Good morning and welcome to the Amnil Pharmaceuticals Second Quarter 2026 Earnings Call. I will now turn the call over to Amnil's Head of Investor Relations, Tony DeMeo.

Good morning, and thank you for joining Amnil Pharmaceuticals Second Quarter 2026 Earnings Call. Today, we issued a press release reporting Q2 results. The earnings press release and presentation are available on the IR page of amnil.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 sections entitled cautionary statements on forward-looking statements in our press release and presentation for factors that may impact future performance we also discussed non-GAAP measures information on use of these measures and reconciliations gap are in the earnings release and presentation. On the call today are Sharag and Shintu Patel, co-founders and co-CEOs, Pasos Konideras, CFO, Joe Renda for specialty, and Jason Daley, Chief Legal Officer. I will now hand the call over to Sharag. Thank you.

Good morning everyone. Emneal is in the midst of the most transformative period in our company's history. We are growing as one of the America's leading affordable medicines businesses with an increasingly diversified and high-impact medicines portfolio, including specialty brands, biosimilars, GLP-1s, and complex generics across dosage forms, such as transdermals and injectables. As we execute our strategy, we're building a larger, more impactful MNEO. That continued momentum is reflected in our second quarter results, where the company delivered revenue of $796 million, adjusted a bid of $206 million, and adjusted EPS of 30 cents at the halfway point of the year we're pleased to once again raise our 2026 outlook this year reflects our seventh consecutive year of top and bottom line growth as a purpose-driven company we have a tremendous opportunity to help the next era of affordable medicines here in the United States and globally by expanding access for patients and providers. While Emineal has always been a growth-oriented, the scale of the opportunity in front of us today has never been greater. With that, let me touch on key growth opportunities. First, in affordable medicines, our Bayes business remains strong, resilient, and growing, with highly relevant and in-demand therapies. In women's health, demand for transdermal patches increased following the revised FDA guidance late last year. We are increasing our capacity. Looking forward, our pipeline remains focused on high-value opportunities, such as Landreotide, where complexity, reliable supply, customer relationship, and executions are key. Second, in biosimilars, we're building a new, large growth platform for Amnil. With the pending acquisition of Akashi, we would become a fully integrated global biosimilar player. from development to commercial supply. And the timing is incredibly compelling. The U.S. biosimilism market is entering a major growth cycle driven by an unprecedented wave of biologics losing exclusivity, streamlined regulatory pathways, attractive commercial structures emerging, including private labels, and accelerating market adoption. Over the next decade, 118 biologics are expected to lose exclusivity in the United States alone. With relatively limited development expected for most molecules, accordingly, we see a broad set of biosimilar opportunities with limited competition that can support reliable and repeatable value creation. Amnil is well positioned to capitalize on these opportunities, approximately 75 percent of our biosimilar portfolio will be focused on targeted lower competition while 25 will address larger market opportunities that mix gives us significant growth potential and meaningful upside biosimilars align with our commercial strength as well Through private label and customer relationship, we can bring products to market efficiently, leveraging our leading U.S. retail and institutional presence, channel access, and scale. This is a national extension of our affordable medicine strategy. Overall, biosimilars are the next major growth area for amnio and fit directly in our mission, expanding access, widening affordability, and building a durable, long-term growth platform. Third, in specialty, we have a differentiated branded product portfolio. Traxon continues to gain traction, and recent Phase 4 data reinforces its potential to become a first-line treatment option for Parkinson's patients. Also, Brake Care continues to see very strong uptake in its first several quarters on the market as it addresses an important unmet need for migraine and cluster headache sufferers. Fourth, in distribution, healthcare continues to provide diversification and access to important government and institutional channels, representing a meaningful opportunity to grow this business over time. In summary, we are incredibly excited about the ongoing strategic evolution of MNIL and highly confident in our ability to sustain this momentum going forward. I'll now turn it over to Chintu.

Thank you Chirag and good morning everyone. I would like to thank our MNIL team for another quarter of very strong execution. Our team continues to deliver across operations quality supply chain R&D commercial execution and customer service this consistency allows us to grow while also building towards the next generation of opportunities such as specialty biosimilars and GLP ones let me begin with an update on one of our manufacturing sites in India one week ago the Gujarat region experienced a severe rainfall and flooding which impacted one of our facilities in India most importantly all MNIL employees are safe and accounted for we expect a limited impact on a select number of products we look to resume operation within the next few weeks I will provide an update on three areas first the strength of our operating platform. Second, the strategic fit and capabilities Kashi brings in biosimilar. And third, the continued momentum across our pipeline. First, in operation, our global high-quality manufacturing and supply chain capabilities remain a core competitive advantage. If you walk into an MNL facility today, it looks remarkably different than just several years ago. Through digitization, automation, and deploying AI tools in different areas, we are unavailing our next generation of manufacturing and quality while also driving continued efficiencies. Strategically, we have built a broad operational network with deep expertise across dosage forms. This matters more than ever. Patients, providers, and all stakeholders of the healthcare system are are focused on the quality, reliability, and resiliency of the pharmaceutical supply chain. We are excited to expand our capabilities and capacity in complex dosage forms, including transdermals, sterile injectables, and lock-acting depots, enabling to increase our volumes and drive very meaningful near-term growth. Our scale, leading US manufacturing footprint, and a strong technical capabilities positions us to deliver reliable high-quality supply while addressing important market needs and drug shortages to that point we are pleased to share that amnes brookhaven new york site was recently selected as one of only seven companies in the fda's pre-check pilot program alongside other leading companies such as eli lily and region wrong the program is intended to advance u.s drug manufacturing and strengthen supply chain resiliency by allowing earlier fd engagement on facility readiness and support access to critical medicine for amnil it is an important recognition of our robust u.s manufacturing particularly as we expand into sterile injectable manufacturing here in the u.s over the next few years. Second, we are very excited about the Kashiv acquisition, which will add the in-house biologics capabilities we need to succeed in biosimilars. The end-to-end capabilities will span cell line and clone development, protein characterization, process development, clinical execution, regulatory expertise, and scaled biologics manufacturing in India and U.S. Karshev is a biologics platform built over a decade with deep scientific expertise across monoclonal antibodies, fusion proteins, cytokines, microbial products, and other complex modalities. Karshev's drug substance capacity is expected to expand from approximately 26,000 liters by the end of 2026 to approximately 75,000 liters by 2028. with kashiv we will be able to do do it all in biologics kashi brings the science development and manufacturing engine and amni brings the u.s commercial engine with our leading retail position and channel expertise this is a powerful combination together this combined model will allow us to advance multiple molecules at the same time, make smart portfolio decisions more quickly, and capture more economics across the value chain. With our current and future biosimilar capacity, we are well positioned to supply a meaningful share at launch with excess capacity to respond to market demand as needed. In addition, the combined pipeline of over 20 biosimilar programs supports a meaningful number of new launches over time. We are very excited about upcoming biosimilar opportunities for Zolaire, Orencia, Simzia, and Endplate, which are attractive molecules with significant market potential and relatively limited competition. We believe each has the potential to become a meaningful growth driver. Longer term, the pipeline extends well into the 2030s providing substantial runway for growth third turning to our affordable medicine pipeline we are in the midst of the most concentrated and impactful wave of high value new launches in our company's history importantly it is not just the number of launches that matters it is the value complexity and durability of these products this momentum is the result of choices we made many years ago. We deliberately prioritized complex genetics and differentiated dosage forms, including injectables, ophthalmics, inhalation products, drug device combinations, 552 opportunities, and other non-oral solid dosage forms, where technical complexity and execution create long-term durable value. Our recent approvals and upcoming launches show the strategies working. This includes the recent approval of romidapsin in oncology, additional strengths of presentation of iohexol and ready-to-use sodium bicarbonate, our latest 5-5-B2 injectables, along with potential approval of landreotide in Q3. Each product reflects the high-impact opportunities that we have been building towards and demonstrate the strength of our affordable medicines pipeline. And the wheel of innovation continues to turn with another 12 to 15 high-value complex ANDA filings planned this year, including two more meter-dose inhalation products. These opportunities exemplify Amnit's core strength, strong R&D, complex manufacturing, deep customer relationships, and a track record of reliable supply. we are using the same playbook that built our affordable medicine business and applying it to biosimilars in specialty we are pleased with the continued strong performance of crack sound and brachia this successful product launches reflect our ability to develop new medicines build brands and bring forward therapies that improve patient care for cracks on the real world evidence for Parkinson's patient is very compelling. We recently shared data from our first phase four open-level study that showed patients converting to klaxon had three or more hours of good on time per day versus dietary and other carbidopa-legodopa therapies and a meaningful improvement in system in symptom control. In Q4, we are starting a new phase four study looking at the impact of Traxond on treatment nine patients recently diagnosed with PD and disease progression. More broadly, we are building on this specialty foundation with additional R&D pipeline opportunities. While Traxond and Brachy are key growth drivers today, they represent the beginning of a broader specialty pipeline that we are advancing and we look to share more in the future. Taken together, we are well positioned for continued growth and remain laser-focused on executing across our key operational, commercial, and pipeline opportunities. I will now hand it over to Thassos.

Thank you, Chunti, and good morning, everyone. The second quarter played out as expected with revenue growth accelerating and growth-based momentum building across our business. Consequently, we are very pleased with our continued strong financial performance and ability to raise our 2026 outlook against this quarter, reflecting the strength and diversification of our business, a number of key growth drivers, and the success of the business model we have strategically built over several years. We expect this momentum to continue through the balance of 2026 and into 2027 and beyond. For the second quarter, total net revenue was $796 million, up 10%, adjusted EBITDA was $206 million, up 12%, and adjusted EPS was $0.30, up 20%. Our results were driven by strong execution across our three business segments, favorable product mix, and operating expense discipline. For the second quarter, Affordable Medicines delivered revenue of $490 million, up 13%, reflecting the strength of our broad-based complex portfolio, including our women's health products, injectables, and higher naloxone sales. In addition, new product launches added $45 million to second quarter revenue growth, including two recently launched products, one in ophthalmology and one in urology. Our specialty revenue was $149 million, up 17%, driven by continued momentum in Crackson, Unithroyd, and Burkia, all ahead of expectations. Moving on to Avcare, where second quarter revenue was $157 million, down 4%, similar to the first quarter, as growth in the government channel was offset by the low-margin distribution business as we expected. As we have shared in the past, we remain focused on the unique value we provide in the government channel and continue to expand Upcare's profitability. Moving down to P&L, our second quarter adjusted gross margin was strong at 46.2%, up 60 basis points year over year, reflecting favorable mix and continued operating efficiencies. Adjusted EBITDA grew 12% due to strong revenue growth, gross margin expansion, and disciplined expense management. From an adjusted EPS perspective, the second quarter grew 20% reflecting the adjusted EBITDA growth and lower interest expense. Let me take a moment to acknowledge the strength of our first half financial performance with total revenues up 7%, adjusted EBITDA up 16%, and adjusted EPS growth of 27%. Furthermore, I'm pleased to report that we recently reprised our $2.4 billion term loan B due in 2032 and reduced our interest expense by 50 basis points, which equate to $12 million dollars in annual interest expense savings given the strength of our business we're very pleased to raise our full year 2026 guidance against this quarter we're increasing our revenue outlook by 50 million to 3.1 billion to 3.2 billion with high single digit growth expected in both specialty and affordable medicines Also, we are raising our adjusted EBITDA guidance by $10 million between $750 and $780 million, reflecting strong revenues and higher gross margin. This guidance includes an estimated $20 million of negative impact anticipated as a result of the recent flood in our India facility, as Jintu mentioned earlier on. From an EPS perspective, we're increasing our guidance by penny between $0.96 and $1.06 due to our higher profitability and lower interest expense following our most recent successful debt repricing. From a CAPEX perspective, we're increasing our expectations from about $110 million to about $150 million to capitalize on multiple near-term opportunities that we see in the marketplace, such as greater market demand for our women's health products and injectable expansion in the U.S. Finally, we're maintaining our operating cash flow guidance. Turning to Cassif for a second, we're entering the transaction from a position of strength supported by a diverse set of growth drivers, strong cash flow, and disciplined balance sheet management. This progress was further validated in April when we received a one-notch credit rating upgrade and our most recent successful term loan day repricing. As we have outlined, the cash shift transaction is compelling both strategically and financially. First, the acquisition enables us to be a leader in the multibillion-dollar global biosimilars market that is growing rapidly. Second, we expect to capture 400 to 500 million in financial benefits driven by tax and local incentives, as well as eliminating milestone and profit-sharing obligations. Third, we see a clear path to deleveraging with net leverage below three times by 2028. We expect the cash shift transaction to close over the next few weeks, pending shareholder vote tomorrow and satisfaction of closing conditions. With that, I will turn the call back to Shiran.

Thank you, Tossos. Our Q2 results demonstrate the strength of Amnil's diversified business and the momentum across our growth platforms. We are delivering strong performance today with more significant opportunities ahead than any point in our company's history. The pending Kashi acquisition is a national extension of our strategy that will create a fully integrated global biosimilar platform, provide us access to a very large market opportunity, and establish a major new long-term growth pillar. We are excited about the future and the substantial value creation ahead. Our goal remains clear to become America's number one affordable medicines company and a leading global provider of essential medicines because innovation only matters when it reaches the patient. With that, let's open the call for Q&A.

We will now begin the question and answer session. Please limit yourself to one question and one follow up question. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from the line of Glenn Santangelo from Barclays. Your line is now open. Please go ahead.

Thanks, and good morning. Thanks for taking the question. Yeah, just two quick ones for me. Chirag, I think I heard you said you're still expecting the timing for Landria Tide to be 3Q, and if memory serves me correct, the biosimilar for Zolaire you're expecting later in the fourth quarter, and so I'm just kind of curious as to maybe what you have included in your in their second half fiscal 26 guide for these launches and then my second question is really around Kashiv I think at the time of the deal you said you're expecting to have six commercial biosimilars in the market by 2027 with a 14 billion TAM I was just wondering if you could just give us you know more you know an update on the timing

and maybe a little bit more transparency into you know which launches will be more meaningful here thanks great good morning glenn cylinder tide is on its way that's what we we we feel as of today it has official goal date in q3 so that we have included some of the forecast number but not not probably the market or very conservative and Zolair is towards very late end of the year or could spill into the January 5th. So nothing is included for Zolair for this year. And in Kashi Biosciences, or your question on the six commercial biosimilars, as you know, We market Alimsis, Ruluko, Philnetra. We are launching Prolia and Xchiva and look forward to launch Zoler sometime next year, hopefully very early. So that becomes six biosimilists commercialized by next year and more to follow there on in 27, 28, 29. Very exciting pipeline. Thank you.

Thank you.

Your next question comes from Chris Scott with JP Morgan. Your line is now open. Please go ahead.

Thank you so much. This is Katerina on for Chris. Just two questions from us. So first, just on tariffs, your thoughts on some of these recent headlines from the administration. How should we think about potential impact both for meal and the industry? And have there been any discussions between generic manufacturers and the administration since the announcement? And then second question is just on Crixon, you know, seems like another very strong quarter for the product. Just any interesting trends you guys are seeing in terms of where uptake is coming from or anything else you're kind of seeing in that market? Thank you.

Thank you. Good morning. As you know, Emneal has a very vast manufacturing network in the United States we always look and also expanding the the our capacity in the United States in sterile and patches as well as far as the recent announcement we look forward for more information and would collaborate with administration as we move forward your second question on correct zone we're seeing 80% of the scripts coming from general neuro which wasn't the case for Ritory and that continues to happen as you know 80 percent prescription are written by the general neurologist so very exciting the phase 4 data is exciting as well well received and the script trend is keep going up every week and it's truly a needed therapy for the Parkinson's patient and our goal will be to make that a first-line therapy replace the immediate release product.

Thanks.

Your next question comes from David Amsalem from Piper Sandler. Your line is now open. Please go ahead.

Thanks. So a couple for me. First on IOhexol with the additional SKUs approved, can you talk about how big of an opportunity that could be, not just this year, but also in 27, if you can quantify that, and your views on how long that could be a situation where there's limited competition and a similar question on land rear tide can you just level set for us to the extent you get approved how long that could be a limited competition situation and then lastly on your specialty business and particularly neurology what's your appetite for adding assets where you can leverage your existing commercial infrastructure in neuro thank you yeah hi there good morning so I would have

is a very complex product and it requires, you know, very good supply chain control and the manufacturing footprint. We are very excited with the new SKUs that are getting approved. We are expecting other one or two more strengths to get approved by end of the year. So I think going into next year, we'll complete the entire basket because it has multiple strengths. same times we have increased our capacity this year and we look forward to capitalize on the full market potential next year from quantification perspective we think these are the 50 plus million dollar opportunity maybe more going forward and we have secured a very good supply chain regarding landreotide it's the same thing it's a very complex manufacturing as you know it's drug device combination is a factor it's a very unique formulation so it has a lots of multiple barriers of entry from coming into the market we have dedicated site and facility we are controlling our in-house supply chain so we are very uh positive and optimistic on on on staying market later upon the launch in Q3 as anticipated. So Landiotide and we have inventory to go, we have perfected the manufacturing so we look forward to Landiotide launch in Q3 of this year.

Great and I'll take the second one on a specialty M&A potential as we have stated before company's focus and goal will turn to the specialty side going from next year and many years to come after that. We have a full mass and great infrastructure for small molecule and large molecule with pending Kashi acquisition. So we'll keep investing in our internal growth, R&D and CapEx for affordable medicines and not take our eyes off. It's great business. Even the existing business is growing remarkably with the new pipeline launches, the women's health, with with the lidocaine expansion with the injectable expansion in the United States we could not even supply more so that is just just a very positive sign and as you know David that would be positive because the 90% scripts are written using genetics product and always the complex products that are in shortages and we are there to support that so very excited about that and biosimilars we have enough and we will keep expanding with capex now with excess cash and other means we would be focusing on cns assets our teams looking at it and we are also looking at oncology assets we'll be adding a pipeline internally and externally and we'll share with you when we are ready.

Your next question comes from Ash Verma with UBS. Your line is now open. Please go ahead.

Oh, great. Yeah, thanks so much for taking our questions and congrats on the progress here. So I had two questions on both individual products, maybe just on like Landry or Tide. So yeah, you've been reiterating like 3Q as an approval and launch. Just help us understand if there could be like any gating items from FDA side on granting the approval? Have you had any kind of like a late cycle review meeting recently? Any back and forth with the FDA that you can talk about? And then on IO-Hexel, so this one, yeah, so you're building out the SKU portfolio. Obviously, like is the adoption of IO-Hexel contingent on you having first all the SKUs or can we start to see meaningful revenue contribution from what you have right now and then it sort of like builds out from the later dosing after that so if you can give any comment on that that'll be great thanks so hi Ash good morning on a land geotide I'll take the first one And we responded to all the queries of FDA with a very comprehensive response.

We are very optimistic. As of today, we haven't had any negative feedback from FDA. So we believe no news is a good news. It is under priority review. As FDA understands, it's an unmet need. So we remain very, very optimistic about 3Q launch. and we have inventory to go upon the approval of the product immediately. On IO-Hexall, our strategy was to get all the SKUs together. So R&D has completed all the work and it's not necessary to have all the SKUs, but I think we took a strategic position so that way we can get a bigger bite at the market share and also we are expanding the capacity. So in 26, Iohexol does not have meaningful revenue, but in 27 onward, it will add substantial revenue growth. Great.

Thank you. Your next question comes from Matt Dellatore with Goldman Sachs. Your line is now open. Please go ahead.

Great. Thanks. Good morning, guys, and congrats on the strong quarter. Maybe stepping back a bit, Chirag, you kicked off the call highlighting how AMUEL is in the most transformative period in the company's history. I think two big things that come to mind here is obviously the recent biosimilars integration and also the Pfizer-Glyph-1 partnership. And I know you discussed the biosimilar side a bit already, but maybe just walk us through what you're most focused on with respect to both of these programs over the next six to 12 months. And then what would you maybe highlight, you know, beyond these programs that you're most excited about that you think we should start paying attention to? And then just on the affordable medicine side, you know, you guys have highlighted significant pickup and demand for estrogen patches post the recent black box removal for those types of products. You know, maybe just walk us through how large is that market potential there and how much is amniote positioned to capture? Thank you.

Great. I'll start with Affordable Medicines, the existing business. As I said, we're the most excited since the last seven years. We used to have this kind of excitement from 2010 to 2018, and those times have come back. Existing, the two reasons, existing products, huge demand for the patches, estrogen patches, and we make them right here in New Jersey. And expansion is underway, 24 by 7. Our teams are working. We were fortunate to work with the equipment supplier to bring the equipment earlier. And we look to triple the capacity by next year. So it's a huge addition in revenue. Also, we're expanding lidocaine that is also in shortage. So that demand is going up as well, the patches, hormonal, I mean, sorry, the lidocaine patches. So with patches, with ophthalmics in high demand, with even the regular products being in a high demand, And new product launches, affordable medicines could add, it's a bigger range, but could add $1 to $2 billion of new revenue from now to 2030. So that, we are very excited with our existing pipeline, new product launches, and in-line products. So amazing times coming up in affordable medicines category. uh biosimilars we have spoken enough a huge growth opportunity now let's in specialty taxons keep expanding break is breaking the records uh and a unithroid is steady eddy growth so we expect these three brands to continue to grow on top of it organic pipeline would be review within probably in first quarter next year, and we will also look to be active in potential partnership acquisitions of branded products that fits our commercial infrastructure and fits our the category we're playing and will keep expanding. And we may add oncology assets as well, since we have the biosimilar oncology team already, more market knowledge over the last three years. So that's very exciting news on specialty, and we look to share that as we have that information. On glyph-1 peptides, you know, Pfizer's results are good. on clinical trials and our partnerships moving extremely well. We look to expand the partnership and both plans are coming up as fast as they can and should be operational 2029 and 30. And we look to start supplying in 2030. And also we have evaluated the markets that we are. We have given the exclusive commercial rights like India and Egypt, and those are looking good as well. So very excited on a GLP-1 peptide opportunity. And also with this large infrastructure, it opens up for additional manufacturing of peptides as well as finished products for either other branded companies or in the future, some genetics products.

On biosimilar, man, I just want to add in the next 6-12 months, we are very much focused on integrating Karshev and also advancing our pipeline on Abedasol, Antplate, and Simzia. Our goal is to, because R&D is going to be key, and that's what aminil is always shining, so work with Karshev and enhance R&D capabilities where we can file three or four biosimilars a year, which is potentially possible. And new into biologics, we are also looking into different platforms within the biologics and look at some new drug device combination within the biologics to come out with kind of a 5.5b2 of biosimilars. So we are just focused on biosimilars. There are plenty of products to go, advancing our pipeline and infrastructure, and some of the 5.5b2s within the biosimilars.

Great. Thank you so much. Yeah, I think we answered. Thank you, Mike.

We have reached the end of the Q&A session. I will now turn the call back to co-CEO Sharag Patel for closing remarks.

Well, thank you very much, everybody, and have a great Thursday. Take care.

This concludes today's call. Thank you for attending. You may now disconnect.