Amneal Pharmaceuticals, Inc. ($AMRX)

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

Good morning, and thank you for joining Amneal Pharmaceuticals' Investor Call. This morning, we issued a press release announcing Amneal agrees to acquire Kashiv BioSciences and reporting preliminary Q1 results. The press release and presentation are available at amneal.com. Certain statements made on this call regarding matters that are not historical facts including, but not limited to, management's outlook or predictions are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discuss non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the press release and presentation. On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs; Tasos Konidaris, CFO; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

Thank you, Tony. Today is a defining moment for our Amneal. This morning, we announced that Amneal agrees to acquire Kashiv BioSciences, creating a fully integrated global biosimilars leader and positioning Amneal to become the #1 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 3. I'll begin the call by discussing the strategic fit of the acquisition and the remarkable biosimilar opportunity ahead. Chintu will share more about Kashiv, our combined capabilities and the robust biosimilar portfolio we will have. Tasos will discuss the transaction, our financial outlook and Amneal's very strong first quarter results, which we preannounced this morning. At a high level, Q1 marked another consecutive quarter of strong top and bottom line growth with revenue up 4%, adjusted EBITDA 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 stand-alone guidance for 2026. This consistent performance is something investors have come to expect from Amneal and something we take great pride in. On Slide 4, we provide an executive summary of this combination. First, this is a highly strategic transaction that creates fully integrated global biosimilars leaders. This unlocks direct access to more than $300 million of worldwide biologic loss of exclusivity over the next decade, by bringing together Kashiv'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 1 with a balanced mix of upfront consideration, performance-based milestones we expect significant financial synergies and we maintain a disciplined financial profile with a clear path to deleverage to below 3x by 2028. Let me turn it over to Chintu to share more about Kashiv.

Thank you, Chirag. Good morning, everyone. Moving to Slide 5, today's acquisition announcement reflects our long-stated goal to be vertically integrated in biosimilars. I want to acknowledge the Amneal and Kashiv teams whose hard work made this possible. Kashiv is a biologics platform eased over 12 years with more than $900 million invested, 600-plus employees and 4 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 6. Kashiv adds the biosimilar development expertise and scaled U.S. and India manufacturing, enabling multiple programs to running parallel with speed and cost efficiency. The platform can support 3 to 5 biosimilars development annually and offers end-to-end biologics capabilities from crown 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 Amneal, 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, Chintu. Turning to the transaction overview on Slide 7. As you can see, we could 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 Amneal shares representing 8% equity dilution. In addition to the upfront value, the deal terms include potential milestones of up to $350 million contingent upon obtaining certain regulatory approval milestones as well as potential royalty in over 12 years contingent on achieving certain gross profit levels. Finally, Amneal will fund operations between signing and closing of the deal. We spent a lot of time structuring this transaction to insulin incentives with the large commercial opportunities ahead of us and doing it in the most balance sheet friendly way. The transaction will be followed by cash on hand as well as some additional debt, and we expect the combined company's net debt leverage ratio at the end of 2026 to be 3.7x adjusted EBITDA, only a slight decrease to 3.5x 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 3x below adjusted EBITDA, net debt adjusted EBITDA by 2028. Finally, we expect this highly strategic transaction to close in a few months as we work through Amneal's shareholder approval and customary closing conditions and regulatory approvals. . Let me now share our expected combined financial growth profile on Slide 8. 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. Amneal's ability to deliver solid top line growth and double-digit adjusted EPS growth in a tumultuous macroeconomic environment is a testament to our strategic choices, strong execution and relevancy of our products. Consequently, on a combined basis, including Kashiv, our 2026 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% 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 2030 and beyond, just like our GLP-1 deal with Pfizer. Let me now hand it back to Chirag.

Thank you, Tasos. On Slide 9, this transaction fits squarely in our long-term strategy. It had 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 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 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 expense and cost lower, delivering meaningful value for patients and the health care system. In 2024, biosimilars were estimated to have saved the U.S. health care system $20 billion. There's a powerful opportunity to improve affordability and expand excess 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 Kashiv, we bring together development, manufacturing and commercialization, enabling faster execution, smarter and bigger portfolio choices and ability to capture food 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. Chirag shared with you the strategy on why biosimilars. Let me share with you the clear reason why Amneal? Looking at Slide 13, since our founding, we have been the leading affordable medicine business. We are now #3 in U.S. retail generics with over 280 products across dosage forms with one of the most complex portfolio in the industry. This is a national 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. Kashiv add scientific expertise and in-house development from cell line through approval, along with skilled biologics manufacturing across the global footprint. Amneal 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 uptick. We done a 10-year-plus partnership with Kashiv, our capabilities are highly complementary and position 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 6 commercial biosimilars by 2027, including biosimilars for Avastin and denosumab and a biosimilar for Xolair, which is pending approval. Second, we expect 6 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 1 or 2 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 catalysts from Kashiv. First, lanreotide is a high-value partner asset expected to be approved in quarter 3. Second, biosimilar Xolair follows with anticipated approval at year-end, which is another Kashiv partnered asset that we now capture full value for. After that, we see a pipeline of additional approvals in 2028 and 2029, including biosimilars for ORENCIA and CIMZIA each representing meaningful future growth drivers. Let me now pass it back to Tasos.

Thank you, Chintu. 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 stand-alone basis. And finally, our proposed acquisition of Kashiv BioSciences, which positions Amneal 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 Amneal supply. This 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 specialty revenue of $133 million grew 23%. First quarter CREXONT revenue of $21 million reflects continued strong market uptake. Earlier this week, we shared with you our additional Phase I data, which sold CREXONT having more than 3 hours drill down time versus retain, reflecting the CREXONT's compelling clinical profile. In addition, we're also delighted with the strong launch trajectory of Brekiya for cluster headaches. Revenue in Q1 2026 was $4.6 million compared to $1.6 million in Q4 2025. With rapid adoption as well as feedback from patients and prescribers confirms the substantial market need and long-term revenue potential for Brekiya. Turning over to Healthcare, where Q1 revenues of $166 million declined by $6 million or 4% as 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 AvKARE'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%. In 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 3.5x adjusted EBITDA compared to 3.9x adjusted EBITDA in March of 2025. So in summary, and before I turn to our acquisition of Kashiv 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 Kashiv's R&D and manufacturing expertise with Amneal's commercial engine. We're strengthening market access, expanding in hospitals and accelerating international growth with our third global platform, we accelerate time to market at lower cost. From a financial standpoint, we expect $400 million to $500 million in cumulative financial synergies over time. There are 2 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 still goes beyond traditional cost synergies, it creates strategic scale and durable value while also avoiding the significant time and capital needed to build a biosimilars platform organically. Let me now hand it back over to Chirag.

Thank you, Tasos. On Slide 18, since 2019, we have built a stronger, more diversified Amneal 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 CREXONT and Brekiya, entered biosimilars with our first products established a novel GLP-1 collaboration with Pfizer, expanded internationally and acquired and more than double the AvKARE business. That said, the opportunity ahead remains significantly greater than what we have achieved to date. We envision Amneal 2030 as a much larger, more diversified biopharmaceutical company, with more than 400 retail in injectable medicines, mostly complex and differentiated, a large pipeline of 20-plus biosimilars and multiple specialty branded products advancing the standard of care, while Amneal 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 Amneal, establishing a fully integrated global biosimilars leader, strengthening our diversified portfolio and extending our durable growth profile into 2030. Our strategy remains clear to become America's #1 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 will open the line for questions.

[Operator Instructions] Your first question comes from the line of Matt Dellatorre with Goldman Sachs.

And congrats on the deal. I know this was a long time coming. So a very exciting. Maybe 2 questions, if I may. First, just on the commercial strategy for the new expanded portfolio. I think you have both the mega blockbusters like Dupi and KEYTRUDA and also many sub $5 billion assets in there. And then also, 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 disclosed more in the pipeline expands. And then I realize you're primarily focused on the U.S. market, but can you just remind us how you guys are thinking about the international biosimilars business as well? And then maybe stepping back, question for Chirag. When you look at this new kind of combined company you all have now, what would you high maybe the 2 to 3 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?

Well, thank you, Matt. So let me address the portfolio mix first, the Kashiv 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 disclosed product. There's certain undisclosed product that just like what we did with small molecule, we want to be the big player, a relevant player and mostly focused on niche products. So how do we achieve that? That is why we have some of the big products like KEYTRUDA, OPDIVO, DUPIXENT. But it each had its own lease and why we have selected -- just give you an example, DUPIXENT 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 2 to 3 competitors. So if you look at overall in the next 10 years, our 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 Kashiv has done, and we love the portfolio. And execution is going to be the key which Amneal has executed over the last 25 years. We will bring the same rigor to execute this big platform on biologics. Your second question on how do we think about U.S. commercialize, I answered most of the products, we will be marketing Amneal directly. We already have a long-standing relationship with big buyers such as CVS, Express Script, Cigna, Optum, United Health. These 3 are about 80% of the market. We also enjoy a great relationship with with smaller customers. So we are 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 asked the Red Oak of the world or Walgreens of the world, they would rank Amneal as the most strategic the best platform, best values, 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. International, our strategy has been clear. India, we have started marketing on our own, mostly the unmet need on the branded side and biosimilars. Rest of the world, we enjoy great partnership as Amneal Kashiv has also built a 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 ground 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. Champion in America as we have a stated goal is America's #1 affordable medicines company, and we are on a 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, I'm sorry, is a 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 cells, the hormonal patches demand 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 5 years than it had for the last 5 years. So tremendous growth opportunity in core business by itself. Second, our specialty brands. Very exciting. You saw the CREXONT data, amazing. I mean we're getting words from our partners in Europe and India that this will become a first-line care. They've been using 40 years old technology platform. The product was made 40 years of why our product, which gives you off time every 2 hours, 3 hours, you think of a life of a Parkinson's patient. CREXONT is the best therapy out there for maintaining their daily lives. So very excited about CREXONT and seeing a great outcome on Brekiya. It's much-needed product, useful product work for cluster headache, patient and severe migraine patients. The third will be on partnership with Pfizer. As we all know, GLP market is going to keep growing in become like steady and then also tremendous capacity would be and capability would be required. This is what we are building with Metsera then 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 low prices that's been out there in -- 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 being better and better. CMS is keep pushing for it. FDA has reduced the regulatory requirements. So this is the perfect time that we integrate this platform and deliver 3 to 5 biosimilars develop and file and commercialize for many years to come. And it also opens up the opportunity for be specifics, right, the fusion proteins and in the future, ADC as well. So if you -- this is why it's so important for Amneal 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. Super helpful. I really appreciate the color.

Your next question comes from the line of Les Sulewski with Truist Security.

Congrats on the transaction. So you noted the capacity scaling from 26,000 to 75,000 liters, how does this compare to some of your peers? And what's the magnitude of dollar spend to get there? And separately, would you say this is rightsized for that business moving forward? And do you see a further need for capacity expansion beyond the 75,000? And then second, on the gross margin profile. Maybe just walk us through the puts and takes around the 1Q and how is the remainder of this year look? And then over the long run, how should we think about the margin profile now that the biosimilars business will be integrated?

Great. Chintu and I will take the first one and pass it to Tasos for the second one. So Kashiv has built the platform manufacturing sites over the last several years, which is -- which coincides with the product approvals timing. So Xolair being first to be manufactured in Piscataway, New Jersey and also the backup side is India as well for global supply, so all key molecules will have 2 sites. U.S., which, as you know, we are a U.S. champion. We always believe in U.S. manufacturing. We keep expanding U.S. manufacturing, and we already have a site in Chicago with Kashiv 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. That is how we see the capacity expansion, and it will be a good problem to have from 2030, '31 to keep expanding. Once we have the infrastructure in the same site, we can expand another keep expanding 25,000 liters and another 25,000 as we need we're always smart about this. We'll keep expanding the capacity. So we never would have issue with capacity. I'll pass it to Chintu to give more lights to this.

So we have perfectly sized the capacity, and it's not only about how many thousands of liters, it's also about how you design in the number of bioreactors because you need flexibility in your manufacturing and for the execution of the filing products. So I think that's a key differentiator that we have hard through that on a long-term basis to cater to our goals of filing a few biosimilars every year and the 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 products, 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 is as a global capacity. So it's not only U.S. subsidiary. 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 a good market share. So that's also there. About the spend, it's about $30 million, $50 million a year. We'll be spending for next 2, 3 years on the CapEx to get to the 75,000 liter.

And Les, this is Tasos, 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 200 -- we're aiming at a 200 basis points expansion. And that's going to come -- that's going to be driven by all the business units. So our affordable 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'll be hearing this from us for the last 6 years now, number one. . Number two is we talked about our conscious decision to increase the gross margins in our AvKARE business, which has been a spectator -- that acquisition has been a spectacular success. And by focusing more 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 low 80s, 81%, 82% 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%. If you will hear about 5, 6 years ago, you will have heard Chirag and Chintu talking about having gross margins in the old days, almost 50%. So this is what we are driving directionally over the next 10 years. So it takes some time to get there, but we see another over the next 3 to 4 years, we look 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 higher price points than the rest of the business.

Your next question comes from the line of David Amsellem with Piper Sandler.

So I have a few. First, can you just comment and elaborate on the insider ownership of Kashiv? 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, is that -- how much of that is a function of just the elimination of the shared economic on biosims. And then the last question is how much of your revenue base by 2030 do you expect will be from biosims?

David, I'll take question number 2 and number 3. So if you can just -- can you just repeat question number 1 for a second, if you don't mind.

Yes, the insider ownership of Kashiv.

Insider ownership of Kashiv. Okay. Got it. Okay. So well, I'll take the first one. I'll the first one. So insider ownership of Kashiv, you can see it essentially in our proxy which has been known by the Amneal Group, which has been also a big shareholders at Amneal since the beginning of time. So once includes of the Amneal Group includes both our CEOs who've always been transparent of that as well as people have been investors in Kashiv and as investors Kashiv and also at Amneal for a very long time and key contributors to what we have built now, which is a big 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 you've got -- I think you know us long enough to know we take our long-term guide and financial commitments 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 expands 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. 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 Amneal and now our brand new colleagues at Kashiv. So everyone, all of our 8,000-plus employees are singularly focused to a set of financial metrics, so it eliminates and been giving 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 were to put out numbers which they are 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 EBITDA expansion, it's combination. It's a combination of both. I don't have the exact percent of this, right? A lot of -- how much of that is 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 these and biosimilars, we'll add to that, right? And then in terms of an EBITDA basis, Q1 EBITDA was up 19%, right? Last year's EBITDA growth was 10% this year. So the base business that is growing at least adjusted EBITDA at 10%. We expect this to continue and add on -- the additional add-on will expect it to come on biosimilars. So that's how we think of it. It is a highly derisked long-term forecast that is based on the growth of the existing business post the acquisition and it's conservative in nature. So hopefully, I'll address some of your...

Yes. How much of your business do you think is going to be biosimilars? Like what's the revenue base going to be in 2030 for now? Yes.

Yes. So if you think about 2030, for example, the guidance we're providing is between $4.3 billion and $4.5 billion probably about $1 billion or a little over $1 billion, $1 billion to $1.3 billion. That's going to be biosimilars. .

Your next question comes from the line of Chris Schott with JPMorgan.

Just 2 for me. 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 and expirations. I know you mentioned there's no clear leader in the space. But do you anticipate there's going to be a more meaningful consolidation of share and there to be a handful of players? Or will this remain a more fragmented market as a whole? And the second one for me just on specific product on lanreotide, the silicone 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 products that could represent for Amneal?

Yes. 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 big companies moved out of favor for biosimilars, as you know, they are more obviously back to the innovative medicines. So that leaves Sandoz obviously a clear global leader at this point and a great company. [indiscernible] is coming in from a South Korean company, which is expanding in the United States and globally and building a large vertically integrated platform Samsung's doing both out-licensing mainly and concentrating also a different division on biosimilars. . India's Biocon has been in the biologics for over 40 years. So they are already in the United States market. And then Kabi with map size ownership, and their own, we see them as a vertically integrated player. So the way it would expand this is why it's an inflection point that we, as Amneal got the platform or getting a platform with the manufacturing capacity with the pipeline that we execute over the next 5 to 7 years. It requires a lot of manufacturing infrastructure, a lot of R&D infrastructure. Number of years even with FDA's Phase III gone still will be 5-plus years from the timing of starting the clone development all the way to the filing and approval and then the IP negotiation, our settlement. All those things would take 5, 7 years. So -- and you can see, like in a small molecule, you have 50 company jumping in from India and China. We don't see that. We see a few companies will come from India, a few maybe from China, but they all have to build these U.S.-oriented infrastructure or your regulated markets, which is a different ballgame than you've been producing biologics for the emerging markets because the requirements of FDA's are much at higher standards than those other countries. And Amneal builds everything first with U.S. and mine. So yes, there will be more competitors the large molecules like KEYTRUDA to you will see 5 to 10 competitors. Some would be partnered. And niche, this is why we Kashiv and Amneal will be focused on is niche molecules where we will see 2 to 3 competitors. So that's how we see the -- a competitive landscape, maybe 8 to 10 players that 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 capabilities 3 to 5 a year. Chintu, do you want to add anything?

I mean there's a lot of high barriers of entry and fans. It's much more complicated than the small molecule it was close to $50 million to $75 million per product. So there are lots of barriers. So I think it still will remain not that competitive, plus as Chirag stated, takes 5, 7 years for a new builder to build this platform and have the manufacturing and development expertise and capacity at Kashiv, we have a fantastic group of 600-plus people. And that experience, I think, gives us the confidence of this 3 to 5 biosimilar. So competition, as Chirag stated, would be the 4, 5 players might be vertically integrated, but still is largely a space for somebody to be a leader and the Amneal will be a leader by 2030.

In lanreotide, Chris, is the market dynamics changed was a supplier in the market, had some contract manufacturing issues, so they are 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 approval and they're working on it. And we could be the first, again, the -- I'm sorry, it's a small molecule and generic lanreotide in the market, and we will supply and create another access for the hospitals and clinics as soon as possible.

[indiscernible] is also global. So we have a pending approval in Europe also, and it's a highly complex product. It's a drug device combination fact type. So we are looking forward to this product and opportunity. .

Your next question comes from the line of Glen Santangelo with Barclays.

Just a couple for me. Chirag, I mean I think everyone we 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 -- we were just talking to Chris' question about the evolution of the competitive landscape, a number of the other players have decided to go more on the partnership licensing route, versus the vertical integration route. And maybe that's a function of how 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 realized that, that number is 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 just sort of given the $400 million to $500 million in synergies we sort of talked about, you had a couple of partnership deals that seem like they're on track and maybe let 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 as it relates to how soon we may see those synergistic benefits in '27 and beyond.

Thank you, Glen. So let me take the first one. I'll pass the pass to Tasos for the second question. So the first one, partnering versus full economics are vertically -- being vertically integrated. Yes, it is complex. This is where it took 10 years for Kashiv to build this platform with significant investment. So this is why we believe it'll be 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 produce. So if we have -- first of all, it gives you full economics. So your margin expands, you have 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 food economics in the United States market, it makes sense to be completely vertically integrated. As I stated before, Glen that it would -- the partnering is great. And in international market, we look to partner and Kashiv already has a 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 has survived being just marketing companies. We've got to do a lot more than that because real complications is R&D, is IP, is manufacturing. I think the PBMs and private labels are making the marketing itself easier, which is how it should. I hope that answers the first question. You can -- may a follow-up, but let me pass it to Tasos.

I love financial modeling questions. So it's kind of things in perspective. So the first point is guidance for 2027 an EBITDA of $820 million is kind of substantially below the street. I'm not to where the Street is number one. I think that they are about $835 million. So us providing guidance of $820 million plus compared to $835 million, 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, it's kind of a notion of deceleration, this year, EBITDA, right, the midpoint is at $755 million is about 10% growth versus prior year. Even if you take the low end of what we gave you for next year of $820 million, 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 observing, even observing a strategic deal, which could have some dilution in year until it becomes accretive 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, on incremental R&D, right, to maximize the opportunity here of $300 billion plus of branded products going generic over the course of time. That's kind of how we all of -- and I try to give guidance for 2027, that's a long time away. So I think it speaks to our confidence about early what we think we can -- the minimum we can deliver next year. So hopefully, that give you some perspective.

Your next question comes from the line of Ash Verma with UBS.

This is [indiscernible] from UBS. I'm just asking questions on behalf of Ash. So I have 2. The first one, and I apologize if this has been discussed before. So -- so the first one, how do you think about the real type market opportunity? It seems like there's just limited competition in this molecule. I just wonder like how confident are you about the approvals have line in 3Q? And what would be the gating item for the launch? And then my second question on gross margin. So I think like it was discussed before the annual -- like in the annual term, it's not like 45% than 1Q, I think like this quarter is 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.

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

Yes, we see our Q1 gross margin follows for a while as -- it was just a record quarter, which was overall up 510 basis points versus Q1 of last year. So it's just to kind of enable the sustainability over 510 basis points is 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 call it a little bit more modest growth in the rest of the year, we still feel confident that overall company gross margins this year in 2026 to be closer to 45%, 45%, maybe a little better compared to about 43% last year. Hope that's helpful.

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

Well, thank you, everyone, and have a great day.

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