Q1 2024 Amneal Pharmaceuticals Inc Earnings Call
Yes.
Operator: Ladies and gentlemen, thank you for your patience. The Amneal Pharmaceuticals first quarter 2024 earnings call will begin shortly. During the presentation, you'll have the opportunity to ask a question by pressing star followed by 1 on your telephone keypad. The call will begin shortly. Thank you. Good morning, and welcome to the Amneal Pharmaceuticals first quarter 2024 earnings call. I will now turn the call over to Amneal's head of investor relations, Tony DiMeo.
Ladies and gentlemen, thank you for your patience.
<unk> Pharmaceuticals first quarter 'twenty 'twenty four earnings call will begin shortly.
During the presentation, you'll have the opportunity to ask a question by pressing star followed by one on your telephone keypad.
<unk> will begin shortly thank you.
[music].
Okay.
Operator: Ladies and gentlemen, thank you for your patience. The Amneal Pharmaceuticals first quarter 2024 earnings call will begin shortly. During the presentation, you'll have the opportunity to ask a question by pressing star followed by 1 on your telephone keypad. The call will begin shortly. Thank you. Good morning and welcome to the Amneal Pharmaceuticals first quarter 2024 earnings call. I will now turn the call over to Amneal's Tablet Investor Relations manager, Tony DiMeo.
Yeah.
Good morning, and welcome to the annual Pharmaceuticals first quarter 2024 earnings call I will now turn the call over to your analyst had an investor relations Tony Gmail.
Anthony DiMeo: Good morning, and thank you for joining Amneal Pharmaceutical's first quarter 2024 earnings call. Today we will issue a press release reporting Q1 results. The earnings press release and presentation are available at Amneal.com. Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for Factors That May Impact Future Performance. We also discussed non-GAAP. Information on the use of these measures and reconciliation to GAP is included in the earnings release and presentation.
Anthony DiMeo: Good morning, and thank you for joining Amneal Pharmaceuticals' first quarter 2024 earnings call. Today, we will issue a press release reporting Q1 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 and Forward-Looking Statements for factors that may impact future performance. We also discussed non-GAAP financial measures. Information on the use of these measures and reconciliation to GAAP is in the earnings release and presentation.
Anthony DiMeo: Good morning, and thank you for joining us and your Pharmaceuticals first quarter 2024 earnings call today, we issued a press release reporting Q1 results.
Speaker Change: <unk> press release and presentation are available at <unk> Dot com.
Anthony DiMeo: 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.
Anthony DiMeo: Please see the section entitled cautionary statements on forward looking statements for factors that may impact future performance.
Anthony DiMeo: We also discuss non-GAAP measures.
Anthony DiMeo: Information our use of these measures and reconciliation to GAAP R&D earnings release and presentation.
Anthony DiMeo: On the call today are Chirag and Chintu Patel, co-founders and co-CEOs, Tasos Konidaris, CFO, our commercial leaders, Andy Boyer for generics, Joe Renda for specialty, and Jason Daly, chief legal officer. I will now hand the call over to Chirag. Thank you, Tony.
Anthony DiMeo: On the call today are Chirag and Chintu Patel, co-founders and co-CEOs, Tasos Konidaris, CFO, our commercial leaders, Andy Boyer for generics, Joe Renda for specialty, and Jason Daly, chief legal officer. I will now hand the call over to Chirag. Thank you, Tony.
Anthony DiMeo: On the call today are surely in Hsinchu Patel co founders and co Ceos taxes, Kony Dara CFO, our commercial leaders Andy Boyer for generic Joe render for specialty and Jason Daly, Chief Legal Officer, I will now hand, the call over to Sharon.
Chirag K. Patel: Turing. Good morning to everyone. Our first quarter performance was outstanding. Record Q1 revenues of $659 million grew 18%. For the first time, all three of our segments generated double-digit growth in the same quarter. Q1 adjusted EBITDA of $152 million grew by 31%, as strong execution continues to drive sustainably higher levels of profit. As momentum builds across Amneal, we are confident in our ability to meet our financial commitments for 2024 and beyond.
Chirag K. Patel: Turing. Good morning to everyone. Our first quarter performance was outstanding. Record Q1 revenues of $659 million grew 18%. For the first time, all three of our segments generated double-digit growth in the same quarter. Q1 adjusted EBITDA of $152 million grew by 31%, as strong execution continues to drive sustainably higher levels of profit. As momentum builds across Amneal, we are confident in our ability to meet our financial commitments for 2024 and beyond.
Sharon: Thank you Tony.
Sharon: Good morning to everyone. Our first quarter performance was outstanding.
Sharon: Record Q1 revenues of $659 million grew 18% for.
Sharon: For the first time, all three of our segments generated double digit digit growth in the same quarter Q1 adjusted EBITDA.
Sharon: $152 million grew by 31%.
Sharon: Strong execution continues to drive.
Sharon: Sustainably higher levels of profits as.
Sharon: As momentum builds across our mill, we are confident in our ability to achieve our financial commitments for 2024 and beyond.
Chirag K. Patel: Our strategic vision for Amneal is to be a global, diversified pharmaceutical company that provides patients, providers, and payers with access to high-quality, affordable, and essential medicines in the United States. Amneal fills approximately 175 million prescriptions per year. In retail pharmacies, we provide complex generic medicines, such as transdermals, topicals, oral solids, and ophthalmic.
Chirag K. Patel: Our strategic vision for Amneal is to be a global, diversified pharmaceutical company that provides patients, providers, and payers with access to high-quality, affordable, and essential medicines in the United States. Amneal fills approximately 175 million prescriptions per year. In retail pharmacies, we provide complex generic medicines, such as transdermals, topicals, oral solids, and ophthalmic. For hospitals and clinics, we supply important acute care injectables where there are chronic shortages. In biosimilars, we are expanding access to oncology therapies and adding more to our portfolio. In specialty, our innovative medicines advance the standard of care, such as in Parkinson's. In our Amcare distribution business, we provide military veterans with access to high-quality medicine. Globally,
Our strategic vision for them Needless to be a global diversified pharmaceutical company that provides patients providers and payers with access to high quality affordable and essential medicines.
Sharon: And the unit.
Sharon: Emil <unk>, approximately 175 million prescriptions a year.
Sharon: In retail pharmacies, we provide complex generics medicines, such as transdermal topical or oral solids and apparel mix for hospitals and clinics, we supply important acute care injectables that are chronic shortages.
Chirag K. Patel: For hospitals and clinics, we supply important acute care injectables where there are chronic shortages. In biosimilars, we are expanding access to oncology therapies and adding more to our portfolio. In specialty, our innovative medicines advance the standard of care, such as in Parkinson's. In our Amcare distribution business, we provide military veterans with access to high-quality medicine globally.
Sharon: Similarly.
Sharon: We are expanding access to oncology therapies, and adding more to our portfolio.
Sharon: And specialty already.
Sharon: Overdue medicines advanced the standard of care such as in Parkinson's disease.
Sharon: Okay distribution business, we provide military veterans with access to high quality medicine.
Sharon: Globally.
Chirag K. Patel: We are addressing unmet health care needs in developing and developed countries. As we continue to grow, Amneal is leading a new era of affordable medicines and having a significant societal impact. Nowhere is our commitment to this mission more evident than our recent approval of Naloxone. Opioid overdose remains a U.S. public healthcare emergency.
Chirag K. Patel: We are addressing unmet health care needs in developing and developed countries. As we continue to grow, Amneal is leading a new era of affordable medicines and having a significant societal impact. Nowhere is our commitment to this mission more evident than our recent approval of Naloxone. Opioid overdose remains a U.S. public healthcare emergency.
Sharon: We are addressing unmet health care needs and doping Endo looked countries as we continue to grow larger.
Sharon: <unk> is a leading new Edo of affordable medicines, and having a significant societal impact.
Sharon: Nowhere in our commitment to this mission more evident than our recent approval of naloxone.
Sharon: Opioid overdose remains a U S public health care emergency.
Chirag K. Patel: We are expanding access to this critical rescue medicine as an over-the-counter product at pharmacies and for the public interest in states and cities across the United States. We were pleased to finalize our partnership with the state of California, with more to come. We are so proud that this essential, life-saving medicine is made in America and manufactured here in New Jersey by Amneal. Let me now walk you through our business at a high level, where we remain confident in our strategy, our ability to execute well and drive growth, and the opportunity to have a tremendous impact.
Chirag K. Patel: We are expanding access to this critical rescue medicine as an over-the-counter product at pharmacies and for the public interest in states and cities across the United States. We were pleased to finalize our partnership with the state of California, with more to come. We are so proud that this essential, life-saving medicine is made in America and manufactured here in New Jersey by Amneal. Let me now walk you through our business at a high level, where we remain confident in our strategy, our ability to execute well and drive growth, and the opportunity to have a tremendous impact.
Sharon: We're expanding access to this critical rescue medicine, as an OTC product at pharmacies and for the public interest through states and cities across the United States.
We're pleased to finalize a partnership with the state of California with more to come.
We are so proud that this essential life saving medicine is made in America.
Sharon: <unk> manufacturing here in new Jersey by email.
Sharon: Let me now walk through our business at a high level.
We remain confident in our strategy.
Sharon: Our ability to execute well and drive growth and the opportunity to have a tremendous impact.
Chirag K. Patel: First, our affordable medicines business, which is our generic segment, has consistently grown each year since 2019. We are seeing this growth accelerate in 2024, driven by our diverse portfolio of retail, injectables, and biosimilars. Amneal has a track record of quality.
Chirag K. Patel: First, our affordable medicines business, which is our generic segment, has consistently grown each year since 2019. We are seeing this growth accelerate in 2024, driven by our diverse portfolio of retail, injectables, and biosimilars. Amneal has a track record of quality.
Sharon: First our affordable medicines business, which is the other genetic segment.
Sharon: <unk> consistently grown each year since 2019.
Sharon: We're seeing this growth accelerate in 2024, driven by our newest portfolio of retail Injectables and Biosimilars.
And Neil has a track record of quality.
Chirag K. Patel: Innovation and Customer Service. Those hallmarks continue to resonate in the U.S. pharmaceutical market, plagued by supply shortages with perpetual demand for high-quality medicine. The durability of our complex portfolio and the regular cadence of new launches each year position Amneal well to continue expanding our leadership position in affordable medicines and driving sustainable long-term growth. In the retail pharmaceutical market, our portfolio of around 240 medicines is complex and diversified. With industry-wide supply chain disruption due to site inspections and manufacturer discontinuations, price erosion in the United States generic industry remains lower than it has been for several years.
Chirag K. Patel: Innovation and Customer Service. Those hallmarks continue to resonate in the U.S. pharmaceutical market, plagued by supply shortages with perpetual demand for high-quality medicine. The durability of our complex portfolio and the regular cadence of new launches each year position Amneal well to continue expanding our leadership position in affordable medicines and driving sustainable long-term growth. In the retail pharmaceutical market, our portfolio of around 240 medicines is complex and diversified. With industry-wide supply chain disruption due to site inspections and manufacturer discontinuations, price erosion in the United States generic industry remains lower than it has been for several years.
Sharon: Innovation and customer service.
<unk> hallmarks continue to resonate in the U S pharmaceutical market.
Speaker Change: Blake by supply shortages, we've put virtual demand for high quality medicines.
Speaker Change: The durability of whole complex portfolio and regular.
The cadence of new launches each year position.
Speaker Change: Position <unk> well to continue expanding our leadership position in it.
Speaker Change: Portable medicines and driving sustainable long term growth.
Speaker Change: In the retail pharmaceutical market our portfolio of around 240 medicines is complex and diversified with industry wide supply chain disruption due to site inspections and manufacturer discontinuation price erosion in the United States generic industry remains low.
Speaker Change: Sure than it has been in several years.
Chirag K. Patel: In injectables, we are expanding our portfolio and have a significant capacity to help address drug shortages in hospitals and clinics. Our injectable strategy focuses on providing unique, ready-to-use products, like our recent launch of PEM Ready RTU for the treatment of certain lung cancers. Across retail and injectables, we are on track to launch over 30 new products this year, following our record 39 new launches last year. In biosimilars, we are seeing the next wave of affordable medicine.
Chirag K. Patel: In injectables, we are expanding our portfolio and have a significant capacity to help address drug shortages in hospitals and clinics. Our injectable strategy focuses on providing unique, ready-to-use products like our recent launch of PEM-Ready RTU for the treatment of certain lung cancers. Across retail and injectables, we are on track to launch over 30 new products this year, following our record 39 new launches last year. In biosimilars, we are seeing the next wave of affordable medicine.
Speaker Change: In Injectables, we are expanding our portfolio and have a significant capacity to help address drug shortages and hospitals and clinics.
Speaker Change: Our injectable strategy focuses on providing unique ready to use products like our recent launch of <unk> <unk>.
Speaker Change: <unk> for the treatment of certain lung cancers across retail and Injectables. We are on track to launch over 30, new products. This year. Following a record 39, new launches last year.
In Biosimilars, we are seeing the next wave of affordable medicines from 2024 to 2028 and estimated $192 billion in annual branded biologics value will lose exclusivity.
Chirag K. Patel: From 2024 to 2028, an estimated $192 billion in annual branded biologics value will lose exclusivity. We expect most biosimilars market to be less competitive, given the inherent complexities of these molecules and the investment required to bring them to market.
Chirag K. Patel: From 2024 to 2028, an estimated $192 billion in annual branded biologics value will lose exclusivity. We expect most biosimilars market to be less competitive, given the inherent complexities of these molecules and the investment required to bring them to market.
Speaker Change: We expect most biosimilar markets.
Speaker Change: To be less competitive.
Speaker Change: Given the inherent complexity complexities of these molecules.
Speaker Change: The investment required to bring them to market.
Chirag K. Patel: Adoption rates for early biosimilars are now 80%, particularly in oncology, where we operate. Our excellent commercial team is driving strong adoption at both community oncology and hospital integrated delivery networks. That, coupled with our pipeline and with trusted partners, gives us confidence in continued momentum.
Chirag K. Patel: Adoption rates for early biosimilars are now 80%, particularly in oncology, where we operate. Our excellent commercial team is driving strong adoption at both community oncology and hospital integrated delivery networks. That, coupled with our pipeline, with trusted partners, gives us confidence in continued momentum.
Speaker Change: Adoption rates for early Biosimilars are now, 80%, particularly in oncology, where we operate.
Speaker Change: Our excellent commercial team is driving strong adoption at both community oncology and hospital integrated delivery networks.
Speaker Change: That coupled with our pipeline and with trusted partners.
Speaker Change: It gives us confidence and continued momentum.
Chirag K. Patel: We are well on our way to achieving over $125 million of revenue in 2024 with $90 million in Biosumers revenue over the last 12 months. We look to in-license one to two biosimilars each year or more and to be vertically integrated over time. Internationally, we will continue to expand our reach and build a strong foundation. This is happening most notably in India, where we are building a customized portfolio of therapies for unmet needs like critical care. Thalmology, Oncology, and Diagnostics in other geographies.
Chirag K. Patel: We are well on our way to achieving over $125 million of revenue in 2024, with $90 million in biosimilars revenue over the last 12 months. We look forward to working with you to license one to two biosimilars each year or more and to be vertically integrated over time. Internationally, we will continue to expand our reach and build a strong foundation. This is happening most notably in India, where we are building a customized portfolio of therapies for unmet needs like critical care. Thalmology, Oncology, and Diagnostics in other geographies.
Speaker Change: We are well on our way to achieving over $125 million of revenue and 24.
Speaker Change: With $90 million in Biosimilars revenue over the last 12 months.
Speaker Change: We look.
Speaker Change: To in license, 1% to two biosimilars, each year or more and to be vertically integrated over time.
Speaker Change: Internationally, we will continue to expand our reach and build a strong foundation.
Speaker Change: This is happening most notably in India.
Speaker Change: Where we are building a customized portfolio of therapies for unmet needs like critical care call.
Speaker Change: <unk> oncology and diagnostics.
Speaker Change: In other geographies.
Chirag K. Patel: We are working with partners to register and commercialize select Amneal products. We expect international expansion will add $5,200 million in revenues by 2027 and rapidly scale after that. In our specialty business, we continue to make good progress with our key neurology and endocrinology branded products, as revenues are growing double digits. In Q1, we successfully launched Pongentes and Adjective Therapy for Parkinson's Disease, which we recently licensed to our specialty portfolio. Next up is IPX203, and our action date is on August 7th. Carbidopa-levodopa has been the main therapy for Parkinson's disease for over five decades.
Chirag K. Patel: We are working with partners to register and commercialize select Amneal products. We expect international expansion will add 5200 million revenues by 2027 and rapidly scale after that. In our specialty business, we continue to make good progress with our key neurology and endocrinology branded products, as revenues are growing double digits. In Q1, we successfully launched Pongentes and Adjective Therapy for Parkinson's Disease, which we recently licensed to our specialty portfolio. Next up is IPX203, and our action date is on August 7. Carbidopa-levodopa has been the main therapy for Parkinson's disease for over five decades.
Speaker Change: We are working with partners to register and commercialize select and mill products.
Speaker Change: We expect international expansion will add $200 million revenues by 2027 and quickly scale up to that.
Speaker Change: Next.
Speaker Change: Our specialty business, we continued to make good progress with our key neurology and endocrinology branded products.
Speaker Change: Renews are growing double digits.
Speaker Change: In Q1, we successfully launched.
Speaker Change: <unk> and <unk>.
Speaker Change: <unk> therapy for Parkinson's disease, which we recently in licensed two of our specialty portfolio next up is <unk> III without action date is on August seven.
Speaker Change: <unk> has been the main therapy for Parkinson's disease for over five decades.
Chirag K. Patel: We believe IPX203 meaningfully advances that standard of care with a broad application for all patients. In our healthcare distribution business, we have more than doubled revenues and profits since our acquisition in 2020. We are expanding all three channels, distribution, government, and unit dose, driven by new products from suppliers, including Amneal. We now expect over $650 million in healthcare revenue next year as we expect this to remain a high-growth business. In short, we're starting 2024 with very strong momentum. Our diversified growth profile is sustainable, and our financial performance is accelerating remarkably. I'll now hand it to Chintu.
Chirag K. Patel: We believe IPX203 meaningfully advances that standard of care with a broad application for all patients. In our healthcare distribution business, we have more than doubled revenues and profits since our acquisition in 2020. We are expanding all three channels, distribution, government, and unit dose, driven by new products from suppliers including Amneal. We now expect over $650 million in healthcare revenue next year as we expect this to remain a high-growth business. In short, we're starting 2024 with very strong momentum. Our diversified growth profile is sustainable, and our financial performance is accelerating remarkably. I'll now hand it to Chintu.
Speaker Change: We believe IPX, two or three meaningfully advances that standard of care with a broad application for all patients.
Speaker Change: <unk> distribution business, we have more than doubled revenues and profits since our acquisition in 2020.
Speaker Change: We are expanding all three channels distribution and government and unit dose.
Speaker Change: Driven by new products from suppliers, including <unk> Neil.
Speaker Change: We now expect over $650 million in revenue next year as we expect this to remain a high growth business.
Speaker Change: In short we.
Speaker Change: Starting 2024 with very strong momentum or diversified growth profile is sustainable annual financial performance is accelerating remarkably.
Speaker Change: I'll now hand, it to Jim.
Jim: Good morning, everyone.
Chintu Patel: Good morning, everyone. Thank you. Thank you, Chirag, and thank you to the global Amneal family who works hard every day to help make health possible. I will discuss how our core strengths in both operations and innovation provide us with a long runway for sustainable top and bottom line growth. First, quality has been at the center of everything we do since our founding in 2002.
Chintu Patel: Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who works hard every day to help make health possible. I will discuss how our core strength in both operations and innovation provides us with a long runway for sustainable top and bottom line growth. First, quality has been at the center of everything we do since our founding in 2002.
Jim: Thank you too thank.
Jim: Thank you Sheila and thank you to the global <unk> family, who work hard everyday to help make healthy possibly both.
Jim: I will discuss how our core strengths in both operations and innovation provides us with a long runway for sustainable top and bottom line growth.
Jim: Cost quality has been at the center of everything we do things of our founding in 2002, we continue to invest in quality through <unk>.
Chintu Patel: We continue to invest in quality through automation and AI technologies to advance our global infrastructure. Our success is also driven by our commitment to operational excellence, ongoing efficiency programs, and a robust supply chain. All of our plants are FDA approved.
Chintu Patel: We continue to invest in quality through automation and AI technologies to advance our global infrastructure. Our success is also driven by our commitment to operational excellence, ongoing efficiency programs, and a robust supply chain. All of our plants are FDA approved.
Jim: Automation and AI technologies to advance our global infrastructure.
Jim: Our success is also driven by our commitment to operational excellence ongoing efficiency programs and a robust supply chain all of our plants that are FDA approved in each plant, we are driving optimization and efficiency programs to maintain our exceptional customer service.
Chintu Patel: In each plant, we are driving optimization and efficiency programs to maintain our exceptional customer service levels and gain cost efficiency. Across our supply chain, we are focused on what we call the three R's, redundancy, resiliency, and reliability. In particular, drug shortages are an ongoing challenge in the market. The U.S. FDA released 114 drug shortages, including 75 injectables. At Amneal, we look to be part of the
Chintu Patel: In each plant, we are driving optimization and efficiency programs to maintain our exceptional customer service levels and gain cost efficiency. Across our supply chain, we are focused on what we call the three R's, redundancy, resiliency, and reliability. In particular, drug shortages are an ongoing challenge in the market. The U.S. FDA released 114 drug shortages, including 75 injectables. At Amneal, we look to be part of the
Jim: With levels and gain cost efficiencies across our supply chain. We are focused on what we call. The three Rs redundancy resiliency and reliability.
Jim: In particular drug shortages on an ongoing challenge in the market. The U S. SBA leased 114 drug shortages, including 75 Injectables.
Speaker Change: We look to be part of the solution.
Chintu Patel: We have about 20 commercial and pipeline injectables that are on the shortage list, including oncology medicines. We have also tripled our injectable manufacturing capacity in recent years at multiple plants. Second, our track record for innovation is very strong, and we are off to a great start in 2024 with five key complex product launches. Naloxone Nasal Spray, PAM Ready RTU, Carbidolol ER, FML Eye Drops, and Generic Ciprodex.
Chintu Patel: We have about 20 commercial and pipeline injectables that are on the short list, including oncology medicines. We have also tripled our injectable manufacturing capacity in recent years at multiple plants. Second, our track record for innovation is very strong, and we are off to a great start in 2024 with five key complex product launches. Naloxone Nasal Spray, PAM Ready RTU, Carbidolol ER, FML Eye Drops, and Generic Ciprodex.
Speaker Change: About 20 commercial and pipeline Injectables that are on the sharp at least including oncology medicines.
Speaker Change: <unk> also tripled our injectables manufacturing capacity in recent years at multiple clients.
Speaker Change: Continue to prioritize efforts to help alleviate shortages in the market, particularly for Injectables.
Speaker Change: Second our track record in innovation is very strong and we are off to a great start in 2024.
Speaker Change: <unk> complex product launches naloxone nasal spray bandwidth.
Speaker Change: Card readers.
Our <unk> eye drops and genetic Ciprodex. We currently have 86, new products NDA spending of reached 63 non oral solids. In addition, we have 67 pipeline products, 94% of which are non oral solids.
Chintu Patel: We currently have 86 new products, and ANDA spending, of which 63 are non-oral solids. In addition, we have 67 pipeline products, 94% of which are non-oral solids. With our ongoing shift towards complex innovations, we have improved our R&D efficiencies and are spending less internally, which allows us to allocate more investment to external R&D over time. We were so proud of last week's approval of Naloxone nasal spray, a life-saving treatment for drug overdoses. This is a tremendous milestone for the entire team at Amneal.
Chintu Patel: We currently have 86 new products, ANDA pending, of which 63 are non-oral solids. In addition, we have 67 pipeline products, 94% of which are non-oral solids. With our ongoing shift towards complex innovations, we have improved our R&D efficiencies and are spending less internally, which allows us to allocate more investment to external R&D over time. We were so proud of last week's approval of Naloxone nasal spray, a life-saving treatment for drug overdoses. This is a tremendous milestone for the entire team at Amneal.
Speaker Change: Our ongoing shift towards complex integrations, we have improved over the R&D efficiencies and are spending less internally reached allows us to allocate more investment towards external R&D over time.
Speaker Change: We were so proud of last week's approval of naloxone nasal spray a lifesaving treatment for drug overdoses. This is a tremendous milestone for the entire <unk> Avenue.
Chintu Patel: The product is now available through retail pharmacies as an OTC product and to states and counties across the U.S. We have built robust manufacturing capacity to make up to 10 million two-packs starting next year. We are significantly expanding access to help address the opioid crisis that impacts so many Americans through injectables. We expect to launch over 10 new products this year, following the 14 new injectables we launched in 2023. Our R&D focus is on oncology, ready-to-use bags, and long-acting injectables.
Chintu Patel: The product is now available through retail pharmacies as an OTC product and to states and counties across the U.S. We have built robust manufacturing capacity to make up to 10 million two-packs starting next year. We are significantly expanding access to help address the opioid crisis that impacts so many Americans through injectables. We expect to launch over 10 new products this year, following the 14 new injectables we launched in 2023. Our R&D focus is on oncology, ready-to-use bags, and long-acting injectables.
Speaker Change: The product is now available to retail pharmacies, as an OTC product and two states and counties across the U S. We have built robust manufacturing capacity to make up to 10 million pullback starting next year, we are significantly expanding access to help.
Speaker Change: Address the opioid crisis that impacts so many Americans and Injectables.
Speaker Change: We expect to launch over 10, new products. This year. Following the 14, new Injectables, we launched in 2023, our R&D focus.
He is on oncology ready to use bags and long acting injectables.
Chintu Patel: For years, we have been meeting with clinicians to understand their needs. This emphasis on the voice of the customer has allowed us to develop unique presentations of existing products. Last month, we launched our first 5-5-B-2 injectable in PAM Ready RTU. This new ready-to-use presentation of a frequently used oncology medicine can improve efficiency and reduce medication error.
Chintu Patel: For years, we have been meeting with clinicians to understand their needs. This emphasis on the voice of the customer has allowed us to develop unique presentations of existing products. Last month, we launched our first 505b2 injectable in PAM Ready RTU. This new ready-to-use presentation of a frequently used oncology medicine can improve efficiency and reduce medication error.
Speaker Change: For years, we have been meeting with clinicians to understand their needs. These emphases on the voice of the customer has allowed us to develop unique presentations of existing products last month, we launched our first <unk> injectable in bandwidth.
Speaker Change: These new ready to use presentation offer frequently used oncology medicine can improve efficiency and reduce medication errors.
Chintu Patel: We look to launch two to three 5-5-B-2 injectables each year with approximately 15 in development. Next, biosimilars continue to be a key area of strategic focus. Building on the success of our first three commercial products, we in-licensed two tenosumab biosimilar candidates for Prolia and Xgeva in Q4. Those programs continue to progress with our development partner, MapScience. In addition, we are pleased to share that in Q1, we licensed two additional packed field grafting pipeline programs, the on-body injector and the pre-filled auto-injector. Today, approximately 30-40% of the pack field drafting market is on-body, and fewer competitors are expected this year.
Chintu Patel: We look to launch two to three 505b2 injectables each year with approximately 15 in development. Next, biosimilars continue to be a key area of strategic focus. Building on the success of our first three commercial products, we in-licensed two tenosumab biosimilar candidates for Prolia and Xgeva in Q4. Those programs continue to progress with our development partner, MapScience. In addition, we are pleased to share that in Q1, we licensed two additional PAC Field Grasping Pipeline programs, the On-Body Injector and the Pre-Field Auto Injector. Today, approximately 30-40% of the pack field drafting market is on-body, and fewer competitors are expected in this period.
Speaker Change: Look to launch two to three 5% probably between Injectables each year.
Speaker Change: Approximately 15 in development.
Speaker Change: Next biosimilar continue to be a key area of strategic focus building on the success of our first three commercial products.
Speaker Change: In licensed to Dinos <unk> Biosimilar candidate for Prolia and <unk> in Q4.
Speaker Change: Those programs continue to progress with our development partner websites. In addition, we are pleased to share that in Q1, we in licensed two additional backfill grafting pipeline programs.
Speaker Change: On body injector and refilled auto injector.
Speaker Change: Today, approximately 30% to 40% of the Pegfilgrastim market is on Bharti and fewer competitors I would expect that in this space in total we have three commercial biosimilar and four more under development all in oncology as we establish <unk> as a key.
Chintu Patel: In total, we have three commercial biosimilars and four more under development, all in oncology. As we establish Amneal as the key player, similar players will emerge.
Chintu Patel: In total, we have three commercial biosimilars and four more under development, all in oncology. As we establish Amneal as the key player, similar players will emerge.
Speaker Change: Biosimilar player.
Chintu Patel: We look to add more opportunistic biosimilar molecules to our pipeline over time. Internationally, we have distribution partners in place for approximately 40 emerging markets, market countries including strong markets like Saudi Arabia, Mexico, South Africa, and the Philippines. We are registering products globally, including in Europe, Canada, China, and emerging markets. In Specialty, we are continuously evolving our R&D efforts to move up the value chain. First, our IPX-203 complete response and resubmission is under review.
Chintu Patel: We look to add more opportunistic biosimilar molecules to our pipeline over time. Internationally, we have distribution partners in place for approximately 40 emerging markets, market countries including strong markets like Saudi Arabia, Mexico, South Africa, and the Philippines. We are registering products globally, including in Europe, Canada, China, and emerging markets. In specialty, we are continuously evolving our R&D efforts to move up the value chain. First, our IPX-203 complete response; resubmission is under review.
We look to add more opportunistic biosimilar molecules toward pipeline over time.
Internationally, we have distribution partners in place for approximately 40 emerging markets.
Market countries, including strong markets like Saudi Arabia, Mexico, South Africa, and the Philippines, we are registering products globally, including in Europe, Canada, China and emerging markets in.
In specialty we are.
Speaker Change: <unk> evolving our R&D efforts to move up the value chain cost over IPX towards re complete response Resubmission is under review also.
Chintu Patel: Also, we are advancing our DHE auto-injector program for migraine and cluster headache. We transfer production internally and are excited to complete our application later this year, which puts us in a good position to launch in the first half of next year once approved. In addition, we continue to advance our pipeline with K114 for endocrinology and other programs. We look to launch one to two specialty products each year going forward. Overall, Amneal is expanding and growing in the key areas of medicine, complex generics, injectables, biosimilars, international distribution, and specialty brands. We are so deeply passionate about our company's mission and purpose and the good work that remains ahead. I will now pass it on to Tash.
Chintu Patel: Also, we are advancing our DHE auto-injected program for migraine and cluster headache. We transfer production internally and are excited to complete our application later this year, which puts us in a good position to launch in the first half of next year once approved. In addition, we continue to advance our pipeline with K114 for endocrinology and other programs. We look to launch one to two specialty products each year going forward. Overall, Amneal is expanding and growing in the key areas of medicine, complex generics, injectables, biosimilars, international distribution, and specialty brands. We are so deeply passionate about our company's mission and purpose and the good work that remains ahead. I will now pass it on to Tas.
So we are advancing our <unk> auto injector program for migraine and cluster headache, we transferred production internally at and excited to complete our application later this year.
Speaker Change: In a good position to launch in the first half of next year once approved.
Speaker Change: In addition, we continue to advance our pipeline with <unk> four for endocrinology and other programs, we look to launch one to two specialty products each year going forward.
Speaker Change: Overall, <unk> is expanding and growing in the key areas of medicine complex generics Injectables Biosimilars international distribution in specialty branded.
Speaker Change: So deeply passionate about our company's mission and purpose and the good work that remains ahead I will now pass it over to Tassos.
Anastasios G. Konidaris: Thank you, Chintu, and good morning. At a high level, our diversified business is driving sustainable higher levels of revenues and profits and continued leverage. Our first quarter results were excellent, with total net revenue of $659 million, up 18%. Q1 Generics Net Revenue of $391,014 was driven by our diverse portfolio of complex products. Biosimilars generated $27 million in revenue driven by Almesia.
Anastasios G. Konidaris: Thank you, Chintu, and good morning. At a high level, our diversified business is driving sustainable higher levels of revenues and profits and continued leverage. Our first quarter results were excellent, with total net revenue of $659 million, up 18%. Q1 Generics Net Revenue of $391 Million Group 14% Driven by our Diverse Portfolio of Complex Products, Biosimilars generated $27 million in revenue driven by Almesia. New products launched in 2023 and 2024 added $19 million to Q1 revenue growth.
Tassos: Thank you Tim and good morning at a high level, our diversified business is driving sustainable higher levels of revenues and profits and continued deleveraging.
Our first quarter results were excellent.
It'll net revenue of $659 million up 18%.
Tassos: Q1 generic net revenue of $391 million grew 14% driven by our diverse portfolio of complex products.
Tassos: Biosimilars generated $27 million in revenue driven by old Macys.
Anastasios G. Konidaris: New products launched in 2023 and 2024 added $19 million to Q1 revenue growth. In addition, the remaining base portfolio continued to grow due to the relevancy of our products, strong market demand, less pricing pressure, and Amneal's high quality supply chain. Q1 Specialty Net Revenues of $105 Million, Group 15%, driven by double-digit growth of our key branded products, plus the recent launch of Argentis in March. Q1 after net revenues of $163 million grew 33%, reflecting continued strong growth across all three customer channels driven by new products. Our Q1 adjusted gross margins of 42% increased 250 basis points year over year, and we're ahead of our expectations.
New products launched in 2023, and 2024 added $19 million to Q1 revenue growth.
Anastasios G. Konidaris: In addition, the remaining base portfolio continued to grow due to the relevancy of our products, strong market demand, less pricing pressure, and Amneal's high quality supply chain. Q1 Specialty Net Revenues of $105 Million, Krupp 15%, driven by double-digit growth of our key branded products, plus the recent launch of Argentis in March. Q1 after net revenues of $163 million grew 33%, reflecting continued strong growth across all three customer channels driven by new products. Our Q1 adjusted gross margins of 42% increased 250 basis points year over year, and we're ahead of our expectations.
Tassos: In addition, the remaining base portfolio continued to grow due to the relevancy of our products strong market demand less pricing pressure and <unk> high quality supply chain.
Tassos: Q1 specialty net revenues of $105 million.
Tassos: <unk> grew 15% driven by double digit growth of our key branded products plus the recent launch of a dentist in March.
Tassos: Q1, <unk> net revenues of $163 million grew 33% reflecting.
Tassos: Continued strong growth across all three customer channels driven by new products.
Tassos: Our Q1, adjusted gross margins of 42% increased 250 basis points year over year and were ahead of our expectations.
Anastasios G. Konidaris: Strong gross margins were driven by the favorable mix of revenues that reflected the complexity of our portfolio combined with higher fixed overhead absorption. Q1 adjusted EBITDA of $152 million grew 31%, reflecting robust revenue growth, higher gross margins, tight management of operating expenses, and a favorable comparison to the prior year. Our leveraged growth profile in Q1 is the blueprint for sustainable higher P&L results for the company going forward. Q1 adjusted EPS of $0.14 grew 17%, driven by higher adjusted EBITDA, partially offset by interest and cost.
Anastasios G. Konidaris: Strong gross margins were driven by the favorable mix of revenues that reflected the complexity of our portfolio combined with higher fixed overhead absorption. Q1 adjusted EBITDA of $152 million grew 31%, reflecting robust revenue growth, higher gross margins, tight management of operating expenses, and a favorable comparison to the prior year. Our leveraged growth profile in Q1 is the blueprint for sustainable higher P&L results for the company going forward. Q1 adjusted EPS of $0.14 grew 17% driven by higher adjusted EBITDA, partially offset by interest cost.
Tassos: <unk> gross margins were driven by the favorable mix of revenues that reflected the complexity of our portfolio combined with higher fixed overhead absorption.
Tassos: Q1, adjusted EBITDA over $152 million grew 31%, reflecting robust revenue growth higher gross margins tight management of operating expenses and a favorable comparison to prior year.
Tassos: Our leveraged growth profile in Q1 is the blueprint for sustainable higher P&L results for the company going forward.
Tassos: Q1, adjusted EPS of 14, <unk> grew 17% driven by higher adjusted EBITDA, partially offset by interest costs.
Anastasios G. Konidaris: As a reminder, we have made substantial progress over the last four years driving accelerated top and bottom line growth, reducing leverage, and resolving legacy matters. As a result, our annual adjusted EBITDA has increased from $339 million in 2019 to $594 million over the last 12 months, ending Q1 2024. Also, net leverage has declined from 7.4 times in 2019 to 4.6 times now. As I mentioned earlier, settling legacy legal matters has been a priority of ours.
Anastasios G. Konidaris: As a reminder, we have made substantial progress over the last four years driving accelerated top and bottom line growth, reducing leverage, and resolving legacy matters. As a result, our annual adjusted EBITDA has increased from $339 million in 2019 to $594 million over the last 12 months, ending Q1 2024. Also, net leverage has declined from 7.4 times in 2019 to 4.6 times now. As I mentioned earlier, settling legacy legal matters has been a priority of ours.
Tassos: As a reminder, we have made substantial progress over the last four years driving accelerated top and bottom line growth, reducing leverage and result.
Anastasios G. Konidaris: Two years ago, we settled a PAN-AER litigation, and we just made our final payment in Q1. In addition, today, we announced that we reached an agreement in principle for a nationwide opioid settlement, payable over 10 years, that resolves substantially all opioid litigation. Accordingly, in the first quarter, we recorded a pre-tax charge of $94 million, which reflects cash payments and the supply of naloxone nasal spray, both over the next 10 years. As a result, we have now substantially resolved these two legacy legal matters, which removes. Given the strong start of the year and our improved visibility, including the recent naloxone approval, we are targeting the higher end of our full-year outlook.
Tassos: Legacy matters.
Tassos: As a result, our annual adjusted EBITDA has increased from 339 million in 2000 $19 million to $594 million over the last 12 months ended Q1 2024.
Tassos: Also.
Tassos: Net leverage has declined from seven four times in 2019.
Tassos: To four six times now.
Tassos: As I mentioned earlier settling legacy legal matters has been a priority of ours too.
Anastasios G. Konidaris: Two years ago, we settled a PAN-AER litigation, and we just made our final payment in Q1. In addition, today, we announced that we reached an agreement in principle for a nationwide opioid settlement, payable over 10 years, that resolves substantially all opioid litigation. Accordingly, in the first quarter, we recorded a pre-tax charge of $94 million, which reflects cash payments and the supply of naloxone nasal spray, both over the next 10 years. As a result, we have now substantially resolved these two legacy legal matters, which removes. Given the strong start of the year and our improved visibility, including the recent naloxone approval, we are targeting the higher end of our full-year outlook.
Tassos: Two years ago, we settled a panel or litigation.
Tassos: We just made our final payment in Q1.
Tassos: In addition, today, we announced that we reached agreement in principle for a nation wide opioid settlement payable over 10 years that resolved substantially all opioids litigation.
Tassos: Accordingly in the first quarter, we recorded a pre tax charge of 94 million, which reflects cash payments of the supply of naloxone nasal spray both over the next 10 years.
Tassos: As a result, we have now substantially resolved the Stewart legacy legal matters, which removes these overhangs for the company.
Tassos: Given the strong start of the year and our improved visibility, including the recent <unk> approval.
Tassos: Targeting the higher end of our full year outlook.
Anastasios G. Konidaris: As a reminder, we expect total net revenue of $2,550,000 to $2,650,000 and Adjusted EBITDA of $580 to $620 million, which reflects high single-digit growth on both top and bottom lines. With that, I will turn the call over to Chirag.
Anastasios G. Konidaris: As a reminder, we expect total net revenue of $2,550,000,000 to $2,650,000,000 and Adjusted EBITDA of $580 to $620 million, which reflects high single-digit growth on both top and bottom lines. With that, I will turn the call over to Chirag.
Tassos: As a reminder, we expect total net revenue.
Tassos: Of $2.550 billion to $2 billion $650 million.
Tassos: And adjusted EBITDA of $580 million to $620 million, which reflects high single digit growth on both top and bottom line.
Tassos: With that let me turn the call over to Sheila.
Chirag K. Patel: Thank you, Tasos. Amneal's Q1 performance was excellent across the board and reflects our continued upward trajectory in driving higher financial results over the years. We are so excited about the opportunities ahead. Let's now open the call to questions.
Chirag K. Patel: Thank you, Tasos. Amneal's Q1 performance was excellent across the board and reflects our continued upward trajectory in driving higher financial results over the years. We are so excited about the opportunities ahead. Let's now open the call to questions.
Thank you Tassos <unk> Q1 performance was excellent across the board and reflects our continued upward trajectory and driving higher financial results over the years. We are so excited about the opportunities ahead.
Sheila: Let's now open the call for Q&A Anthony.
Sheila: Okay.
Operator: Thank you, Chirag. Everyone, if you would like to ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. We'll pause here briefly as the questioner returns. Our first question is from Nathan Rich with Goldman Sachs. Your line is open.
Operator: Thank you, Chirag. Everyone, if you would like to ask a question, please press star followed by 1 on your telephone keypad now. If you change your mind, please press star followed by 2. When preparing to ask your question, please ensure your device is unmuted locally. We'll pause here briefly as the questioner returns. Our first question is from Nathan Rich with Goldman Sachs. Your line is open.
Anthony DiMeo: Thank you sure everyone. If you would like to ask a question. Please press star followed by one on your telephone keypad.
Anthony DiMeo: Have you changed your mind, Please press star followed by team.
Anthony DiMeo: When preparing to ask your question. Please ensure your devices from the total company.
Anthony DiMeo: Ross here briefly ask a question at this time.
Anthony DiMeo: Our first question is from Nathan Rich with Goldman Sachs. Your line is open.
Nathan Allen Rich: Hi, good morning. Congratulations on a strong quarter. And thanks for the questions.
Nathan Allen Rich: Hi, good morning. Congratulations on a strong quarter. And thanks for the questions.
Nathan Allen Rich: Hi, good morning, congratulations on a strong quarter and thanks for the questions.
Chirag K. Patel: I maybe wanted to start with Naloxone and specifically the California contract. Can you talk about when that contract starts? And you know, how long it is? And any details you can share, maybe on the type of volume commitment that the state made? And have you gotten additional interest from other states sort of on the back of that? And any comments on the margin profile of Naloxone, maybe relative to the corporate average, would be helpful.
Chirag K. Patel: I maybe wanted to start with Naloxone and specifically the California contract. Can you talk about when that contract starts? And you know, how long it is? And any details you can share, maybe on the type of volume commitment that the state made? And have you gotten additional interest from other states sort of on the back of that? And any comments on the margin profile of Naloxone, maybe relative to the corporate average, would be helpful.
Nathan Allen Rich: Maybe I wanted to start with.
Nathan Allen Rich: <unk> zone in specifically, the California contract can you talk about when that contract starts and how long. It is and any details you can share maybe on the type of volume commitment. The state made and have you gotten additional interest from other states sort of on the back of that and any comments on the margin profile of naloxone maybe relative.
Nathan Allen Rich: To the corporate average would be helpful.
Chirag K. Patel: Nathan, good morning. So California supply starts now, and we will see increased demand as they ramp up our label, and according to the state's press release, they could buy up to 3.2 million units per year. We don't expect them to buy that in the first year, but they'll ramp it up as they go. So somewhere between 2 to 3 million units are expected in the state of California. The remaining contractual terms are confidential.
Chirag K. Patel: Nathan, good morning. So California's supply starts now, and we will see increased demand as they ramp up our label, and according to the state's press release, they could buy up to 3.2 million units per year. We don't expect them to buy that in the first year. They'll ramp it up as they go. So somewhere between, we expect two to three million units in the state of California. The remaining contractual terms are confidential.
Speaker Change: Nathan good morning.
So, California supply starts now.
Nathan Allen Rich: And we will see the increase demand as they ramp up.
Speaker Change: Our label.
Speaker Change: <unk>.
Speaker Change: According to the state's press release, they could buy up to $3 2 million units per year, we don't expect them to buy that in the first year alone.
Speaker Change: Amp it up as they go so.
Speaker Change: Somewhere between we expect two to 3 million units in the state of California.
Speaker Change: The remaining contractual terms are confidential.
Chirag K. Patel: It was a great win for us, and we're very proud of the agreement with the state of California and trusting us to supply and value the made in the United States product. So we really appreciate it. In terms of the margin profile, it is going to be higher and accretive than the current.
Chirag K. Patel: It was a great win for us and we're very proud of the agreement with the state of California and trusting us to supply and value the made in the United States product. So we really appreciate it. In terms of the margin profile, it is going to be higher and accretive than the current.
Speaker Change: It was a great win for us and we're very proud of.
Speaker Change: The agreement with the state of California, and trusting us to supply and valuing the made.
Speaker Change: <unk> made in the United States product. So we really appreciate it.
In terms of the margin profile is going to be higher in accretive than the current gross margins.
Speaker Change: Great.
Chirag K. Patel: Great. And maybe just a poll. Yeah.
Nathan Allen Rich: Great. And maybe just a follow-up.
Speaker Change: Yes, yes.
Speaker Change: Okay.
Chirag K. Patel: It's obviously not just the state of California, so this is impacting; it's an issue across all of our states, and our commercial teams are actively engaged with other internal parties both on the state and federal level. So we're really excited to kind of fill the incremental need that's going to provide for many years.
Chirag K. Patel: It's obviously not just the state of California, so this is impacting; it's an issue across all of our states, and our commercial teams are actively engaged with other stakeholders both on the state and federal level. So really excited to kind of feel the incremental need that's going to be provided for many years. Yes. We're going to build the capacity to supply 10 million units, up to 10 million units, starting early next year. This year we're producing somewhere between two and a half million units.
Speaker Change: Yes, sorry go ahead, it's obviously not just the <unk>.
Speaker Change: And that obviously the issue that the state of California. So this is impacting our it's an issue across all our states and our commercial team.
Speaker Change: <unk> engaged with other.
Speaker Change: Multi policy both on the state and federal level. So so really excited to kind of fill the incremental need that's going to provide for many years, yes, and we have build the capacity to.
Chirag K. Patel: Yes, and we have built the capacity to supply 10 million units, up to 10 million units starting early next year. This year, we're producing somewhere between two and a half to three million units.
Speaker Change: To supply 10 billion units up to 10 million units starting early next year. This year were producing somewhere between two five to 3 million units.
Anastasios G. Konidaris: That's great! Maybe just to follow up on the cadence of earnings this year, you know, Tassos, I know you kind of pointed to the high end of the range, but, you know, looking at the historical EBITDA cadence, I think 20% comes in the first quarter, typically, you know, based on what you did this year, that would imply a number well above that kind of high end of the range. So is there anything to kind of note on just earnings cadence this year that would be different than normal?
Nathan Allen Rich: That's great! Maybe just to follow up on the cadence of earnings this year, you know, Tassos, I know you kind of pointed to the high end of the range, but, you know, looking at the historical EBITDA cadence, I think 20% comes in the first quarter, typically, you know, based on what you did this year, that would imply a number well above that kind of high end of the range. So is there anything to kind of note on just earnings cadence this year that would be different than normal?
Speaker Change: That's great.
Speaker Change: And maybe just a follow up on the <unk>.
Speaker Change: Cadence of earnings this year.
Speaker Change: Toss us I know you kind of pointed to the high end of the range, but I think looking at the historical EBITDA cadence I think 20% comes in the first quarter typically.
Based on what you did this year that would imply.
Speaker Change: A number of well above the kind of high end of the range. So is there anything to kind of note on just the earnings cadence this year that would be different than normal.
Anastasios G. Konidaris: It's you know you take one quarter. We can never annualize this, so you know if you think about we finished the year last year with EBITDA of what 554 million dollars. Right, so we added Q1 so our run rate, the last run rate of the first four of the last four quarters, now it's almost 600 million dollars. 594 million dollars. So the year is playing out how we were hoping it would, which is an acceleration of top and bottom line growth, right?
Anastasios G. Konidaris: It's, it's, you know, you take one quarter; we can never annualize, annualize this. So, you know, if you think about we finished the year last year with EBITDA of, what, $554 million, right? So, we added Q1, so our run rate, right, the last run rate of the four, first four, last four quarters, now it's almost $600 million, $594 million. So the year is playing out how we were hoping it would, which is an acceleration of top and bottom line growth, right?
Speaker Change: It's.
Speaker Change: You take one quarter, we can never annualize annualize. This so if you think about we finished the year last year.
Speaker Change: EBITDA.
Speaker Change: $554 million right. So we added Q1, so our run rate right. The run rate of the four first four.
Speaker Change: The full quarters now its almost $600 million $594 million so.
Speaker Change: The year is playing out how we were hoping it which is acceleration of top and bottom line growth right. So I have so great great improvement. So now we're targeting the high end of the range and we are saying is there more right.
Anastasios G. Konidaris: So we're having some great, great improvement. So now we're targeting the high end of the range, and you're saying, is there more, right? And you can count on us to try to maximize performance, but at the same time, right, we're also focused on driving and making investments primarily in our R&D, primarily in kind of tuck-in licensing deals for biosimilars and complex drugs to not just maximize this year or the next but build long-term growth for 2026 and 2027.
Anastasios G. Konidaris: So we're having some great, great improvement. So now we're targeting the high end of the range, and you're saying, is there more, right? And you can count on us to try to maximize performance, but at the same time, right, we're also focused on driving and making investments primarily in our R&D, primarily in kind of tuck-in licensing deals for biosimilars and complex drugs to not just maximize this year or the next but build long-term growth for 2026 and 2027.
Speaker Change: And you can count on us to try to maximize the performance, but at the same time right.
Speaker Change: Also focused on driving and making investments primarily in R&D, primarily kind of tuck in licensing deals that biosimilars and complex drugs to not just maximize this year or the next but build a long term growth for 2000 26027. So you are now missing anything the only thing.
Anastasios G. Konidaris: So you're not missing anything. The only thing we're gonna be mindful of is wanting to make sure we have room in our operating expenses to make investments over the next, call it nine months, primarily in R&D, and then also, depending on how things play out with IPX203, kind of making sure we kind of make the right investments there to drive that growth as quickly as possible.
Anastasios G. Konidaris: So you're not missing anything. The only thing, you know, we're gonna be mindful is wanna make sure we have room in our operating expenses to make investments over the next, call it nine months, primarily in R&D. And then also, depending on how things play out with IPX203, you know, kind of making sure we kind of make the right investments there to drive that growth as quickly as possible.
Nathan Allen Rich: Okay, that's helpful. Thank you.
Speaker Change: Would it be mindful ease.
Speaker Change: When it make sure we have room.
Speaker Change: Our operating expenses to make investments over there over the next call it nine months.
Similarly in R&D, and then also depending how things play out with IPX two or three.
Speaker Change: Kind of making sure we we cannot make the right investments there to drive that growth as quickly as possible.
Nathan Allen Rich: Okay, that's helpful. Thank you.
Speaker Change: Okay. That's helpful. Thank you.
Operator: Thank you. The next question is from Les Sulewski with Truist Security. Your line is open.
Leszek Sulewski: Thank you. The next question is from Les Sulewski with Truist Security. Your line is open.
Speaker Change: Thank you. The next question is from Les Sulewski with curious to guarantee.
Leszek Sulewski: Your line is open.
Leszek Sulewski: Good morning, thank you for taking my questions. Can you just provide some initial update commentary on the Gentes, given the new ownership structure, perhaps some feedback from prescribers, and then also on Primidri? I have a follow-up.
Leszek Sulewski: Good morning, thank you for taking my questions. Can you just provide some initial update commentary on GENTIS given the new ownership structure, perhaps some feedback from prescribers, and then also on Primidri and have a follow-up.
Leszek Sulewski: Good morning. Thank you for taking my questions can you just provide some initial uptake commentary on agenda, given the new ownership structure and perhaps some feedback from prescribers and then also on <unk> and I had a follow up.
Joe Renda: Yep, great. Les, I'm going to turn it over to Mr. Joe Rinder here. Yeah, thanks, Les.
Joe Renda: Yep, great. Les, I'm going to turn it over to Mr. Joe Renda here. Yeah, thanks, Les.
Speaker Change: Yes, Greg.
Turning it over to Mr. Joe Randell here, Yes, I think so far we've been very pleased with on Gen tests as well as the partnership with <unk>, It's been a great partnership and we've been working very closely with them in their global team.
Joe Renda: So far, we've been very pleased with Ungentis, as well as the partnership with BeAll. It's been a great partnership, and we've been working very closely with them and their global team, executing upon the strategies that they've learned from over the years. I would say probably the three pieces of feedback that would be significant would be, one, we are hearing very positive feedback from prescribers. There was a concern that Ungentis would not be remaining in the market.
Joseph Todisco: Executing upon the strategies that we they've learned from over the years I would say probably the three pieces of feedback that would be significant would be one we are hearing very positive feedback from prescribers there was a concern.
Joseph Todisco: Debt on Genesis would not be remaining in the market. So prescribers were very pleased when they heard we were going to be taking over this brand.
Joe Renda: So, prescribers were very pleased when they heard we were going to be taking over this brand, and we've been able to sign on a few more contracts from an access standpoint. So, our goal there is to increase the access, the market access, that is, for Ungentis in the market beyond what it was. And so far, we've been very pleased with that performance and progress. And finally, I would say one of the things we're looking at closely to kind of determine the uptick is what our NBRX performance has been, new patients to brand. And we're up some 20% in NBRXs from a performance standpoint. So, so far, we're very pleased, and it's been a great partnership, and it's also been a really good addition to Rytary.
Joseph Todisco: And we've been able to sign on a few more contracts from an access standpoint. So our goal there is to increase the access the market access that is for <unk> and the market beyond what it was and so far we've been very pleased with that performance and progress and finally I would say one of the things we're looking at closely to.
Joseph Todisco: Determine the uptick.
Joseph Todisco: What our NV Rx performance has been new new patients to brand.
Joseph Todisco: And were up some 20% in <unk>.
Joseph Todisco: From a performance standpoint, so so far we're very pleased and it's been a great partnership and it's also been a really good.
Joseph Todisco: Mentation to Rytary.
Chirag K. Patel: Unless you had a question on the I'm Ready RTU. Yeah, the way to think about that for Amneal is, right, it's another complex innovation on the injectable side. It's our first 505B2 launch. We'll do two to three a year going forward. And it's a ready-to-use oncology therapy that reduces steps. So think of it as, you know, a new factor of growth for the company.
Joseph Todisco: And like you had a question on ready.
Joseph Todisco: Ready RTL.
Joseph Todisco: Yes.
Speaker Change: Yes, the way to think about that for annual rate. It's another complex innovation on the injectable side. It's our first 505 to launch will be two to three eight youre going forward.
Speaker Change: And our.
Speaker Change: Our ready to use oncology therapy that reduces steps so think of it.
Speaker Change: A new vector of growth for the company.
Joe Renda: Great, appreciate that extra color. Now, moving on to IPX 203 and with your action date circled for August 7th, can you just talk about perhaps your launch readiness, your plans with the Salesforce, and just overall impact, potential guidance, if any? Thank you.
Great I appreciate that extra color.
Joe Renda: Yeah, go ahead. Okay, yeah.
Speaker Change: Moving on to IPX, two or three and what your action date circled for August seven can you just talk about perhaps your launch readiness.
Speaker Change: <unk> with the sales force.
Speaker Change: Overall impact potential guidance if any thank you.
Joe Renda: So first of all, I would say, you know, one of the things that is significant for us is that we've really become a leader in the Parkinson's space. Rytary has enabled us to develop and deepen relationships with key prescribers and movement disorder specialists across the country and around the world, for that matter. And that is coupled with the fact that we've developed a market access capability that has created an access stream for Rytary that is the best in the Parkinson's community.
Speaker Change: Yes go ahead, okay. Yeah. So first of all I would say.
Speaker Change: One of the things that is significant for us as we've really become a leader in the Parkinsons space Rytary has enabled us to develop and deepen relationships with key prescribers and movement disorder specialists across the country really around the world for that matter and and that also is coupled with the fact that.
Speaker Change: We've developed a market access capability that has created an access stream for Rytary thats the best in the Parkinson's community. So we enjoy some 70% commercial coverage.
Joe Renda: So we enjoy some 70% commercial coverage and about 60 or so percent of the Part D coverage. And then the Ongentis that I just spoke to has enabled us to actually increase our prescriber base. So we're going deeper now into general neurologists. So when you look at our go-to-market strategy with IPX, the three components there are, one, leveraging and working off of those deep relationships that we've built over the last decade in the Parkinson's community. And then second, to leverage that market access capability that we have.
Speaker Change: And about 60, or so percent of the part D coverage and and then the agenda as I just spoke to has enabled us to actually increase our prescriber base that would go we're going deeper now into general neurologists. So when you look at our go to market strategy with IPX. The three components. There are one leveraging and working off of those deep relationships that we have.
Speaker Change: That we've built over the last decade.
Joe Renda: We'll use that same strategy to gain access for IPX203, comparable to what we have with Rytary. And then, finally, I would say that the novel formulation that is IPX203 really offers greater efficacy, better on time, and fewer dosing. So the Parkinson's community itself is very excited. In fact, just last night, we were at a Parkinson's Foundation gala, and there was a lot of buzz and talk about when IPX203 is coming to market. So we're very ready and eager to get IPX203 into the hands of the patients that need it out there, and Les in terms of
Speaker Change: The Parkinson's community and then second is to leverage that market access capability that we have we'll use that same strategy to gain access for IPX, two or three comparable to what we have with Rytary and then finally I would say that the novel formulation that is IPX, two or three really offers greater efficacy better on time fewer dosing.
Speaker Change: So the Parkinson's community itself is very excited in fact, just last night, we were at a Parkinson's Foundation gala.
Speaker Change: And there is a lot of buzz and talk about win IPX, two or three is coming to market. So.
Speaker Change: We're very ready and eager.
Speaker Change: To get IPX, two or three to the hands of the patients that needed out there.
Leszek Sulewski: Great. I appreciate it. Thank you.
Chirag K. Patel: And Les, in terms of potential peak revenues, assuming approval, we continue to feel great about it. The number that we, you know, right now is a couple hundred million dollars in annual revenues, right? The guidance we have given about IPX203 is peak revenues of 300 to 500 million dollars. We think, based on the product profile and the fact that IPX203 has only been used by about 5% of the available patients, right, I think, right away, I'm sorry, so there's a tremendous market opportunity out there for the remaining 95% of the market that's not been using it right away. And I think our peak year revenue is between 300 and 500. I think we're just well within what the team is capable of. Yep.
Speaker Change: And less in terms of potential.
Speaker Change: Peak revenues, assuming approval continue to feel great about it because the number though right right now there's a couple of hundred million dollars in annual revenues.
The guidance, we have given about IPX to three is peak revenues of $300 million to $500 million.
Speaker Change: We think based on that product profile and the fact that IPX two or three is only being used by about 5% of the available patients.
Speaker Change: Alright, though im sorry.
Speaker Change: So there is a tremendous market opportunity out there for the remaining 95% of the market that has not been.
Speaker Change: Utilizing rivalry and pickier revenues $3 to 500, I think I'd, just well within what they think is capable.
Speaker Change: Yes.
Speaker Change: Great appreciate it thank you.
Operator: Thank you. The next question is from David Amsellem with Piper Zemla.
Speaker Change: Thank you. The next question is from David Kelley with Piper Sandler Your line is open.
Speaker Change: Okay.
David A. Amsellem: Thank you. Just have a few questions. Wanted to drill down on the $100 million plus in new product revenue in 2024. Can you talk about the mix between retail and injectable contribution to that $100 million?
David Kelley: Thank you just have a few questions wanted to drill down on the 100 million plus in new product revenue in 2024 can you talk about the mix between retail and injectable.
David Kelley: Contribution in that $100 million.
David Kelley: That's number one number two is how much of the injectable contribution is coming from shortage products.
David Kelley: As.
David Kelley: Complex products.
Speaker Change: So that's another question.
Speaker Change: And then also.
Speaker Change: Switching gears to illnesses bevacizumab.
Similar can you just talk about the dynamics here that are driving the strong sales is it.
Speaker Change: A limited competition in the market.
Speaker Change: Are there other things at play here and just talk about your expectations for.
Speaker Change: For that product.
Speaker Change: And what informs your 100 million plus in sales by 2025. Thank you.
Chirag K. Patel: Great, David. Good, good morning.
Speaker Change: Great David.
David Kelley: Good morning.
Speaker Change: So let me, it's a new product launches, let's just go back a little bit lost five years if you.
Chirag K. Patel: So let me talk about new product launches. Let's go back a little bit. For the last five years, if you go by the NPLs, and you total that to this year's revenue, which is about $765 million, we have added in new product launches and what we see going forward, and this is just within generics, injectables, and biosimilars. We can break it down for you later on, but let's stay on the bigger picture of why we are able to grow this and why, in the United States, this business, this is just a U.S. number. Internationals are separate. Why is this a big deal?
Speaker Change: Go buy the Npls and <unk> total debt to this year's revenue is about $765 million, we have added and new product launches.
David Kelley: And what we see going forward and this is just within generics Injectables and Biosimilars, we can break it down for you later on but stay on the bigger picture is that why we are able to grow this and why in the United States. This business. This is just a U S number international as a separate why this is a big deal.
Chirag K. Patel: Because I think it's over time, people have been focused on price erosion and have ignored the entire biggest market for affordable medicines is the United States. And we now expect the next four years, if you annualize our revenue for the next four years from now, that would be an additional 800 million to a billion dollars added to the new NPLs. So this is, and you know we've been working on such a strong pipeline and in licensing strong products.
David Kelley: Because I think it's four over time people have been focused on price erosion and have ignored the entire biggest market toward affordable medicines is United States.
David Kelley: And we now expect the next 40 years. So if you annualize our revenue next 40 years from in 'twenty eight.
David Kelley: It would be additional $800 million to $1 billion.
David Kelley: Added to the new new to Mpls.
David Kelley: So this is.
David Kelley: You know we've been working on.
David Kelley: Such a strong pipeline and in licensing strong products on page seven of our presentation. We have listed out many of them at 60 products being launched in 2004 and 2005.
Chirag K. Patel: On page seven of our presentation, we have listed out many of them, like 60 products being launched in 24 and 25, 15 of them are high value. So you can see, and more and more high values are happening year out.
David Kelley: 15 of them at high value. So you can see in more and more high value that happening as you go out and we have not disclosed certain pipeline assets for competitive reasons as well as we have not disclosed some of the in licensing products that we are working on it for competitive reasons.
Chirag K. Patel: And we have not disclosed certain pipeline assets for competitive reasons, as well as some of the in-licensing products that we have or are working on for competitive reasons. So very excited to, and these are the risk-adjusted number I gave you. So this $100 million is the breakdown we can provide you later on between the... Well, I can provide it now. I can provide it.
David Kelley: So very excited to and these are risk adjusted number I gave you.
David Kelley: So this $100 million.
David Kelley: Breakdown, we can provide you later on between.
Speaker Change: Look I can provide color.
Chirag K. Patel: So $100 million, it's a combination of a couple of things. Combination of products, if you remember last year towards the end of Q4, quite a number of new products, close to, I think, 13 or so products that were approved in Q4 of last year. So that's kind of the annualization of those revenues, right? As well as new product launches this year. So that $100 million number isn't a certainty, but a high degree of confidence, point number one.
Speaker Change: $100 million its combination of a couple of things combination of products. If you remember last year towards the at the end of Q4 quite a number of new products close to I think 13, or so products that were approved in Q4 of last year. So that's kind of the annual amortization of those revenues as well as new product launches this year.
Speaker Change: So that $100 million number it's not a certainty but high degree of confidence point number one when you break it out between retail and injectable is pretty much almost like 50, 50 60 40 between so it's evenly split retail products like naloxone right.
Chirag K. Patel: When you break it out between retail and injectable, it's pretty much almost like, you know, 50-50, 60-40 between the two. So it's evenly split between retail products like Naloxone, right, on one side, and injectable products like Permedi and, you know, the remaining of the other smaller injectable products. So it's pretty evenly split between retail and injectables.
Speaker Change: On one on one side injectable products.
For many in the remaining of the other smaller injectable products. So it's pretty evenly split between retail and Injectables.
Chirag K. Patel: So yeah, and the next question on the shortages versus regular we're shortages make up very small numbers at this point, which are regular products that we've been expanding the market demands coming our way because we are the best quality and consistent supplier out in the market. So our customers are trusting us, and more and more trust has been established. Your question regarding Olympsis. We have a very strong team; I mean, the commercial team has done a superb job.
Speaker Change:
Speaker Change: And the next your next question on the shortages versus regular.
Speaker Change: Shortages makeup very small numbers at this point with our regular products that we've been we've been expanding the market the demand is coming our way because we.
Speaker Change: We are the best quality and consistent supply it out in the market. So our customers are trusting us and more and more trust has been established your question regarding <unk>, we have a very strong team.
Chirag K. Patel: Amneal's reputation, Amneal's basket of 300 products, we bring a lot more to the table for our customers than if you're a pure play biosimilar. So this is why I believe that in the future, you will see companies being more successful who have a broader portfolio and who are working closely with oncologists, community oncologists, hospitals, or pharmacy benefit managers because we provide tremendous value to them. So we have better negotiating power with them or advantages versus pure play biosimilars.
The commercial team has done a superb job and Neil reputation and meals basket up 300 products, we bring a lot more to the table for our customers than if you're a pure play biosimilar. So this is why I believe.
Speaker Change: For the future you will see the companies being more successful who have a broader portfolio and who are working closely whether it's.
Speaker Change: On <unk>, the community oncologist or the the hospitals all the pbms.
Speaker Change: Because we provide tremendous value to them. So we have.
I have a better negotiating power with them or advantages versus the pure play Biosimilars and we're going to keep.
Speaker Change: Improving in those lenses youll see even higher market share coming coming up as well as thrilled when we add OPI, you'll start seeing the uptake on our market share as well.
Chirag K. Patel: And we're going to keep improving on those. So Alemsis, you will see even higher market share coming up, as well as Phil Netra. When we add OBI, you will start seeing an uptake in market share as well.
David A. Amsellem: That's helpful. Just to clarify, the $100 million does not include Naloxone. I think I saw a footnote for that in the slides. I just want to make sure that's correct.
Speaker Change: That's helpful and just to clarify the $100 million does not include.
Speaker Change: Naloxone I think thats all footnote for that in the slides I just want to make sure Thats correct. The $100 million does not include naloxone.
Chirag K. Patel: David, that's correct. The estimate we had on the Q4 call and reiterated $30 million plus for naloxone; $100 million is for the rest of the NPLs this year.
David Kelley: David that's correct.
David Kelley: The estimate we had on the Q4 call and reiterate 30 million plus for naloxone $100 million is for the rest of the Npls This year.
David A. Amsellem: Great. Okay. Helpful. Thank you.
Speaker Change: Great. Okay helpful. Thank you.
Chirag K. Patel: And David, you can see the five, which my brother mentioned, five already launched, which are good value products and complex.
Speaker Change: And you can see the firewood my brother mentioned <unk> already launched.
Speaker Change: Good value products complex.
Operator: Thank you. The next question is from Balaji Prasad with Barclays. Your line is open.
Speaker Change: Thank you. The next question is from the Rajiv Prasad with Barclays. Your line is open.
Balaji V. Prasad: Hi, good morning, everyone, and congratulations on the results. A couple of questions from me. I was starting with the generic side. I was slightly surprised to see Amneal's paraphore on Zyfaxan. Bausch has been vehemently defending this for years against a host of generic companies settled there. So how differentiated is your paraphore versus others? How realistic of an opportunity is this versus any other generic company? And a similar question on Restasis too.
Hi, good morning, everyone.
Balaji V. Prasad: Congratulations on the results.
Balaji V. Prasad: Couple of questions from me I was starting to.
Balaji V. Prasad: Generic side.
Balaji V. Prasad: Slightly surprised to see <unk> and <unk>.
<unk> been vehemently defending them from Erin Wilson of wholesale generate companies settled there so how differentiator in Egypt power for flushes, others, all realistic off and the opportunity is there.
Balaji V. Prasad: Any other generating company.
Balaji V. Prasad: For years, generic companies have flagged this as an opportunity and struggled to get approval for their version. How should we think about it? Secondly, on healthcare, I saw that versus last quarter's presentation, where you had the long-term guide at $600 million, you raised it to $650 million. What drove that increase in revenue guidance and what is the EBITDA impact on
Balaji V. Prasad: And similar question on stainless till four years generate companies are flagged as as an opportunity and struggle to get approval for the margin.
Balaji V. Prasad: How should we think about it.
Balaji V. Prasad: Secondly on al Khair I saw that versus last quarter's presentation.
Balaji V. Prasad: Where you have the long term guide of $600 million in lanes into $650 million what drove that.
Balaji V. Prasad: Increase in revenue guidance and what is the EBITDA impact of it. Thank you.
Chintu Patel: Hey Balaji, this is Chintu. Good morning.
Balaji V. Prasad: Hey, Bob as it is Tim.
Bob: Good morning.
Bob: Yes.
Bob: On the margin.
Bob: Go ahead Jim.
Chintu Patel: [inaudible]
Jim: Yeah, Hi, Roger good morning. Thank.
Jim: Thank you.
Jim: So under the Fox domain.
Chintu Patel: Yeah. Hi Balaji. Good morning.
Jim: We always work on rather unique in key products and we do have.
Chintu Patel: Thank you. So, Balaji, Fox to me, you know. We always work on very unique and key products, and we do have a... There is something confidential I don't want to get into details.
Jim: <unk>.
Jim: It'd be something confidential I don't want to get into the detail.
Chintu Patel: We are excited about Rifastamin, unfortunately, but it remains to be seen how it develops. There are multiple things that are involved, so we cannot comment at this time on any of the details. On Ristaz, yeah, it is a very complex product. We are advancing our ANDA, and we are expected to launch Ristaz next year in 2025. We are very hopeful about that.
Jim: We are excited about besides the mean approach will be.
Jim: But it remains to be seen how it develops.
Speaker Change: There are multiple things that is involved so we cannot comment at this time.
Speaker Change: Any of the details on this stuff.
Speaker Change: It is a very complex product to the other one.
Speaker Change: Similarly NDA.
Speaker Change: We expect it to launch that he starts his next year in 2025.
Speaker Change: We are very hopeful on that.
Sheila: Go ahead Sheila.
Chintu Patel: Yeah, and your FCARE question, Balaji, is, yeah, it is growing really well. And the Lord of Government product, VADOD, as this is the advantage for, you get some advantage being the American company and having manufacturing capacity in America. So we're taking full advantage of that. And this is why you see the growth in FCARE, and it will continue to grow.
Speaker Change: Yes.
Speaker Change: Good question.
Sheila: Biology is.
Sheila: It is growing really well and the <unk>.
Sheila: A lot of Golar remain product <unk> as this is the advantage for you get some advantage being the being.
Sheila: Being an American company.
Sheila: And having manufacturing capacity.
Sheila: In America, So we're taking a full advantage of that and.
Sheila: This is why you see the growth in health care and it will continue to grow.
Chintu Patel: And Balaji, can you just repeat your other question?
Okay and <unk> can you just repeat your other question.
Balaji V. Prasad: So, yeah, the impact of Avcare and EBITDA, what I'm also trying to figure out is, with your last 12-month revenue, EBITDA already being close to $590 million, and with a stronger revenue trajectory looking that much clearer for us now, what are the upside-downside risks towards the higher end of your EBITDA guidance, and if the Avcare long-term guidance raise, and what's the impact of Avcare guidance raised on the eBid.
Sheila: So yes, the impact of Alcan and EBITDA, what I'm also trying to figure it out let the last 12 months revenue EBITDA already being close to $590 million.
Sheila: Stronger revenue trajectory looking that much clearer for us now.
Sheila: What are the upside downside risk towards the higher end up fitting with our guidance and if the <unk> longer term guidance raise.
Sheila: And what's the impact of Afghan.
Sheila: Guidance range on the EBITDA.
Sheila: Okay.
Anastasios G. Konidaris: Got it. So what has happened is Avcare has been growing along with the rest of the business. So we're now relying on any specific segment, whether or not it's generic, Avcare, specialty, biosimilars, to kind of carry the day. So our growth continues to be across all our businesses, point number one. Point number two is, you know, the upsides and the downsides of the businesses, you know, who continue to rely on new product launches, right, robust new product approvals and launches to kind of carry the day. So we're not always in control of that. So that depends, as you know, on the regulatory authorities.
Speaker Change: Got it so what happens out there I was curious it's been growing.
Speaker Change: Along with the rest of the business. So we're now rely on any specific segment, whether or not these generic specialty.
Speaker Change: Specialty biosimilars.
Speaker Change: Good day, so growth continues to be across all of our all our businesses at that point number one.
Speaker Change: Point number two is.
Speaker Change: The upsides the downsides of the businesses will continue to rely on the new product launches right, a robust new product approvals and launches.
Speaker Change: To kind of carry the day. So we're not always in control of that so that defense as you know with the.
Anastasios G. Konidaris: So some years we may be ahead of schedule, some years we may be a little delayed, but all of those will come. But the cadence of it, right, is not totally in our control. So that's something, you know, we just want to be mindful of, number one. Number two is IPX-203.
Speaker Change: The regulatory authorities. So some years, we may be ahead of plan. Some some years, we may be a little delayed but all of those will come but the cadence of it right is not is not totally in our control. So that's something we just want to be mindful of number one.
Anastasios G. Konidaris: So as we discussed, the vast majority of the potential launch expenses of IPX-203 are kind of built into our existing guidance, right? So we are conservative. If we get approval, then we will have to look at, I think, kind of an incremental top and bottom line contribution of that revenue. So the downside is protected, the upside has not been built in, and after that, it just continues to grow nicely.
Speaker Change: Number two is <unk> three so as we discussed the vast majority of the potential launch expenses of IPX, two or three year kind of built into our existing guidance right. So that we worked on we are conservative and if we get approval. Then we will have to look at I think it kind of incremental top and bottom line.
Speaker Change: Contribution of that of that of that revenue. So the downside is protected the upside has not been has not been built in.
Anastasios G. Konidaris: So hopefully, that gives you a sense. And then the final thing I would say is the type of investments we choose to make, right, to kind of drive. So a lot of it is variable. It's not within our control. So if we think the year plays out incredibly well, we may choose to make some additional investments. If the year plays out a little tighter than we thought, we may just, you know, kind of push back on a couple potential deals.
Speaker Change: And <unk> just.
Speaker Change: Continues to grow nicely. So hopefully that gives you a sense and then the final thing I would say.
Speaker Change: The type of investments, we choose to make right.
To kind of drive so that a lot of it is variable it's within our control. So if we think the year plays out.
Speaker Change: Ill.
Incredibly well, who may choose to make some additional investments.
Speaker Change: If the year is playing a little tighter than we thought we may just kind of pushed back a couple of potential deals.
Chirag K. Patel: The momentum Balaji has been strong, as you can see the six key products have been approved already, so we feel very good about it how the momentum is great and the pipeline is delivering. Congratulations.
Speaker Change: Got it thanks, but momentum biology has been strong as you can see the six key products have been approved already so we feel very good on that.
Speaker Change: Sure.
Speaker Change: The momentum is great and that the pipeline is delivery.
Balaji V. Prasad: Congratulations! Thank you.
Speaker Change: Thank you.
Thank you.
Operator: The next question is from Chris Schott with J.P. Morgan. Your line is open.
Speaker Change: The next question is from Chris Schott with Jpmorgan. Your line is open.
Christopher Thomas Schott: Great. Thanks so much for the questions. Just a couple for me.
Christopher Thomas Schott: Okay, great. Thanks, so much for the questions. Just a couple from me maybe first on Biosimilar Prolia and <unk> could you just elaborate a little bit more on the opportunity for these two and maybe just specifically launch timelines in light of the recent sandoz settlement and of the two brands.
Chirag K. Patel: Maybe first on the biosimilars, Prolia, and Xgeva. Can you just elaborate a little bit more on the opportunity for these two, and maybe just specifically launch timelines in light of the recent Sandoz settlement, and of the two brands, is one more interesting to you than the other, just given the obviously different market dynamics between the two of them? Second question, Naloxone. Between the public market and the retail channel, what are you seeing as the bigger opportunity, and does the opioid settlement at all impact how you think about that? And then, maybe just finally, AppCare. Obviously, great performance here, but just interested in your latest thoughts on the potential to monetize that business and how you're thinking about that. Thank you. Good morning, Chris.
Christopher Thomas Schott: Either more interesting to you than the other just given obviously different market dynamics between the two of them.
Second question naloxone between the public market and retail channel what are you seeing as the bigger opportunity and does the opioid settlement at all impact how you think about that.
And then maybe just finally app care, obviously, great performance here, but just interested in your latest thoughts on potential to monetize that business and how youre thinking about that thank you.
Chirag K. Patel: Good morning, Chris. So let's start with biosimilars, Prolianix, and Jeeva. We are equipped to sell in both channels, the Encore channel as well as PBM. We expect the launch on 26, maybe a bit early. We'll see how the filings go; I think one is early, and one is going to be a little bit later.
Speaker Change: Hey, good morning, Chris.
Speaker Change: So, let's start with Biosimilars Prolia and <unk> we are.
Speaker Change: Are equipped to sell and more channel the encore encore channel as well as ppm.
Speaker Change: We expect the launch in 'twenty six.
Maybe a bit early we'll see how the filing I think one is early one is going to be a little bit later.
Speaker Change: And we expect the market penetration to be very good because we already have established relationship and by then we will have more established relationship with the community oncologists oncology groups as well as the hospital groups and.
Chirag K. Patel: And we expect the market penetration to be very good because we already have established relationships, and by then, we'll have more established relationships with the community oncologists, oncology groups as well as the hospital groups and contracting, PBMs, the relationship overall. So we expect to generate good peak sales should go well above $100 million for these products. Your second question: naloxone.
Speaker Change: Contracting pbms relationship overall, so we expect to.
Speaker Change: To generate a good.
Speaker Change: Peak sales should go well above $100 million for these products.
Second question Naloxone.
Chirag K. Patel: The retail side is slow. The government is where most of the demand is state-wise. Retail is probably 10 percent, 20 percent. We already have contracts with CVS and Walgreens to supply them, and they already have supplied them, both of them. And government is the state of California, the biggest state we get.
Speaker Change: The.
Speaker Change: The retail side is slow the government is where most of.
Speaker Change: The demand is state wise.
Speaker Change: Retail is probably 10%, 20% we are already have contracts with Cvs and Walgreens to supply them and already have supplied them both of them and government is state of California biggest stage, we get we're working with other major states always Neil at home States.
Chirag K. Patel: We are working with other major states, obviously our home states. And we should be getting more business from the government, and this opportunity will become really big. And our settlement does not really impact it if you do the math, which Tony can follow up with you later on.
Speaker Change: And we should be getting more business from government in this.
Speaker Change: This opportunity will become really big and there were settlement does not really impact.
Matt: Matt switch.
Matt: Tony can follow up with you later on there's very little products, which we have 10 million capacity, so no issue whatsoever and healthcare.
Chirag K. Patel: There's very little of the products, which we have 10 million capacity for, so no issue whatsoever. And healthcare, as we have said earlier, strategic options are open. The business is performing really well, so we're not in the rush to do anything. If we get the right price, we will transact and deal our massively, pay down the gross debt by a huge amount, which will be a great acquisition for us. And either way, we're fine with the healthcare.
Matt: As we have said it earlier strategic options are open the business is performing really well, we're not in a rush to do anything if we get the right price, we will transact and Delever massively pay down the gross debt in a huge amount which.
Matt: It's been a great acquisition for us.
Matt: And either way, we are fine with that.
Matt: Okay.
Speaker Change: Great. Thanks, so much.
Speaker Change: Thank you Chris.
Speaker Change: Thank you we have no further questions. So I'll hand back over to Sarah to talk to conclude the call.
Chirag K. Patel: Thank you. We have no further questions, so I will hand the call back over to Chirag Patel to conclude the call.
Sarah: Thank you. Thank you. So Q1 was an outstanding start to 2024 as a momentum build across all areas of our diversified business from a recent naloxone launches latest example, Annette and Neil below what we do and our teams are.
Chirag K. Patel: Thank you, thank you. So Q1 was an outstanding start to 2024 as the momentum builds across all areas of our diversified business. Our recent Naloxone launch is the latest example. And at Amneal, we love what we do. And our teams are fired up, high momentum across the company all over the United States, Ireland, all over India, and we just could not be even more excited about the overall health and performance of our company. So thank you, everybody, everyone, and have a great day.
Sarah: Fired up high momentum with cross.
Sarah: Company.
Sarah: All over the United States, Ireland, all over India.
Sarah: And we just could not be even more excited for overall.
Sarah: The health and performance of our company. So thank you everybody, everyone and have a great day.
Operator: Thank you, Chirag. This concludes today's call. Thank you for joining us. You may now disconnect your line.
Speaker Change: Thank you Sir this concludes today's call. Thank you for joining you may now disconnect your lines.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: [music].
[music].
Speaker Change: Okay.