Amneal Pharmaceuticals Q1 2025 Earnings Report

Amneal Pharmaceuticals EPS Results

• Actual EPS: $0.19
• Consensus EPS: $0.14
• Beat/Miss: Beat by +$0.05
• One Year Ago EPS: N/A

Amneal Pharmaceuticals Revenue Results

• Actual Revenue: $695.42 million
• Expected Revenue: $714.78 million
• Beat/Miss: Missed by -$19.36 million
• YoY Revenue Growth: N/A

Amneal Pharmaceuticals Announcement Details

• Quarter: Q1 2025
• Date: 5/2/2025
• Time: Before Market Opens
• Conference Call Date: Friday, May 2, 2025
• Conference Call Time: 8:30AM ET

Amneal Pharmaceuticals (NASDAQ:AMRX) is a specialty pharmaceutical company that develops, manufactures and commercializes a broad portfolio of generic and specialty medicines. Its products include dosage forms such as tablets, capsules, injectables, ophthalmic products and inhalation therapies, with a focus on complex generics and other products that can be more difficult to develop or manufacture.

The company also markets branded specialty pharmaceuticals in areas including central nervous system disorders, endocrinology, metabolic disease and other therapeutic categories. Its portfolio includes treatments for conditions such as Parkinson’s disease, epilepsy and diabetes, as well as products for other chronic and specialty-care needs.

Amneal was formed through the combination of Amneal Pharmaceuticals and Impax Laboratories, which became a publicly traded company in 2018. Based in Bridgewater, New Jersey, the company serves customers in the United States and selected international markets. Amneal is led by co-chief executive officers Chirag Patel and Chintu Patel, who are also among the company’s founders.

Amneal Pharmaceuticals Q1 2025 Earnings Call Transcript

Key Takeaways

• In Q1, Amneal delivered $695 million in revenue (up 5%), $170 million in adjusted EBITDA (up 12%) and $0.21 in adjusted EPS (up 50%), and reaffirmed full-year 2025 guidance of $3.0–3.1 billion in revenue and $650–675 million in EBITDA.
• The specialty launch of Crexon for Parkinson’s has achieved over 1% market share within six months, secured ~60% payer coverage (vs. Rytary’s multi-year ramp), and is on track for >3% share by year-end with peak sales expected at $300–500 million.
• Amneal’s collaboration with MedCera in the GLP-1 obesity space names Amneal as preferred global supplier, supports construction of peptide drug-substance and sterile fill-finish facilities, and targets a midyear Phase IIb readout for MedCera’s monthly injectable MED097i.
• The affordable medicines segment continues broadening via retail generics, injectables, and biosimilars—Amneal launched four 505(b)(2) injectables in the last year, generated $25 million from three biosimilars in 2024, filed five additional biosimilar applications this year, and aims to have six biosimilars on market by 2027.
• With seven FDA-approved U.S. manufacturing sites—the largest domestic footprint in the industry—and investments in digitization, automation and AI, Amneal is positioned to ensure supply security, address drug shortages and mitigate potential tariff pressures.

Presentation

[Operator]

Good morning and welcome to the Amneal Pharmaceuticals first quarter 2025 earnings call. I'd now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

[Tony DiMeo, Head of Investor Relations at Amneal Pharmaceuticals]

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. 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 measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation. 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.

[Tony DiMeo, Head of Investor Relations at Amneal Pharmaceuticals]

I will now hand the call over to Chirag.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

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 EBITDA of $170 million grew 12%. Over the years, we have made deliberate decisions and investments across our business and delivered on our commitments. Over time and through market cycles, we have differentiated Amneal from our peers by delivering sustainable growth, driven by our leadership in quality, innovation, and execution. Today, Amneal is in a stronger position as ever. 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.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

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, and Parkinson's disease. For Amneal, made in America isn't just a label. It's been a cornerstone of our strategy since our founding in 2002 in Paterson, New Jersey. Let me now walk you through the key areas of our business. First, in our specialty segment, the launch of CREXONT for Parkinson's disease continues to exceed expectations in its first year of commercialization. Market uptake has been strong, with market share already surpassing 1% and on track to reach over 3% by the end of this year.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

We have received remarkable feedback from patients and providers, as one key opinion leader who is also a patient shared the following: "CREXONT has made me feel and move tremendously better compared to RYTARY. I have concrete examples of how CREXONT has changed my life. It has made a huge difference." In addition, we are pleased with the continued progress and momentum in expanding market access. This year so far, CREXONT has been added to several major insurance plans, including the Veterans Administration, UnitedHealthcare, CVS Health, and Cigna Commercial. This 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, CREXONT has achieved in six months what RYTARY took years to accomplish in market access coverage. We are highly confident in achieving U.S. peak sales of $300 million-$500 million for CREXONT.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Overall, we are focused on expanding our specialty branded portfolio over time, 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, which represents a new integrated business model to drive innovation at scale in GLP-1s. Metsera is rapidly advancing its pipeline of ultra-long-acting injectable and oral candidates. As they have shared, Metsera's lead program, MET-097i, a monthly ultra-long-acting injectable, is expected to deliver phase II-B 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. 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.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

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 Metsera; second, potential CMO offerings for other large companies; and lastly, manufacturing capacity we can provide for generic weight loss therapies globally. 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 BORUZU, which is our fourth 505(b)(2) 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. 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.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

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. 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.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

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. 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. I will now turn it over to Chintu.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

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. 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 U.S., India, and Ireland.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

In 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 footprints in the industry as we produce many of our generics and specialty products, including CREXONT in the U.S. 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 have seven U.S. FDA-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. Amneal is proud of its Made in America heritage, which is a competitive advantage and a core part of our strategy. Turning to innovation, we are pleased with the progress of CREXONT in the first six months of launch, with strong KPIs across the board.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

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 CREXONT. In particular, sleep disturbances affect up to 80% of PD patients. Further, our open-label phase IV study is underway to generate additional real-world evidence. With robust early adoption and strong feedback from the neurology community and patients, CREXONT is poised to become the leading branded product for Parkinson's disease. 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.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

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 million-$100 million peak sales opportunity. In addition, our strategic partnership with Metsera 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 fill finish manufacturing. These facilities will enable high-volume production as Amneal serves as Metsera'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-1s. On our complex generics portfolio, each year we expect to launch 20-30 new products.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

We have launched eight new products so far in 2025. Later this year, we have several key complex product launches, including Pred Forte, ophthalmic suspension and risperidone 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. In particular, we have launched four new 505(b)(2) injectables over the last year, which is a new growth vector for our business. In April, we launched BORUZU, our fourth 505(b)(2) injectable. In addition, we have 10-12 more 505(b)(2) injectables in development.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

Other complex injectable R&D programs, including microspheres, liposomals, 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 portfolio. 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 denosumab biosimilars were submitted with goal dates in quarter four. Next, the supplemental BLA filings for pegfilgrastim, OBI, and auto-injector are expected in the third quarter, followed by the BLA filing for biosimilar XOLAIR set for quarter four. We look to expand our biosimilar portfolio and be vertically integrated over time.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

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. Thank you, and with that, I will hand it over to Tasos.

[Tasos Konidaris, CFO at Amneal Pharmaceuticals]

Thank you, Chintu, and good morning, everyone. In the first quarter, we saw continued broad-based growth across our three segments, excellent uptake of CREXONT, 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. 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 or 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.

[Tasos Konidaris, CFO at Amneal Pharmaceuticals]

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. In our specialty segment, Q1 revenue of $108 million grew 3%, driven by CREXONT, which added $9 million, and UNITHROID, which added $4 million in the quarter. We're delighted by the market acceptance of CREXONT and upcoming payer coverage expansion. Consequently, we're confident that CREXONT will meet or exceed its 2025 revenue goal of $50 million. Q1, AvKARE revenues of $172 million, grew 6%. Our 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.

[Tasos Konidaris, CFO at Amneal Pharmaceuticals]

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. In summary, we're off to a strong start for the year, driven by strong execution across a multitude of growth drivers. In addition, we continue to strengthen our overall financial position with strong cash flow generation, no near-term debt maturities, and continuing 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. Let me now turn to tariffs.

[Tasos Konidaris, CFO at Amneal Pharmaceuticals]

Even though it's difficult to quantify precise implications, our team is developing numerous mitigating actions across multiple scenarios. First, our financial forecasts already include the modest impact of our current tariff provisions. 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 shareholders. These include increasing our U.S.-based inventory, securing alternative sources of API, renegotiating supply agreements, driving portfolio optimization, and other productivity initiatives. Finally, from a long-term perspective, we believe our multiple growth vectors, extensive U.S. manufacturing capabilities, and leading commercial presence position Amneal well in being a top-tier growth company.

[Tasos Konidaris, CFO at Amneal Pharmaceuticals]

Finally, we are pleased to affirm our full-year 2025 expectations. As a reminder, we expect total net revenue between $3 billion and $3.1 billion, which reflects 7%-11% top-line growth. Adjusted EBITDA between $650 million-$675 million, reflecting 4%-8% growth, and adjusted EPS of $0.65-$0.70, reflecting 12%-21% growth. I will now turn the call back to Chirag.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you, Tasos. Our performance in Q1 reflects the strength of our diversified business, continued execution of our strategy, and the dedication of our team. We remain confident in our ability to drive sustainable value as we advance in this exciting next chapter of growth. Let's now open the call for questions and answers.

[Operator]

Thank you. We will now begin the Q&A session. 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. Our first question today comes from David Amsellem from Piper Sandler. Your line is now open.

[David Amsellem, Managing Director and Senior Research Analyst at Piper Sandler]

Hey, good morning, and thanks. 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? I am particularly interested in how big you think ALYMSYS could be. I think you, in the past, have cited it as being about $100 million of contribution, but I just wanted to level set those expectations for biosimilars for this year. You talk about vertical integration regarding your biosimilar business.

[David Amsellem, Managing Director and Senior Research Analyst at Piper Sandler]

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? That is on biosimilars. 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? Just help us better understand what you think injectable top-line contribution is going to be this year. Thank you.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you, David, and good morning. Biosimilars were in line with what we have said, around $150 million-$160 million in total contribution on a top line, with ALYMSYS being a leading product. You're in the ballpark somewhere between $90 million-$100 million. That's what we are driving towards. That's the current existing products. Your question on vertical integration, we're looking at options, and we expect to execute on options by probably the end of this year, maybe beginning of next year, because we see time as at essence now. We would like to be very, very a big player in biosimilars, having the development capabilities, having manufacturing capacity in the United States and in India or other locations in the world. This week, as we said, there's a void in biosimilar. There's so many products we can work on.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

When we do look to vertically integrate, we will hope that the partner has a big pipeline, and the contribution from a biosimilar business over five years and 10 years is going to be very significant. It is the whole, as you know, the value of the biosimilars are huge. The total branded value is $250 million-$300 million, and about $100 million losing exclusivity over the next 10 years. It is all about execution. The market dynamics on a commercial side, we believe, will work it out over time, just like how it worked out in GX, but not exactly like GX because the competition here is very less from the supplier standpoint. Right now, we see about somewhere 7-10 active companies in the United States that work on the pipeline, serious pipeline.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

I know it's a long answer, but it's a very, very important vertical for us, biosimilars, to grow. And it's in our wheelhouse. This is what we do. We are a complex development, device combination. Biosimilars are very complex manufacturing and great commercialization in the United States and work with partners in the international market. So it's a great international opportunity. On injectable, I'll pass it over to my younger brother.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

Hi, David. Good morning. On injectables, over the last few years, we have expanded our manufacturing footprints and R&D capabilities to work on complex, and at the same time, we have the capacity which we can work on certain volume products. We are very passionate about solving the drug shortage because we believe that drug shortage should not exist. We have many products where it does not affect or impact our ability on the complex development. We are focusing on both areas. Our complex portfolio is moving very, very well. This year, we'll be launching Consta. We have launched many other 505(b)(2) injectables programs. We have a 10-12 pipeline of 505(b)(2) injectable programs, along with microspheres, are making good progress. Our liposomes are making good progress. We have a deep expertise on drug-device combination. We have now infrastructure of about 22 injectable lines with three to four locations.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

We are also looking to some manufacturing in the U.S. in coming time also. 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.

[David Amsellem, Managing Director and Senior Research Analyst at Piper Sandler]

Thank you.

[Operator]

Thank you. The next question is from Les Sulewski from Truist Securities. Your line is now open.

[Les Sulewski, VP and Spec Pharma Equity Research Analyst at Truist Securities]

Good morning. Thank you for taking my questions. First, I wanted to focus on AvKARE. How exposed is AvKARE to the federal government cuts, if any? How are you positioning this business in the current environment, I guess? Second, are you seeing any sort of FDA delays, whether it's on approvals or feedback on the generics front, and any sort of, I guess, initial potential from facility site visit delays as well? Second, just kind of talk to us about the ongoing partnership selection on CREXONT, ex-U.S. I know you've identified EU and South America and Canada, but perhaps can you just 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.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you, Les, and good morning. These federal cuts do not apply to the pharmaceuticals. VA is actually expanding 18 million lives, and more of our veterans are becoming older, so more prescription drugs. We see volume growth, actually, in VA DOD, so we do not see any issue there. Your question on FDA, we have not seen any delays from FDA at this point, so no issue there. CREXONT, ex-US, we have the partnership in place for Canada, Latin America, Europe, and now we just signed Southeast Asia, India, where we are going to market by ourselves. Europe is the largest market size will be for us, and partners doing a phase four, additional small phase four for European requirements to get a proper reimbursement. India, we have not gauged the exact market size, but it is a much-needed drug all over the world.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Only IR is available for the last 30-40 years, and these patients really will benefit from CREXONT. Looking at China and Japan, those talks are going on right now.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

Les, just to add one thing on FDA, none of our gold dates have been impacted. All our products are progressing well, and it's part of the GDUFA user fee also, so site inspection, plus Amneal's all plants are FDA approved and in very, very good standing. That also benefits us from any potential delays. As of today, we have not seen any delays on our application or the gold dates.

[Les Sulewski, VP and Spec Pharma Equity Research Analyst at Truist Securities]

Thank you.

[Operator]

Thank you. The next question is from Chris Schott from JPMorgan. Your line is now open.

[Chris Schott, Managing Director at JPMorgan]

Great. Thanks so much for the questions. I'd say maybe to start with a two-parter on tariffs. I know you have a different manufacturing footprint versus peers. If we were to see tariffs applied to pharmaceuticals, do you see an opportunity to further leverage your U.S. manufacturing footprint? 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, 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? Maybe one follow-up after that.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you, Chris. If tariffs were to come on generics pharmaceuticals, leveraging our U.S. 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 8-10 billion more units of oral solids, of liquid manufacturing, topical manufacturing, transdermal manufacturing we can produce in the United States. We are ready set to go, but it has to be economically viable. Your question on increase in prices, obviously, look, if there are tariff-related increases, we would work with our big, big customers. They have to participate in that, which is CVS and UnitedHealthcare and Cigna. These are large companies.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

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. That is the news so far. Thank you, Chris.

[Chris Schott, Managing Director at JPMorgan]

Great. Maybe just as a follow-up on CREXONT, in looking at scripts, I mean, obviously, great trend so far. It seems like we're seeing very little cannibalization from RYTARY as we've seen the ramp. I know that hasn't been the focus, but as we get maybe closer to that RYTARY 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.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Yeah, Chris. 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 CREXONT. RYTARY reached up to 40,000. We are already at a run rate of 20,000 patients now. By year-end, we'll have 25,000. Next year, we could reach easily double that or more. 80% of that is coming from the new patient, IR, which was our goal. RYTARY, as I pointed out, the KOL by himself took RYTARY over the years, now taking CREXONT, seeing a huge impact. As the patient or many of these MDs already have started shifting their patient to CREXONT because it's just a much better drug than RYTARY. We would see both, but we're not doing anything particular. We don't need to move or convert aggressively from RYTARY to CREXONT at all.

[Chris Schott, Managing Director at JPMorgan]

Great. Thanks so much.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you, Chris.

[Operator]

Thank you. We have no further questions. I would like to hand back to Chirag for concluding.

[Chirag Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you very much. We're so excited at Amneal, and we wish everybody a great weekend. Thank you.

[Chintu Patel, Co-CEO at Amneal Pharmaceuticals]

Thank you, everyone.

[Operator]

Thank you. This does conclude today's call. You may now disconnect your lines and enjoy the rest of your day. Thank you.

Participants

Executives

• Chirag Patel, Co-CEO
• Chintu Patel, Co-CEO
• Tony DiMeo, Head of Investor Relations
• Tasos Konidaris, CFO

Analysts

• David Amsellem, Managing Director and Senior Research Analyst at Piper Sandler
• Chris Schott, Managing Director at JPMorgan
• Les Sulewski, VP and Spec Pharma Equity Research Analyst at Truist Securities