Good morning and welcome to the Amnil Pharmaceuticals First Quarter 2025 Earnings Call. I'd now like to turn the call over to Amnil's Head of Investor Relations, Tony DiMaio.

Good morning and thank you for joining Amnil Pharmaceuticals First Quarter 2025 Earnings Call. Today we issued a press release reporting Q1 results. The earnings press release and presentation are available at 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. We see this section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discussed non-GAAP measures. Information on use of these measures and reconciliations to GAP are in the earnings release and presentation. On the call today are Shirag and Shintu Patel, co-founders and co-CEOs, Tasos Konidera, 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 Sharad.

Thank you, Tony. Good morning, everyone. In Q1, we delivered another quarter of strong performance and continued growth, driven by the successful execution of our strategy. Q1 revenues of $695 million grew 5% and adjusted EBITDA of $170 million grew 12%. Over the years, we have made deliberate decisions and investments across our business and delivered on our commitments over time and through market cycles we have differentiated mneal from our peers by delivering sustainable growth driven by our leadership and quality innovation and execution Today, MNIL is in as strong a position as ever. We are embarking on our next phase of growth with momentum and confidence in our ability to deliver on our goals in 2025 and beyond. Big picture, MNIL is a trusted leader in an essential industry, providing millions of Americans with access to affordable and innovative treatments. Each year, we fill over 162 million scripts for American patients. Amnil has one of the largest U.S. pharmaceutical manufacturing footprints in the industry. With a broad portfolio of over 280 products, over 150 of our medicines are made in the United States. From antibiotics, antivirals, to medicines that treat Alzheimer's, cancer, Parkinson's disease, or M. Neal, made in America, isn't just a label. It's been a cornerstone of our strategy since our founding in 2002 in Petterson, New Jersey. Let me now walk you through the key areas of our business. First, in our specialty segment, the launch of Crexon for Parkinson's disease continues to exceed expectations in its first year of commercialization. Market uptake has been strong. with market share already surpassing 1% and on track to reach over 3% by end of this year. We have received remarkable feedback from patients and providers as one key opinion leader who is also a patient shared the following. Crexon has made me feel and move tremendously better compared to Ritory. I have concrete examples of how Crexon has changed my life. It has made a huge difference. In addition, we are pleased with the continued progress and momentum in expanding market access. This year so far, Crexon has been added to several major insurance plans, including the Veteran Administration, UnitedHealthcare, CVS Health, and Cigna Commercial. These doubles the total U.S. coverage from approximately 30% at the end of 2024 to approximately 60% of U.S. covered lives today. To put that in perspective, Crackson has achieved in six months that right away took years to accomplish in market access coverage. We are highly confident in achieving U.S. peak sales of 300 to 500 million for Trexon. Overall, we are focused on expanding our specialty branded portfolio over time. Next, with the anticipated launch of our DHE auto injector later this year. Second, in GLP-1s, we continue to advance our partnership with MetSERA in the weight loss and obesity space, which represents a new integrated business model to drive innovation at scale in GLP-1s. MetSERA is rapidly advancing its pipeline of ultra-long-acting injectable and oral candidates. As they have shared, MedSERA's lead program, Med097i, a monthly ultra-long-acting injectable, is expected to deliver Phase 2B trial results mid-year. Amnil is MedSERA's preferred global supplier across the United States, Europe, and other markets. Also, M-Neil will commercialize their products in 20 emerging markets, including India. To support this plan, we are leveraging our existing infrastructure while constructing a high-volume peptide manufacturing facility and an advanced sterile fill-and-finish production facility. Over time, we expect GLP-1s will be a long-term growth driver for M-Neal with three avenues of value creation. First and foremost, our collaboration with MetSera. Second, potential CMO offerings for other large companies. And lastly, manufacturing capacity we can provide for generic weight loss therapies globally third in our affordable medicine segment which includes retail genetics injectables and biosimilars growth continues to be driven by our diversified complex portfolio and new launches in particular our injectables portfolio is expanding Last month, we launched Beruzu, which is our fourth 55B2 injectable launch over the last These ready-to-use solutions improve hospital efficiency by eliminating medication preparation steps and have unique reimbursement coding for hospitals. Fourth, turning to biosimilars. This represents a next major wave of affordable medicines in the United States. According to an IQVIA report, more than 100 biologics will lose exclusivity over the next decade. Yet, only 10% have biosimilars in development. Biosimilars for the remaining 90% could save approximately $189 billion over 10 years. For patients, biosimilars improve affordability and access to essential therapies. For MNEAL, they represent a compelling long-term growth opportunity that we are well positioned to lead. Today, our strategic focus has been in licensing our biosimilar portfolio and establishing a commercial platform. In 2024, our first three biosimilars generated $125 million revenue. In addition, we have expanded our pipeline with regulatory applications for five additional biosimilars being filed this year. By 2027, we expect to have six biosimilars on the market across eight product presentations. Our strategic goal is to be vertically integrated in biosimilars and leverage our proven ability and expertise to develop, manufacture, and commercialize complex biopharmaceuticals at scale. Finally, growth in our healthcare segment continues to be driven by new launches across three channels, distribution, government, and unit dose. We expect type care revenue to reach over $900 million by 2027. This business adds stability and diversification to Amnil's portfolio. In summary, Amnil has diverse array of growth drivers that enhance our competitive differentiation, drive sustainable value creation, and improve access and care for patients. Our strategic focus and long-term investments have been intentional and thoughtful. We could not be more excited about what the future holds as we advance our vision to be America's number one affordable medicines company. I will now turn it over to Chintu.

Thank you, Chirag, and good morning, everyone. Let me begin by expressing my deep appreciation to our MNIL team. Their passion and commitment continue to drive MNIL forward as a purpose-driven company focused on innovation, execution, and value creation. This morning, I will provide an update on our strategic priorities across operations, innovation, and our portfolio. First, on operations, our global high-quality manufacturing infrastructure remains a key differentiator. MNIL continues to be recognized for its stellar quality track record and operational excellence. We are investing in digitization, automation, and AI technologies across our network to drive operational efficiency and our trusted quality and customer service reputation. This foundation positions us well to launch new products, help address drug shortages in the market and serve more patients. Amnil has a robust and diverse manufacturing footprint across the U.S., India, and Ireland. In the U.S., our extensive manufacturing infrastructure and capabilities are the foundation of our leadership position. We are one of the largest domestic pharmaceutical manufacturing footprints in the industry as we produce many of our generics and specialty products, including Claxon, in the U.S. Over the years, we have built deep pharmaceutical manufacturing expertise across a wide range of dosage forms in the U.S., from oral solids to highly complex formulations. We have seven US FDA-approved manufacturing facilities across four sites capable of making oral solids, liquids, topicals, trans-dermal patches, and nasal spray dosage forms with excess capacity to meet market needs. Amnil is proud of its made-in-America heritage, which is a competitive advantage and a core part of our strategy. Turning to innovation, we are pleased with the progress of Craxon in the first six months of launch with strong KPIs across the board. The product is engineered for rapid onset and extended efficacy, delivering more good on-time with fewer doses for Parkinson's patients. At the American Academy of Neurology meeting last month, our team shared new data from our Phase III study showing significant improvements in sleep quality for patients on Paxot. In particular, sleep disturbances affect up to 80% of PD patients. Further, our open-label phase 4 study is underway to generate additional real-world evidence. With robust early adoption and strong feedback from the neurology community and patients, CREPSON is poised to become the leading branded product for Parkinson's disease. Next in our specialty pipeline is the DHE auto-injector for migraine and cluster headache. Our goal date is coming up this month. This innovative presentation of a well-known molecule was developed and will be manufactured in-house. This first and only DHE auto-injector is intended to help patients avoid emergency room visits during these painful headache episodes. We look to launch this product later this year and see the DHE auto-injector as a 50 to 100 million peak cells opportunity. In addition, our strategic partnership with MATSERA in the GLP-1 space is progressing as planned. As part of this collaboration, we are building two new manufacturing facilities, one for peptide drug substance production and another for advanced sterile field finish manufacturing. These facilities will enable high-volume production as MNIL serves as MATSERA's preferred global supplier and will support large-scale GLP-1 commercialization if this collaboration exemplifies how we are leveraging our strong core competencies in R&D and complex manufacturing to lead in high growth therapeutic areas like GLP-1 on our complex genetics portfolio each year we expect to launch 20 to 30 new products we have launched eight new products so far in 2025. Later this year we have several key complex product launches including Bradford ophthalmic suspension and respiratory injection overall we have 81 ANDA spending approval of which 65 percent are non-oral solids and 47 products in development of which 96 percent are non-oral solids we continue to prioritize within our rmd portfolio and allocate investment towards higher growth areas like specialty brands injectables and biosimilars over time in injectables we launched 12 new products in 2024 and expect to launch over 10 new injectables in 2025. in particular we have launched four new 5-5-B2 injectables over the last year, which is a new growth vector for our business. In April, we launched Boruzu, our fourth 5-5-B2 injectable. In addition, we have 10 to 12 more 5-5-B2 injectables in development. Other complex injectable R&D programs, including microspheres, liposomas, and drug device combinations continue to progress well. MNIL is well positioned to be a leader in the injectable space in the coming years with our robust manufacturing footprint, deep scientific capabilities, and expanding portfolios. In biosimilar, we see a significant market potential given the upcoming wave of LOEs for biologics and the clear opportunity for MNIL to establish a leadership position in the space. This year, we are filing our next five biosimilar pipeline candidates, which launch is targeted for 2026 and 2027. The BLA filings for two Danazuma biosimilars were submitted with goal dates in quarter Next, the supplemental BLA filings for pack-field grafting, OBI, and auto-injected is expected in the third quarter, followed by the BLA filings for biosimilar Zolaire. set for quarter four we look to expand our biosimilar portfolio and be vertically integrated over time in summary we have continued our strong operational momentum and execution in 2025 our strategic focus on innovation quality and manufacturing excellence sets us for sustainable growth and leadership across our business thank you and with that i will hand it over to pastors Thank you, Chintu, and good morning, everyone.

In the first quarter, we saw continued broad-based growth across our three segments, excellent uptake of Craigson, and new product launches that further enhance our growth profile and diversification. As a result, we're incredibly proud of our global teams for delivering growth of 5% in revenue, 12% in adjusted EBITDA, and 50% growth in adjusted EPS. I'll first cover our Q1 results in more detail, then touch on tariffs, and finally, affirm our 2025 full-year guidance. In the first quarter of 2025, total net revenues of $695 million grew 5% in line with our expectations. Q1, affordable medicines revenue of $415 million, grew by $23 million, or 6%, as new products launched in 2024 and 2025 added 41 million. Our affordable medicines portfolio includes approximately 270 products across retail, injectables, and biosimilars. As Yurag and Chintu mentioned, MNL's R&D success, excellent supply chain, and commercial execution are key strengths, driving consistent revenue growth, broadening of our product portfolio, and delivering value to our customers, providers, and patients. In our specialty segment, Q1 revenue of $108 million grew 3%, driven by Crexon, which added $9 million, and Unithroid, which added $4 million in the quarter. We're delighted by the market acceptance of Crexon and upcoming payer coverage expansion. Consequently, we're confident that Craigslist will meet or exceed its 2025 revenue goal of $50 million. Q1 up-to-date revenues of $172 million through 6%, a strong growth in the government channel was partially offset by softness in the lower margin distribution channel. From a gross margin perspective, we're extremely pleased to report Q1 adjusted gross margins of 43.1% up 120 basis points year over year. The strong margin expansion was driven by favorable product and channel mix, new product launches, and higher efficiencies at the plant level. Q1 adjusted EBITDA of 170 million through 12% reflecting revenue growth, higher gross margin, and operating expense leverage. From an EPS perspective, we're pleased to report Q1 Adjusted EPS of $0.21, which represents 50% growth driven by higher adjusted EBITDA and lower interest expense. In summary, we're off to a strong start for the year driven by strong execution across a multitude of growth drivers. In addition, we continue to strengthen our overall financial position and strong cash flow generation, no near-term debt maturities, and continue to reduce leverage. In Q1, gross leverage was further reduced to 4.0 versus 4.1x at year end 2024, and net leverage remained at 3.9x. Let me now turn to tariffs. And even though it's difficult to quantify precise implications, since our team is developing numerous mitigating actions across multiple scenarios. First, our financial forecasts already include a modest impact of our current tariff provisions. Second, we already have a large and growing manufacturing presence in the U.S., which produces two-thirds of our affordable medicines and specialty revenues. The remaining one-third mostly comes from our indie operations, and imports from the rest of the world are not very meaningful. Third, our teams are taking several mitigating actions to ensure we deliver our commitments to patients and shareholders. These include increasing our U.S.-based inventory, secure alternative sources of API, supply, renegotiating supply agreements, driving portfolio optimization, and other productivity initiatives. Finally, from a long-term perspective, we believe our multiple growth vectors, extensive U.S. manufacturing capabilities, and leading commercial presence position MNIO well in being a top-tier growth company. Finally, we're pleased to affirm our full year 2025 expectations, and as a reminder, we expect total net revenue between 3 and 3.1 billion, which reflects 7 to 11 percent upline growth, adjusted EBITDA between 650 to 675 million, reflecting 4 to 8 percent growth and adjusted DPS of 65 to 70 cents reflecting 12 to 21 percent growth. I will now turn the call back to Chirag.

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

Thank you. We will now begin the Q&A session. To ask a question, please press star, followed by one on your telephone keypad now. If you change your mind, please press star, followed by two. When preparing to ask your question, please ensure your device is unmuted locally. Our first question today comes from David Anselm from Piper Sandler. Your line is now open.

Hey, good morning and thanks. So, I have a couple of questions on biosimilars and generic injectables. First, on biosimilars, can you just give us a refresher on what you expect the 25 contribution, top-line contribution to be, and particularly interested in how big you think Olymsus could be. I think you, in the past, have cited it as being about $100 million of contribution, but I just wanted to just level set those expectations for biosimilars for this year. And then secondly, you talk about vertical integration regarding your biosimilar business. I guess my question here is, when do you think that's going to actually come to pass, And how should we be thinking about not just the next couple of years, but sort of the next five years as we think about the cadence of new launches and just your overall thoughts on contribution for biosimilars to the top line? So that's some biosimilars. And then on injectables, I know you've cited shortages, but you've also cited more complex products. I guess as you think about, you know, the business, is there a lean into one versus the other and just help us better understand what you think injectable top line contribution is going to be this year.

Thank you, David. And good morning. Biosimilism, we're in line with what we have said, around $150,000,000,000 in total contribution on top line with LNOSIS being a leading product. You're in the ballpark somewhere between 90 to 100 million. That's what we are driving towards. So that's the current existing products. And then your question on vertical integration, we're looking at options, and we expect to execute on options by probably end of this year, maybe beginning of next year because we see time as that essence now would like to be very very a big player in biosimilars having the development capabilities having manufacturing capacity in the United States and in India or other locations in the world and I have this we as we said this is There's a void in biosimilar. There's so many products we can work on. And when we do look to vertically integrate, we will hope that the partner has a big pipeline and the contribution from a biosimilar business over five years and 10 years is going to be very significant. It is the whole, as you know, the value of the biosimilars are huge. the total branded values 250 300 billion dollars and about 100 losing exclusivity over the next 10 years so there is it's all about execution the market dynamics on a commercial side we believe will work it out over time just like how it worked out in GX but not exactly like GX because competition here is very less from the supplier standpoint right now we see about somewhere seven to ten active companies in the united states that work in the pipe work on the pipeline serious pipeline so i know it's a long answers but it's a very very important uh uh vertical for us biosimilists to grow and it's in our wheelhouse this is what we do we complex development device combination, biosimilars, very complex manufacturing and great commercialization in the United States and work with partners in the international market. So it's a great international opportunity. On Injectable, I'll pass it over to my younger brother.

Good morning. On injectables, over the last few years, we have expanded our manufacturing footprints and R&D capabilities to work on complex and same times we have the capacity which we can, you know, work on certain volume product. We are very passionate about solving the truck shortage because we believe that truck shortage should not exist. And we have many products where it does not affect or impact our ability on the complex development. So we are focusing on both areas. Our complex portfolio is moving very, very well. This year we'll be launching CONSTAR. We have launched many other 5.5b2 programs. We have a 10-12 pipeline of a 5.5b2 injectable programs along with microspheres are making good progress. Our liposomers are making good progress. We have a deep expertise on drug device combination. We have now infrastructure of about 22 injectable lines with three to four locations, and we are also looking to some manufacturing in the U.S. in coming time also. So we are well positioned on injectables, it's a focused area, and we're not leaning one over another. We are prioritizing both space equally.

Thank you.

Thank you. The next question is from Les Lewicki from Truer Securities. Your line is now open.

Good morning. Thank you for taking my questions. First, I wanted to focus on AFSCARE. How exposes AFSCARE to the federal government cuts, if any? How are you positioning this business in the current environment, I guess? And then second, are you seeing any sort of FDA delays, whether it's approvals or feedbacks on the generics front and any sort of, I guess, initial potential from facility site visits delays as well. And then second, just kind of talk to us about the ongoing partnership selection on Crexon, ex-US. I know you've identified EU and South America and Canada, but perhaps maybe just give us a little bit of timeline on other parts and then specifically with your timeline to launch in India and the opportunity there. Thank you.

Thank you, Les, and good morning. So VA, these federal cuts do not apply to the pharmaceuticals. VA is actually expanding 18 million lives and more Our veterans are becoming older, so more prescription drugs, so we see volume growth actually in VA, DOD, so we do not see any issue there. The question on FDA, we haven't seen any delays from FDA at this point, so no issue there. And then Craxon ex-US, we have the partnership in place for Canada, Latin America, Europe, and now we design Southeast Asia. India, we're going to market by ourselves. Europe is the largest market size will be for us. and partners doing a phase four additional small phase four for European requirements to get a proper reimbursement. And then India, we haven't gauged the exact market size, but it's much needed all over the world. Only IR is available for the last 30, 40 years.

And these patients really will benefit from taxon and looking at china and japan that those talks are going on right now let's just to add one thing on fda uh none of our gold dates have been impacted all of our products are progressing well and it's part of the gadufa user fee also so site inspection plus amnius all plants are fd approved and in a very very good standing uh that also benefits us from any potential delays. But as of today, we have not seen any delays on our application or the goal dates.

Thank you.

The next question is from Chris Schott from JP Morgan. Your line is now open.

Great. Thanks so much for the questions. I said maybe to start with a two-parter on tariffs. I know you have a different manufacturing footprint versus peers. So, if we were to see tariff supplied to pharmaceuticals. Do you see an opportunity to further leverage your U.S. manufacturing footprint? And may I just talk a little bit about what type of capacity you'd have to utilize if, in fact, we did see tariff supplied? My second question on the tariff front was for some of the products that are potentially exposed to tariffs and thinking about the affordable medicines portfolio, what is the ability to increase price on some of these products to offset some of those pressures? Or is the goal of MNEAL more to pivot the manufacturing to either your own capacity or third parties to more avoid tariffs on those? And then maybe one follow-up after that.

Thank you, Chris. So if tariffs were to come on generics pharmaceuticals leveraging over US manufacturing footprint, we have a traditional capacity we have one idle plant for a long time now which we would restart if economically viable we still have to do that it's a long-term economically viable about eight to ten billion more units of auto solids of liquid manufacturing topical manufacturing transdermal manufacturing we can produce in the United States, so we are ready, set to go, but it has to be economically viable. And your question on increase in prices, obviously, look, if there are tariff-related increases, we would work with our big, big customers. You know, they have to participate in that, which is CVS and UnitedHealth and Cigna. These are large companies. And there is some positive indication from the customers that they would partner in if something has to happen, because the last thing we want is any kind of discontinuation or shortages. So that's the news so far. Thank you, Chris.

Great. And maybe just as a follow-up on Corxellant, by looking at Scripps, I mean, obviously great trends so far. It seems like we're seeing very little cannibalization from Retari as we've seen the ramp. I know that hasn't been the focus, but as we get maybe closer to that Retari LOE, is there an opportunity to maybe accelerate some of the conversion of those patients ahead of generic entry, or is the focus more on just the broader market here? Thanks so much.

Yeah, Chris. So our focus, as we have said from the beginning, it's a broader market. It's a huge market. Almost 650,000 patients we could potentially be on Crexon. Rightly reached up to 40,000. We are already at a run rate of 20,000 patients now. And by year end, we'll have 25,000. And then next year, we could reach, I would easily double that or more. So 80% of that is coming from the new patient, IR, which was our goal. And Reiteri, as I pointed out, the KOL by himself took Reiteri over the years, now taking Crexon, seeing a huge impact. So as the patient are, many of these MDS already have started shifting their patient to Crexon because it's just a much better drug than RITERI.

So we would see both, but we're not doing anything particular.

We don't need to move or convert aggressively from RITERI to Crexon at all.

Thanks so much.

Thank you. We have no further questions, so I'd like to hand back to Shirag for concluding.

Well, thank you very much. We're so excited at Emneal, and we wish everybody a great weekend. Thank you. Thank you, everyone.

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