AMRX - NASDAQ

Good morning, and welcome to the Amneal Pharmaceuticals Second Quarter 2025 Earnings Call. I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amneal Pharmaceuticals Second Quarter 2025 Earnings Call. Today, we issued a press release reporting 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. 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 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. I will now hand the call over to Chirag.

Thank you, Tony. Good morning, everyone. The second quarter was another consecutive quarter of strong performance and growth with revenues of $720 million and adjusted EBITDA of $184 million. 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. Since our founding in 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 6 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 CREXONT for Parkinson's disease, Brekiya autoinjector for severe migraine, new biosimilars such as biosimilar of XOLAIR, our continued cadence of 20, 30 new generics launches each year, particularly complex products, including unique 505(b)(2) injectables for hospitals and our GLP-1 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. Over time, Amneal has strategically evolved from generics to innovative and complex medicines. And we are entering our next phase of growth with strong momentum and clear confidence in growth ahead. First, in our Specialty segment, the launch of CREXONT 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. Notably, about 80% of CREXONT 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 CREXONT will achieve U.S. peak sales of $300 million to $500 million. Let me now turn to our newest specialty branded product, Brekiya autoinjector, which received U.S. FDA approval in May. Brekiya is the first and only autoinjector form of DHE, a therapy that has been trusted for over 70 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 Brekiya with a commercial rollout in October. We continue to see this as a $50 million to $100 million peak sales opportunity. Second, in GLP-1s, we are advancing our partnership with Metsera to help deliver innovative therapies at scale. Amneal is Metsera's preferred global supplier for developed markets, including the U.S. and Europe. We will also commercialize their products in 20 emerging markets, including India. We see GLP-1 as a long-term opportunity, and we look forward to sharing more on this key catalyst over time. Third, in our Affordable Medicines 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 3 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. Over the next decade, the number of biologic patent expirations is expected to double compared to the past 10 years, creating significant opportunity as approximately 90% of these products do not have biosimilars in development. At the same time, development time lines 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 STELARA. Against this backdrop, our biosimilars in- licensing strategy has enabled us to build an initial portfolio. With 3 biosimilars already commercialized and 5 more in development, we anticipate having 6 marketed biosimilars across 8 presentations by 2027. Specifically, biosimilar XOLAIR represents our largest biosimilar opportunity to date. As we have said in the past, our strategic intention is to be vertically integrated in biosimilars over time. Finally, performance in the AvKARE segment continues to be driven by a broad portfolio of products and new launches delivered across 3 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 million 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 #1 affordable medicines company, and we are well on our way. I'll 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, 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. 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 investments in digitization and automation across our network to improve efficiency and scalability. We also stay focused on our cost structure 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 patients we serve. Amneal has built one of the largest and most advanced U.S. 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 ApiJect to start U.S. injectable manufacturing, leveraging their blow-fill-seal technology capabilities. This partnership strengthens our ability to serve both commercial and government markets with large production capacity while supporting U.S. emergency preparedness and national health security. This expansion extends our leading U.S. 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 CREXONT in the first year of launch. CREXONT is uniquely designed to deliver rapid onset and sustained efficacy, giving Parkinson's patients more good on time with fewer daily doses. Our Phase IV study remains on track, and we expect this real-world data to further reinforce CREXONT's clinical value and differentiation. Next, in our specialty business is Brekiya, the now approved DHE autoinjector for migraine and cluster headache. This is the first and only autoinjector 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-1, our strategic partnership with Metsera is advancing. We are building 2 state-of-the-art manufacturing facilities, one for high-value peptide drug substance production and the other for advanced sterile fill-finish capabilities. Metsera's lead programs are progressing well through development with impressive efficacy and strong product profiles and time lines that are not too far out, positioning us to participate meaningfully in this high-growth market. This collaboration draws on our core strength in complex pharmaceutical R&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 Medicines 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 Pred-Forte, a complex ophthalmic product. Among upcoming key launches this year, there is Risperdal injection for schizophrenia, a generic version of Restasis for dry eye and many more. Overall, our Affordable Medicines pipeline remains deep 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, liposomes and 505(b)(2) injectables. We are also making strong progress in inhalation, which will become a new vector of growth beginning next year with 2 commercial inhalation product launches expected in 2026. As of Q2, there are 76 ANDA's 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&D portfolio and allocate investment towards higher growth areas like Specialty brands, injectables and biosimilars. In biosimilar, we see an opportunity for Amneal to establish a leadership position in the space. This year, we are filing 5 biosimilar pipeline candidates with launches targeted for 2026 and 2027. The BLA filings for 2 denosumab biosimilars were submitted with goal dates in quarter 4. Next, we look to submit the supplemental BLA for our pegfilgrastim OBI and autoinjector in quarter 4, followed by the BLA filing for biosimilar XOLAIR in quarter 4. We are pleased that our pegfilgrastim OBI and autoinjector product as well as our biosimilar to XOLAIR will be made in America, underscoring our commitment to high-quality U.S.-based manufacturing and supply chain reliability. Recently, we shared positive Phase III data for biosimilar XOLAIR, positioning us to be among the first entrants in the $3 billion 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 up well for sustainable growth and category leadership across our business over time. Thank you. And with that, I will hand it over to Tasos.

Thank you, Chintu, 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 2032. From a top line perspective, Q2 was another quarter of growth with total net revenues up 3%. Our Affordable Medicines revenue of $433 million grew 1% on top of last year's exceptional growth of 14%. Our current quarter growth was driven by new products, where 2024 and 2025 launches added $33 million. It is important to note that during the second quarter, our commercial teams built strong foundation with our clients across a number of new 505(b)(2) 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 million as it grew 23% year-over-year. This growth was driven by our 3 main branded products with CREXONT adding $11 million, RYTARY adding $9 million, up 19% and UNITHROID adding $4 million, up 12%. We continue to be very pleased by the market acceptance of CREXONT and expect full year 2025 revenue in excess of our initial estimate of $15 million. In the second quarter, AvKARE revenues of $163 million declined 4%, while gross margin increased by 540 basis points and operating income increased by 44%. As we discussed in the first quarter, we're very pleased by the financial performance of AvKARE 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&L, where Q2 adjusted gross margins were very strong at 45.6%, up 470 basis points year-over-year. These higher gross margins were driven by favorable product mix in each of the 3 segments and ongoing operating efficiencies. Notably, Q2 adjusted gross margins of Affordable Medicines grew 270 basis points to 44.3%. Our second quarter adjusted EBITDA of $184 million grew 13%, driven by top line growth, higher gross margins and higher investments in R&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 million 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 290 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 4 important topics. First, we're excited about our multiple growth drivers, ensuring robust top line growth. This includes over 20 new product launches annually, strong uptake of CREXONT, the upcoming launch of Brekiya 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. 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 favored nation pricing action. Third, from a balance sheet perspective, we're extremely pleased by the full refinancing we opportunistically completed last week. In summary, we refinanced $2.7 billion of debt by issuing $2.1 billion in a new 7-year term loan B and a brand-new $600 million 7- 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 million 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 million in cash tax savings, most of which will occur in 2026, improving our cash flow. This benefit is primarily driven by the immediate expensing of R&D and upfront depreciation of assets. With the strength of our first half performance, the multiple levers of growth drivers and solid execution, we're pleased to update our 2025 financial guidance. For revenues, we continue to expect $3 billion to $3.1 billion. We're increasing adjusted EBITDA by about $15 million in the range of $665 million and $685 million. We're increasing our adjusted EPS by about $0.05 between $0.70 and $0.75. And we're also raising our operating cash flow guidance, excluding discrete items by about $20 million in the range of $300 million and $330 million. With that, I'll turn the call back to Chirag.

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 #1 affordable medicines company. Let's now open the call for question and answers.

[Operator Instructions] Our first question comes from David Amsellem from Piper Sandler.

Just a couple from me. First, on CREXONT and RYTARY and the overall Parkinson's franchise. As we move through '25 and into '26, 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? Just help us understand that, particularly as we move into next year. That's number one. And then number two, on the Metsera collaboration, I noted 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?

David, this is Tasos. So let me take the first one. So just to directly answer your question in terms of the trough of the business, just from a context perspective. So last year, RYTARY did about $210 million worth of revenue. And obviously, we had no CREXONT. 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 going to -- is helping us this year. And it's also, I think, it's going to help us in the short term next year whenever generics become available. Our gut feel is this year with probably CREXONT doing, let's say, $55 million or so. Maybe RYTARY does about $150 million, so essentially, the combined portfolio is essentially kind of flat to last year from a revenue perspective. 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 CREXONT. The trough, we believe, comes next year, right, from a revenue perspective, because next year, RYTARY probably will have obviously more of a generic competition than this year. But at the same time, CREXONT is growing very, very rapidly. So I think the trough comes next year from a revenue perspective, okay? 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 absorbed a substantial headwind to EBITDA because of the investments of CREXONT. But nevertheless, even if there is a bit of a headwind next year from an EBITDA perspective as well, we 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 Chirag on Metsera.

Yes. So David, Metsera collaborations moving forward very awesomely. We have so many scientists, engineers that at work, my brother, everybody, and we work with Clive and with team over there. Great progress, and we could not be even more happier than this about our partnership. 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 we are not sizing up the margins at this point, but they are higher than obviously the generics margins, much higher. And the 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, Lilly launched Mounjaro in India at $160 a month. So of course, there will be some Ozempic generics competition, and we hear that could be launching at $60, $80 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 it will be lower than India's prices in any of those countries. And significant number of patients that could be on this therapy, it's -- the India number at this price, somewhere between [ $60 ] to [ $160 ]. I mean the product is in shortage already -- is some 50 million patients, 5-0. So these are large numbers of patients, volume will drive margins and higher penetration we could do would be driving significant revenue. We'll be sizing all these starting from beginning of 2026. I would say these are very significant opportunities for us for supplying Metsera as well as for our own international marketing. So that's for Metsera.

Our next question comes from Leszek Sulewski from Truist Securities.

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? 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 Metsera 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 '27 and beyond?

Yes. So let me take -- I'll take the RYTARY generic question, then I'll pass it over to Joe, who heads up commercial operations, commercial business for Specialty. Then I'll turn it over to Chirag and Chintu for some of the partnerships, and I'll tackle the margin profile. So in terms of generics, so, so far -- so Teva has a 180-day exclusivity on the generic RYTARY. They currently have not been approved. And frankly, I know as much as you do on when that may happen, right? So that's as much as I can tell you and so forth. Our view is it's a sizable opportunity. We expected in our planning that generics were going to become available August 1. 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 will 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. Let me turn it over to Joe to give you an update on the reimbursement on CREXONT.

Yes. Thanks, Tasos. Yes, Les, thanks for the question. We've been really pleased with coverage so far with CREXONT 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. 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 from the market continues to be really strong from our key prescribers. 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.

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 of those partnerships. So what we have said, right, is that in -- over the course of time, 99.9% of our revenue is U.S.-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 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. 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 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. We have a few hundred people. We've established a commercial team based in Mumbai. We have a few hundred 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. In the rest of the markets, we out-licensed CREXONT in Europe. So that regulatory process is -- it's in process. So that's going to come over the next couple of years of product approval and slowly building that revenue portfolio. So that's a little bit. I think those are the 2 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 margin. So what you should expect from us is kind of continue to drive gross margin increases steadily over the course of time. 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 Chintu or Chirag to see if they have anything else to add.

Thank you, Tasos. I just wanted to add on international partnership. First of all, we are very happy and pleased with CREXONT and how all the testimony for patients 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 2026 and in India late '26 to early '27. So our regulatory applications are moving well, and we are excited. Plus we have a diversified manufacturing footprint and a cost advantage, we are also qualifying our India site for CREXONT to improve our margins. Just wanted to add that.

Our next question comes from Chris Schott from JPMorgan.

This is Ekaterina on for Chris. So first question is just 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? 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 in EMEA. 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?

Ekaterina, 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 is nothing fundamentally different other than the typical, what I would call, cadence of new product introductions. So products that we launched late in 2024, early 2025, they keep building momentum over the course of time. That's number one. Number two is even though the vast majority -- the majority of the products we were expecting to launch in 2025 have already launched, but there are 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. So all of those things will play into the second half of the year to have kind of stronger revenue performance than the 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 Chirag and see to maybe tell us a little bit about all their adventures coming out of Washington, D.C.

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 2 things, what is driving these pharma investigation. The one is national security. So heavily overreliance and antibiotics will be like 95% of key starting material coming from China. And many -- 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 factories, more plants in the United States. So with that, we -- not negotiating, but we will be putting new solutions because if you put a 150%, as you said, or 200% tariffs, it's going to 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 will keep making money, and this is not us alone. It's all the companies. We are least impacted because there are almost 2/3 of our manufacturing values in the United States. And -- but 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, bring the 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 in China and India. So with all that, it's still unknown. We'll see what happens. It's still under investigation. As of now, pharma is exempted from all tariffs. We'll stay tuned.

Our next question is from Matt Dellatorre from Goldman Sachs.

Congrats on the continued progress. Maybe first, just to 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, post the 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?

Matt, this is Tasos. First, on AvKARE, we expect growth in the second half, substantially more growth in the second half. There is -- and that's really driven by what I call stability on the distribution channel. 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 1 or 2 large product opportunities that will become available in Q3, and AvKARE will be in a position to capitalize on that opportunity. That's kind of number one. From a refinancing perspective, before I turn it over to Chirag to talk about -- so from a refinancing perspective, as I mentioned before, that was just incredibly successful substantially reduces our interest expense. Depending what we use, it decreases our interest expense between 16% and 20% per year. So that's a dramatic improvement. Number one, extends maturities by 4 years to 2032. 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 kind of capitalize on the opportunities that we have, number one. And also deleveraging over the course of time is really important to us, and 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 4, 5 years. So that's kind of our area of focus. Chirag, anything else?

Yes. Thank you, Tasos. And 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, how fast we can execute. FDA has been very cooperative along with MHRA, EMA, entire world, obviously, for obvious reasons, tremendous cost savings, but most importantly, it creates more access. More patients, we have seen 2.5x 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 bad start with HUMIRA as a market, but it now -- there are 100 biologics. 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 a pipeline of 30 products, 35. We can keep going and make a lot of products in the United States and India and have this combination, which allows us a global supply and global cost position and much faster execution on a number of products. So we look to -- since it's a race, we look to do it as soon as possible. But we'll be very disciplined and obviously do the deal, which doesn't blow any of 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 afford and provides tremendous growth to Amneal going forward. We see this as a great business for the next 10 years.

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

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

Thank you.

Thanks, everyone.