Q1 2025 Amneal Pharmaceuticals Inc Earnings Call
Unknown Attendee: Hello everyone, and thank you for joining the Amneal Q1 2025 earning. Please register your questions… are four by one. Minds, please press star.
Hello, everyone and thank you for joining the Amnio Q1, 'twenty 25 earnings call. This call will begin shortly.
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Unknown Attendee: Good morning and welcome to the Amneal Pharmaceuticals first quarter 2025.
Speaker Change: Good morning, and welcome to the Amnio Pharmaceuticals first quarter 2025 earnings call.
Unknown Attendee: I'd now like to turn the call over to Amneal's Head of Investment. Good morning, and thank you for joining Amneal Pharmaceuticals' first quarter 2025 earnings call. Today, we issued a press release reporting Q1 results. The earnings press release and presentation are available at Amneal.com.
I'd like to turn the call amnio.
Speaker Change: <unk> head of Investor Relations pennies MAA.
Daniel: Good morning, and thank you for joining Daniel Pharmaceuticals, first quarter 2025 earnings call.
Speaker Change: Today, we issued a press release reporting Q1 results.
Speaker Change: Earnings press release, and presentation are available and Youll Dot com.
Unknown Attendee: 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.
Speaker Change: Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions.
Speaker Change: Forward looking statements that are based solely on information that is now available to us.
Speaker Change: Please see the section entitled cautionary statements on forward looking statements.
Speaker Change: Factors that may impact future performance.
Unknown Attendee: We've also discussed non-GAAP measures. Information on use of these measures and reconciliations to GAP are in the earnings release and presentation.
Speaker Change: We will also discuss non-GAAP measures.
Speaker Change: Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation.
Unknown Attendee: On the call today are Chirag and Chintu Patel, co-founders and co-CEOs, Tasos Konidaris, CFO, our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer.
On the call today, Archrock and <expletive> to Patel co founders and co Ceos passes plenty Dennis CFO, our commercial leaders, Andy Boyer for Affordable medicines, Joe Randell for specialty and Jason Daly Chief Legal officer.
Chirag Patel: I will now hand the call over to Chirag. Thank you, Tony. Good morning, everyone. In Q1, we delivered another quarter of strong performance and continued growth, driven by the successful execution of our strategy. Q1 revenues of $695 million grew 5% and adjusted a bit to $170 million, grew 12%. Over the years, we have made deliberate decisions and investments across our business. and delivered on our commitment. over time and through market cycles. We have differentiated Amneal from our peers by delivering sustainable growth, driven by our leadership and quality, innovation and execution. Today, Amneal is in as strong a position as ever.
Speaker Change: Now I'll hand, the call over to Iraq. Thank you Tony.
Speaker Change: Good morning, everyone. In Q1, we delivered another quarter of strong performance and continued growth driven by the successful execution of our strategy.
Speaker Change: Q1 revenues of $695 million grew 5% and then just a little bit under $70 million.
Speaker Change: 12%.
Speaker Change: Over the years, we have made deliberate decisions and investments across our business.
Speaker Change: And delivered on our commitments.
Speaker Change: Good times and through market cycles.
Speaker Change: Appreciate it a meal from what appears by delivering sustainable growth.
Speaker Change: They run by our leadership in quality innovation and execution.
Speaker Change: And Neil is in a stronger position and as ever.
Chirag Patel: We are embarking on our next phase of growth with momentum and confidence in our ability to deliver on our goals in 2025 and beyond. Big picture, Amneal is a trusted leader in an essential industry. providing millions of Americans with access to affordable and innovative treatments. Each year, we fill over 162 million scripts for American patients. Amneal has one of the largest U.S. pharmaceutical manufacturing footprints in the industry. with a broad portfolio of over 280 products. Over 150 of our medicines are made in the United States. from antibiotics, antivirals to medicines that treat Alzheimer's, cancer, Parkinson's disease.
Speaker Change: We are embarking on our next phase of growth with momentum and confidence in our ability to deliver.
Speaker Change: I know, where it goes in 2025 and beyond.
Speaker Change: Big picture.
Speaker Change: <unk> is a trusted leader in an essential industry.
Speaker Change: Providing millions of Americans with access to affordable and innovative treatments each year, we feel over a 162 million scripts for the American patients.
Speaker Change: And Neil has one of the largest U S pharmaceutical manufacturing footprint in the industry.
Speaker Change: With a broad portfolio of over 280 products.
Speaker Change: 450, <unk> medicines I've made in the United States.
Speaker Change: Antibiotics antivirals.
Speaker Change: Medicines that treat Alzheimer's cancer Parkinson's disease.
Chirag Patel: What Amneal, Made in America, isn't just a label. It's been a cornerstone of our strategy since our founding in 2002 in Patterson, New Jersey.
Speaker Change: What a meal.
Speaker Change: In America, and then just a label it's been a cornerstone of our strategy since our founding in 2002 and pages in New Jersey.
Chirag Patel: Let me now walk you through the key areas of our business.
Speaker Change: Let me now walk you through the key areas of our business.
Chirag Patel: First, in our specialty segment, the launch of Crexon for Parkinson's disease continues to exceed expectations in its first year of commercialization.
Speaker Change: Cost.
Speaker Change: Our specialty segment the launch of correct song for Parkinson's disease continues to exceed expectations in its first year of commercialization.
Chirag Patel: Market Update. has been strong with market share already surpassing 1% and on track to reach over 3% by end of this year. We have received remarkable feedback from patients and providers as one Key Opinion Leader. who is also a patient, shared the following, Crexon has made me feel and move tremendously better compared to Ritary. I have concrete examples of how Crexon has changed my life. It has made a huge difference.
Speaker Change: Market uptake.
Speaker Change: Has been strong.
Speaker Change: With market share already surpassing one person.
Speaker Change: And on track to reach over 3% by end of this year.
Speaker Change: We have received remarkable feedback from patients and providers as one.
Speaker Change: Key opinion leader.
Speaker Change: Who is also a patient shared the following.
Speaker Change: Nexon has made me feel and moved tremendously better compared to Rytary.
Speaker Change: Concrete examples.
Greg: Greg <unk> has changed my life.
Speaker Change: It has made a huge difference.
Chirag Patel: In addition, we are pleased with the continued progress and momentum in expanding market access. This year so far, CREXON has been added to several major insurance plans, including the Veteran Administration, UnitedHealthcare, CVS Health, and Cigna Commercial. These doubles the total U.S. coverage from approximately 30% at the end of 2024 to approximately 60% of U.S. covered lives today. To put that in perspective, Craigson has achieved in six months that Rytary took years to accomplish in market access coverage.
Speaker Change: In addition, we are pleased with the continued progress and momentum and expanding market access.
Speaker Change: This year so far.
Speaker Change: <unk> has been added to several major insurance plans, including the veterans administration.
Speaker Change: <unk> healthcare, Cvs health and Cigna commercial.
Speaker Change: This doubles the total U S coverage from approximately 13% at the end of 2024 to.
Speaker Change: Approximately 60% of U S covered lives today.
Speaker Change: To put that in perspective for Exxon has achieved in six months later, it took years to accomplish and market access coverage.
Chirag Patel: We are highly confident in achieving US peak sales of 300 to 500 million. Overall, we are focused on expanding our specialty branded portfolio over time.
Speaker Change: We are highly confident in achieving USB sales of three to $300 million to $500 million.
Speaker Change: Exxon overall, we are focused on expanding our specialty branded portfolio over time.
Chirag Patel: Next, with the anticipated launch of our DHE auto injector later this year. Second, in GLP-1s, we continue to advance our partnership with Metsera in the weight loss and obesity space.
Next with the anticipated launch of our <unk> auto injector later this year.
Speaker Change: Second in GOP once we continue to advance our partnership with <unk>.
Speaker Change: In the weight loss and obesity space.
Chirag Patel: which represents a new integrated business model to drive innovation at scale in GLP1. Mathsera is rapidly advancing its pipeline of ultra-long acting injectable and oral candidates. As they have shared, MEDSERDA's lead program, MED097I, a monthly ultralong acting injectable, is expected to deliver Phase IIb trial results mid-year. Amneal is Metsera's preferred global supplier across the United States, Europe, and other markets. Also, Amneal will commercialize their products in 20 emerging markets, including India.
Speaker Change: Which represents a new integrated business model to drive innovation at scale and <unk>.
<unk> is rapidly advancing its pipeline of ultra long acting injectable and oral candidates.
Speaker Change: As they have shared <unk> lead program <unk> 197.
Speaker Change: The monthly ultra long acting injectable is expected to deliver phase two b trial.
Speaker Change: Midyear.
Neil: And Neil as much there as a preferred global supplier.
Neil: The United States Europe, and other markets also and Neil will commercialize their products in 20 emerging markets, including India.
Chirag Patel: To support this plan, we are leveraging our existing infrastructure while constructing a high volume peptide manufacturing facility and an advanced sterile fill and finish production facility. Over time, we expect GLP-1s will be a long-term growth driver for Amneal with three avenues of value creation. First and foremost, our collaboration with Medsera. Second, potential CMO offerings for other large companies. And lastly, manufacturing capacity we can provide for generic weight loss therapies globally.
Neil: To support this plan, we are leveraging our existing infrastructure.
Neil: Constructing a high volume peptide manufacturing facility and an advanced sterile fill and finish production facility.
Neil: Overtime, we expect GOP ones will be a long term growth driver for a meal with three avenues of value creation.
Stan: Well, Stan foremost, our collaboration with <unk> et cetera.
Stan: Second potential CMO offerings for other large companies and lastly manufacturing capacity, we can provide for genetic weight loss therapies globally.
Chirag Patel: Third, in our affordable medicine segment, which includes retail generics, injectables and biosimilars, growth continues to be driven by our diversified, complex portfolio and new launches. In particular, our injectables portfolio is expanding. Last month, we launched Buruzu, which is our fourth 552 injectable launch over the last year. These ready-to-use solutions improve hospital efficiency by eliminating medication preparation steps and have unique reimbursement coding for hospitals.
Stan: Third.
Stan: At Affordable Medicine segment, which includes retail generics Injectables and Biosimilars.
Stan: Growth continues to be driven by our diversified complex portfolio and new launches in particular, our injectables portfolio is expanding.
Stan: Last month, we launched <unk>.
Stan: Which is our fault five probably do injectable launch over the last year. These ready to use solutions improve hospital efficiency by eliminating medication preparation steps and have unique reimbursement coding for hospitals.
Chirag Patel: Fourth, turning to biosimilars. This represents a next major wave of affordable medicines in the United States. According to an IQVIA report, more than 100 biologics will lose exclusivity over the next decade. Yet, only 10% have biosimilars in development. biosimilars for the remaining 90% could save approximately $189 billion over 10 years. For patients, biosimilars improve affordability and access to essential therapies. For Amneal, they represent a compelling long term growth opportunity that we are well positioned to lead. Today, our strategic focus has been in licensing our biosimilar portfolio and establishing a commercial platform. In 2024, our first three biosimilars generated 125 million revenue.
Stan: Both.
Stan: Turning to Biosimilars. This represents our next major wave of affordable medicines in the United States. According to an IQ report more than 100 biologics will lose exclusivity over the next decade.
Stan: Only 10% no biosimilars in development.
Stan: Biosimilars for the remaining 90% could save approximately $189 billion over 10 years.
Stan: Patients biosimilars improve affordability and access to essential therapies.
Stan: For our new data present, a compelling long term growth opportunity that we are well positioned to lead.
Stan: To date, though his strategic focus has been in licensing our biosimilar portfolio and establishing a commercial platform.
Stan: In 2024.
Stan: Our first three biosimilars generated $125 million revenue.
Chirag Patel: In addition, we have expanded our pipeline with regulatory applications for five additional biosimilars being filed this year. By 2027, we expect to have six biosimilars on the market across eight product presentations. Our strategic goal is to be vertically integrated in biosimilars and leverage our proven ability and expertise to develop, manufacture and commercialize complex biopharmaceuticals at scale.
Stan: In addition, we have expanded our pipeline with regulatory applications for five additional biosimilars being filed this year.
Stan: By 2027, we expect to have six biosimilars on the market across eight product presentations.
Stan: Our strategic goal is to be vertically integrated in biosimilars and leverage our proven ability and expertise to develop manufacture and commercialize complex biopharmaceuticals at scale.
Chirag Patel: Finally, growth in our healthcare segment continues to be driven by new launches across three channels, distribution, government, and unit dose. We expect healthcare revenue to reach over $900 million by 2027. This business adds stability and diversification to Amneal's portfolio.
Stan: Finally growth in our <unk> segment continues to be driven by new launches across across these channels distribution government and unit dose we.
Stan: We expect <unk> revenue to reach over $900 million by 2027.
Stan: This business adds stability and diversification to revenues portfolio.
Chirag Patel: In summary, Amneal has a diverse array of growth drivers that enhance our competitive differentiation, drive sustainable value creation, and improve access and care for patients. Our strategic focus and long-term investments have been intentional and thoughtful. We could not be more excited about what the future holds as we advance our vision to be America's number one affordable medicines company.
Speaker Change: In summary, and Neil has diverse array of growth drivers that enhance our competitive differentiation.
Speaker Change: Drive sustainable value creation, and improve access and care for patients.
Speaker Change: Our strategic focus and long term investments have been intentional and popcorn.
Speaker Change: We could not be more excited about what the future holds as we advance <unk> vision to be America's number one affordable medicines company.
Chintu Patel: I will now turn it over to Chintu. Thank you, Chirag. And good morning, everyone. Let me begin by expressing my deep appreciation to our Amneal team. Your passion and commitment continue to drive Amneal forward as a purpose driven company focused on innovation, execution and value creation.
Jim: I will now turn it over to Jim.
Jim: Thank you Gerard and good morning, everyone.
Jim: Let me begin by expressing my deep appreciation to our M&A team.
Jim: Their passion and commitment.
Jim: Can you do drive revenues forward as the pipelines driven company focused on innovation execution and value creation. This morning.
Chintu Patel: This morning, I will provide an update on our strategic priorities across operations, innovation and our portfolio. First on operations, our global high-quality manufacturing infrastructure remains a key differentiator. Amneal continues to be recognized for its stellar quality track record and operational excellence. We are investing in digitization, automation, and AI technologies across our network to drive operational efficiency and our trusted quality and customer service reputation. This foundation positions us well to launch new products, help address drug shortages in the market, and serve more patients. Amneal has a robust and diverse manufacturing footprint across the US, India, and Ireland.
Jim: An update on our strategic priorities across operations innovation in our portfolio.
Jim: First on operations, our global high quality manufacturing infrastructure remains the key differentiator M&A continues to be recognized for its better quality track record and operational excellence, we are investing in digitization automation and AI technologies.
Jim: Lower net growth to drive operational efficiency and they were trusted quality and customer service reputation This foundation positions us.
Jim: As well to launch new products help address shortages in the market and some are more patients.
Jim: <unk> has a robust and diverse manufacturing footprint across across the U S. India in Ireland and the U S. Our extensive manufacturing infrastructure and capabilities are the foundation of our leadership position. We are one of the largest domestic pharmaceutical manufacturing.
Chintu Patel: In the US, our extensive manufacturing infrastructure and capabilities are the foundation of our leadership position. We are one of the largest domestic pharmaceutical manufacturing footprints in the industry as we produce many of our genetics and specialty products, including Hexant, in the US. Over the years, we have built deep pharmaceutical manufacturing expertise across a wide range of dosage forms in the US, from oral solids to highly complex formulation. We have seven USFD approved manufacturing facilities across four sites capable of making oral solids, liquids, topicals, transdermal patches, and nasal spray dosage forms with excess capacity to meet market needs.
Jim: Brings in the industry as we produce many of our genetics and specialty products, including <unk> in the U S.
Jim: Over the years, we have built deep pharmaceutical manufacturing expertise across a wide range of dosage forms in the U S from oral solids to highly complex formulations we.
Jim: We have seven U S FDA approved manufacturing facility across four sites.
Jim: Making oral solids liquids topic goes transdermal patches and nasal spray dosage forms.
Jim: Excess capacity to meet market needs.
Chintu Patel: Amneal is proud of its Made in America heritage, which is a competitive advantage and a core part of our strategy.
Jim: Proud of it's maybe in America have usage, which is a competitive advantage and a core part of our strategy.
Chintu Patel: Turning to innovation, we are pleased with the progress of Craxon in the first six months of launch, with strong KPI across the board. The product is engineered for rapid onset and extended efficacy, delivering more good on time with fewer doses for Parkinson's patients. At the American Academy of Neurology meeting last month, our team shared new data from our Phase III study, showing significant improvements in sleep quality for patients on Craxon. In particular, sleep disturbances affect up to 80% of PD patients. Further, our open-label phase 4 study is underway to generate additional real-world evidence. with robust early adoption and strong feedback from the neurology community and patients cracked on these boys to become the leading, leading branded product for Parkinson's disease.
Jim: Turning to innovation, we are pleased with the progress of <unk> in the first six months of launch with strong kpis across the board.
Jim: <unk> is engineered for rapid onset and extended efficacy delivering more and good on time with four fewer doses for Parkinson's patients a.
Jim: At the American Academy of Neurology meeting last month, our deemed shed new data from our phase III study showing significant improvements in sleep quality for patients on <unk> in particular sleep disturbances effect.
Jim: 80% of PD patients.
Jim: Our open label Phase <unk> study is underway to generate additional evidence.
Jim: With robust early adoption and strong pre buy from the neurology community and patients to extra Exxon is poised to become the leading leading branded product for Parkinson's disease.
Chintu Patel: Next in our specialty pipeline is the DHE auto-injector for migraine and cluster headache. Our goal date is coming up this month. This innovative presentation of a well-known molecule was developed and will be manufactured in-house.
Jim: Next day or specialty pipeline is the BMC operating injector for migraine and cluster headache.
Jim: Gordon date is coming up this month.
Jim: As you know, we do presentation of a well known molecule was dialogue and we'll be manufacturing in house and.
Chintu Patel: This first and only DHE auto-injector is intended to help patients avoid emergency room visits during these painful headache episodes. We look to launch this product later this year and see the DHE auto-injector as a 50 to 100 million pixels opportunity.
Jim: In these first and only <unk> or green injected is.
Jim: Intended to help patients avoid emergency room visits during this painful headache episodes, we look to launch this product later this year and <unk> Green injector.
Jim: 50 to 100 million peak sales opportunity.
Chintu Patel: In addition, our strategic partnership with Maxera in the GLP-1 space is progressing as planned. As part of this collaboration, we are building two new manufacturing facilities, one for peptide drug substance production and another for advanced sterile field finish manufacturing. These facilities will enable high volume production as Amneal serves as Maxera's preferred global supplier and will support large-scale GLP-1 commercialization. This collaboration exemplifies how we are leveraging our strong core competencies in R&D and complex manufacturing to lead in high-growth therapeutic areas like GLP-1.
Jim: In addition, our strategic partnership with net setup in the <unk> space is progressing as planned as.
Jim: As part of this collaboration we are building two new manufacturing facilities, one for peptide drug substance production and another.
Jim: So im thrilled finish manufacturing.
Speaker Change: This facility will unable to high volume production and new stores as Matt said is pretty important global supplier and will support large scale GMP broader commercialization.
Speaker Change: These collaboration exemplifies how we are leveraging our strong core comprehensive in R&D and complex manufacturing to lead in high growth at everyday gave you is <unk>.
Chintu Patel: on our Complex Genetics Portfolio. Each year, we expect to launch 20 to 30 new products. We have launched eight new products so far in 2025. Later this year, we have several key complex product launches, including Bradford Ophthalmic Suspension and Respiratory Injection. Overall, we have 81 ANDAs pending approval, of which 65% are non-oral solids, and 47 products in development, of which 96% are non-oral solids. We continue to prioritize within our R&D portfolio and allocate investment towards higher growth areas like specialty brands, injectables, and biosimilars over time. In injectables, we launched 12 new products in 2024 and expect to launch over 10 new injectables in 2025.
Speaker Change: On our complex generics portfolio.
Speaker Change: Each year, and we expect to launch <unk> towards the new products, we have launched eight new products so far in 2025.
Speaker Change: This year, we have several key complex product launches, including <unk> ophthalmic suspension investigator going to injection overall, we have <unk> Anda is pending approval of beach, 65% non oral solids and 47 products in development.
Speaker Change: <unk> reached 96% are non oral solids.
Speaker Change: Continue to prior guidance within our R&D portfolio, and allocating investment towards higher growth areas like expression dividends Injectables and biosimilars overtime.
Speaker Change: And inject it wants to be launched brand new product and brand deeper than before and expect to launch over 10, New injector was in 2025 and.
Chintu Patel: In particular, we have launched four new 55E2 injectables over the last year, which is a new growth vector for our business. In April, we launched Boruzu, our fourth 55E2 injectable. In addition, we have 10 to 12 more 55E2 injectables in development. Other complex injectable R&D programs, including microspheres, liposomers, and drug device combinations, continue to progress well. Amneal is well positioned to be a leader in the injectable space in the coming years with our robust manufacturing footprint, deep scientific capabilities, and expanding portfolios.
Speaker Change: For <unk>, we have launched four new firefighters Green gave us over the last year, which is a new growth vector part of our business in April we launched <unk> or <unk>.
Speaker Change: Forest firefighter doing injectable and.
Speaker Change: In addition, we have tend to have more firepower to injectables in development other complex injectable R&D programs, including microspheres LIBOR zones, and drug device combinations continue to progress Violet.
Speaker Change: <unk> is well positioned to be a leader in the injectable space in the coming years to meet the robust manufacturing footprint.
Speaker Change: Scientific capabilities and expanding portfolio and Biosimilars, we see a.
Chintu Patel: In biosimilar, we see a significant market potential given the upcoming wave of LOEs for biologics and the clear opportunity for Amneal to establish a leadership position in the space. This year, we are filing our next five biosimilar pipeline candidates, with launches targeted for 2026 and 2027. The BLA filings for two Danazumab biosimilars were submitted with goal dates in quarter four. Next, the supplemental BLA filings for Pacfil-Grastin, OBI, and AutoInject is expected in the third quarter, followed by the BLA filings for biosimilar Zolair set for quarter four. We look to expand our biosimilar portfolio and be vertically integrated over time.
Speaker Change: Significant market potential given the upcoming view of alloys for biologics and the clear opportunity for revenues.
Speaker Change: Establish a leadership position in this space.
Speaker Change: This year, we are filing our next final biosimilar pipeline candidates with launches targeted for 'twenty.
Speaker Change: And 2027.
Speaker Change: Filings for <unk> Biosimilars were submitted with Golar date in quarter four.
Speaker Change: Next the supplemental BLA filings for Pegfilgrastim.
Speaker Change: And our body injector is expected in the third quarter, followed by EMEA filings for Biosimilar Xolair set for quarter four.
Speaker Change: To expand our Biosimilars portfolio and we were deeply integrated over time in summary, we have continued our strong operational momentum and execution in <unk> five our strategic focus on innovation quality and manufacturing excellence.
Chintu Patel: In summary, we have continued our strong operational momentum and execution in 2025. Our strategic focus on innovation, quality, and manufacturing excellence sets us for sustainable growth and leadership across our business.
Speaker Change: For sustainable growth and leadership across our business.
Tasos Konidaris: Thank you, and with that, I will hand it over to... Thank you, Chintu, and good morning, everyone. In the first quarter, we saw continued broad-based growth across our three segments, excellent uptake of CREXAM, and new product launches that further enhance our growth profile and diversification. As a result, we're incredibly proud of our global teams for delivering growth of 5% in revenue, 12% in adjusted EBITDA, and 50% growth in adjusted EPS.
Brussels: And with that I will hand, it over to Brussels.
Speaker Change: Thank you Tim and good morning, everyone in the first quarter. We saw continued broad based growth across our three segments.
Speaker Change: Excellent uptake of Craig some and new product launches that further enhance our growth profile and diversification.
Speaker Change: As a result, we're incredibly proud of our global teams for delivering growth of 5% in revenue.
Speaker Change: <unk> percent in adjusted EBITDA, and 50% growth in adjusted EPS.
Tasos Konidaris: I'll first cover our Q1 results in more detail, then touch on tariffs, and finally affirm our 2025 full-year guidance. In the first quarter of 2025, total net revenues of $695 million grew 5% in line with our expectations. Q1 affordable medicines revenue of $415 million grew by $23 million for 6% and new products launched in 2024 and 2025 added $41 million. Our affordable medicines portfolio includes approximately 270 products across retail, injectables, and biosimilars. As Chirag and Chintu mentioned, Amneal's R&D success, excellent supply chain and commercial execution are key strengths, driving consistent revenue growth, broadening of our product portfolio, and delivering value to our customers, providers, and patients.
Speaker Change: I'll first cover our Q1 results in more detail then touch on tariffs and finally, a fair amount of 2025 full year guidance.
Speaker Change: In the first quarter of 2025 total net revenues of $695 million grew 5% in line with our expectations.
Speaker Change: Q1, affordable medicines revenue of $400.
Speaker Change: <unk> grew by 23 million four 6% of new products launched in 2024, and 2025 added $41 million.
Speaker Change: Our affordable medicines portfolio includes approximately 270 products across retail Injectables and Biosimilars.
Speaker Change: As <unk> mentioned Npls R&D success excellent supply chain and commercial execution, our key strengths.
Speaker Change: Driving consistent revenue growth.
Speaker Change: Broadening of our <unk>.
Product portfolio and delivering value to our customers providers and patients.
Tasos Konidaris: In our specialty segment, Q1 revenue of 108 million grew 3%, driven by CREXON, which added 9 million, and Unitroid, which added 4 million in the quarter. We're delighted by the market acceptance of CREXON, an upcoming payor coverage expansion. Consequently, we're confident that Craigson will meet or exceed its 2025 revenue goal of $50 million. Q1, healthcare revenues of $172 million grew 6%. A strong growth in the government channel was partially offset by softness in the lower margin distribution channel. From a gross margin perspective, we're extremely pleased to report Q1 adjusted gross margins of 43.1% up 120 basis points year over year.
Speaker Change: In our specialty segment Q1 revenue of about $108 million grew 3% driven by <unk>, which added $9 million in.
Speaker Change: And unit growth, which added $4 million in the quarter.
Speaker Change: We are delighted by the market acceptance of products and upcoming payer coverage expansion.
Speaker Change: And sequentially, we're confident that correct, Sam will meet or exceed its 2025 revenue goal of $50 million.
Speaker Change: Q1 revenues of $172 million grew 6% a strong growth in the government channel was partially offset by softness in the lower margin distribution channel.
Speaker Change: From a gross margin perspective, we're extremely pleased to report Q1, adjusted gross margins of 43, 1%.
Speaker Change: Up 120 basis points year over year.
Tasos Konidaris: This strong margin expansion was driven by favorable product and channel mix, new product launches, and higher efficiencies at the plant level. Q1 Adjusted EBITDA of $170 million grew 12%, reflecting revenue growth, higher gross margin, and operating expense leverage. From an EPS perspective, we're pleased to report Q1 Adjusted EPS of $0.21, which represents 50% growth driven by higher adjusted EBITDA and lower interest expense.
Speaker Change: With strong margin expansion was driven by favorable product and channel mix.
New product launches and higher efficiencies at the plant level.
Speaker Change: Q1, adjusted EBITDA of $170 million grew 12% reflecting revenue growth.
Speaker Change: Higher gross margin and operating expense leverage.
Speaker Change: From an EPS perspective, we're pleased to report Q1, adjusted EPS of <unk> 21.
Speaker Change: Which represents 50% growth driven by higher adjusted EBITDA and lower interest expense.
Tasos Konidaris: In summary, we're off to a strong start for the year driven by strong execution across a multitude of growth drives. In addition, we continue to strengthen our overall financial position with strong cash flow generation, no near-term debt maturities, and continue to reduce leverage. In Q1, gross leverage was further reduced to 4.0 versus 4.1x at year-end 2024, and net leverage remained at 3.9x.
Speaker Change: In summary, we're off to a strong start for the year driven by strong execution across a multitude of growth drivers.
Speaker Change: In addition, we continued to strengthen our overall financial position and strong cash flow generation, no near term debt maturities and continuing to reduce leverage.
Speaker Change: Q1, gross leverage was further reduced to four <unk> versus four onex at year end 2024.
Speaker Change: Net leverage remained at $3 Nymex.
Tasos Konidaris: Let me now turn to tariffs. And even though it's difficult to quantify precise implications, our team is developing numerous mitigating actions across multiple scenarios. First, our financial forecast already includes a modest impact of our current tariff provision. Second, we already have a large and growing manufacturing presence in the U.S., which produces two-thirds of our affordable medicines and specialty revenues. The remaining one-third mostly comes from our India operations and imports from the rest of the world are not very meaningful. Third, our teams are taking several mitigating actions to ensure we deliver on our commitments to patients and their homes.
Speaker Change: Let me now turn to tariffs.
Speaker Change: And even though it's difficult to quantify precise implications our team is developing numerous mitigating actions across multiple scenarios.
Speaker Change: First our financial forecast already include a modest impact.
Speaker Change: The current tariff provisions.
Speaker Change: Second we already have a large and growing manufacturing presence in the U S, which produces two thirds are about a affordable medicines and specialty revenues.
Speaker Change: The remaining one third mostly comes from our India operations and imports from rest of the world.
Speaker Change: Very meaningful.
Speaker Change: Third our teams are taking several mitigating actions to ensure we deliver on our commitments to patients and shareholders.
Tasos Konidaris: This includes increasing our U.S.-based inventory. secure alternative sources of API. Renegotiating Supply Agreements. Thriving Portfolio Optimization and Other Productivity Initiatives.
Speaker Change: These include increasing our U S based inventory.
Speaker Change: Secure alternative sources of API.
Speaker Change: Renegotiating supply agreements.
Speaker Change: Driving portfolio optimization and other productivity initiatives.
Tasos Konidaris: Finally, from a long term perspective, we believe our multiple growth vectors, extensive US manufacturing capabilities, and leading commercial presence position Amneal well in being a top tier growth company.
Speaker Change: Finally from a long term perspective, we believe our multiple growth vectors extensive U S manufacturing capabilities, and leading commercial presence position <unk> well in being a top tier growth company.
Tasos Konidaris: Finally, we're pleased to affirm our full year 2025 expectations. And as a reminder, we expect total net revenue between 3 and 3.1 billion, which reflects 7 to 11% upline growth. Adjusted EBITDA between $650 to $675 million, reflecting 4% to 8% growth and adjusted EPS of $0.65 to $0.70, reflecting 12% to 21% growth.
Speaker Change: Finally, we're pleased to affirm our full year 2025 expectations.
Speaker Change: As a reminder, we expect total net revenue between three and $3 1 billion.
Speaker Change: Which reflects 7% to 11% topline growth.
Speaker Change: Adjusted EBITDA between $650 million to $675 million, reflecting 4% to 8% growth.
Speaker Change: Adjusted EPS of <unk> 65 to 70.
Speaker Change: Reflecting 12% to 21% growth.
Chirag Patel: I will now turn the call back to Chirag. Thank you. Our performance in Q1 reflects the strength of our diversified business, continued execution of our strategy, and the dedication of our team.
Chuck: I will now turn the call back to Chuck.
Chuck: Thank you.
Speaker Change: So our performance in Q1 reflects the strength of our diversified business.
Chuck: <unk> execution of our strategy.
Chuck: And the dedication of our team.
Chirag Patel: We remain confident in our ability to drive sustainable value as we advance in this exciting next chapter of growth.
We remain confident in our ability to drive sustainable value as we advance in this exciting next chapter of growth.
Unknown Attendee: Let's now open the call for question and answer. We will now begin the Q&A session. To ask.
Chuck: Let's now open the call for question and answers.
Chuck: Thank you we will now begin the Q&A session.
To ask a question. Please press star followed by one I'll go to the thank you Pat now.
Unknown Attendee: of Mines, Dave Pesta. Please feel free to ask your questions.
Pat: If you change your mind, Please press star one.
Pat: Ask your question. Please ensure your device is underneath it lately.
David Amsellem: Our first question today comes from... and Jolijn Nijboer. Hey, good morning and thanks. So I have a couple of questions on biosimilars and generic injectables. First on biosimilars, can you just give us a refresher on what you expect the 25 contribution, top line contribution to be and particularly interested in how big you think Olympus could be? I think you in the past have cited it as being about 100 million of contribution, but I just wanted to just level set those expectations for biosimilars for this year. And then secondly, you talk about vertical integration regarding your biosimilar business.
David: Our first question today comes from David <unk> from Piper Sandler Your line is now open.
Okay.
Speaker Change: Hey, good morning, So I have a couple of questions on Biosimilars and generic Injectables first on Biosimilars can.
Speaker Change: Can you just give us a refresher on what you expect the 25 contribution top line contribution.
Speaker Change: To be particularly interested in how big you think.
Speaker Change: Olympus could be I think in the past have cited it as being about $100 million contribution, but I just wanted to just level set those expectations for biosimilars for this year.
Speaker Change: And then secondly, you talk about vertical integration regarding your Biosimilar business I guess my question here is when do you think that's going to actually come to pass and.
David Amsellem: I guess my question here is, when do you think that's going to actually come to pass? And how should we be thinking about not just the next couple of years, but sort of the next five years as we think about the cadence of new launches and just your overall thoughts on contribution for biosimilars to the top line? So that's on biosimilars.
Speaker Change: How should we be thinking about not just the next couple of years, but sort of the next five years as we think about the cadence of new launches and just your overall.
Speaker Change: Thoughts on contribution for Biosimilars to the top line.
Speaker Change: That's our Biosimilars and then on Injectables.
David Amsellem: And then on injectables, I know you've cited shortages, but you've also cited more complex products. I guess as you think about the business, is there a lean into one versus the other? And just help us better understand what you think injectables, top line contributions are. is going to be this year. Thank you, David. And good morning. Biosymbolism, we're in line with what we have said, around $150-$60 million in total contribution on the top line, with Ellimsis being a leading product. You're in the ballpark somewhere between $90-$100 million. That's what we are driving towards. So that's the current existing products.
Speaker Change: I know you've cited shortages.
Speaker Change: But you've also.
Speaker Change: <unk> had more complex products I guess as you think about the business is there a lean into.
Speaker Change: One versus the other.
Speaker Change: Just help us better understand what you think injectables topline contribution is.
Speaker Change: Is going to be this year. Thank you.
David: Thank you David.
Speaker Change: Good morning.
Speaker Change: Similarly, we are in line with what we have to say that $150 million to $60 million in total contribution on the top line with <unk> being a leading product that you are in the ballpark somewhere between.
Speaker Change: $90 million to $100 million, that's what we're driving towards so thats our current existing products and then your question on.
David Amsellem: And then your question on vertical integration, we're looking at options, and we expect to execute on options. And we are also looking to some manufacturing in the U.S. in the coming time also. So we are well-positioned on injectables. It's a focused area, and we're not leaning one over another. We are prioritizing both space equally. Thank you.
Speaker Change: Vertical integration.
Speaker Change: We're looking at options and we expect to.
Speaker Change: To execute on options.
Speaker Change: But probably end of this year, maybe beginning of next year.
Speaker Change: Because we see time is that essence now.
Speaker Change: Would like to be ready, we're a big player in Biosimilars having.
Speaker Change: The development capabilities, having manufacturing capacity in the United States and in India.
Speaker Change: Other locations in the world.
Speaker Change: Hi.
Speaker Change: This really as we said this is awarded and Biosimilar, there's so many <unk>.
Speaker Change: <unk>, we can work on and when we do look to deeply integrate.
Speaker Change: Will.
Speaker Change: We will hope that the partner that has a big pipeline and the contribution from our Biosimilar business over five years and 10 years is going to be very significant it is as a whole as you know the value of the biosimilars are huge the total branded value $253 1 billion.
Speaker Change: And about a 100, losing exclusivity over the next 10 years. So there is it's all about execution the market dynamics on a commercial side. We believe we'll get out overtime, just like how it worked out and gx, but not exactly like gx because of competition.
Speaker Change: And here is really less from the supplier standpoint, right now we see about somewhere seven to 10 companies in the United States that work and the work on the pipeline <unk> pipeline. So I know, it's a long answer but it is a very very important.
Speaker Change: Where do you go for us Biosimilars to grow and it's a real house. This is what we do.
Speaker Change: Complex.
Speaker Change: And device combination.
Speaker Change: Biosimilars are very complex manufacturing.
Speaker Change: And.
Speaker Change: Greg commercialization in the United States and work with the partners in the international market. So it's a great international opportunity.
Speaker Change: Injectable I'll pass it over to.
Speaker Change: My younger brother.
Speaker Change: Good morning.
Speaker Change: On Injectables or the last few years, we have expanded our manufacturing footprint and R&D capabilities.
Speaker Change: Garten complex at the same times to meet the capacity of each weekend.
Speaker Change: Work on certain volume project, we are very passionate about solving that drug shortage, because we believe that drug shortages should not exist.
Speaker Change: And we have many products.
Speaker Change: But not affect or impact our ability on the complex development. So we are focusing on both areas.
Speaker Change: Our complex coronary is moving very very well.
This year, we will be launching <unk> launch.
Speaker Change: Many of the firefight redo programs.
Speaker Change: Rather than dwell pipeline profile, probably between injectable programs, along with microspheres are making good progress of our LIFO is always making good progress we have a deep expertise on drug device combination.
Speaker Change: No infrastructure it up about 22 injectable lines.
Speaker Change: 3% to four locations.
Speaker Change: And we are also looking to some manufacturing in U S. Incoming coming time also so we have added position on Injectables is a focused area.
Speaker Change: We are not leaning one order that we are prioritizing both space equally.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: Thank you. The next question is from less lately from maturing Securities. Your line is now.
Leszek Sulewski: The next question is from Les.
Leszek Sulewski: Good morning. Thank you for taking my questions.
Speaker Change: Good morning. Thank you for taking my questions. So first wanted to focus on ask her how exposes advocate to the federal government cuts if any.
Leszek Sulewski: First, I wanted to focus on AFCAIR. How exposes AFCAIR to the federal government cuts, if any? How are you positioning this business in the current environment, I guess?
Speaker Change: How are you positioning this business in the current environment I guess and then second on.
Leszek Sulewski: And then second, are you seeing any sort of FDA delays, whether it's on approvals or feedbacks on the generics front, and any sort of, I guess, initial potential from facility site visits, delays as well?
Speaker Change: Are you seeing any sort of FDA delays, whether it's on approvals or feedbacks.
Speaker Change: On the generics front and any sort of I guess initial potential from our facility site visits delays as well.
Leszek Sulewski: And then second, just kind of talk to us about the ongoing partnership selection on CREXON, XUS. I know you've identified EU and South America and Canada, but perhaps if you could give us a little bit of timeline on other parts, and then specifically with your timeline to launch in India and the opportunity there. Thank you.
Speaker Change: And then second just kind of talk to us about the ongoing partnership selection on cracks on ex U S.
Speaker Change: I know, you've identified EU, and South America, and Canada, but perhaps in which gave us a little bit of timeline.
Speaker Change: On the other part and then specifically and we'll get a timeline to launch in India and the opportunity there. Thank you.
Leszek Sulewski: Thank you, Les, and good morning. So, VA, these federal cuts do not apply to the pharmaceuticals. VA is actually expanding 18 million lives. So, and more, our veterans are becoming older. So, more prescription drugs. So, we see volume growth, actually, in VA, so we do not see any issue there. The question on FTA, we haven't seen any delays from FTA at this point. So, no issue there. And then Craxon XUS, we have the partnership in place for Canada. Latin America, Europe, and now we just signed Southeast Asia. India, we're going to market by ourselves. Europe is the largest.
Speaker Change: Well, thank you Liz and good morning.
Speaker Change: So.
Speaker Change: This federal of cuts do not apply to the pharmaceuticals.
Speaker Change: <unk> is actually expanding the 18 million lives so.
Speaker Change: And more.
Speaker Change: But we're ready to really start becoming.
Speaker Change: Becoming older so more prescription drug so we see volume growth actually in EMEA.
Speaker Change: So we do not see any issue there.
Speaker Change: Question on FBA, we haven't seen any any delays from FDA at this point. So another issue that and then tax on ex U S. We have the the partnership in place for Canada.
Speaker Change: Latin America.
Speaker Change: And now we've just signed southeast Asia.
Speaker Change: India, we're going to market by ourselves.
Speaker Change: Europe is the largest.
Leszek Sulewski: I mean, the largest market size will be for us. And partner is doing phase four, additional small phase four for European requirements to get a proper reimbursement. And then India, we haven't gauged the exact market size, but it's much needed all over the world. Only IR is available for the last 30, 40 years. And these patients really will benefit from taxon and looking at China and Japan that those talks are going on right now.
Speaker Change: Our largest market size.
Speaker Change: We will be for us and partners doing.
Speaker Change: Phase four additional small base portfolio European requirements to get a property in Lisbon, and then India, we havent gauged the exact market size, but its much needed drilling all over the world only items available for the last 30 40 years.
Speaker Change: And these patients really will benefit from tax on and looking at China, and Japan that those talks are going on right now.
Leszek Sulewski: Let's just add one thing on FDA. None of our gold dates have been impacted. All of our products are progressing well. And it's part of the good for user fee also. So site inspection plus Amneal, all plants are FDA approved and in a very, very good standing. That also benefits us from any potential delays. But as of today, we have not seen any delays on our application or the gold dates.
Speaker Change: Just to add one thing on FDA, none of our Golden Gates have been impacted all of our products are progressing well and it's part of their go to acquire user fee also site inspection plus and all clients.
Speaker Change: And in a very very good spending.
Speaker Change: <unk> also benefits us from any potential delays, but as of today, we have not seen any any delays on what application Arthur coordinates.
Thank you.
Christopher Schott: The next question is from Chris Schott from J.P. Morgan, your line is open. Great, thanks so much for the questions.
Speaker Change: The next question is from Chris Schott from J P. Morgan Your line is now open.
Chris Schott: Great. Thanks, so much for the questions I just had.
Christopher Schott: I said maybe to start with a two-parter on tariffs. I know you have a different manufacturing footprint versus peers. So if we were to see tariffs applied to pharmaceuticals, do you see an opportunity to further leverage your U.S. manufacturing footprint and maybe just talk a little bit about what type of capacity you'd have to utilize if in fact we did see tariffs applied? My second question on the tariff front was for some of the products that are potentially exposed to tariffs and thinking about the affordable medicines portfolio, what is the ability to increase price on some of these products to offset some of those pressures?
Chris Schott: Maybe to start with a two parter on tariffs I know you have a different manufacturing footprint versus peers. So if we were to see tariffs applied to pharmaceuticals do you see an opportunity to further leverage U S manufacturing footprint and can you just talk a little bit about what type of capacity you would have to utilize if in fact, we did see.
Chris Schott: Tariffs applied.
Chris Schott: My second question on the tariff front was for some of the products that are potentially exposed to tariffs and thinking about the affordable medicines portfolio. What is the ability to increase price on some of these products to offset some of those pressures or is the goal of M deal more to pivot the manufacturing.
Christopher Schott: Or is the goal of Amneal more to pivot the manufacturing to either your own capacity or third parties to more avoid tariffs on those?
Chris Schott: To either your own capacity or or third parties to more avoid tariffs on those and then maybe one follow up after that.
Christopher Schott: And then maybe one follow-up after that. Thank you, Chris. So if tariffs were to... come on Generics Pharmaceuticals. Leveraging our US manufacturing footprint, we have additional capacity. We have one idle plant for a long time now, which we would restart if economically viable. We still have to do that. It is a long term economically viable, about eight to 10 billion more units of autosolids of liquid manufacturing, topical manufacturing, transdermal manufacturing we can produce in the United States. So, we are ready, set to go, but it has to be economically viable. And your question on increase in prices, obviously, look, if there are...
Chris Schott: So thank you Chris so if tariffs.
Chris Schott: <unk>.
Chris Schott: Come on generics pharmaceuticals.
Chris Schott: Leveraging our U S manufacturing footprint, we have.
Chris Schott: Additional capacity, we have won Idaho planned for a long time now.
Chris Schott: You would restart economically viable.
Chris Schott: We still have to do that.
Chris Schott: The long term economically viable about eight to 10 billion more units of oral solids of liquid manufacturing.
Chris Schott: <unk> manufacturing faster move manufacturing, we can produce in the United States.
Chris Schott: So we would we are ready to go but it has to be economically viable.
Chris Schott: And your question on.
Chris Schott: Increase in prices of as they look.
Chris Schott: That are.
Christopher Schott: There are tariff-related increases. We would work with our big, big customers. You know, they have to participate in that, which is CVS and UnitedHealth and Cigna. These are large companies. And there is some positive indication from the customers that they would partner in if something has to happen because the last thing we want is any kind of discontinuation or shortages.
Chris Schott: The tariff related increases we would work with our big customers. They have to participate in that which is the Cvs and United and Cigna and these are large companies and.
Chris Schott: There is some positive indications from the customers that they would.
Chris Schott: They would partner.
Chris Schott: Something has to happen because we last thing we want is any kind of discontinuation or shortages. So thats a new sofa. Thank you Chris.
Christopher Schott: So that's the news so far. Thank you, Chris. Great.
Chris Schott: Great and maybe just as a follow up.
Christopher Schott: And maybe this is a follow-up on Corcelent. By looking at Scripps, I mean, obviously great trend so far. It seems like we're seeing very little cannibalization from Ritari as we've seen on the ramp.
Chris Schott: Uncorked silent.
Chris Schott: But looking at scripts I mean, obviously, a great trend so far it seems like we're seeing very little cannibalization.
Chris Schott: From Rytary as we've seen the ramp I know that hasnt been the focus, but let's forget maybe closer to that Rytary Hello.
Christopher Schott: I know that hasn't been the focus, but as we get maybe closer to that Ritari LOE, is there an opportunity to maybe accelerate some of the conversion of those patients ahead of generic entry or is the focus more just the broader market here? Thanks so much. Yeah, Chris. So our focus, as we have said from the beginning, it's a broader market. It's a huge market, almost 650,000 patients we could potentially be on Trexant. Right now we've reached up to 40,000. We are already at a run rate of 20,000 patients now. And by year end, we'll have 25,000.
Speaker Change: Is there an opportunity to maybe accelerate some of the conversion of those patients ahead of generic entry or is the focus more on just the broader market here. Thanks, so much.
Chris Schott: Yes, Chris.
Chris Schott: Our focus as we have said from the beginning it's a broader market. It's a huge market and almost 650000 patients we could potentially be on tax on light duty.
Chris Schott: Reached up to 40000, we had already at a run rate of 20000 patients now.
Chris Schott: By year end to 25000, and then next year, we could reach.
Christopher Schott: And then next year, we could reach, we could easily double that or more. So 80% of that is coming from the new patient, IR, which was our goal. And Rytary, as I pointed out, the KOL by himself took Rytary over the years, now taking Trexant, seeing a huge impact. So as the patient, many of these MDS already have started shifting their patient to Trexant, because just a much better drug than Rytary. So we would see both, but we're not doing anything particular. We don't need to move or convert aggressively from Rytary to Trexant at all.
Chris Schott: It could easily double that or more so 80% of that is coming from.
Chris Schott: The new patient II, which was our goal and in light duty as I pointed out that kols by himself to gradually over the years now taking clicks on seeing a huge impact so as the patients are.
Chris Schott: Many of these Mds are already have started shifting that patient to Exxon because just much better drug granularity. So we would see both but we have we're not we're not doing anything particular, we don't need to remove.
Chris Schott: <unk> aggressively from Rytary to Exxon at all.
Christopher Schott: Great. Thanks so much. Thank you, Chris. Thank you.
Chris Schott: Great. Thanks, so much.
Yes.
Chris Schott: Thank you Chris.
Speaker Change: Thank you we have no further questions I would like to hand back to scirocco completed.
Unknown Attendee: We have no further questions.
Unknown Attendee: Well, thank you very much. We're so excited at Amneal. And we wish everybody a great weekend. Thank you. Thank you, everyone. Thank you. a call.
Speaker Change: Well. Thank you very much we're so excited at our Neal.
Speaker Change: And we wish everybody a great weekend. Thank you.
Speaker Change: Gary.
Speaker Change: Thank you. This does conclude today's call you may now disconnect your lines and enjoy the rest of your day. Thank you.
Unknown Attendee: lines and enjoy the rest of your day.
Speaker Change: Okay.