you Dr. <unk>.

Chirag Patel: Thank you, Tassos. In summary, 2023 was a very good year across the board for Amneal. Looking forward, we believe 2024 will be even better as our future is so bright. Let's now open the call for Q&A.

Chirag K. Patel: In summary, 2023 was a very good year across the board for Amneal. Looking forward, we believe 2024 will be even better, as our future is so bright. Let's now open the call for Q&A. Thank you. If you would like to ask a question, please press star followed by 1 on your telephone keypad. If you would like to withdraw your question, please press star followed by 2. When preparing to ask a question, please ensure that your device is unmuted locally.

Sheila: In summary, 2023 was a very good year across the board for a meal looking forward. We believe 2024 will be even better as the future is so bright.

Sheila: Let's now open the call for Q&A.

Operator: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by two. When preparing to ask a question, please ensure your device is unmuted locally. First question comes from Nathan Rich with Goldman Sachs. Your line is open. Please go ahead.

Sheila: Okay.

Sheila: Thank you.

Sheila: I'd like to ask a question. Please press star followed by one on your telephone keypad.

Speaker Change: I'd like to withdraw your question. Please press star followed by two.

Speaker Change: Im trying to ask a question, please and showing some license reshaped locally.

Nathan Allen Rich: The first question comes from Nathan Rich with Goldman Sachs. Your line is open, please go ahead. Great. Good morning and congratulations on a strong year and for all the details that you showed on the call this morning. I wanted to start with the guidance for the specialty segment in 2024. It seems like you're expecting a nice acceleration in growth. But I think, Tassos, if I heard you correctly, it doesn't include IPX

Speaker Change: First question comes from Nathan Rich with Goldman Sachs. Your line is open. Please go ahead.

Nathan Rich: Great. Good morning, and congrats on the strong year and for all the details that you shared on the call this morning. I wanted to start with the guidance for the specialty segment in 2024. It seems like you're expecting a nice acceleration in growth. I think, Tasos, if I heard you correctly, it doesn't include IPX-203. Could you maybe just talk about what's driving the growth there? You know, how much is maybe coming from ONGENTYS and adding that into the portfolio?

Nathan Allen Rich: Great Good morning, and congrats on the strong year end for all the details that you shared on the call. This morning.

Nathan Allen Rich: I wanted to start with the guidance for the specialty segment in 2024.

Like you were expecting a nice acceleration in growth.

Nathan Allen Rich: I think houses if I heard you correctly. It doesn't include IPX two or three so could you maybe just talk about what's driving the growth there how much is maybe coming from on Genesis and adding that into the portfolio and then bigger picture could you maybe just talk about the initial feedback of adding on Genesis in and.

Anastasios G. Konidaris: So could you maybe just talk about what's driving the growth there? You know, how much is maybe coming from Ongentis and adding that to the portfolio? And then, bigger picture, could you maybe just talk about the initial feedback about adding Ongentis in? And, you know, can you talk about what the commercial strategy will be, you know, assuming IPX203 gets approved later in the year? And how will that help your market position relative to what the experience has been with Rotary? And I'd like to make the first part as to kind of what's driving the accelerated growth. And I think it just really comes across.

Nathan Rich: bigger picture, you know, could you maybe just talk about the initial feedback of adding ONGENTYS in and, you know, can you talk about what the commercial strategy will be, you know, assuming IPX-203 gets approved later in the year, and how that'll help, your market position relative to what the experience has been with RYTARY?

Nathan Rich: Bigger picture, you know, could you maybe just talk about the initial feedback of adding ONGENTYS in and, you know, can you talk about what the commercial strategy will be, you know, assuming IPX-203 gets approved later in the year, and how that'll help, your market position relative to what the experience has been with RYTARY?

Nathan Allen Rich: Can you talk about what the commercial strategy will be assuming IPX tier III gets approved later in the year and how that will help your market position relative to what the experience has been with Rytary.

Tasos Konidaris: Hi, Nate. I'll take the first part as to kinda what's driving the accelerated growth. I think it just really comes down to Unithroid. It just continues to be doing incredibly well, growing at double-digit rates, number one. RYTARY, we aligned our field force for our commercial field forces last year. We have a new leader in that market and just continues to drive high single-digit prescription growth. Then finally, as you correctly pointed out, ONGENTYS. In 2024, we have a full year of revenues that should contribute, you know, between $25 to 30 million of incremental revenue. It's really kinda driven across all of those three key branded products.

Nathan Allen Rich: The first part as to what's driving the accelerated growth and I think it's just really comes across unit draw. It just continues to be doing incredibly well.

Anastasios G. Konidaris: Unithroid just continues to be doing incredibly well, growing at double-digit rates, number one. Rytary realigned its commercial and field forces last year. We have a new leader in that market and just continues to drive high single-digit prescription growth. And then finally, as you correctly pointed out, Argentis.

Nathan Allen Rich: Growing at double digit rates number one.

Nathan Allen Rich: Right.

Aligned our sales of our commercial our field force is last year, we have a new leader in that market and just continues to drive high single digit prescription growth.

Nathan Allen Rich: And then finally.

Nathan Allen Rich: You correctly pointed out <unk>. So next year. This year in 2024, we have a full year of revenues.

Chirag K. Patel: So, next year, in 2024, we have a full year of revenues that should contribute, you know, between $25 to $30 million of incremental revenue. So, it's really kind of driven across all of those three key branded products. And as you mentioned correctly, we don't have, we have not built the IP, any potential IPX revenues in our guidance. Hopefully, we'll get approval later this year, and we should be in a position to add those in the latter part of the year. Yeah. And Nate, just Chirag, just taking it further, why Argentis has worked out really well for us.

Nathan Allen Rich: That should continue to contribute between $25 million to $30 million of incremental revenue.

Nathan Allen Rich: So it's really kind of driven across all of those three key branded products.

Tasos Konidaris: As you mentioned correctly, we have not built in any potential IPX revenues in our guidance. Hopefully, we'll get approval later on this year, and we should be in a position to add those, in the latter part of the year.

Nathan Allen Rich: And as you as you mentioned correctly.

Nathan Allen Rich: We have not billed VIP any potential IPX revenues in our guidance hopefully we will get approval later on this year and we should be in a position to us those are in the latter part of the year, Yeah Nay discharge just taking it further why.

Chirag Patel: Yeah. Nate, this is Chirag. Just taking it further how ONGENTYS has worked out really well for us. It's a COMT inhibitor. It's complementary with CD/LD. It improves the off time for certain patients. Excellent start of transitioning the product from Neurocrine to us and great partnership with Bial, the Portuguese innovative company. The sales force already relaunched it at AAN last week and very excited to complement ONGENTYS with currently RYTARY and going forward with IPX-203. IPX-203, we're also ready to launch. As you know, that's completely differentiated product than the RYTARY and obviously much better than the IR with the 1.55 hours of good on time per dose, which is significant.

Nathan Allen Rich: <unk> has worked out really well for us.

Chirag K. Patel: It's a comp inhibitor that's complementary to CDLD. It improves the off time for certain patients. So, an excellent start of transitioning the product from Neurocrin to us and a great partnership with BIA, the Portuguese innovative company. And the sales force is already, we launched it at Amnil last week and are very excited to complement Argentis with currently Rytary and going forward with IPX203. IPX203, we're also ready to launch. And as you know, that's a completely differentiated product than the Rytary and obviously much better than the IR with the 1.55 hours of good on time per dose, which is significant. And 95% of Parkinson's patients still take the IR product. Only 5% are on Rytary.

Nathan Allen Rich: <unk> inhibitor it is.

Nathan Allen Rich: Complementary with.

Nathan Allen Rich: CDL Lee.

Nathan Allen Rich: <unk>.

Nathan Allen Rich: Improves off time.

Nathan Allen Rich: For the certain patients so.

Nathan Allen Rich: Excellent start of transitioning the product from Neurocrine to us.

Nathan Allen Rich: And great partnership with BR, the Portuguese innovated innovative company.

Nathan Allen Rich: And.

Nathan Allen Rich: The salesforce already relaunched last.

Nathan Allen Rich: Last week and really excited to complement on genders with currently Rytary and going forward with IPX towards III IPX, two or three we're also ready to launch and as you know that's completely differentiated product then.

Nathan Allen Rich: <unk>, obviously much better than the IR with a 155.

Nathan Allen Rich: Hours of good on time charter.

Nathan Allen Rich: <unk>, which is significant.

Chirag Patel: 95% of Parkinson's patients still take IR product. Only 5% are on RYTARY. We're going on a broad-based strategy to general neurologists. We have target lists. We've been in contacts with payers for a while now, and we're ready to have a successful launch with all the learnings of last 7 years with RYTARY. Our teams are very excited, and we expect the conversion of these IR to IPX-203 and complementing with ONGENTYS to be much higher percentages than RYTARY. Globally also, as my brother mentioned, we have licensed out the products in Europe, in South America, in Canada, soon to be in China, Japan, India. India will be marketing by ourselves.

Nathan Allen Rich: 95% of Parkinson's patients still take II product only 5% of our own directory. So we're going on a broad based strategy too.

Chirag K. Patel: So, we're going on a broad-based strategy to general neurologists. We have target lists. We've been in context with pairs for a while now, and we're ready to have a successful launch with all the learnings of the last seven years with Rytary. Our teams are very excited, and we expect the conversion of these IR to IPX203 and complementing with Argentis to be a much higher percentage than Rytary. And globally, as my brother mentioned, we have licensed out the products in Europe, in South America, in Canada, and soon to be in China, Japan, and India. India will be marketing by itself. So, Parkinson's patients globally should be using the latest and greatest formulations and technology and have a better life every day than use 35, 40 years old technology of IR and go through the ups and downs of daily life. And it helps their caretakers as well.

Nathan Allen Rich: General neurologist target list, we bid in context with <unk>.

Nathan Allen Rich: Payers for a while now and.

Nathan Allen Rich: We are ready to have a successful launch with all the learnings of last seven years with Rytary.

Nathan Allen Rich: Our teams are very excited and we expect the the.

Nathan Allen Rich: The conversion of these IR to IPX, two or three and complementing with Amgen has to be a much higher percentages than rytary.

And globally also as my brother mentioned, we have licensed out the products in Europe.

Nathan Allen Rich: In South America, and Canada soon to be in China, Japan, India, India will be marketing by ourselves. So Parkinson's patients globally should be using latest and greatest formulation and technology.

Chirag Patel: Parkinson's patient globally should be using latest and greatest formulation and technology and have a better life every day than use 35, 40 years old technology of IR, and go through the ups and downs of daily life. It helps their caretakers as well. Very excited on specialty growth. Then it continues in 2025 with DHE auto-injector launch and more to come after that.

Nathan Allen Rich: We have a better life every day, then use $35 40 years old technology of IR.

Nathan Allen Rich: And go through the ups and downs of daily life.

And it helps the caretakers as well so very excited on specialty growth and then it continues in 2025 with BHG auto injector launch and more to come after that.

Nathan Allen Rich: So, very excited about specialty growth. And then it continues in 2025 with the DHE auto-injector launch and more to come after that. Great. And then maybe just a kind of higher-level question, you know, looking at the guidance for this year. Topline came in stronger. I think margins are going to be pretty consistent year over year, maybe down slightly.

Nathan Rich: Great. Then, maybe just a kinda higher level question. You know, looking at the guidance for, you know, this year, you know, top line came in stronger. I think margins are gonna be pretty consistent, year over year, maybe down slightly. I guess I'd just be curious, you know, as we think about, you know, the view kind of 3 to 5 years out, you know, how do you see the margin profile of the business evolving as you bring a lot of these new products to market? You know, once we start to see that, especially on the specialty side, I'd just be curious to get your view on, you know, where you think margins for the business can go longer term. Thank you.

Nathan Allen Rich: Great.

Nathan Allen Rich: And then.

Speaker Change: Maybe just kind of higher level question looking at the guidance for.

Speaker Change: This year topline.

Speaker Change: Top line came in stronger I think margins are going to be pretty consistent.

Speaker Change: Year over year, maybe down slightly I guess I'd just be curious.

Anastasios G. Konidaris: I guess I'd just be curious, you know, as we think about, you know, the view kind of three to five years out, you know, how do you see the margin profile of the business evolving as you bring a lot of these new products to market? And, you know, once we start to see that, especially on the specialty side, I'd just be curious to get your view on where you think margins for the business can go in the longer term. Thank you. You know, I can. I can take that.

Speaker Change: As we think about the view kind of three to five years out how do you see the margin profile of the business evolving as you bring a lot of these new products to market in.

Speaker Change: Once we start to see that especially on the specialty side.

Speaker Change: Just to be curious to get your view.

Where you think margins for the business can go longer term. Thank you.

Tasos Konidaris: Yeah, I can take that. As you said, margins have been pretty consistent, number one, the last few years. What we've been able to do is really focus on incremental revenues, on incremental EBITDA, right? Transition the business to a more complex, more durable, cash generating business. Our focus has been primarily

Speaker Change: Yes, I can take that as you said margins have been pretty consistent.

Anastasios G. Konidaris: As you said, margins have been pretty consistent, number one, for the last few years. So, and what we've been able to do is really focus on incremental revenues, on incremental EBITDA, right? And transition the business to a more complex, more durable, cost-generating business.

Speaker Change: But one of the last the last few years.

So and with <unk>.

Speaker Change: We've been able to do is really focus on incremental revenues and incremental EBITDA right and transition that business to a more complex more durable.

Speaker Change: Cash generating.

Speaker Change: Business. So our focus has been primarily on driving incremental incremental top line bottom line and cash over the course of time, our profitability profile should decrease.

Anastasios G. Konidaris: So, our focus has been primarily on driving incremental top line, bottom line, and cost. Over the course of time, our profitability profile should increase. It will increase for a couple of reasons. Number one is, as our generic portfolio continues to evolve into the world of more complex businesses, right? Those businesses have higher levels of profitability.

Chirag Patel: On driving incremental top line, bottom line, and cash. Over the course of time, our profitability profile should increase. It'll increase for a couple reasons. Number one is as our generic portfolio continues to evolve into the world of more complex businesses, right? Those businesses have higher levels of profitability, number one. The same thing over the last couple of years in 2024. On the specialty side, we continue to build out those infrastructures. Those costs will be behind us. Over the course of time, you know, when you look at the EBITDA profile and the gross margin profile, it will continue to grow over time.

Tasos Konidaris: Over the course of time, our profitability profile should increase. It'll increase for a couple reasons. Number one is as our generic portfolio continues to evolve into the world of more complex businesses, right? Those businesses have higher levels of profitability, number one. The same thing over the last couple of years in 2024. On the specialty side, we continue to build out those infrastructures. Those costs will be behind us. Over the course of time, you know, when you look at the EBITDA profile and the gross margin profile, it will continue to grow over time.

Speaker Change: Increased for a couple of reasons number one is.

Speaker Change: Our generic portfolio continues to evolve into the world of more complex businesses right.

Speaker Change: Those those those those those businesses have higher levels of profitability number one the same thing over the last couple of years in 2024 on the specialty side, we continue to build out those infrastructures those costs will be behind us. So over the course of time when you look at the EBITDA profile of the gross margin.

Chintu Patel: Number one, the same thing over the last couple of years. In 2024, on the specialty side, we continue to rebuild those infrastructures. Those costs will be behind us. So, over the course of time, when you look at the EBITDA profile and the gross margin profile, they should continue to grow over time. And just to add, Nathan, our injectable plants are underutilized as we are launching new products. So in the coming years, both of our new injectable facilities will be totally utilized. Plus, our inhalation plant in Europe, where we do not have a commercial product, we expect to have a launch by the end of the year or early next year. I think that will also improve the margin.

Speaker Change: <unk> profile should continue to grow over time.

Chintu Patel: Just to add, Nathan, our injectable plants are underutilized, and we are launching new products. In coming years, both our new injectable facilities will be totally utilized, plus our inhalation plant in Europe, where we don't have a commercial product. We expect to have a launch by end of the year or early next year. I think that will also improve the margin. I think as Tasos mentioned, you know, many, many complex product and the plant utilization in certain complex area will improve the margins in coming years.

Chirag Patel: Just to add, Nathan, our injectable plants are underutilized, and we are launching new products. In coming years, both our new injectable facilities will be totally utilized, plus our inhalation plant in Europe, where we don't have a commercial product. We expect to have a launch by end of the year or early next year. I think that will also improve the margin. I think as Tasos mentioned, you know, many, many complex product and the plant utilization in certain complex area will improve the margins in coming years.

Speaker Change: And just to add Nathan our injectable clients.

Speaker Change: Utilize as you're launching new products or in coming years.

Speaker Change: Both of our new injectable facilities will be totally utilized fluctuate inhalation plant in Utah.

We don't have a commercial product we expect to have a launch brand of the year. Early next year I think that will also improve the margin. So I think as Tassos mentioned, many many complex product in the plant.

Anastasios G. Konidaris: So I think, as Anastasios mentioned, many, many complex products and plant utilization in certain complex areas will improve margins in the coming years. Yeah, and more specialty revenues as well. Yeah. Great. That's helpful. Thanks very much. We now turn to David Amsellem with Piper Sandler.

Speaker Change: Vision in certain complex area will improve their margins in coming years, yeah, and more specialty revenues as well.

Chirag Patel: Yeah, more specialty revenues as well.

Tasos Konidaris: Yeah, more specialty revenues as well.

Chintu Patel: Yeah.

Chirag Patel: Yeah.

Nathan Rich: Great. That's helpful. Thanks very much.

Speaker Change: Great. That's helpful. Thanks very much.

Operator: We now turn to David Amsellem with Piper Sandler. Your line is open. Please go ahead.

Speaker Change: We now turn to David <unk> with Piper Sandler. Your line is open. Please go ahead.

David A. Amsellem: Your line is open, please go ahead. Hey, thanks. Good morning.

David Amsellem: Hey, thanks. Good morning. So couple of questions. First on IPX-203, can you just talk about the payer landscape, and how that is going to evolve, bearing in mind that we'll see generics for RYTARY. So just talk about what you think are going to be the challenges here regarding access. That's number one. Then secondly, on injectables, can you just talk about how much contribution from shortage products you're gonna be getting, not just this year, but longer term, and how big of a priority is it to focus on the range of different shortage products that we're seeing, and what is the priority vis-à-vis more complex injectable products that you're developing. So if you could talk to that would be helpful. Thank you.

David: Hey, Thanks, good morning.

Chirag K. Patel: So, a couple of questions. First, on 203, can you just talk about the payer landscape and how that is going to evolve, bearing in mind that we'll see generics for Ritari? So, just talk about what you think are going to be the challenges here regarding access. That's number one.

David: Couple of questions first on two or three can you just talk about the payer landscape.

David: And how.

David: That is going to evolve bearing in mind that.

David: We'll see generics for Rytary.

David: Just talk about what you think are going to be the challenges.

David: Here regarding access.

David: That's number one and then secondly.

Harsher Singh: Then, secondly, on injectables, can you just talk about how much contribution from shortage products you're going to be getting, not just this year but longer term? And how big of a priority is it to focus on the range of different shortage products that we're seeing? And what is the priority vis-a-vis more complex injectable products that you're developing? So, if you could talk about that, that would be helpful.

David: On Injectables can you just talk about how much contribution.

From shortage products youre going to be getting not just this year, but longer term and how big of a priority is it to focus on the.

David: The range of different shortage products.

David: That we're seeing.

David: And what is the priority.

David: <unk>.

David: More complex injectable products that youre developing.

Speaker Change: You could talk to that that would be helpful. Thank you.

Chirag K. Patel: Thank you. Thank you, David. I'll take the first one and hand it off to Harsher, who is head of our Institutional Business and Biosimilar Business, to answer the injectable product question. So IPH203 coverage, the initial discussions, which go back to last year, have been very positive. Our entire strategy on pricing, keeping access in mind because we want to reach more, Neurologist, more patients. It has been extremely positive. I do not know if you know, but RITERI has the best pair coverage among the class.

Chirag Patel: Thank you, David. I'll take the first one and hand it off to Harsha Singh, who is head of our institutional business and biosimilar business to answer the injectable product question. IPX-203 coverage, the initial discussions, which is going back to last year, has been very positive. Our entire strategy on pricing with keeping the access in mind, 'cause we want to reach more neurologists, more patients, it has been extremely positive. I do not know if you know, but RYTARY has the best payer coverage among the class. It's 80% covered, which we expect the similar coverage for IPX-203. We're very positive on the coverage, which we're under initial discussions, and it should be coming online upon approval as well as few months after that.

Speaker Change: Thank you David I'll take the first one and.

Speaker Change: I'll hand, it off to her share who is head of what an institutional business and Biosimilar business trends. So the injectable product question, so likely X two or three coverage. The initial discussions which is going back to last year has been very positive.

Her Share: Our entire strategy on pricing with keeping the excess in mind, because we want to reach more neuro.

Speaker Change: <unk> largest more patients.

Speaker Change: Has been extremely positive I do not know if you know, but right now he has the best payer coverage among the.

Chintu Patel: It's 80% covered, which we expect to have similar coverage for IPX203. So we're very positive about the coverage, which is under initial discussions, and we should be, it should be coming online upon approval as well as a few months after. Just to add on IPX, that RITERI only covers 5% of the patient, and IPX is a very unique formulation that will have a broader reach, so I think when the generics of RITERI come, we don't believe that we'll have much of a bearing on IPX adaptation because it's a very unique, much more stable formulation in the way that it provides long-term blood concentration, good on time, 1.55

Speaker Change: Glass, it's 80% is covered.

Share: We expect the similar coverage for IPX two or three.

Share: So we're very positive on the coverage, which we're in.

Share: Initial discussions and we should be it should be coming online upon approval as well as a few months after that.

Chintu Patel: Just to add on, IPX-203, that RYTARY only covers 5% of the patient, and IPX-203 is a very unique formulation which will have a broader reach. I think when the generics of RYTARY comes, we don't believe that will have much of a bearing on IPX-203 adoption because it's very unique, much more stable formulation in a way that it provides long-term blood concentration, good on time, 1.55 hours. I think it's distinctly different product than RYTARY. We are very excited on the offering for the Parkinson's patient. We'll continue to conduct further studies. As soon as approval comes, we're conducting more studies on IPX-203. I'll pass it on to injectables, and then David, if you have any follow-up, we'll...

Speaker Change: Just to add on.

Speaker Change: IPX.

Speaker Change: Right any only covers 5% of the patient and <unk> is a very unique formulation, which will have a broader reach so I think we are in the generics of dietary comes.

Speaker Change: We don't believe that we will have much of a batting on IPX adoption, because it's rather unique much more.

Speaker Change: Table formulation of <unk> long term blood concentration good on tiny 155 hours. So I think is distinctly different product and rightly. So we are very excited on the offloading for the Parkinson's patient.

Chintu Patel: So I think it's a distinctly different product than Riteri, and we are very excited about the offering for the Parkinson's patient. And we'll continue to conduct further studies. So as soon as approval comes, we're conducting more studies on IPX2. I'll pass it on to injectables, and then David, if you have any follow-up, we'll... or David with regard to injectables. This is Harsher. Look, it's hard to give you an actual number that breaks down.

Speaker Change: And we'll continue to do.

Speaker Change: Conduct further studies as soon as approval comes we are conducting more studies on IPX jewelry.

Speaker Change: I'll pass it onto Injectables and then David if you have any follow up.

Harsha Singh: David, with regard to injectables, this is Harsha. Look, it's hard to give you an actual number that breaks up steady products versus shortage products. What I will say is the strategy here is to support the market in areas where the market fails in order to build franchises that are sustainable. You can see in our history there is a product readily available called methylprednisolone acetate, where we effectively did that, where we went from about 2% share to a 50% share and then retained that share even after other competitors returned to market by creating a franchise. I think that's what we look to do with our diversified manufacturing base that allows us to rapidly scale up and support markets where there are structural failures.

Harsher Singh: David, with regard to injectables, this is Harsha. Look, it's hard to give you an actual number that breaks up steady products versus shortage products. What I will say is the strategy here is to support the market in areas where the market fails in order to build franchises that are sustainable. You can see in our history there is a product readily available called methylprednisolone acetate, where we effectively did that, where we went from about 2% share to a 50% share and then retained that share even after other competitors returned to market by creating a franchise. I think that's what we look to do with our diversified manufacturing base that allows us to rapidly scale up and support markets where there are structural failures.

Speaker Change: David with regard to Injectables. This is for sure.

Speaker Change: Look it's hard to give you an actual number that breaks up.

Speaker Change: Steady products versus shortage products.

Harsher Singh: What I will say is the strategy here is to support the market in areas where the market fails in order to build franchises that are sustainable. You can see in our history, there is a product readily available called methylprednisone acetate where we effectively did that, where we went from about a 2% share to a 50% share, and then retained that share even after other competitors returned to the market by creating a franchise. And I think that's what we look to do with our diversified manufacturing base that allows us to rapidly scale up and support markets where there are structural failures. We expect to see more of those failures in the coming months, and I think the market is ripe for solutions like those that we provide.

David: We'll see is the strategy here is to support the market in areas, where the market fields in order to build franchises that are sustainable.

David: And you can see in our history as a product readily available called metal prednisolone acetate, where we effectively did that where we went from one 2% share to 50% yet and then retain that share even after other competitors return to market by creating a franchise and I think that's what we'll look to do with our diversified manufacturing base that allows us to wrap.

David: <unk> scale up and support markets, where there are structural failures, we expect to see more of those failures in the coming months.

Harsha Singh: We expect to see more of those failures in the coming months, and I think the market is ripe for solutions like those that we provide. Our capacity has been tripled from 20 million to 60 million units per year. That allows us to address more shortages. What we are building out is especially addressing oncology shortages and how we can be helpful for the clinics and the hospitals to bring more of those products and consistently provide them.

Harsher Singh: We expect to see more of those failures in the coming months, and I think the market is ripe for solutions like those that we provide.

David: I think the market is ripe for solutions like those that we provide and our capacity has been triple from 20 million to 60 million units per year. So that allows us to address more shortages and.

Chirag Patel: Our capacity has been tripled from 20 million to 60 million units per year. That allows us to address more shortages. What we are building out is especially addressing oncology shortages and how we can be helpful for the clinics and the hospitals to bring more of those products and consistently provide them.

Harsher Singh: And our capacity has been tripled from 20 million to 60 million units per year. So that allows us to address more shortages, and what we are building out is especially addressing oncology shortages, and how can we be helpful for the clinics and the hospitals to bring more of those products and consistently provide them. Based on a priority in development, our priority is always the complex injectable product.

David: <unk>.

David: We are building out as especially addressing oncology shortages and how can we be helpful for the clinics the hospitals to bring more and more of those products and consistently provide them.

Chintu Patel: Based on a priority in development, our priority is always the complex injectable product.

Chintu Patel: Based on a priority in development, our priority is always the complex injectable product. We are continuing to focus on complex because those are much more higher barriers to entry. We do have shortage products, and with expanded capacity, we can cater to the market, and provide those products.

David on a priority and development of our priority is always the complex injectable product. So we are continuing to focus on complex because those are much more higher barriers to entry, but we do have shortage products, even with expanded capacity, we can cater to the market.

Harsha Singh: We are continuing to focus on complex because those are much more higher barriers to entry. We do have shortage products, and with expanded capacity, we can cater to the market, and provide those products.

Harsher Singh: So we are continuing to focus on complex because those are much higher barriers to entry. But we do have shortage products, and with expanded capacity, we can cater to the market and provide those products. Okay, that's very helpful, Culler. Just a quick follow up. I'm sorry if I missed this. Are you right sized on injectable capacity?

David: And provide those products.

David Amsellem: Okay. That's very helpful, Caller. Just a quick follow-up. I'm sorry if I missed this. Are you right-sized on injectable capacity, or are you planning more capacity expansion?

Speaker Change: Okay. That's very helpful color just a quick follow up.

Speaker Change: And I'm sorry, if I missed this are you right sized on injectable capacity or are you planning mark.

David A. Amsellem: Are you planning more capacity expansion? Right now, we have what we need. Okay, helpful.

Speaker Change: Capacity expansion.

Chirag Patel: Right now we have what we need.

Speaker Change: Right now we have.

Speaker Change: What we need.

Speaker Change: Yes.

David Amsellem: Okay. Helpful. Thank you.

Speaker Change: Okay helpful. Thank.

Balaji V. Prasad: Thank you. We now turn to Balaji Prasad with Barclays. Your line is open, please go ahead.

Speaker Change: Thank you.

Operator: We now turn to Balaji Prasad with Barclays. Your line is open. Please go ahead.

Balaji V. Prasad: We now turn to collateral Prasad with Barclays. Your line is open. Please go ahead.

Balaji Prasad: Good morning, everyone, and congratulations on the performance and also the strong guidance that you have provided. Starting on the guidance, on the key launches that you're expecting for 2024, at least some of the ones immediately look like they're set to contribute $100 to 130 million. I want to see if there are any gating factors like inspections that are to be concluded for any of these launches, and or not. Kind of trying to adjust the risk levels for these launches. Maybe secondly on the launch timeframe for both donanemab, naloxone, I heard that you have launched recently. Can you also comment on the pushes and pulls towards the market share and the total number of units that are potentially there in this market? Thank you. That's one.

Chintu Patel: Good morning everyone, and congratulations on the performance and also the strong guidance that you have provided. So, starting with the guidance. On the key launches that you're expecting for 2024, at least some of the ones that immediately look like they're set to contribute $100 to $130 million, I want to see if there are any gating factors like inspections that are to be concluded for any of these launches or not. So, kind of trying to adjust the risk levels for these launches. And maybe, secondly, on the launch timeframe for both DenizMab and Naloxone. I heard that you have launched recently. Can you also comment on the pushes and pulls towards market share and the total number of units that are potentially there in this market? Thank you. That's one.

Balaji V. Prasad: Good morning, everyone and congratulations on the performance and also the strong guidance that you've provided.

Balaji V. Prasad: Starting on the guidance.

Prasad: On the key launches that you are expecting for 2020 for at least some other ones immediately looked like they're set to contribute $100 million to $130 million I wanted to see if there are any gating factors like inspections that I hate to be concluded for any of these launches.

Speaker Change: And are not so.

Speaker Change: Just the risk levels for these launches and maybe secondly on the launch timeframe for bone Denosumab Naloxone <unk> launch recently can also comment on the pushes and pulls towards the market share in the total number of units that are potentially data in this market.

Balaji Prasad: 2, on guidance, again, 2024 strong EBITDA guidance. Extension of the previous question, how would these new launches impact the guidance in either direction? Or is this current guidance based mostly on products that you launched in 2023 and would gain traction in 2024? Thanks.

Speaker Change: Thank you and this one to one guidance again 2020 for strong EBITDA guidance.

Chintu Patel: Two on guidance, again, 2024, strong EBITDA guidance. Extension on the previous question, how would these new launches impact the guidance in either direction? Or is this current guidance based mostly on products that you launched in 2023 and would gain traction in 2024? Thank you. Yeah, Balaji. This is Chintu, so I'll answer the first one.

Speaker Change: Extension of the previous question, how would these new launches impact guidance in either direction.

Speaker Change: Is this kind of guidance based mostly on products that you launched in 'twenty, three and we will gain traction in 'twenty four.

Chintu Patel: Yeah. Yeah. Balaji, this is Chintu. I'll answer the first one. You know, Amneal has a standard quality track records, over 100 inspections, over the last 20 years. All of our plants are FDA approved, including our inhalation. For all the launches that we are expecting in 2024, we don't anticipate any PAI as of now because we had recent inspections of all the plant, like our naloxone facility, our injectable plant. I don't think there is any gating factor that's going to prevent the approval of those products in 2024. On donanemab, our launch is 2025, 2026. Guidance, the key launches, so we launched 39 products. About 20-plus was launched in the Q4 2024.

Speaker Change: Yes, but I didn't think so.

Speaker Change: Answer the first one.

Chintu Patel: You know, Amneal has a better quality track record, over 100 inspections over the last 20 years, and all of our plants are FDA approved, including our inhalation. So for all the launches that we are expecting in 2024, we don't anticipate any PAI as of now, because we have had recent inspections of all the plants, like our Naloxone facility, and our injectable plant. So I don't think there is any gating factor that's going to prevent the approval of those products in 2024. For Nazumab, our launch is 2025-2026. Yeah, so guidance, the key launches, we launched 39 products, so about 20-plus were launched in the fourth quarter, 24. So those get annualized, so revenues already that are approved will feel good.

Speaker Change: <unk> has a static quality track records over 100 inspections over the last 20 years and all of our plants are FDA approved including road installation. So for all the launches that we're expecting in 2024.

Speaker Change: We don't anticipate any as of now because we had recent inspections of all different leg of our naloxone facility or injectable plant. So I don't think there is.

Speaker Change: Any gating factor thats going to.

Speaker Change: Peering.

Speaker Change: Approval of those products in 'twenty four.

Speaker Change: On the <unk> launches 'twenty five 'twenty six.

Chirag Patel: Guidance, the key launches, so we launched 39 products. About 20-plus was launched in the Q4 2024. Those get annualized. Revenue is already there approved. We feel good. Naloxone is the new, FML, we just launched in January. Naloxone is coming soon with a potential of quite a bit this year and a lot more in 2024, I mean, 2025, 2026. Plus we expect a couple of big GX launches as well, which we haven't disclosed, which is coming up in May, June timeframe, July timeframe. Very excited on the complex product launches, obviously the naloxone, annualizing the last year launches, which includes injectable launches. Several injectable launches will be annualized as well. That is how the launches shape up, and we feel very comfortable with push and pulls. Since having multiple launches, that should not be any problem.

Speaker Change: Sure.

Speaker Change: Guidance the key launches.

Speaker Change: We launched 39 products are about 20 plus was launched in.

Speaker Change: In the fourth quarter 2000, <unk> also those get annualized so revenues already approved.

Chirag Patel: Those get annualized. Revenue is already there approved. We feel good. Naloxone is the new, FML, we just launched in January. Naloxone is coming soon with a potential of quite a bit this year and a lot more in 2024, I mean, 2025, 2026. Plus we expect a couple of big GX launches as well, which we haven't disclosed, which is coming up in May, June timeframe, July timeframe. Very excited on the complex product launches, obviously the naloxone, annualizing the last year launches, which includes injectable launches. Several injectable launches will be annualized as well. That is how the launches shape up, and we feel very comfortable with push and pulls. Since having multiple launches, that should not be any problem.

We feel good.

Chintu Patel: Naloxone is the new FML was just launched in January. Naloxone is coming soon with the potential to do quite a bit this year and a lot more in 24 – I mean, 25-26. Plus, we expect a couple of big GX launches as well, which we haven't disclosed, which are coming up in May, June timeframe, and July timeframe. So very excited about the complex product launches, the – obviously, the Naloxone, annualizing the last year's launches, which includes injectable launches, so several injectable launches would be annualized as well. So that is how the launches shape up, and we feel very comfortable with push and pull.

Speaker Change: <unk> is the new FML was we just launched in January the Lockdown is coming soon with a potential of.

Speaker Change: For quite a bit this year and a lot more in 'twenty four.

Speaker Change: $25 26.

Plus we expect a couple of big Gx launches as well, which we haven't disclosed which is coming up in.

Speaker Change: May June July timeframe, so really excited on the complex product launches.

Speaker Change: Obviously, the naloxone annualize in the last year launches, which includes injectable launches so several injectable launches would be.

Speaker Change: Would be annualized as well so that is how.

Speaker Change: The launches shape up.

Speaker Change: And we feel very comfortable pushing tools.

Chintu Patel: And since we have multiple launches, that should not be any problem. Thank you for your time. It was a pleasure.

Speaker Change: And since having multiple launches that should not be any problem.

Balaji Prasad: Tasos, on the guidance?

Speaker Change: Yes, it was on the guidance.

Tasos Konidaris: Oh, I figured that was. You guys did a pretty good job addressing it. There is nothing inherently risky in our guidance this year than last year, Balaji. In prior years, our EBITDA tended to be more back-end loaded, which, you know, typically investors don't love. Our guidance this year is more evenly split throughout the year, so we're not planning any huge ramp-ups towards the back end of the year. You know, there are just different levels, different products, and it's not just the revenue we're accounting at. It's also the operating expenses. You know, we continue to drive a number of operating expense efficiencies here. If something were to happen on any product, which always happens by the way, right?

Chirag K. Patel: Oh, I figured that was, you guys did a pretty good job addressing it. There is nothing inherently risky here in our guidance this year than last year, Balaji. So, in prior years, Arabia tended to be more back-end loaded, which typically investors don't love.

Speaker Change: I figure that was.

The guys did a pretty good job of addressing it there is nothing inherently risk in our guidance this year than last year.

Speaker Change: So.

Speaker Change: In prior years, our EBITDA tended to be more backend loaded, which typically investors don't love.

Anastasios G. Konidaris: Our guidance this year is more evenly split throughout the year, so we're not planning any huge ramp-ups towards the back-end of the year. And there are just different levels, different products. And it's not just the revenue we're accounting for. It's also operating expenses.

Speaker Change: Our guidance this year is more evenly split throughout throughout the year. So we're not planning any huge ramp ups towards the backend of the year.

Speaker Change: And theyre just different different levels different products and it's not just a revenue accounting out. It's also the operating expenses. So we continue to drive a number of operating expense efficiencies year. So if something were to happen on any product, which always happens by the way right.

Anastasios G. Konidaris: So we continue to drive a number of operating expense efficiencies here. So if something were to happen on any product, which always happens, by the way, something were to happen on the revenue side, we're just looking to pull other levers in the operating expense side to protect the bottom line. So hopefully, this kind of gives you enough insight. Yeah, Balaji, we feel much better this year than we felt at the same time last year.

Chirag Patel: If something were to happen on the revenue side, we're just looking to pull other levers in the operating expense side to protect the bottom line. Hopefully this kind of gives you enough insight. Yeah, Balaji. We feel much better this year than we felt same time last year.

Tasos Konidaris: If something were to happen on the revenue side, we're just looking to pull other levers in the operating expense side to protect the bottom line. Hopefully this kind of gives you enough insight.

Speaker Change: Something would happen on the revenue side, we're just looking to pull out.

Speaker Change: Leveraging the operating expense side to protect the bottom line. So hopefully this gives you enough insight, yes, but I think we feel much better this year than we felt same time last year.

Chirag Patel: Yeah, Balaji. We feel much better this year than we felt same time last year.

Balaji Prasad: Great. Thank you. Maybe a quick follow-up. Chintu, in your comments, you spoke about the US generic industry having turned a corner after years of price erosion. It's a call we've been making and good to see that being validated across the board. I want to understand if there's going to be additional competitive maneuvers from the buy side or is there an equilibrium that is being reached now between the manufacturers and the buy side? Thanks.

Balaji V. Prasad: Great. Thank you. Maybe a quick follow-up. Chirag, in your comments, you spoke about the U.S. generic industry having turned a corner after years of price erosion. It's a call we've been making, and it's good to see that being validated across the board. I want to understand if there are going to be additional competitive maneuvers from the buy side, or is there an equilibrium that is being reached now between the manufacturers and the buy side? Thanks.

Speaker Change: Great. Thank you maybe a quick follow challenge in your comments.

Speaker Change: The bulk of all of the U S generic industry, having turned the corner after years of price erosion.

Let's call, we've been making and good to see that being validated across the board.

Speaker Change: I wanted to kind of there's going to be additional competitive menu work from the buy side or is that equilibrium that has been reached now between the manufacturers and the buy side. Thanks.

Chirag Patel: Balaji, it's still work in progress. We are seeing good signs and most importantly it is causing shortages and it could cause further shortages. FDA is really worried. As you can see, Congress constantly putting out hearings and White House meetings, which our team attends as well. This is a real problem. It has to get better. Six years of massive price erosion, nobody can invest in quality. Nobody can invest in a proper infrastructure, new machinery. All these constant dialogues and us being a leading company, obviously we are forefront of those dialogues with our esteemed partners. It's been a good change. We're in more of a long-term stability programs with one of our largest buyers. Another big retailer is moving in the same direction.

Chirag K. Patel: Balaji, it's still a work in progress, we are seeing good signs, and most importantly, it is causing shortages, and it could cause further shortages. So FDA is really worried. As you can see, Congress is constantly putting out hearings and White House meetings, which our team attends as well. This is a real problem.

Speaker Change: Apology it still work in progress.

Speaker Change: We are seeing good signs and most importantly, it is.

Speaker Change: It is causing shortages and it could cause further shortages the FDA is really worried.

Speaker Change: As you can see the Congress constantly.

Speaker Change: Putting out hearings and.

Speaker Change: White House.

Speaker Change: Meetings, which.

Speaker Change: Or deem it turns as well.

Speaker Change: This is a real problem.

Chirag K. Patel: It has to get better. Six years of massive price erosion; nobody can invest in quality. Nobody can invest in proper infrastructure, new machines.

Speaker Change: It has to get better six years of massive price erosion.

Speaker Change: Nobody can can invest in quality nobody can invest in the proper infrastructure new machineries. So all these.

Chirag K. Patel: So all these were constant dialogues, and us being a leading company, obviously, we're at the forefront of those dialogues with our esteemed partners. And it's been a good change. We're in a more long-term stability programs with one of our largest buyers; another big retailer is moving in the same direction. So we're very hopeful about what we are seeing because it is just not right to have prices from manufacturers that are pennies or below pennies. It just does, nobody can even supply it, nobody can even invest in it, and it will cause quality issues and shortages. And I'm afraid that if the consumer starts knowing that the pill they're taking is being made or sold for one penny. It may have a very negative placebo effect.

Speaker Change: Constant dialogues and us being a leading company of Brazil forefront of those dialogues with our <unk> partners.

Speaker Change: It's been a good change were more on a long term stability programs with over one of our largest buyers on other big retailers moving in the same direction. So we're very hopeful forward. We are seeing because it is just not right to have prices from manufacturer.

Chirag Patel: We're very hopeful for what we are seeing because it is just not right to have prices from manufacturers which are pennies or below pennies. Nobody can even supply, nobody can even invest, and it will cause quality issues and shortages. I'm afraid that if consumer starts knowing that the pill they're taking is being made or sold for one penny, it may have a very negative placebo impact.

Speaker Change: Which are pennies or below pennies.

Speaker Change: Does.

Speaker Change: Nobody can even supply nobody can even invest and it will cause quality issues and shortages.

Speaker Change: Im afraid that if consumer starts knowing that the pill, they're taking is been made or sold for one penny.

Speaker Change: It may have a very negative placebo impact.

Balaji Prasad: Thanks, Chirag.

Balaji V. Prasad: Thank you, Chirag. We now turn to Chris Scott with J.P. Morgan. Your line is open, please go ahead. Great. Thanks so much. Just a couple here.

Speaker Change: Thanks Tara.

Operator: We now turn to Chris Schott with JPMorgan. Your line is open. Please go ahead.

Speaker Change: You May now turn to Chris Scott with Jpmorgan. Your line is open. Please go ahead.

Chris Schott: Great. Thanks so much. Just a couple here. I guess first on the generic Avastin dynamics. Just elaborate a little bit more in terms of what you think's allowed Amneal to take share and succeed in this market the way you have. And just any learnings, I guess, from these first three launches that's informing, I guess, the type of assets that you're considering and how aggressively you know you're kind of looking at the biosimilar market as a whole. And then my second question was just to follow up on IPX-203. I know you're not including sales in the guidance this year for conservatism, but it does sound like you expect coverage to come on board fairly quickly post-approval.

Christopher Thomas Schott: Great. Thanks, so much just a couple here I guess first on the generic Avastin dynamics, just elaborate a little bit more.

Christopher Thomas Schott: I guess first on the generic Avastin dynamics, just elaborate a little bit more in terms of what you think has allowed Amneal to take share and succeed in this market the way you have, and just any learnings, I guess, from these first three launches that's informing the type of assets that you're considering and how aggressively you're kind of looking at the biosimilar market as a whole. And then my second question was just to follow up on IPX203. I know you're not including sales in the guidance this year for conservatism, but it does sound like you expect coverage to come on board fairly quickly post-approval. So my question is, do you expect pair dynamics to be a limiting factor at all early in launch, or is this a product that we should expect could roll up and ramp pretty quickly post-approval? Thanks so much. Great So, uh... Chris, how are you?

Christopher Thomas Schott: Terms of what you think is allowed and Neil.

Take share and succeed in this market the way you have.

Christopher Thomas Schott: And just any learnings from these first three launches that's informing I guess the <unk>.

Christopher Thomas Schott: The assets that you're considering and how aggressively you're kind of looking at the biosimilar market as a whole.

Speaker Change: And then my second question, just a follow up on apex, two or three I know youre not including sales.

Speaker Change: The guidance this year for conservatism, but it sounds like you expect coverage to come onboard fairly quickly post approval.

Chris Schott: I guess my question is, do you expect payer dynamics will be a limiting factor at all early in the launch? Or is this a product that we should expect could roll up and ramp pretty quickly post-approval? Thanks so much.

Speaker Change: I guess my question is do you expect payer dynamics will be a limiting factor at all early in the launch or is this a product that we should expect could could roll up and ramp pretty quickly post approval. Thanks. So much.

Chirag Patel: Great. Chris, how are you? Let me turn over to Harsha first for Avastin and how we are building the Onco franchise, and then I'll take on the overall biosimilar markets as well as IPX-203.

Speaker Change: Great. So.

Speaker Change: Sure.

Speaker Change: Chris.

Speaker Change: Are you <unk>.

Harsher Singh: Let me turn over to Harsher first on Avastin and how we are building the Onco franchise, and then I'll take on the overall biosimilar markets as well as IPX. Thank you for your question. As we look at Fabastian and our oncology slash biosimilar franchise as a whole, what we recognize is that the marketplace is challenged by pricing dynamics that are not consistent with their expectations. And what we were able to deliver was a solution that effectively met the needs of the market in a marketplace that had become challenging for some of those, particularly providers but also payers. And by learning a little bit from the dynamics that we've seen in the past and putting forward a solution that we felt addressed those, we were able to create what is a fairly stable pricing dynamic and fairly stable uplift that looks like it improves Q over Q.

Christopher Thomas Schott: Me turn it over to her share for us for the Avastin and <unk>.

Speaker Change: How we are building the Hong Kong franchise, and then I'll take on the overall biosimilar markets as well as IPX.

Harsha Singh: Chris, thank you for your question. As we look at Avastin and our oncology slash biosimilar franchise as a whole, what we recognize is that the marketplace is challenged by pricing dynamics that are not consistent with their expectations. What we were able to deliver was a solution that effectively met the needs of the market in a marketplace that had become challenging for some of those, particularly providers, but also payers. By learning a little bit from the dynamics that we'd seen in the past and putting forward a solution that we felt addressed those, we were able to create what is a fairly stable pricing dynamic and fairly stable uplift that looks like it improves Q over Q.

Harsher Singh: Chris, thank you for your question. As we look at Avastin and our oncology slash biosimilar franchise as a whole, what we recognize is that the marketplace is challenged by pricing dynamics that are not consistent with their expectations. What we were able to deliver was a solution that effectively met the needs of the market in a marketplace that had become challenging for some of those, particularly providers, but also payers. By learning a little bit from the dynamics that we'd seen in the past and putting forward a solution that we felt addressed those, we were able to create what is a fairly stable pricing dynamic and fairly stable uplift that looks like it improves Q over Q.

Christopher Thomas Schott: Thank you for your question.

Speaker Change: As we look at Avastin in oncology Slash Biosimilar franchise as a whole what we recognize is that the marketplace is challenged by.

Speaker Change: What by pricing dynamics that are not consistent with the expectations.

Speaker Change: Expectations, and what we were able to deliver a solution that effectively met the needs of the market in a marketplace that that had become challenging for some.

Speaker Change: Im, particularly providers, but also builds.

Speaker Change: And by learning a little bit from the from.

Speaker Change: From the dynamics that we've seen in the past and putting forward a solution that we felt address those.

Speaker Change: We were able to create what is a fairly stable pricing dynamic.

Speaker Change: Fairly stable uplift that looks like it improved Q over Q.

Harsha Singh: We think that is a repeatable business model, and we think that is a business model where our relationships and our longevity and our ability to do it time and again is going to differentiate us, which is why we continue to look at oncology, and you'll see us launching products like PEMRYDI, which we expect to launch next quarter.

Harsher Singh: We think that is a repeatable business model, and we think that is a business model where our relationships and our longevity and our ability to do it time and again is going to differentiate us, which is why we continue to look at oncology, and you'll see us launching products like PEMRYDI, which we expect to launch next quarter.

Harsher Singh: We think that that is a repeatable business model, and we think that is a business model where our relationships and our longevity and our ability to do it time and again is going to differentiate us, which is why we continue to look at oncology, and you'll see us launching products like PEM Ready, which we expect to launch next quarter. Thank you, Harsher.

Speaker Change: We think that that would be repeatable business model and we think that is a business model, where our relationships and our longevity and our ability to do it time and again youre going to differentiate us.

Speaker Change: Which is why we continue to look at oncology and Youll see us.

Speaker Change: Launching products like been ready, which we expect to launch next quarter.

Chirag Patel: Thank you, Harsha. Overall, biosimilar market is going to be large over next several years, and it becomes more healthier and healthier as new launches come in. It is going to be competitive, so you have to be mindful on the investments, and you have to select which products you want to enter in. Our strategy has been more buy and build or combination of buy and build and PBM-driven, and we'll continue to invest in those assets. Currently, we are only front-end commercial for United States. Over time, we can integrate potentially or partner more strategically. All those avenues are open for us, but we are committed to biosimilar business. We believe it will be a size of global size of about $80 to 100 billion by 2031, 2032 for the manufacturers.

Chirag K. Patel: And the overall biosimilar market is going to be Lodge over the next several years, and it will become healthier and healthier as new launches come in. It is going to be competitive, so you have to be mindful of the investment, and you have to select which product you want to enter. Our strategy has been more buy and build or a combination of buy and build and PBM driven, and we will continue to invest in those assets. Currently, we are only front-end commercial for the United States.

Speaker Change: Thank you our share in overall biosimilar market is going to be.

Speaker Change: Large over next several years and they.

Speaker Change: It becomes more healthier and healthier as new launches come in.

Is going to be competitive so you have to be mindful on the investment.

Speaker Change: You have to select which products you wanted to enter in our strategy has been more buy and bill or combination of buy and bill and ppm, driven and we will continue to invest in those assets.

Speaker Change: Currently we are only front end commercial for the United States.

Chirag K. Patel: As we grow over time, we can integrate potentially or partner more strategically. So, all those avenues are open for us, but we are committed to buying a similar business. We believe it will be a global size of about 80 to 100 billion by 2031-32 for the manufacturers.

Speaker Change: Over time, we can integrate well.

Speaker Change: Surely all partner more strategically so all of those avenues are open for us, but we are committed to biosimilar business. We believe it will be a size of global size of about $80 billion to $100 billion by 2031 32 for the manufacturers.

Chirag Patel: That is a fantastic market for a company like us who is completely focused on affordable medicines as we lead the retail segments, pretty soon to be leading injectable segments. Now here comes the biosimilar segments, and we intend to lead, especially in the United States. IPX-203, that's good news. We expect the coverage to be right away as well as the uptake to be right away because of our experience with RYTARY, the relationship with KOLs, relationship with foundations, the patients, the patients' caretakers, have started building relationship with 700 neurologists, which we never reached out before, for the purpose of IPX-203. Having a great market access team, MSL teams, the sales team which have relationship over the last 7 to 8 years, we're very excited. It's a strong uptake and shouldn't take.

Chirag K. Patel: So that is a fantastic market for a company like us who is completely focused on affordable medicines as we lead the retail segment, and pretty soon, we will be leading the injectable segments. And now there are the biosimilar segments, and we intend to lead, especially in the United States.

Speaker Change: So that is.

Speaker Change: Testing market for a company like US who has come.

Speaker Change: <unk> focused on affordable medicines as we lead the retail segments its pretty soon to be leading injectable segment and now here comes the biosimilar segments, and we intend to lead.

Speaker Change: And especially in the United States.

Chirag K. Patel: IPX203, that's good news. We expect the coverage to be right away as well as the uptake to be right away because of our experience with RITERI, the relationship with KOLs, the relationship with foundations, the patients, and the patients' caretakers have started building relationships with 700 neurologists which we never reached out to before in the purpose of IPX203, having a great market access team, MSL teams, the cells team, which have been working together for the last seven to It's a strong uptake and shouldn't take; it's not a new molecule that should take a longer time going to the peak cells. I'm so excited about IPX203.

Speaker Change: <unk> three <unk>.

Speaker Change: The good news, we expect coverage to be right away as well as the uptake to be <unk> because of our experience with rytary the relationship with Kols relationship with foundations the patients the patients caretakers.

Speaker Change: Started billing relationship with 700, neurologists, which we never reached out before.

Speaker Change: It was up <unk>, three having a great market access team.

Speaker Change: MSL teams the sales team, which have relationship over.

Speaker Change: The last seven to eight years, we are really excited it's a strong uptake and it shouldnt take.

Chirag Patel: It's not a new molecule that should take a longer time for going to the peak sales, so excited about IPX-203. Thank you.

Speaker Change: It's not a new molecule that should take a longer time quarter for going to the peak sales. So excited about extraordinary thank you.

Leszek Sulewski: Thank you. Our final question comes from Les Sulewski with Truist Securities. Your line is open, please go ahead. Good morning. Thank you for taking my questions. I have two.

Chris Schott: Thank you.

Speaker Change: Thank you.

Operator: Our final question comes from Leszek Sulewski with Truist Securities. Your line is open. Please go ahead.

Speaker Change: Our final question comes from Les Sulewski with <unk> Securities. Your line is open. Please go ahead.

Leszek Sulewski: Good morning. Thank you for taking my questions. I have two. Just a quick follow-up on the ONGENTYS. So taking the early performance trends of ONGENTYS into consideration, do you envision treating this product as an essential product relaunch? And how do you think the peak sales potential is for the product now that it's on your platform? And then second, you highlighted the focus on neurology and endocrinology to grow your branded portfolio. What opportunities do you see out there within these two therapeutic areas and potentially outside to add to your specialty segment? And also, I guess, high level, how are you thinking about other chunkier BD plans? Thank you.

Les Sulewski: Good morning. Thank you for taking my questions. I have two. Just a quick follow-up on the ONGENTYS. So taking the early performance trends of ONGENTYS into consideration, do you envision treating this product as an essential product relaunch? And how do you think the peak sales potential is for the product now that it's on your platform? And then second, you highlighted the focus on neurology and endocrinology to grow your branded portfolio. What opportunities do you see out there within these two therapeutic areas and potentially outside to add to your specialty segment? And also, I guess, high level, how are you thinking about other chunkier BD plans? Thank you.

Leszek Sulewski: Good morning. Thank you for taking my questions I have two just a quick follow up on the agenda.

Chirag K. Patel: Just a quick follow-up on the Gentes. Taking the early performance trends of the Gentes into consideration, do you envisage treating this product as an essential product relaunch? And how do you think this peak sales potential is for the product now that it's on your platform? And then second, you highlighted a focus on neurology and endocrinology to grow your branded portfolio. What opportunities do you see out there within these two therapeutic areas and potentially outside to add to your specialty segment? And also, at a high level, how are you thinking about other chunkier BD plans? Thank you. Yeah, hi Les.

Leszek Sulewski: So taking the early performance trends on the Genesis into consideration.

Leszek Sulewski: Integration trading this product as a essential product relaunch and how do you think.

Leszek Sulewski: Peak sales potential for the product now that it's on your platform.

Leszek Sulewski: Then second you highlighted the focus on neurology.

Leszek Sulewski: Analogy to grow your branded product folio.

Leszek Sulewski: Opportunity do you see out there within these two therapeutic areas and potentially outside to add to your specialty segment and also I guess high level. How are you thinking about other chunk here at BD plans. Thank you.

Chirag Patel: Yeah. Hi, Les. On ONGENTYS, Neurocrine had done a good job with taking that continuous platform, and it has been a smooth transition. We thank Neurocrine team as well. We are now expanding the reach and the message on a complementary outcome between the on ONGENTYS, which is a COMT inhibitor, which extends the life of levodopa, therefore reducing the off time. It's a classic complementary products between our soon to be IPX-203, currently RYTARY, and then with COMT inhibitor, which is on ONGENTYS. We expect the peak sales to keep going up. We haven't been public, but it should cross the $50 million and keep going.

Yes, hi, less so on genders neurocrine inherited.

Chirag K. Patel: So on Gentis, NeuroKreen did a good job with taking that continuous platform, and it has been a smooth transition. So we thank the NeuroClean team as well. And we are now expanding the reach and the message on a complementary outcome between The angentis, which is a comp inhibitor that extends the life of levodopa, therefore, reducing the off time. So, it's a classic, complementary product between the soon-to-be IPX203, currently Riteri, and then with COMP inhibitor, which is on Gentis. So we expect the peak cells to keep going up. We haven't been public, but it should cross the 50 million mark and keep going. And then on the pipeline for neurology, we are looking at different assets, whether they are in phase two, phase three, and will probably be announcing certain deals this year, which are hopeful, and that would be a more expanded pipeline. We are now going after products that can generate revenue similar to IPX203, three to $500 million. So we're not looking at smaller assets anymore.

Speaker Change: Good job, we're taking that.

Speaker Change: Continuous platform and it has been a smooth transition so we think new recruiting team as well.

Speaker Change: And we are now expanding the reach and the message on complementary.

Speaker Change: Outcome between.

Speaker Change: The agenda, which is a company builder, which extends the life of lower dopa.

Speaker Change: Therefore, reducing the off time, so it's a classic complementary products between the.

Speaker Change: Soon to be IPX, two or three currently Rytary and then with company winter, which has an agenda. So we expect the peaks us to keep going up.

Speaker Change: We haven't been public but should cross the $50 million.

Chirag Patel: On the pipeline in the neurology, we are looking at different assets whether they are in phase 2, phase 3, and we'll be probably announcing certain deals this year. We're hopeful, and that would be more expanded pipeline. We are now going after the products that can generate similar to IPX-203, $300 to 500 million in revenue. We're not looking at smaller assets anymore. On endocrinology, we have our K114, which we're very excited if we can get through the regulatory hurdles. It's the much-needed products in the market with a combination with T3 and T4.

Speaker Change: And keep going and then on.

Speaker Change: The pipeline for.

Speaker Change: In neurology, we are looking at.

Speaker Change: Different assets.

Whether they're in phase II phase III.

Speaker Change: And we will be.

Speaker Change: Probably announcing certain deals this year, who were hopeful and that would be more expanded pipeline. We're now going after the products that can generate similar to it.

Speaker Change: <unk>, two or three 3% to $500 million in revenue so were not looking at a smaller assets anymore.

Chirag K. Patel: And on endocrinology, we have K114, which we're very excited about if we can get through the regulatory hurdles. It's a much needed product in the market combined with the T3 and T4. We believe that product also can be a pretty large contributor. We are also looking at a couple of pipeline assets in phase two and three in ENDO as well.

Speaker Change: And on endocrinology, we have our K, one for which we are.

Speaker Change: Really excited if we can get through the regulatory hurdles.

Speaker Change: It's it's the much needed products in the market with the combination with <unk> four we believe that product also can be a pretty large contributor.

Chirag Patel: We believe that product also can be a pretty large contributor, and also looking at a couple of pipeline assets in our Phase 2 and 3 in endo as well.

Speaker Change: <unk>.

Speaker Change: Also looking at couple of pipeline assets in their phase, two and three and endo as well.

Leszek Sulewski: Thank you.

Les Sulewski: Thank you.

Chirag K. Patel: Thank you. This concludes our Q&A, and I'll now hand it back to Chirag Patel for final remarks. Well, first, thank you to the global Amneal family for a very strong performance in 2023. And our mission is clear, and it hasn't changed since our founding: provide access to high-quality, affordable, and essential medicines. With building momentum across our diversified pharma business, we believe 2024 will be even better as we continue to grow, expand our reach, and impact more patients than ever before.

Speaker Change: Thank you.

Operator: This concludes our Q&A. I'm gonna hand back to Chirag Patel for final remarks.

Speaker Change: Okay.

Speaker Change: Concludes our Q&A I'll now hand back to Huron, that's Alex our final remarks.

Speaker Change: Yeah.

Chirag Patel: Well, first, thank you to the global Amneal family for a very strong performance in 2023. Our mission is clear, and it hasn't changed since our founding, provide access to high quality, affordable, and essential medicines. With building momentum across our diversified pharma business, we believe 2024 will be even better as we continue to grow, expand our reach, and impact more patients than even before. Thank you very much.

Huron: Well first thank you to the global <unk> family for very strong performance in 2023.

Huron: And our mission is clear and it hasnt changed since our founding provide access to high quality affordable and essential medicines with building momentum across our diversified pharma business. We believe 2024 will be even better as we continue to grow expand our reach and impact more pace.

<unk> then even before thank you very much.

Chirag K. Patel: Thank you very much. Ladies and gentlemen, today's call is now concluded. We'd like to thank you for your participation. You may now disconnect your lines.

Operator: Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.

Speaker Change: Ladies and gentlemen, thanks call is now concluded we'd like to thank you for your participation you may now disconnect your lines.

Speaker Change: [music].

Speaker Change: Yeah.

Q4 2023 Amneal Pharmaceuticals Inc Earnings Call

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