Amneal Pharmaceuticals, Inc. (AMRX) Q1 2026 Earnings Call Transcript

Good morning, and welcome to today's Amniel Pharmaceuticals Investor Call. I will now turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amniel Pharmaceuticals Investor Call. This morning, we issued a press release announcing Amniel agrees to acquire Kashiv Bioscientist and reporting preliminary Q1 results. The press release and presentation are available at amniel.com. Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook, or predictions are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for Factors that May Impact Future Performance. We also discussed non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the press release and presentation. On the call today are Sharag and Shintu Patel, co-founders and co-CEOs, Tatos Konideris, CFO, and Jason Daly, Chief Legal Officer. I will now hand the call over to Sharag. Thank you, Tony.

Today is a defining moment for M.Neal. This morning, we announced that Amnil agrees to acquire Kashyyyk Biosciences, creating a fully integrated global biosimilars leader, and positioning Amnil to become the number one affordable medicines company in the United States. We have long said this was our goal, and today we're showing exactly how to get there. Turning to slide three, I'll begin the call by discussing the strategic fit of the acquisition and the remarkable biosimilar opportunity ahead. Shintu will share more about Kashiv, our combined capabilities, and the robust biosimilar portfolio we will have. Tassus will discuss the transaction, our financial outlook, and MNIL's very strong first quarter results, which we pre-announced this morning. At a high level, Q1 marked another consecutive quarter of strong top and bottom line growth with revenue of 4%, but just a bit up 19% and EPS up 29%. Our strong start of the year combined with growth of existing and new products gives us confidence to raise our standalone guidance for 2026. This consistent performance is something investors have come to expect from MMEAL and something we take great pride in. On slide four, we provide an executive summary of this combination. First, this is a highly strategic transaction that creates fully integrated global biosimilars This unlocks direct access to more than $300 billion of worldwide biologic loss of exclusivity over the next decade by bringing together Kashiw's deep R&D and manufacturing capabilities with our proven commercial scale. This combination builds on a long-standing partnership that significantly reduces execution risk. Second, this combination creates immediate scale in biosimilars. We expect multiple launches each year going forward, supported by a robust pipeline of more than 20 biosimilars programs. Third, this adds biosimilars as a key growth pillar within affordable medicines. The transaction further diversifies our business and extends our growth profile well into 2030s. while also creating a footprint to expand internationally over time and fourth the deal is structured to create value from day one with a balanced mix of our print consideration performance-based milestones we expect significant financial synergies and we maintain a disciplined financial profile with a clear path to be leveraged to below 3x by 2028.

Let me turn it over to Chintu to share more about Kashin. Thank you Girag, good morning everyone. Moving to slide 5 today's acquisition announcement reflects our long stated goal to be vertiginally integrated in biosimilars. I want to acknowledge the M. Neal and Kashin teams whose hard work made this possible. Kashin is a biologics platform built over 12 years with more than 900 million invested 600 plus employees and four r&d and manufacturing sites it brings proven capabilities a differentiated portfolio and a global operational footprint in u.s and india which provides reliable supply chain and cost efficiencies turning to slide six Kashi adds deep biosimilar development expertise and scaled U.S. and India manufacturing, enabling multiple programs to run in parallel with speed and cost efficiency. The platform can support three to five biosimilars developments annually and offers end-to-end biologics capabilities from crone development and protein characterization through clinical and regulatory execution. These expertise spans key modalities and the vast majority of biologics, including microbials, monoclonal antibodies, fusion proteins, bispecifics, and cytokines. From a manufacturing perspective, drug substance capacity is expected to scale from 26,000 liter in 2026 to 75,000 liter by 2028. Combined with MNIL, this creates a fully integrated global biosimilar platform. I will hand it over to Tasos to share more on the transaction.

Good morning and thank you, Cintur. Turning to the transaction overview on slide 7, as you can see, we have purposely structured this deal to balance upfront value and success-based consideration to ensure alignment of interests. The upfront value of $750 million is a 50-50 mix of cash and equity. The equity portion translates to approximately $29 million of MNEL shares representing 8% equity dilution. In addition to the upfront value, the deal terms include potential milestones of up to $350 million contingent upon attaining certain regulatory approval milestones as well as potential royalties over 12 years contingent on achieving certain gross profit levels. Finally, EMIL will fund operations between signing and closing of the deal. We spend a lot of time structuring this transaction to ensure it aligns incentives with the large commercial opportunities ahead of us and doing it in the most balance sheet friendly way. The transaction will be funded by cash on hand as well as some additional debt and we expect a combined company's net debt leverage ratio at the end of 2026 to be 3.7 times adjusted EBITDA, only a slight increase to the 3.5 times adjusted EBITDA at the end of 2025. It is important to note that we expect to resume our deleveraging in 2027 and expect our net leverage ratio to be three times below adjusted EBITDA, the debt adjusted EBITDA by 2028. Finally, we expect this highly strategic transaction to close in a few months as we work through MNIL shareholder approval and customary closing conditions and regulatory approvals. Let me now share our expected combined financial growth profile on slide eight. First, we're embarking on this acquisition from a position of strength. As you may have seen from our press release this morning, we announced record first-quarter preliminary financial results, and we also raised our full-year stand-alone guidance. EMIL's ability to deliver solid top-line growth and double-digit adjusted EPS growth in a tumultuous microeconomic environment is a testament to our strategic choices, strong execution and relevancy of our products. Consequently, on a combined basis, including CASHIB, our 2022 NT6 view remains largely unchanged aside from a small impact to cash flow related to near-term transaction and integration costs. Importantly, we're maintaining the higher adjusted EBITDA and EPS outlook, which we believe is a clear signal of the underlying momentum and confidence in the trajectory of our business for 2027 and beyond we expect the combined company to continue to grow both in terms of top and bottom line performance and by 2030 we expect revenues to have grown by approximately 1.2 billion or 40 percent over 2026 and eps up by approximately $0.70 or 70% over 2026. Finally, we expect substantial operating cash flow growth which supports our continuing deleveraging. While increased financial performance is important, I cannot emphasize enough the impact this acquisition is having in enhancing our diversification, providing us with access to large markets into 2013 and beyond, just like our GLP-1 deal with Pfizer. Let me now hit it back to Shirak.

Thank you, Tassos. On slide nine, this transaction fits squarely in our long-term strategy. It adds biosimilars as a key growth pillar and positions us higher on the value curve with greater scale and higher growth. So why now? In looking at slide 10, it's because we are entering the golden era for biosimilars. The global market is expected to grow from about $40 billion today towards $200 billion by 2035, driven by the largest biologic loss of exclusivity in history over the next decade. Advancing to slide 11, biosimilars represent the next major wave of affordable medicines, and we are at an inflection point. physician adoption is accelerating, patient access is expanding, and the U.S. regulatory advancements are lowering development time and cost. Today, about half of U.S. drug spend is concentrated in a high-cost biologics. Furthermore, biopharma pipelines continue to shift towards biologics, with most therapies in development being large molecules. Each biologic is a future biosimilar opportunity. With biosimilars, excess expands and costs lowers, delivering meaningful value for patients and the healthcare system. In 2024, biosimilars were estimated to have saved the U.S. healthcare system $20 billion. There's a powerful opportunity to improve affordability and expand access because what is the point of innovation if it is not accessible turning to slide 12 despite this opportunity there are only a handful of integrated global players and today there is no clear u.s biosimilar leader most players have relied on partnerships to date. With Kashi, we bring together development, manufacturing, and commercialization, enabling faster execution, smarter and bigger portfolio choices, and ability to capture full economics. We believe this level of vertical integration is a true competitive advantage. I'll pass it back to Chintu to share more on the combined capabilities and portfolio.

Thank you. Kirak shared with you the strategy on why biosignalics. Let me share with you the clear reason why I'm nil. Looking at slide 13, since our founding, we have built a leading affordable medicine business. We are now number three in US retail generics with over 280 products across dosage forms with one of the most complex portfolio in the industry this is a natural extension of our strategy and we will execute with the same rigor and discipline in biosimilars on slide 14 we show how this combination brings together end-to-end biosimilar capabilities cash you add scientific expertise and in-house development from cell line through approval along with skilled biologics manufacturing across the global footprint and it brings a proven commercial engine leveraging our leading affordable medicines business long-standing customer relationships and the specialty branded infrastructure to drive market access and uptake built on a 10 year plus partnership with kashiv our capabilities are highly complementary and positions us to execute well next let's look at slide 15 and the combined portfolio together we have a combined portfolio of 20 plus biosimilars that targets over 100 billion in u.s opportunity and more globally first we expect to have six commercial biosimilars by 2027 including biosimilars for arrastin and anusumab and a biosimilar for zoler which is pending approval second we expect six or more additional approvals from our advanced pipeline by 2030 and third in 2030 and beyond we have a deep pipeline of future programs that extend our growth well into the next decade strategically this is a balanced and durable portfolio mix many opportunities are biologics with less than one or two competitors expected and others are widely used products with large markets creating a durable and scalable growth engine on slide 16 we have a clear line of sight to steady cadence of near-term catalyst from Kashyyub first landreotide is a high-value partner asset expected to be approved in quarter three second biosimilar solar follows with anticipated approval at year end which is another Kashyyub partnered asset that we now capture full value for after After that, we see a pipeline of additional approvals in 2028 and 2029, including biosimilars for Orentia and Simzia, each representing meaningful future growth drivers. Let me now pass it back to Tasos.

Thank you, Sindhu. I'm very pleased to share with you our exceptional first quarter preliminary results, our confidence in the strength of our business, which translates to increasing our full-year guidance on a standalone basis, and finally, our proposed acquisition of Cassif Biosciences, which positions Samuel as a leader in the large global biosimilars market. Let me first start with our first quarter preliminary financial results, which were characterized by robust top-line growth, exceptional bottom-line growth, and continuing deleveraging. Moving to slide 22 in the appendix, total net revenues in the first quarter of $723 million grew 4%. Q1 affordable medicines revenue of $423 million grew 2% driven by strong performance of key women's health and ADHD products due to high market demand and increased meal supply. These high-margin products drove Q1 segment gross margin to 47.3%, up 320 basis points versus Q1 of 2025. We continue to expect affordable medicines revenue growth of 7% to 8% this year, driven by the strength of new product launches and strong execution by our teams. Q1's specialty revenue of $133 million grew 23%. First quarter, Crackson revenue of $21 million reflects continued strong market uptake. Earlier this week, we shared with you our additional Phase 4 data, which showed Crackson as having more than three hours, good on-time versus rate hourly, reflecting the Crackson's compelling clinical profile. In addition, we're also delighted with the strong last trajectory of Brachia for cluster headaches. Revenue in Q1-2026 was $4.6 million compared to $1.6 million in Q4-2025. This rapid adoption as well as feedback from patients and prescribers confirms the substantial market need and long-term revenue potential for Brachia. Turning over to Avcare, where Q1 revenues of $166 million declined by $6 million or 4%. A strong growth in our government channel was offset by expected decline in the low-margin distribution channel. As you recall, this is part of our strategy to enhance profitability, and we're happy to report that Avcare's gross margin in the quarter grew by 690 basis points versus first quarter last year. Moving to slide 21, from a bottom line perspective, the strong growth of adjusted gross margins by approximately 500 basis points and thoughtful expense management translated to Q1 2026 adjusted EBITDA of $202 million, up 19%, and Q1 Adjusted EPS of $0.27, up 29%. Finally, our strong financial performance and discipline continue to reduce leverage, and our net leverage ratio in March of 2026 declined to 3.5 times adjusted EBITDA compared to 3.9 times adjusted EBITDA in March of 2025. So, in summary, and before I turn to our acquisition of Cassif Biosciences, our business fundamentals, financial outlook, and balance sheet have never been stronger, which positions us well to consider such a strategic deal. Turning back to the acquisition for a moment, as we outlined on slide 17, This is a highly synergistic transaction, adding significant value to our commercial and operating business model and providing substantial financial benefits over the course of time. From an integration perspective, we're combining Cassif's R&D and manufacturing expertise with Emniel's commercial engine, we're strengthening market access, expanding in hospitals, and accelerating international growth. With our shared global platform, we accelerate time to market at lower cost. From a financial standpoint, we expect 400 to 500 million in cumulative financial synergies over time. There are two key elements to this. First, we're now capturing full economics from partnered assets by eliminating milestones and profit sharing obligations that existed as part of prior licensing deals. Second, we also expect to realize substantial tax benefits as well as incentives from the local Indian authorities. Importantly, this deal goes beyond traditional cost synergies. It creates strategic scale and durable value by also avoiding the significant time and capital needed to build a biosimilars platform organically. Let me now hand it back to over to Shirai. Thank you, Tassos.

On slide 18, since 2019, we have built a stronger, more diversified amniac and delivered consistent top and bottom line growth each year. We have done this by executing well across our business. We launched 20 to 30 products annually, expanded specialty with Crexon and Brachia, entered biosimilars with our first products, established a novel GLP-1 collaboration with Pfizer, expanded internationally and acquired and more than doubled the healthcare business. That said, the opportunity ahead remains significantly greater than what we have achieved to date. We envision Amnil 2030 as a much larger, more diversified biopharmaceutical company with more than 400 retail and injectable medicines, mostly complex and differentiated, a large pipeline of 20 plus biosimilars and multiple specialty branded products advancing the standard of care, while Amnil fills hundreds of millions of U.S. prescriptions each year. In summary, the key takeaway from today's call are on slide 19. Today marks a pivotal moment for M. Neal, establishing a fully integrated global biosimilars leader, strengthening our diversified portfolio, and extending our durable growth profile into 2030s. Our strategy 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 patients.

With that, thank you, and we'll open the line for questions. Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 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 comes from the line of Matt Dellatore with Goldman Sachs. Your line is open. Please go ahead.

Guys, and congrats on the deal. I know this was a long time coming, so very exciting. Maybe two questions, if I may. First, just on to the commercial strategy for the new expanded portfolio. I see you have both, you know, the mega blockbusters like Doopey and Contruda and also many sub-5 billion assets in there. And then also, you know, it's a healthy mix of pharmacy benefit and medical benefit drugs. So could you maybe just speak a bit on how you approach portfolio construction and what type of assets we should expect over time as you all disclose more in the pipeline expands? And then I realize you're primarily focused on the U.S. market, but could you just remind us how you guys are thinking about this international biosimilars business as well? And then maybe stepping back, a question for Chirag. When you look at this new kind of combined company you all have now, what would you highlight as maybe the two to three specific things that you're most excited about and that you think could drive upside to this long-term guidance that you're giving today? Thanks a lot.

Well, thank you. Matt, good morning. So let me address the portfolio mix first, the Kashi pipeline. So markets are shifting more towards PBM, as we know. We predict 70-75% market to be driven by private label pbms specialty pharmacies and 25 or so percentages will be driven by buy and build so it's a well thought out portfolio if you look at it the discourse product there are certain undisclosed product that just like what we did with small molecule we want to be the big player relevant player, and mostly focus on niche products. So how do we achieve that? That is why we have some of the big products like Cape Trudeau, Optivo, Dupixin. But it each has its own reason why we have selected. Just to give you an example, Dupixin requires such a large biologics capacity. We're building it, and at the right time, it will be ready to deliver. Then we have niche products, which we expect two to three competitors. So if you look at overall in the next 10 years, a portfolio would be probably 70% would be niche. About 30% would be the large molecule that we must have to offer a complete package to the customers. So that is how the portfolio makes very well. And obviously, the IP driven, a lot of strategy, what goes behind it for the last 10 years, what Kashyyub has done. And we love the portfolio. And execution is going to be the key, which MNIL has executed over the last 25 years. We'll bring the same rigor to execute this big platform on a biologics. Your second question on how do I think about U.S. commercial, as I answer most of the products, we will be marketing Amnil directly. We already have a longstanding relationship with big buyers such as CVS, Express Script, Cigna, Optum, United Health. These three are about 80% of the market. We also enjoy a great relationship with smaller customers. So we're well set to commercialize products in the United States with a broad portfolio of small molecule. Don't forget that plays a role as well. It's the same people, same relationship, same trust that we have established. If you ask the Red Oak of the world or Walgreens of the world, they would rank MNIL as the most strategic, the best platform, best values, use the most complicated products that we come up with and create a massive patient access at affordable prices. We intend to do the same with biosimilars. Your international, our strategy has been clear. India, we have started marketing on our own, mostly the unmet need on a branded side and biosimilars. The rest of the world, we enjoy great partnership as Amnil. Kashiv has also built great partnership with companies as well, which will be disclosed in the near future. So I'm a big believer in a partnership model. So you can, there is a biosimilar void. There's 118 biosimilars. How do we deliver as an industry on all of that? So partnership will make great sense. And we don't intend to have boots on grounds in Europe or South America or Canada. That's not where we are focused on. We are solely focused on delivering biosimilars at scale, staying in the molecule for a long time. So, be a champion in America, as we have a stated goal, is America's number one affordable medicine company, and we are on our way to get there. Maybe 2030, 32, we have multi-decade strategies. So, we are completely focused and internationally great partners. We look forward to work with them. The last one, and sorry, the long answer, but I'm so excited. The new combined company, what is the most exciting thing? So let's go back. I mean, our core business is performing at a full throttle. The women's health, the hormonal patches, demands has gone up. The inhalation products demand, ophthalmic products demand, they're all at a high level. And also the small molecules, LOEs, are going to double in the next five years than it had for the last five years.

So tremendous growth opportunity in core business by itself.

Second, especially brands. Very exciting. You saw the cracks on data. Amazing. I mean, we're getting words from our partners in Europe and India that this would become a first-line therapy.

Because they've been using 40 years old technology platform.

The product was made 40 years ago, IR products, Sinemet, which gives you off time every two hours, three hours. You think of a life of a Parkinson's patient. Crexon is the best therapy out there for maintaining their daily lives. So very excited about Crexon and seeing a great outcome on brachia. It's a much-needed product, useful product for cluster headache patient and severe migraine patient. The third, GLP-1 partnership with Pfizer. As we all know, GLP market is going to keep growing and it's going to become like Stettin. So tremendous capacity and capability would be required. This is what we are building with MetSera, then it's with Pfizer. We enjoy a great relationship with Pfizer, the win-win situation, global markets, global demand. We have 18 countries, emerging countries, including India. We've been given the rights to market Pfizer's branded products, which came from MetSera portfolio. That's a completely unique strategy than fighting over the generics at such a low crisis that's been out there and just started in India and rest of the world. And we believe this is consumer products, so everybody would want less side effects, longer duration, which potentially Pfizer products delivers. And the last one, as we've been talking on this call, is all about biosimilars, huge growth. We've been saying that this is the inflection point. The providers are excited. The 80% now turns into biosimilars. The insurance company, the coverage is becoming better and better. CMSs keep pushing for it. FDA has reduced the regulatory requirements. So this is the perfect time that we integrate this platform and deliver three to five biosimilars, develop and file and commercialize for many years to come. And it also opens up the opportunity for B-specifics, right, the fusion proteins, and in the future, ADC as well. So this is why it's so important for amnil to now have a complete platform, small molecule platform and large molecule platform. Long answer, but I hope it was helpful, Matt.

Yes, yes. No, thank you. You're super helpful. I really appreciate that, Nicole.

Your next question comes from the line of Les Zalewski with Truist Security. Your line is open. Please go ahead.

Thank you. Congrats on the transaction. So you noted the capacity scaling from 26,000 to 75,000 liters. You know, how does this compare to some of your peers and what's the magnitude of dollars spent to get there? And separately, would you say this is right-sized for that business moving forward and you know do you see a further need for capacity expansion beyond the 75k and then second on the gross margin profile maybe just walk us through the the puts and takes around one q and how does the remainder of this year look and then over the long run how should we think about the margin profile now that the biosimilars uh business will be integrated thank you great uh chindu and i will take the first one and pass it to tasks for the second one so kashi has been the platform manufacturing sites over the last several years which is which coincides with uh with the product approvals timing so solar being first

to be manufactured in piscata in new jersey and also the backup site is india as well for global supply so all key molecules will have two sites us which as you know we are us champion uh we always believe in U.S. manufacturing, we keep expanding U.S. manufacturing, and we already have a site in Chicago with Kashi Requisition, which is for E. coli. So the current capacity is sufficient for first few launches. And then over 27, 28, 29, we're expanding to 75,000 liter, which is again matches with the pipeline execution and pipeline approval and launch timing uh that is how we see the capacity expansion and it'll be a good problem to have from 2030 31 to keep expanding once we have the infrastructure in the same site we can expand uh another keep expanding 25 000 liter another 25 000 as we need we will we are always smart about this will it keep expanding the capacity so we never would have issue with capacity i'll pass it to chintu to give more

lights to this yeah hi les good morning uh so we have a perfectly sized the capacity and it's not only about the how many thousands of liter it's also about how you design and the number of bioreactors because you need flexibility in your manufacturing and and for the execution of the filing product so i think that's the key differentiator that how we have part through that on a long-term basis to cater to our goals of filing a few biosimilars every year and same time also commercially to make sure that we have the excess capacity and we are We have diversified our supply chain from U.S. and India perspective also. So if it's a cost-sensitive product, we will have enough capacity in India and also in U.S. So I think we are positioned well to cater to all the 20 products that we have. And we have also considered this as a global capacity. So it's not only U.S. just issue. We are playing globally in this market. So we are pretty comfortable with the 20 products having 75,000 liters. It's all about the design and how we have thought through that. And we have taken under consideration good market share. So that's also there. About the spend, it's about $30,000, $50 million a year. We'll be spending for the next two, three years on a capex to get to the 75,000 liters.

And Les, good morning. this is around gross margin. So I'll just speak in annual terms. So if you think about our gross margin in 2025, full year total company, we were at 42.9%. So let's call it 43%. And my gut feel is I think we will finish 2026 at about 45%. So at least at 200, we're aiming at a 200 basis points expansion. And that's going to be driven, A, by all the business units. So our affordable medicines margins will continue to expand as we have continued to evolve the pipeline to more and more complex products with higher price points, right? You've been hearing this from us for the last six years now, number one. Number two is we talked about our conscious decision to increase the gross margins in our Amcare business, which has been a spectacular, that acquisition has been a spectacular success. And by focusing more so on the government at the expense of the low margin distribution business, so that continues to pay dividends. And then finally, in our specialty business, which already has, you know, low 80s, you know, 81, 82 percent gross margins, kind of continue to drive that adoption. So those have been the drivers why our gross margin this year should be at about 45% compared to about 43% last year. As you think over the course of time, margins have more room to grow, more room to grow beyond the 45%. You know, if you were here about five, six years ago, you will have heard Chirag and Chintu talking about having, gross margins in the old days, almost 50%. So this is where we are driving directionally over the next 10 years. So it takes some time to get there, but we see another over the next three to four years, we're looking at the 45% gross margin to be closer to call it 47% gross margin as the portfolio continues to be driven by biosimilars, which have a higher price point than the rest of the business.

Very helpful. Thank you. Your next question comes from the line of David Amsalem with Piper Sandler. Your line is open. Please go ahead.

Thanks. So I have a few. First, can you just comment and elaborate on the insider ownership of Cashive? That's number one. Number two is, why provide long-term revenue, EBITDA targets, not just 27, but also out to 2030? what was the rationale there? And just remind us, is the EBITDA margin expansion that you're factoring in between 2027 and 2030, how much of that is a function of just the elimination of the shared economics on Biosims? And then the last question is, how much of your revenue base by 2030 do you expect will be from Biosense? Thanks.

Hey, David. I'll take question number two and number three. Can you just repeat question number one for a second, if you don't mind?

Yeah, the insider ownership of Kashif.

Insider ownership of Kashif. Okay. Got it. Okay. So, well, I'll take the first one. I'll start with the first one. So, the insider ownership of Kashif, You can see it essentially in our proxy, which has been known by the MNIL group, which has been also a big shareholder at MNIL since the beginning of time. So ownership of the MNIL group includes both our CEOs, who have always been transparent of that, as well as people have been investors in Kassiv and also at MNIL for a very long time and key contributors to what we have built now, which is a great company. So that kind of thing addresses question number one, hopefully. Number two is no CFO that I know likes to provide long-term guidance because it's a catch-22 as a lot of things can happen over the course of time. Having said that, and I think you know us long enough to know, we take our long-term guide and financial commitments incredibly, incredibly seriously. So for us to provide long-term guidance, we have to feel pretty confident on our ability to deliver on those commitments, number one. Number two, I think it speaks to the tremendous amount of diligence we have done in this acquisition, which probably expends at least a year's worth of work by tens of people in our R&D group, in our legal group, in our business development group, in our financial group, in the commercial group to convince me and convince us as a management team to lay those numbers out for our investors. You know, the final thing is, I would say, why provide long-term guide to us. It provides a focal point by which we focus 8,000 employees at Emniel and now our brand new colleagues at Kashif. So everyone, all of our 8,000 plus employees are singularly focused to a set of financial metrics so it eliminates ambiguity. you. So this is what's behind why provide those targets. And also, you've got to assume we're being prudently conservative, right? No management team, at least that I know, wants to put out numbers which, you know, they're at risk at missing. So that's kind of how we thought about and why we provide those long-term targets. Now, in terms of revenue and Nibida expansion, So it's a combination. It's a combination of both. I don't have the exact percentages, right? A lot of how much of that is in a new acquisition versus how much of that is the existing business. As I mentioned before, we have an existing business. You look at our affordable medicines, every part of our business is growing. So we are doing this deal not because we need to, because we think this is the right deal to do at the right time with the right risk parameters to drive growth for this business in 2030 and beyond. So you look at our affordable business, and that business is growing this year. We expect it to grow 7% to 8%. That growth will continue, and you can model this, and biosimilars will add to that, right? And then in terms of an EBITDA basis, you know, Q1 EBITDA was up 19 percent, right? Last year's EBITDA growth was 10 this year, so the base business that is growing at least adjusted EBITDA 10 percent. We expect this to continue and the additional add-on will expect it to come on biosimilars. So that's how we think of it. It is a highly de-risk long-term forecast that is based on the growth of the existing business across the acquisition, and it's conservative in nature. So hopefully that addresses some of your questions.

Yeah, and how much of your business do you think is going to be biosimilars? Like what's the revenue base going to be in 2030?

Yeah, so if you think about 2030, for example, the guidance we're providing is between $4.3 and $4.5 billion, dollars probably about a billion a little a billion a little over a billion dollars a billion to a billion three that's going to be biosimilars all right helpful thanks everyone your next question comes from the line of chris shot with jp morgan your line is open please go ahead uh just two for me um maybe just first a bigger picture question on biosimilars can you just talk

a little bit more about how you see the competitive landscape evolving as we approach this very large cycle of biologic patent experiments. I know you mentioned there's no clear leader in the space, but do you anticipate it's going to be a more meaningful consolidation of share and there's going to just be a handful of players or will this remain a more fragmented market as a whole? And the second one to me is just on a specific product on Len Rietai, the civil tooling depot. Can you just talk a little bit about that opportunity as we think about 2026 in terms of market dynamics and competitive landscape and just how meaningful a product that could represent for Amnil. Thanks so much.

Yeah, thank you, Chris. Competitive landscape on biosimilars. As we know, the vertically integrated players are taking more market share. Amgen, obviously, one brand company that is still investing in biosimilars. The rest of the brand companies have moved out out of favor for biosimilars as you know they're more obviously back to the innovative medicines so that leaves sandoz obviously clear uh global leader at this point uh and a great company uh selgion is coming in as a from a south korean company which is expanding in the united states and globally and building a large vertically vertically integrated platform. Samsung's doing both out licensing mainly and concentrating also different division on biosimilars. India's Biocon has been in the biologics for over 40 years. So they're already in the United States market. And then Kabi with map science ownership and their own uh we see them as a vertically integrated player so the way it would expand is this is why it's inflection point that we as mneal got the platform or getting a platform with the manufacturing capacity with the pipeline that we execute over next five to seven years it requires a lot of manufacturing infrastructure a lot of r d infrastructure number of years even with fts phase three gone still will be five plus years from the timing of starting the clone development all the way to the filing and approval and then the ip negotiation of settlement all those things would take five seven years so and you can see like in a small molecule you have 50 companies jumping in from India and China. We don't see that. We see few companies will come from India, a few maybe from China, but they all have to build these U.S.-oriented infrastructure or regulated markets, which is a different ballgame than you've been producing biologics for the emerging markets because of the requirements of FDAs are much at higher standards than those other countries. And Emneal builds everything first with U.S. in mind. So yes, there will be more competitors. The large molecules like K-Truda of DO, you will see five to ten competitors. Some would be partnered. And niche, this is why Kashi and Emneal will be focused on is niche molecules where we will see two to three competitors so that's how we see the uh a competitive landscape maybe eight to ten players there are 118 molecules to go after big biosimilar void is there so that is a large large number of products to work on and not everybody can do every product as we said our capacity capability is three to five per year uh chintu you want to add anything to this?

I mean, there's a lot of high barriers of entry and science. It's much more complicated than the small molecule. It will cost close to $50 to $75 million per product. So there are lots of barriers. So I think it still will remain not that competitive. Plus, as Gerard stated, it takes five, seven years for a nuclear to build this platform and have the manufacturing and development expertise and capacity. At Kashi, we have a fantastic group of 600 plus people. And that experience, I think, gives us the confidence of these three to five wide senior. So competition, as Chirac stated, would be this four or five player, might be vertically integrated, but still is largely a space for somebody to be a leader, and the MNIC will be a leader by 2030.

In Landry Tide, Chris, the market dynamics changed. changed. CIPLA was in the market, had some contract manufacturing issues, so they're no longer in the market. It leaves it only with brand, and the product is in high demand. We're getting calls from everybody, so we have requested FDA to expedite the approval, and they're working on it, and we could be the first, again, the bio, I'm sorry, it's small molecules and generic landreotide in the market, and we will supply and create another access for the hospitals and clinics as soon as possible.

And this is also a global, so we have a banding approval in Europe also, and it's a highly complex product. It's a drug device combination peptide, so we are looking forward to this product, and it's a pleasure.

Your next question. Your next question comes from the line of Glenn Santangelo with Barclays. Your line is open. Yeah, good morning.

Thanks for taking my question. Just a couple for me. You know, Chirag, I mean, I think everyone would generally agree strategically that a deal like this kind of makes sense. But I'm kind of curious to get your perspective on the operational complexities of sort of what's involved here. Because if you look at the, you know, we were just talking to Chris's question about the evolution of the competitive landscape, a number of the other players have decided to go more in the partnership licensing route versus the vertical integration route. And maybe that's a function of how, you know, complicated or operationally complex it is. And so I'm kind of curious if you worry at all about increasing the risk profile of the company in that way. And then maybe secondarily, I wanted to talk about the 2027 EBITDA guidance that you put out today. I mean, I'm guessing you kind of realize that that number's a decent amount below what the street was already forecasting for fiscal 27 and kind of implies some deceleration in the EBITDA growth rate in 27 versus 26. And, you know, just sort of given the four to five hundred million in synergies we sort of talked about, you know, you had a couple of partnership deals that seem like they're on track and maybe you'll have full ownership of them by the time they come to fruition. I'm just trying to reconcile all the pieces that you've laid out here and, you know, as it relates to, you know, how soon we may see those synergistic benefits in 27 and beyond.

Thank you, Glenn. So let me take the first one. I'll pass it to Tassos for the second question. So the first one, partnering versus full economics or being vertically integrated. Yes, it is complex. This is why it took 10 years for Kashi to build this platform with significant investment. So this is why we believe it'd be a competitive light compared to obviously the small molecule and why you can take the last few molecules right who could stay in the market who could take the leadership position and stay all the way until the molecule needs to be to be delivered and produced so if we have a first of all it gives your full economics. So your margin expands, your full freedom of selecting products, and it's not easy to in-license 20 products. We have 20 products by a similar basket, and we're going to add more in coming years. So that freedom, the full economics, in the United States market, it makes sense to be completely vertically integrated. As I stated before, Glenn, that partnering is great. And in international market, we look to partner, and Kashi already has partnership with the key players globally who are well set globally. So I see the combined model, but mostly the companies that would be successful if you look back in 2030 or 35 are going to be all vertically integrated. They will not be, just like in small molecule, there are not any companies that have survived being just the marketing companies. You've got to do a lot more than that because real, real complications is R&D, is the IP, is manufacturing. I think the PBMs and private labels are making the marketing and sales easier, which is how it should be. I hope that answers the first question. You may have a follow-up, but let me pass it to Tassos for you.

Good morning, Glenn. I love financial modeling questions. So let's kind of put things in perspective. So the first point is guidance for 2027 on EBITDA of $820 million is kind of substantially below where the street is. I'm not sure where the street is. Number one, I think that there are about $835 million. So us providing guidance of 8.20 plus compared to 8.35, I don't think it's substantially less than that. Kind of point number one, but also, obviously, we don't run our business to kind of satisfy anybody else other than us and our shareholders. Kind of point number one. Point number two, this kind of notion of kind of deceleration. You know, this year EBITDA, right, the midpoint is at 7.55. It's about 10% growth versus prior year. Even if you take the low end of what we gave you for next year of 820, that's about 9%. So 9% versus 10%, I don't think it's a big deceleration, number two. And number three, we feel great about growing EBITDA 9%, 10%, even absorbing a strategic deal, which is going to have some dilution next year until it becomes a creative in 2028. So we feel great about being able to give our shareholders a view about next year of adjusted EBITDA up of about at least 9%, number one, and at the same time, funding incremental R&D, right, to maximize the opportunity here of, you know, $300 billion plus of branded products going generic over the course of time. That's kind of how we thought of it. And, you know, and trying to give you guidance for 2027, you know, that's a long time away. so i think it speaks to our confidence about telling you what we think we can the minimum we can deliver next year so hopefully they give you some some perspective nope that's perfect i appreciate both those answers thank you very much thank you glenn your next question comes from the line of ash verma with bbs your line is open please go ahead hey this is d from ubs i'm just asking questions on behalf of Ash.

Thanks for taking our questions. So, I have two. The first one, and I apologize, this has been discussed before. So, the first one, how do you think about the land real-time market opportunity? It seems like there's just limited competition in this molecule. So, I just wonder, like, how confident are you about the approval timeline in 3Q, and what will be the gating items for the launch. And then my second question on growth margin, so I think it was discussed before, in annual term, it's about like 45%, but then 1Q, I think this quarter, it's about like 48%. does that mean like we're going to see some gross margin normalization later this year? If you can give some clarification on that, that would be helpful. Thank you.

Thank you, Dee. The gating item is only the FDA approval. We're ready to supply, and it's a great opportunity for MDU. I'll pass it to Tasos on the gross margin.

Yeah, good morning, Dave. Yeah, our Q1 gross margin followed for a while. It was just a record quarter, which was, you know, overall up 510 basis points versus Q1 of last year. So it just, you know, just to kind of enable the sustainability of a 510 basis point, it's kind of hard to keep repeating quarter after quarter. So this is why I think we're being – we have a little bit more modest gross margin expansion for the rest of the year, and this is why, though, even though we'd a little – call it a little bit more modest growth the rest of the year, we still feel confident that overall company gross margins this year in 2026 should be closer to 45 percent, 45 maybe a little better, compared to about 43 percent last year. Hopefully that's helpful.

Yep. Thank you.

There are no further questions at this time. I will now turn the call back to Chirag Patel for closing remarks.

Thank you everyone and have a great day.

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