Amneal Pharmaceuticals Q2 2025 Earnings Report

Amneal Pharmaceuticals EPS Results

• Actual EPS: $0.23
• Consensus EPS: $0.17
• Beat/Miss: Beat by +$0.06
• One Year Ago EPS: N/A

Amneal Pharmaceuticals Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Amneal Pharmaceuticals Announcement Details

• Quarter: Q2 2025
• Date: 8/5/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, August 5, 2025
• Conference Call Time: 8:30AM ET

Amneal Pharmaceuticals (NASDAQ:AMRX), together with its subsidiaries, develops, manufactures, markets, and distributes generics, injectables, biosimilars, and specialty branded pharmaceutical products worldwide. The company operates through three segments: Generics, Specialty, and AvKARE. The Generics segment offers immediate and extended release oral solid, powder, liquid, sterile injectable, nasal spray, inhalation and respiratory, biosimilar, ophthalmic, film, transdermal patch, and topical products. The Specialty segment develops, promotes, sells, and distributes pharmaceutical products with focus on central nervous system disorders, including Parkinson's disease, and endocrine disorders. This segment also provides Rytary, an oral capsule formulation of carbidopa-levodopa to treat Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism; Unithroid for the treatment of hypothyroidism; and IPX203, a pipeline product for Parkinson's disease. The AvKARE segment offers pharmaceuticals, medical and surgical products, and services primarily to governmental agencies, the Department of Defense, and the Department of Veterans Affairs. This segment also distributes bottle and unit dose pharmaceuticals under the AvKARE and AvPAK names; and packages and distributes pharmaceuticals and vitamins to its retail and institutional customers. It sells its products through wholesalers, distributors, hospitals, chain pharmacies, and individual pharmacies. The company was formerly known as Atlas Holdings, Inc. and changed its name to Amneal Pharmaceuticals, Inc. in 2018. Amneal Pharmaceuticals, Inc. was founded in 2002 and is headquartered in Bridgewater, New Jersey.

AMNEAL PHARMACEUTICALS Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Amneal reported Q2 2025 net revenues of $720 million (up 3% year-over-year) and adjusted EBITDA of $184 million (up 13%), and raised full-year guidance to $3.0–3.1 billion in revenue and $665–685 million in adjusted EBITDA.
• Positive Sentiment: The specialty segment delivered 23% revenue growth to $128 million, driven by strong uptake of Crexan, Rydari, and Unithroid.
• Positive Sentiment: Key new launches include Crexan for Parkinson’s (2% U.S. market share, targeting $300–500 million peak sales) and Brekhia DHE auto-injector for migraine (FDA approved, October rollout, $50–100 million peak potential).
• Positive Sentiment: A $2.7 billion debt refinancing extends maturities to 2032 and cuts annual interest expense by over $33 million, improving financial flexibility.
• Negative Sentiment: Potential U.S. tariffs on imported APIs could raise production costs, though Amneal’s large domestic manufacturing footprint may offer some mitigation.

Presentation

[Operator]

Good morning, and welcome to the Amneal Pharmaceuticals Second Quarter twenty twenty five Earnings Call. I will now turn the call over to Amneal's Head of Investor Relations, Tony D'Amio.

[Anthony DiMeo, Head - IR at Amneal Pharmaceuticals]

Good morning, and thank you for joining Amneal Pharmaceuticals' second quarter twenty twenty five earnings call. Today, we issued a press release supporting Q2 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.

[Anthony DiMeo, Head - IR at Amneal Pharmaceuticals]

We also discuss 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 Sharav and Shinti Patel, Co Founders and Co CEOs Tassos Conidera, CFO our commercial leaders Andy Boyer for Affordable Medicines Joe Renda for Specialty and Jason Daley, Chief Legal Officer. I will now hand the call over to Sharav.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Thank you, Tony. Good morning, everyone. The second quarter was another consecutive quarter of strong performance and growth with revenues up $720,000,000 and adjusted EBITDA of $184,000,000 At the halfway point of the year and with confidence in our outlook, we are pleased to raise 2025 guidance. I'm so excited to walk you through the multiple growth drivers that are shaping the future of Amneal. At Amneal, we focus each day on delivering innovative and affordable medicines that are essential for patients.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Since our founding in 02/2002, we have methodically diversified beyond generics to build a broad and differentiated portfolio of branded and complex products. Amneal has stood out from the pack by generating consistent growth in each of the last six years, and we expect growth will continue in the years ahead. In the process, we have transformed Amneal and have entered the most exciting chapter yet. In this new chapter, there are a number of new growth drivers, including Trexor for Parkinson's disease, Brachy Auto injector for severe migraine, new biosimilars such as biosimilar of Xolair, our continued cadence of 2,030 new generic launches each year, particularly complex products, including unique five zero five(two) injectables for hospitals and our GLP-one opportunity with Metsera. These new medicines and new opportunities are designed to create substantial value by one, advancing the standard of care and increasing access to medicines for patients two, further expanding and differentiating our portfolio for providers and three, adding to our growth story for investors.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Over time, Amneal has strategically moved from generics to innovative and complex medicines, And we are entering our new next phase of growth with strong momentum and clear confidence in growth ahead. First, in our specialty segment, the launch of Crexon for Parkinson's disease continues to exceed our expectations in the first year of the launch. Uptake has been very strong with U. S. Market share about at 2% and on track for over 3% by the end of the year.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Notably, about eighty percent of Krexone scripts are coming from IR patients, which is a strong indicator of our successful strategy to pursue the broader Parkinson's market. The patient testimonials have been inspiring, and we have highlighted a few in our earnings presentations. We are highly confident that Trexon will achieve U. S. Peak sales of $300,000,000 to $500,000,000 Let me now turn to our newest specialty branded product, Breqya Auto injector, which received U.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

FDA approval in May. Brekia is the first and only auto injector form of DHE, a therapy that has been trusted for over seventy years for the acute treatment of migraine and cluster headaches in adults. In the migraine treatment landscape, there is significant unmet need for patients who do not respond to existing therapies. This new product gives patients sustained headache relief when they need it the most and eliminates the need for time consuming hospital visits. We are excited to launch Brekhia with a commercial rollout in October.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

We continue to see this as a 50,000,000 to 100,000,000 peak sales opportunity. Second, in GLP-1s, we are advancing our partnership with MedCera to help deliver innovative therapies at scale. Amneal is MedCera's preferred global supplier for developed markets, including The US and Europe. We will also commercialize their products in 20 emerging markets, including India. We see GLP-1s as a long term opportunity, and we look forward to sharing more on this key catalyst over time.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Third, in our affordable medicine segment, growth continues to be fueled by our diversified portfolio of complex products and addition of new differentiated offerings. Broadly, we continue to see favorable macro trends across all three pillars, retail generics, injectables and biosimilars, and remain confident in our ability to execute, advance new innovations and drive sustainable growth long term. Within biosimilars specifically, we see a favorable long term outlook for The U. S. Market.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Over the next decade, the number of biologic patent expirations is expected to double compared to the past ten years, creating significant opportunity as approximately 90% of these products do not have biosimilars in development. At the same time, development timelines and costs are trending lower with fewer Phase III study requirements and generally less competition per molecule, excluding some of the largest biologics such as Humira and Stelera. Against this backdrop, our biosimilars in licensing strategy has enabled us to build an initial portfolio. With three biosimilars already commercialized and five more in development, we anticipate having six marketed biosimilars across eight presentations by 2027. Specifically, biosimilars ZOLLAIR represents our largest biosimilar opportunity to date.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

As we have said in the past, our strategic intention is to be vertically integrated in biosimilars over time. Finally, performance in the Healthcare segment continues to be driven by a broad portfolio of products and new launches delivered across three distinct channels, government distribution and unit dose. This business, which adds stability and diversification to Amneal's portfolio, is expected to drive revenue of over $900,000,000 by 2027. In summary, Amneal has a diverse array of growth drivers that build upon our distinct market position, drive sustainable value creation, and improve access and care for patients. Our strategic goal is to be America's number one affordable medicines company, and we are well on our way. I'll now turn it over to Chintu.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Thank you, Chirag, and good morning, everyone. Let me begin by expressing my deep appreciation to our Amneal team. Your passion, resiliency, and unwavering commitment continues to drive Amneal forward as a deeply purpose driven company. This morning, I will provide an update on our strategic priorities across operations, innovation and expanding portfolio and how these are translating into strong execution and sustained performance in 2025.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

First in operations, our global high quality manufacturing infrastructure remains a key competitive advantage. Amneal continues to be recognized for its quality track record and industry leading reliability. Each year, we make targeted investment in digitization and automation across our network to improve efficiency and scalability. We also stay focused on our cost structures through various operational excellence programs. These capabilities enable us to launch new complex products, help address drug shortages, and meet the needs of our customers and the patient we serve.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Amneal has built one of the largest and most advanced US pharmaceutical manufacturing footprints anchored in New York and New Jersey with broad capabilities across oral solids, liquids, topicals, transdermals, and complex formulations, making Made in America a core strategic advantage. In the second quarter, we announced our collaboration with EpiJet to start US injectable manufacturing, leveraging their blow fill field technology capabilities. This partnership strengthens our ability to serve both commercial and government markets with large production capacity while supporting US emergency preparedness and national health security. This expansion extends our leading US pharmaceutical manufacturing footprint and expands our domestic capabilities for future complex products in sterile dosage forms. Turning to innovation, we are very pleased with the continued strong performance of in the first year of launch.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Crexant is uniquely designed to deliver rapid onset and sustained efficacy, giving Parkinson's patients more good on time with fewer daily doses. Our Phase four study remains on track, and we expect this real world data to further reinforce TREXONE's clinical value and differentiation. Next, in our specialty business is Brechia, the now approved DHE auto injector for migraine and cluster headache. This is the first and only auto injector formulation of this well established therapy. This paves the way for us to develop other drug device combination products that are clinically relevant for providers and can help patients in other branded therapeutic areas. In GLP, once our strategic partnership with MedCera is advancing, we are building two state of the art manufacturing facilities, one for high value peptide drug substance production and the other for advanced sterile fillfinish capabilities. Metsera's lead programs are progressing well through development with impressive efficacy and strong product profiles and timelines that are not too far out, positioning us to participate meaningfully in this high growth market.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

This collaboration draws on our core strengths in complex pharmaceutical R and D and manufacturing through our differentiated integrated business model, we believe we can drive innovation at scale and deliver new impactful obesity therapies for patients. In our affordable medicine portfolio, we expect to launch 20 to 30 new products each year. We have launched 15 new products so far in 2025. In Q2, we were pleased to receive approval for our generic version of PREV-forty, a complex ophthalmic product. Among upcoming key launches this year, there is raspiridone injection for schizophrenia, a generic version of Restasis for dry eye, and many more.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Overall, our affordable medicine pipeline remains key and robust, capable of producing new products for years. We are very pleased with our continued progress in developing complex products across key categories such as microspheres, liposomal and five zero five(two) injectables. We are also making strong progress in inhalation, which will become a new vector of growth beginning next year with two commercial inhalation product launches expected in 2026. As of Q2, there are 76 ANDAs pending approval, out of which 67% are non oral solids and 47 products in development, out of which 96% are non oral solids. We continue to prioritize our R and D portfolio and allocate investment towards higher growth areas like specialty brands, injectables, and biosimilars.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

In biosimilar, we see an opportunity for Amneal to establish a leadership position in the space. This year, we are filing five biosimilar pipeline candidates with launches targeted for 2026 and 2027. The BLA filings for two denazumab biosimilars were submitted with goal dates in quarter four. Next, we look to submit the supplemental BLA for our PAC filgrasting OBI and auto injector in quarter four, followed by the BLA filing for biosimilar ZOLED in quarter four. We are pleased that our backflip filgrasting OBI and auto injector product as well as our biosimilar to ZOLED will be made in America, underscoring our commitment to high quality U.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

S.-based manufacturing and supply chain reliability. Recently, we shared positive Phase III data for biosimilar ZOLED positioning us to be among the first entrants in the $3,000,000,000 market. We are focused on advancing these programs and continuously adding new programs to expand our biosimilar portfolio. In summary, we have continued our strong operational momentum and execution in 2025. Our strategic focus on innovation, quality and manufacturing excellence sets us well for sustainable growth and category leadership across our business over time.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Thank you. And with that, I will hand it over to Tarshish.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Thank you, Tien tu, and good morning, everyone. We're very pleased with our second quarter financial performance as the resiliency of our diversified business model, strong growth in our specialty business and focus on efficiency delivered revenue growth of 3%, adjusted EBITDA growth of 13% and adjusted EPS growth of 56%. Furthermore, we reduced net leverage to 3.7x versus 3.9x adjusted EBITDA in December 2024 and fully refinanced our debt, which will reduce interest costs substantially and extend maturities to 02/1932. From a top line perspective, Q2 was another quarter of growth with total net revenues up 3%. Our affordable medicines revenue of $433,000,000 grew 1% on top of last year's exceptional growth of 14%.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Our current quarter growth was driven by new products, where 2024 2025 launches added $33,000,000 It is important to note that during the second quarter, our commercial teams built strong foundation with our clients across a number of new five zero five(two) products, while our global supply teams completed a few production facilities upgrades. The combination of multiple highly innovative products and enhanced manufacturing supply to meet market demand gives us confidence for even higher revenues in subsequent quarters. Q2 specialty revenue was also very strong at 128,000,000 as it grew 23% year over year. This growth was driven by our three main branded products with KREXAN adding $11,000,000 RYDARI adding $9,000,000 up 19% and Unithroid adding $4,000,000 up 12%. We continue to be very pleased by the market acceptance of Prexant and expect full year 2025 revenue in excess of our initial estimate of $50,000,000 In the second quarter, AvKARE revenues of $163,000,000 declined 4%, while gross margin increased by five forty basis points and operating income increased by 44%.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

As we discussed in the first quarter, we're very pleased by the financial performance of Altair and the team's focus on higher profitability by maximizing the unique value we provide to the VA and DoD compared to the lower margin distribution channel. Let me now move down the P and L. Our Q2 adjusted gross margins were very strong at 45.6%, up four seventy basis points year over year. Desired gross margins were driven by favorable product mix in each of the three segments and ongoing operating efficiencies. Notably, Q2 adjusted gross margins of affordable medicines grew two seventy basis points to 44.3%.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Our second quarter adjusted EBITDA of $184,000,000 grew 13% driven by top line growth, higher gross margins and higher investments in R and D and sales and marketing to ensure future growth. Finally, we were extremely pleased by the 56% growth in adjusted earnings per share, driven by the higher adjusted EBITDA, favorable foreign exchange and lower interest expense. Looking at our first half financial performance, our total company revenues grew 4%, our adjusted EBITDA of $354,000,000 grew 12% and our adjusted EPS of $0.45 is up 50%. We're also very pleased by the increased level of profitability as adjusted gross margin of 44.3% grew two ninety basis points and adjusted EBITDA of 25% grew 180 basis points. Before I conclude with our updated 2025 financial guidance, I'll just touch on four important topics.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

First, we're excited about our multiple growth drivers ensuring robust top line growth. These include over 20 new product launches annually, strong uptake of Crexon, the upcoming launch of Brechia for migraine and cluster headaches, multiple new biosimilar launches next year and large new product opportunities available to the VA and DoD. Second, from a tariff perspective and while we don't have full clarity, we have multiple levers to mitigate any potential negative impact. As we have discussed, we have one of the largest U. S.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Manufacturing footprints in our industry. We have extensive experience with tech transfers. We have no meaningful exposure to Mexico, Canada, China or Europe. And finally, no exposure to any most favorable nation pricing action. Third, from a balance sheet perspective, we're extremely pleased by the full refinancing we opportunistically completed last week.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

In summary, we refinanced $2,700,000,000 of debt by issuing $2,100,000,000 in a new seven year term loan B and a brand new $600,000,000 seven year senior secured note. The refinancing was extremely well received and oversubscribed many times over and achieved long term interest cost reduction of more than $33,000,000 annually and extended maturity to 2032 versus 2028. Fourth point worth mentioning is that because of the new federal tax legislation, we expect about $46,000,000 in cost tax savings, most of which will occur in 2026, improving our cash flow. This benefit is primarily driven by the immediate expensing of R and D and upfront depreciation of assets. The strength of our first half performance in multiple levels levers of growth drivers and solid execution, we're pleased to update our 2025 financial guidance.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

For revenues, we continue to expect 3,000,000,000 to $3,100,000,000 We're increasing adjusted EBITDA by about $15,000,000 in the range of $665,000,000 and $685,000,000 We're increasing our adjusted EPS by about $05 between $0.70 and $0.75 and we're also raising our operating cash flow guidance excluding discrete items by about $20,000,000 in the range of $300,000,000 and $330,000,000 With that, I'll turn the call back to Shirak.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Thank you, Tasos. Q2 results and increased 2025 guidance reflects the continued strength of our diverse business. We are confident in our ability to continue advancing in this new chapter of growth towards our goal of being America's number one affordable medicines company. Let's now open the call for question and answers.

[Operator]

Thank you. We will now begin our Q and A session. Our first question comes from David Amsellem from Piper Sandler. Your line is now open. Please go ahead.

[David Amsellem, Senior Research Analyst at Piper Sandler Companies]

Thanks. Just a couple for me. First on Krexant and Rytary in the overall Parkinson's franchise. As we move through 2025 and into 2026, with the LOE of Rytary, how should we think about when the Parkinson's franchise reaches a trough? And when you think you'll be in a position to return that business to growth once you've absorbed the full impact of the LOE?

[David Amsellem, Senior Research Analyst at Piper Sandler Companies]

Just help us understand that particularly as we move into next year. That's number one. And then number two on the Metcera collaboration, I noticed that you talked about commercial manufacturing for at cost plus a margin. Just wondering how profitable that is going to be and the extent to which that those economics ultimately will expand your overall profitability. Thanks.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Hey, David. Good morning. This is Tasos. So let me take the first one. So what just to directly answer your question in terms of the growth of the business, just from a context perspective.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

So last year, Raetari did about $210,000,000 worth of revenue, and obviously, we had no cracks on it. My gut feel is this year, as you know, even though the LOE of Rytary was on July 31, there has been no approval for a generic Rytary. So that's gonna it's helping us this year, and it's also, I think, is gonna help us in the in the short term next year whenever generics become available. Our gut feel is this year with probably Krexham doing, let's say, dollars 55,000,000 or so. Maybe right, Ari, that's about $150,000,000 So essentially, the combined portfolio is essentially kind of flat to last year from a revenue perspective.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

EBITDA is a bit of a drag this year, which we're obviously able to overcome because of the growth of the rest of the business and just reflects the investments we need to make to grow Craigsum. The trough, we believe, comes next year, alright, from a revenue perspective. Because next next year, right, probably will have, you know, obviously, more of a generic competition than this year. But at the same time, Crexane is growing very, very rapidly. So I think the trough comes next year from a revenue perspective, okay?

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

But I believe from an EBITDA perspective, trough is probably I don't expect much of dilution than this year from an EBITDA perspective because this year we already observed a substantial headwind to EBITDA because of the investments of Craigsson. But nevertheless, even if there is a bit of a headwind next year from an EBITDA perspective as well, we'll feel confident we will be able to overcome this as the rest of the business will more than offset that. So at the end of the day, trough comes next year, highly confident we will be overcoming because we're trying to drive the total business to continue to grow top line and bottom line. So, hopefully, that works for you. Let me turn to Sirota Metsera.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Yeah. So, David, good morning. Metsera collaborations, moving forward, very awesomely. We have so many scientists, engineers, that I'd worked, my brother, everybody's, and we work with, Clive and with team over there. Great progress, and we could not be even more happier than this model of partnership.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

It is very properly structured as we have taken a lot of risk upfront building the sites. So we would expect more margins than typical CMO or CDMO because we have taken upfront risk. So those we are not sizing up the margins at this point, but they are higher than, obviously, the generics margins, much higher. And second point is international markets, which we control the marketing. We do not know yet exactly what price it would be sold at, but give you the reference.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Lee launched Manzaro in India at $160 a month. So if of course, there'll be some Ozempic genetics competition, and we hear they could be launching at $60.80 dollars a month, for monthly treatment. So you can see it's a substantial opportunity for us, and we have 20 rights to 20 countries. And India would be setting the prices for most of the countries, and I don't think we will be lower than India's prices in any of those countries. And significant number of patient that could be on this therapy.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

It's the India number at this price, somewhere between $60 to $160 I mean, the product is in shortage already, It's some 50,000,000 patient, five zero. So these are large numbers of patient. Volume will drive margins and higher higher penetration we could do would be driving significant revenue. We will be sizing all these starting from 2026. I would say these are very significant opportunities for us for supplying MedCera as well as for our own international marketing. So that's for MedCera.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Helpful. Thank you.

[Operator]

Thank you. Our next question comes from Luzak Selowski from Jurass Securities. Your line is now open. Please go ahead.

[Les Sulewski, VP - Biotech Equity Research at Truist Securities]

Good morning. Thank you for taking my questions. First on the Parkinson's franchise, maybe just provide a latest status of the Rytary generic launches. And also can you maybe provide some additional commentary on where you stand with the reimbursement? And separately, what's the update on the regulatory approval process across some of the other partners internationally that you've disclosed before?

[Les Sulewski, VP - Biotech Equity Research at Truist Securities]

And maybe provide any additional time lines that you'd expect on your international or your launch in India on the product? Maybe how do you think about the size of that opportunity? And then separately, maybe just kind of a longer view, as you're capturing some of the uptake from these partnerships, including MedCera and others, and lean more into innovative products, how are you thinking about the overall gross margin profile for the enterprise kind of moving into 'twenty seven and beyond?

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Yeah. So let let me take I'll take the, right, our generic question, then I'll pass it over to to Joe, who who heads up commercial operations commercial business for specialty. Then I'll turn it over to to Shirag and Shintu for some of the the partnerships, and then I'll I'll tackle the margin profile. So in terms of generics, so far, so Teva has a one hundred and eighty day exclusivity on the generic Rydari. They currently have not been approved.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

And, frankly, I know as much as you do on on when that may happen. Right? So that that's that's that's as much as I can as much as I can tell you and so forth. Our our view is it's a sizable it's a sizable opportunity. You know, we expect it in our planning that generics were gonna become available August 1.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Obviously, this kind of what I will call short term delay kind of helps us from a financial perspective. It allows us to reinvest in the business. It allows us to increase our guidance. But at some point in time, there'll be generics maybe later on this year, sometime next year, and we'll be in a great position to overcome any headwind that may come out of that. So I think that's the answer to your first question.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

So let me turn it over to Joe to give you an update on the reimbursement Yes.

[Joe Renda, SVP & Chief Commercial Officer - Specialty at Amneal Pharmaceuticals]

Thanks, Tom. So it's Hynes.

[Joe Renda, SVP & Chief Commercial Officer - Specialty at Amneal Pharmaceuticals]

Yes, thanks for the question. We've been really pleased with coverage so far with Crexat in the market. Actually, it's above our expectations. We are anticipating around 50% coverage or so far this year. We've garnered now over 60% commercial coverage, which includes some of the biggest payers in the market, United, CVS, VA, DoD.

[Joe Renda, SVP & Chief Commercial Officer - Specialty at Amneal Pharmaceuticals]

So really pleased with coverage and we anticipate that to continue because we're in good dialogue with the payers related to some of the Part D plans. So we're looking to land those. So our goal was always around 70% coverage. We're well on our way there. And the feedback for the market continues to be really strong from our key prescribers.

[Joe Renda, SVP & Chief Commercial Officer - Specialty at Amneal Pharmaceuticals]

So we're anticipating that the growth we're seeing is going to continue, and it's partly because of that great access that we've created so far.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Let me take a crack also at some of the question more about regulatory progress on some of the ex U. S. Business or kind of the margin profile with those partnerships. So what we have said, right, is that over the course of time, 99.9% of our revenue is U. S.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Based, right? So that leaves a lot of white space, call it ex U. S. So we have made the strategic choice that the best way for us from a capital allocation perspective is instead of trying to build the infrastructures in those markets, right, which is has a very long term payback period to develop the partnership model for all markets except India. And obviously, there is a lot of our own heritage in India.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

We have 6,000 employees already over there. And more importantly, if you think about India, the standard of living is growing substantially. The size of the pharmaceutical market there is supposed to grow is expected to grow dramatically. So combination of our heritage, combination of our existing infrastructure in India, a relevant product portfolio and a very large market, it's only made sense to extend to kind of for us to launch our own Amneal brand in those in that market. And the uptake is growing very nicely.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

We have a few 100 people. We do we've established a commercial team based in Mumbai. We have a few 100 commercial team as we're building it out. Early days of the product portfolio launching there, and that's going to build over the course of time. You shouldn't expect anything drastic over the next couple of years, but that's going to build over the course of time.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

In the rest of the markets, we out licensed Craigsson in Europe, So that regulatory process is where it's in process. So that's going to come over the next couple of years with product approval and slowly building that revenue portfolio. So that's a little bit I think those are the two main kind of what I will call drivers of growth of our international business over the next few years. From a margin perspective, listen, we are not in the business of diluting margins. So what you should expect from us is kind of continue to drive gross margin increases steadily over the course of time.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Our adjusted EBITDA to revenue has been hovering at about 22.5. You should expect this over the course of time to increase. And we're not doing anything to do anything dramatic because we want to continue to invest in the business because we see tremendous amount of growth, whether or not it's in the injectables, biosimilars, international, I just mentioned it. But we're not in the business of diluting margins or diluting our cash flow. So with that, let me turn it over to Chintas or Shirak to see if they have anything else to add.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Thank you, Das. I just wanted to add on international partnership. First of all, we are very happy and pleased with Trexor and how all the testimony information and our partners in Europe and LATAM are very pleased, and we are very excited. And we hope to launch these products in Europe by late twenty twenty six and in India late twenty six to early twenty seven. So our regulatory applications are moving well, and we are excited.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Plus, we have a diversified manufacturing footprint and a cost advantage. We are also qualifying over India site for cracks on to improve our margins. Just wanted to add that.

[Les Sulewski, VP - Biotech Equity Research at Truist Securities]

Very helpful. Thank you.

[Operator]

Thank Our next question comes from Chris Stott from JPMorgan. Your line is now open. Please go ahead.

[Analyst]

Thank you so much. This is Catarina on for Chris. So first question is around guidance. I think the revenue range does imply a bit of a step up as we kind of think about revenues in the second half versus the first half of the year. Can you maybe elaborate what are the main drivers of this?

[Analyst]

I'm assuming some of this is the timing of new launches and perhaps the delay in Rytary, but just anything else to kind of keep in mind? And second question is just around tariffs. Just latest thoughts on what these could mean for the industry and Emil. And I think, specifically, what are you hearing out of Washington on how generic products and API could be treated as we think about the 150 or 250% tariffs that are kind of being thrown around? You.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Hey, Catherine. I can take the first one. We expect a stronger second half from a revenue perspective than the first half. And as you said, there nothing fundamentally different other than the typical, what I will call, cadence of new product introductions. So products that we launched late in 2024, early twenty twenty five, they keep building momentum over the course of time.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

That's number one. Number two is even though vast majority the majority of the products we were expecting to launch in 2025 have already launched, but there were just a few more that are supposed to be coming in Q3 and Q4. So those will add to the revenue growth. And the third point is really we're looking at, as I mentioned in my script, in Q1 and Q2, we completed a number of facility upgrades that kind of prevented us from meeting market demand, primarily on our injectable portfolio. Now with those essentially behind us, it just frees up capacity and just improves our global supply ability to meet market demand.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

So all of those things will play into the second half of the year to have kind of stronger revenue performance than first half. And then obviously, we're looking for growth from a top line perspective kind of going into 2026 and 2027 with a strong tailwind behind us. I'll turn it over to Shirag and Sid to maybe tell us a little bit about all their adventures coming out of Washington DC.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Great. That's the hardest job to do. So we've been meeting and giving our perspective to the administration, which is rightfully focused on two things while what is driving these pharma investigation. The one is national security. So heavily overreliance in antibiotics will be, like, 95% of keep starting material coming from China.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Mhmm. And many we we hardly make anything in The United States. Even finished goods, it's less than 2%. So if you take each of these critical categories, we have virtually no manufacturing in The United States. Second thing is socioeconomics, obviously, that it creates American jobs and more more factories, more plants in The United States.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

So with that, we when not negotiating, but we've been putting new solutions because if you put a 150%, as you said, or 200% tariffs, it's gonna be chaotic because nobody knows how long the tariffs would stay. So if there are such a large tariffs, obviously, the pricing would have to go up to our customers because we have to keep supplying the products, and we are keep making money. And this is not us alone. It's all the companies. We are least impacted because they're almost two third of manufacturing values in The United States.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

And but they they could create shortages as well. And it may not be the solution what administration is trying to do, which we fully support, is for the national security, bringing the product production of critical products in The United States from the key starting material API to finished goods by creating a demand for American made products because it will be obviously expensive products to make in America compared to coming out of China or China and India. So with all that, it's still unknown. We'll see what happens. It's still under investigation.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

As of now, pharma is exempted from all tariffs. We'll we'll stay tuned.

[Analyst]

Thank you so much. I appreciate all the color.

[Anthony DiMeo, Head - IR at Amneal Pharmaceuticals]

Thank you, Catherine.

[Operator]

Next Our next question is from Matt Dell'Etor from Goldman Sachs. Your line is now open. Please go ahead.

[Matthew Dellatorre, Analyst at Goldman Sachs]

Hey guys, good morning and thanks for the question and congrats on the continued progress. Maybe first just a follow-up on the prior question on the revenue guide. Should we expect the Generics and Distribution segments to inflect or catch up in second half? And then second question, opposed to recent debt refinancing, what are your latest thoughts on the potential vertical integration of your biosimilars business in terms of timing or, likelihood? And then maybe more broadly, how does this increased flexibility that you now have impact your broader capital allocation strategy? Thank you.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Matt. This is Tasos. Good morning. First on, Natke, we expect growth in the second half, substantial more growth in the second half. There is and that's really driven by what I call stability on the distribution channel.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

So at this point in time, point number one. And number two is we expect our government business to accelerate the growth that we have already seen this year because there is a number of large product launches. I don't want to talk specifics. There is at least one or two large product opportunities that will become available in Q3 and Napier will be in a position to capitalize on that opportunity. That's kind of number one.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

From a refinancing perspective, I turn it over to Shirag to talk about so from a refinancing perspective, as I mentioned before, that was just incredibly successful, substantially reduces our interest expense. Depending what month we use, it decreases our interest expense between 1620% per year, so that's a dramatic improvement. Number one, extends maturities by four years to 02/1932. And we don't expect this to change our capital allocation policy. So over the course of time, what we have said is we want to make sure that we fund our business appropriately and to kinda capitalize on the opportunities that we have, number one.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

And also deleveraging over the course of time is really important to us, and and, you know, that doesn't need to be linear, right, every single quarter, every single year. But over the course of time, I think we've done a really good job essentially cutting leverage by half in the last four or five years. So that's kind of our area of focus. Anurag, anything else?

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Yeah.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Thank you, Raj. So then your second question, Matt, on how when do we look to integrate. So first of all, biosimilars, the entire market, it's a race right now. We how fast we can execute. FDA has been very cooperative along with MHRA, EMA, entire world, obviously, for obvious reasons.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Tremendous cost savings, but most importantly, it creates more access, more patient. We have seen two and a half times more volume because of more access because of lower prices. So how many new patients are getting this product? So total support from, all of the regulatory agency, government agencies. I know we had a, the bad start with Humira in the market, but it it now there are 100 biologics.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Only 20 are being worked on. 80 are not being worked on. So our goal is we have done this so well with complex generics products, and we have invested so much in this. We could do this. We could have pipeline of 30 products, 35.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

We can keep going and and make a lot of products in The United States and India, and and have this combination, which allows us a global supply and global cost position and much faster execution on number of products. So we look to since it's a race, we look to do it as soon as possible.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

But we'll be very disciplined and obviously do the deal, which doesn't blow any of the the we have worked hard to get our debt to EBITDA ratio down. We would like to maintain or have some flexibility there and then set up a deal which we can can afford and to it provides tremendous growth to Amneal going forward. We see this as a great business for next ten years.

[Matthew Dellatorre, Analyst at Goldman Sachs]

Great. Thank you both.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

You.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Thanks, Mehta.

[Operator]

This concludes our Q and A session. So I'll hand back to Shrek for closing remarks.

[Chirag Patel, Co-Founder, Co-CEO, President & Director at Amneal Pharmaceuticals]

Thank you very much, everybody. Have a great day today. Thank you.

[Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals]

Thank you.

[Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals]

Thanks, everyone.

[Operator]

Thank you. This concludes today's call. Thank you for joining. You may now disconnect your lines.

Participants

Executives

• Chirag Patel, Co-Founder, Co-CEO, President & Director

Analysts

• Anthony DiMeo, Head - IR at Amneal Pharmaceuticals
• Chintu Patel, Co-Founder, Co-CEO & Director at Amneal Pharmaceuticals
• Tasos Konidaris, EVP & CFO at Amneal Pharmaceuticals
• David Amsellem, Senior Research Analyst at Piper Sandler Companies
• Les Sulewski, VP - Biotech Equity Research at Truist Securities
• Joe Renda, SVP & Chief Commercial Officer - Specialty at Amneal Pharmaceuticals
• Analyst
• Matthew Dellatorre, Analyst at Goldman Sachs