Amneal Pharmaceuticals, Inc. Class A Stock

Good morning, and welcome to the Amneal Pharmaceuticals' Third Quarter 2026 Earnings Call.

I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Good morning. And thank you for joining Amneal Pharmaceuticals' third quarter 2026 earnings call.

Today, we issued a press release reporting Q3 results. The earnings press release and presentation are available on the IR page of 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 sections entitled Cautionary Statements on Forward-Looking Statements in our press release and presentation for factors that may impact future performance.

We also discuss non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation.

On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs; Tasos Konidaris, CFO; Joe Renda for Specialty; and Jason Daly, Chief Legal Officer.

I will now hand the call over to Chirag.

Thank you, Tony. Good morning, everyone.

Today, Amneal is a stronger, more diversified company than ever before with a portfolio focused on high-value products designed to drive durable growth. We have expanded across specialty, biosimilars and complex products while building the capabilities and capacity to drive these businesses long term.

2026 marks our seventh consecutive year of top and bottom line growth, a track record that stands out in the industry. Our third quarter performance reflects that progress with revenue of $863 million, up 10%; adjusted EBITDA of $207 million, up 30%; and adjusted EPS of $0.26, up 53%. The breadth of our portfolio and the depth of our pipeline give us confidence that we are still early in realizing Amneal's full potential.

Let me highlight the progress across our key growth areas. First, in biosimilars, we closed the Kashiv transaction in Q3. Amneal now has the end-to-end capabilities to succeed in biosimilars, R&D, manufacturing and commercial in-house. Now it is all about execution.

From a macro perspective, we have access to a large and growing biosimilar market with approximately $234 billion of U.S. biologic sales losing exclusivity over the next decade. At the same time, streamlined regulatory pathways, new commercial models such as private label and accelerating market adoption are creating a major inflection point for the U.S. biosimilar industry. Against this backdrop, our portfolio strategy is deliberately differentiated, balancing targeted lower competition molecules with a select number of broader biologic opportunities.

We believe this approach positions Amneal to capture attractive economics and sustain long-term value creation, for Amneal biosimilars are a natural extension of our purpose, making key medicines more accessible and affordable while building a durable growth platform.

Biologics accounts for more than half of U.S. drug spending, yet represents only 5% of total prescriptions, highlighting the significant affordability and access challenge. We believe we can help address that gap and create value for patients.

Second, complex generics remains a core strength with a proven track record of execution. We have an expanding, diversified portfolio of high-demand complex therapies, including Women's Health, transdermal patches and important new injectable products approvals such as lanreotide, romidepsin and iohexol. Across dosage forms, these are significant opportunities for sustained growth. We have strategically evolved our portfolio toward high-value complex products where our science manufacturing capabilities and capacity, reliable supply and customer relationships set us apart.

Third, in Specialty, our key brands are performing very well. 2 years after launch, CREXONT for Parkinson's disease continues to gain share. This is being driven by positive patient experience and compelling clinical evidence with more than 3 additional hours of Good On time per day versus other therapies. BREKIYA is also gaining strong traction in migraine and cluster headache, performing ahead of our expectations this year. We see our Specialty segment becoming considerably large over time.

Fourth, AvKARE remains an important aspect of our business that provides diversification and access to government and institutional channels for our high-value products, including biosimilars in the future.

Fifth, we are advancing our GLP-1 collaboration with Pfizer as construction of our new dedicated GLP-1 manufacturing facilities for both drug substance and drug product remain on track for 2028.

Taken together, Amneal has a fundamentally stronger and more diversified growth profile than ever before. With more growth engines, more innovation and more opportunities ahead, our focus is on the execution, delivering across each of these areas, converting that potential into results. We believe the momentum of 2026 positions us very well for continued high growth in 2027 and beyond.

With that, I'll turn it over to Chintu.

Thank you, Chirag, and good morning, everyone. I want to thank the entire Amneal team, which continues to execute at a high level. Their strong performance enable us to pursue increasingly ambitious opportunities while continuing to deliver across our existing businesses. Since our last call, we closed the Kashiv transaction in August. The combined team is working as one across development, manufacturing and commercialization to build our biosimilar business.

Also, as we shared on our Q2 call, one of our India facilities experienced flooding back in late July. The team worked tirelessly to limit the impact, and we are pleased to share that operations have fully resumed. In addition, in September, we received FDA approval for lanreotide, a high-value complex injectable.

Let me focus on 4 areas. First, integrating Kashiv and advancing our biosimilar pipeline; second, our global operational strategy; third, our R&D portfolio; and fourth, growing our specialty business.

First, in biosimilar, we now have the end-to-end capabilities from cell line and clone development through clinical execution, regulatory expertise, biologics manufacturing and commercialization. Kashiv brings the science, development and biologics manufacturing, while Amneal brings commercial scale, channel expertise and customer relationships. Together, we can move faster, run effectively and capture more value, reinforcing biosimilars as a key long-term growth pillar for Amneal. The combined platform is designed to make disciplined portfolio decisions, advance multiple molecules in parallel and create a repeatable path from R&D to commercialization.

Our biosimilars manufacturing footprint in New Jersey and India is expanding, which enable us to work on a growing number of biosimilar R&D programs and also meet commercial demand. Our biosimilars pipeline is focused on early-to-market global opportunities where we are targeting being first or second to launch. We built this playbook and executed it well in complex generics, and we are now applying it to biosimilars.

Second, in operations, our priorities remain clear: quality, reliability and resiliency. Across our global manufacturing and supply chain network, we continue to deepen our capabilities and capacity in complex generics, sterile injectables, and biosimilars.

Our facilities have transformed in recent years through digitization, automation, and AI-enabled tools. We are advancing our manufacturing capabilities and quality while improving efficiency. At the same time, we are scaling capacity for our key growth areas, including significant expansion for women's health transdermal patches this year, new U.S. sterile injectable capabilities by 2028, expanding our complex injectable capacity for key programs like lanreotide and risperidone, building out our 2 new GLP-1 facilities and increasing biosimilar capacity to support our pipeline. These initiatives are designed to meet increasing market demand and drive meaningful new growth.

This broad operational platform is differentiated in the industry. Our large manufacturing footprint across 20 global facilities and technical expertise position Amneal well to deliver reliable supply, address important market needs and pursue new growth opportunities at the same time.

Third, turning to our complex generics pipeline. We continue to convert many years of R&D hard work into significant commercial products. Complex generics build this company, and we are not slowing down. That strategy is visible in the differentiated portfolio, spanning injectables, ophthalmics, inhalation, transdermal drug-device combinations, 505(b)(2) products and other dosage forms.

Recent approvals are important proof points. Recent approvals include key complex generics and 505(b)(2) products such as lanreotide, romidepsin RTU, sodium bicarbonate IV bag and additional strength and presentations of iohexol. These products expand our portfolio into large attractive markets and demonstrate our ability to develop, manufacture and commercialize increasingly complex medicines in-house.

Looking ahead, we are advancing a deep pipeline of long-acting injectable 505(b)(2) and inhalation programs. We continue to have the most CGT approvals in the U.S. pharmaceutical industry.

One year ago, on our Q3 call, we highlighted 20 key launches across 2025 and 2026 that we believe would propel our Affordable Medicines business to a new level. Today, almost all are now approved and launched. Looking forward, we see a next wave of new product launch opportunities between 2027 and 2029, particularly new sterile injectable and bag products. This gives us high confidence that growth in Affordable Medicines will continue to stay elevated in the years ahead.

Importantly, this is not a onetime launch cycle. It reflects the innovation engine we have built over many years and the steady conversion of those programs into successful commercial launches.

Specifically, innovation is a new growth platform that we have been building. Last year, we received our first 2 approvals ProAir and QVAR. Looking ahead, we are targeting additional MDI and soft mist approvals over the next 3 years. We see innovation as a new vector of growth for the business.

Fourth, in Specialty, we are very pleased with the continued performance of CREXONT and BREKIYA. The strength is visible not only in higher revenues, but also in prescription trends, physician adoption and the growing number of patients benefiting from these impactful therapies.

For CREXONT, we continue to build on the clinical and real-world evidence supporting its differentiated profile in Parkinson's treatment landscape. We are pursuing second Phase IV study evaluating its effect on disease progression as awareness and physician experience expand, the opportunity clearly to expand CREXONT's reach among the 700,000 patients in the U.S. on carbidopa/levodopa therapy. Beyond CREXONT and BREKIYA, we are advancing additional 505(b)(2) and novel R&D programs to build a broader specialty platform focused on differentiated medicines that improve patient outcomes.

Across our businesses, our formula remains the same: strong science, quality first, robust planning, care for customers and patients and disciplined execution. The progress made in 2026 and the catalysts ahead gives us very strong confidence heading into 2027.

With that, I will turn it over to Tasos.

Thank you, Chintu. And good morning, everyone.

I'm very pleased to share our third quarter exceptional financial results, which are a testament to our strategic choices and strength of execution. Revenue of $863 million increased 10%, adjusted EBITDA of $207 million increased 30% and adjusted EPS of $0.26 increased 53%.

Our growth profile remains very strong due to the relevancy and complexity of our growth product portfolio as well as the fact that we play in large and growing markets. As a result, we're very pleased to once again increase our 2026 financial guidance and expect strong momentum in 2027 and beyond.

In the third quarter, Affordable Medicines delivered revenue of $547 million and grew 19%. This reflects growth across our 3 channels of retail, injectables and government.

From a product perspective, growth was mainly driven by women's health transdermal patches, new product launches, which added $54 million in the quarter and favorable timing of a large biosimilar customer order, which added about $40 million. It is worth noting that lanreotide made a very small contribution in Q3 as we launched in late September. However, we're already seeing terrific uptake and expect much larger contribution of lanreotide in subsequent quarters as we fulfill substantial market demand.

Specialty revenue was $150 million, up 20%, driven by continued growth across CREXONT, BREKIYA autoinjector and UNITHROID. Strong underlying trends and smart execution across these 3 brands support continued growth into future years.

AvKare revenue was $165 million, down 17% as expected due to the nonrepeating nature of a large product introduction in the third quarter of last year, where revenue grew 25%. Putting this one factor aside, AvKare revenue in the quarter was stable, while adjusted EBITDA was up double digits as our team continues to prioritize profitability over simple revenue growth.

Moving down the P&L. Q3 adjusted gross margin was 43.2%, up 50 basis points year-over-year, reflecting favorable mix. Adjusted EBITDA grew 30% due to strong revenue growth and disciplined expense management. Q3 adjusted EPS grew 53%, reflecting higher adjusted EBITDA and lower interest expense.

It is important to note that our year-to-date financial performance is also extremely strong with revenues up 8%, adjusted EBITDA up 20% and adjusted EPS up 34%.

As a result, we're very pleased to update our full year 2026 guidance. Revenues increased by $50 million at the midpoint of the new range of $3.15 billion to $3.25 billion. Adjusted EBITDA is increased by $43 million at the midpoint of the new range between $800 million and $815 million. Adjusted EPS is also increased by $0.05 at the midpoint of the new range of $1.04 and $1.08.

Finally, operating cash flow is slightly down by $25 million at the midpoint of the new range of $325 million to $375 million. The operating cash flow adjustment is driven by timing and reflects our decision to increase internal finished goods inventory to satisfy strong revenue demand and timing of some collections being pushed to Q1 of 2027.

From a balance sheet perspective, net leverage was 3.5x adjusted EBITDA as of Q3, reflective of closing the Kashiv acquisition. We expect to finish 2026 at 3.6x adjusted EBITDA, in line with year-end 2025 and continue to feel confident of being below 3x adjusted EBITDA by 2028.

Let me now finish with our Kashiv acquisition, where the integration is progressing very well. As you may recall, in addition to the large market opportunity this deal represented, we also highlighted $400 million to $500 million in expected financial benefits driven by elimination of profit-sharing obligations and various tax incentives.

We feel very confident about capturing these benefits, and I'm happy to share 2 recent proof points. First, our newly launched product, lanreotide, was originated at Kashiv. And as a result of the acquisition, Amneal now gets to keep 100% of this product's profits. Second, last week, we secured $60 million in tax credits from the New Jersey Economic Development Authority. Large part of these benefits relates to the manufacturing expansion in support of the Kashiv acquisition and the future biosimilars product road map.

In summary, we're extremely pleased with our strong results, increased financial outlook for 2026 and the strong momentum for continued growth in 2027 and beyond.

With that, I'll turn the call back to Chirag.

Thank you, Tasos.

Our Q3 results reflect the breadth and depth of Amneal. We are executing well across our growth pillars, complex generics, biosimilars, specialty and health care with GLP-1 continue to advance very well.

Since our last call, we closed the Kashiv transaction to create an integrated biosimilars platform. We received important approvals, including lanreotide and our specialty brands, CREXONT and BREKIYA continue to drive uptake. These are tangible achievements, and there is more ahead. The strength we are delivering in 2026, combined with our upcoming catalysts and pipeline gives us confidence in continued strong growth in 2027 and beyond.

Our goal remains clear: to become America's #1 affordable medicines company and a leading provider of essential medicines globally.

With that, let's open the call for Q&A.

We will now begin the question-and-answer session. [Operator Instructions] Your first question is from Les Zalewski with Oppenheimer.

This is [ Jean ] on for Les.

Could you clarify the revenue book for lanreotide in 3Q? And what are you seeing on early metrics from initial stocking versus patient demand?

And then as a follow-up, I think the FDA only approved the 120-milligram syringe. Are the 60- and 90-milligram strengths filed? And when could they be approved?

This is Tasos. Number one is we launched lanreotide in Q3 actually, very late in September. The revenue was very small, about $7 million, right? You can expect multiple times of that in Q4. And as we think about kind of continued growth of the product throughout next year and beyond, our team is aiming at about 30% to 40% market share.

With that, let me pass it on to Chintu for part 2.

Yes. Thank you.

So on other 2 strengths, 60 and 90, our post-approval supplement is ready, and we will be filing both the strengths in this quarter and expect the launch in the second half of next year.

So most of the cells in these strengths.

Yes, the 90% of the strengths are in the 120-milligram strength.

Your next question is from David Amsellem with Piper Sandler.

So on XOLAIR, can you talk about when in '27 you think you'll be in a position to launch? And just remind us what has to happen in order to be in a position to launch?

And then secondly, on XOLAIR, how are you thinking about competitive dynamics and how impactful it could be in '27 to the extent that you, say, one or 2 biosimilars on the market?

And then just another quick question on BREKIYA that seems to be ramping nicely. Can you talk about access dynamics and how you're thinking about the trajectory of that product going forward?

XOLAIR, we have a goal date early next year, and we are in active discussion, which I cannot give you more detail on the patent settlement than a date, but we expect to launch in second half next year towards late and we on the competition side, as you know, Celltrion is in the market. We expect to be the second. And then Teva has filed the product as well.

It's an excellent molecule, large demand. We're already working with customer channels on various customer channels to maximize our opportunity there for years to come as well as we have the approval in MHRA and a positive opinion from EMA for XOLAIR, which we expect the final approval in late November and launch again according to the patent settlement, which we'll let you know when we strike. So very excited about XOLAIR.

Let's talk about BREKIYA. So BREKIYA, we're getting good 50%, 60% conversion, and it's a much needed drug. We're not getting too many payers blocked yet, so let the uptake happen and then we'll worry about the coverage. But right now, it's going through fine.

Your next question is from Chris Schott with JPMorgan.

This is Ekaterina on for Chris.

So on your 2030 outlook, it seems like you're expecting very healthy top line growth. Just how much of that is coming from Affordable Medicines versus Specialty and AvKARE? And then can you help us also bridge from the top line to your EPS number? Just any key assumptions in terms of margins or anything like that that you're kind of embedding in that 2030 outlook?

And then second question is around [indiscernible] Women's Health. Just latest trends you're seeing for the product and your expectations for '27. How big can this become once you have some of the additional kind of capacity come online?

I may have to repeat a couple of those questions. I'm fast, but you're even faster than me.

As we think about 2030, just to kind of ground everyone, what we said was we expect the revenue to go from about $3.1 billion this year, right, $3.1 billion to $3.2 billion to about $4.3 billion to $4.5 billion. So that's an incremental over $1 billion of growth. The majority of that growth is going to come from our Affordable Medicines space and primarily from Biosimilars, okay? That was a key impetus for the Kashiv acquisition

Now since we announced the biggest majority of that calling, as I said before, is going to come from Affordable Medicines. And within Affordable Medicines, biggest chunk biosimilars, but also you heard us a lot about the growing businesses such as women's health care transdermal patches that are growing as well around our injectable business. So those are the other components within Affordable Medicines that we expect to grow.

AvKARE, we expect that will continue to grow. I think we had this year a little bit of a reset from a revenue perspective as we deprioritize our low-margin distribution channel, but adjusted EBITDA is up 26% this year, just to kind of give you a flavor. So we continue to see a huge runway of AvKARE primarily as they enter play bigger player within the government channel and passing through more biosimilar products. So we're working closely with them about developing a strategic road map of biosimilars within the government channel. And that road map obviously is going to include Amneal products as well as other third parties. So I think that covers the revenue.

Can you just tell me what will be the other question around margins and maybe bottom line growth?

Yes. Just kind of what are you embedding in just in terms of gross margins and any other kind of key assumptions as you kind of think about bridging from the revenue to the EPS?

So great question. So one of the things that we have done over the last few years is focus on increasing our gross margins. So as an example, you can see our gross -- year-to-date as an example, Affordable gross margins are up 300 basis points as an example. And gross margin for the business this year, we're probably going to be -- total Amneal probably at about 46.5% compared to about 45.5% last year. So solid growth rate in terms of gross margins.

As we think about 2030, gross margins will improve further. And they're going to improve further for a number of different reasons. Number one is as biosimilars in general, have a higher gross margin than the rest of our business, and with the acquisition of Kashiv, now we're able to keep all 100% of those economics. So that acquisition and Biosimilars being a key growth driver bodes well from a mix perspective, number one.

Number two, for many years now, we continue to focus on our complex generics for the Women's Health. So part of the reason we did that was, number one, is we saw a big market opportunity, number one; simply the competitive dynamics in that space is better; and number three, the average price point and profitability for those products is higher than what will be for a typical oral generic.

And the third thing is our teams work day and night to continue to drive operating efficiencies. So everyone is busy kind of doing more with less and increasing our efficiency rates, and there is a lot of internal effort that our CEOs are leading in terms of embedding AI more and more in our day-to-day operations.

So over the course of time, as we think about 2030, we see revenue growth accelerating, margins continue to improve, and this is what's going to drive substantial bottom line growth rates as well as reducing debt over the course of time.

This is Chirag. I'm going to add a couple of things. So since we are talking about now to 2030, and I think for the overall for all the questions, I guess, this is very important. So our base business is growing actually. So we are very excited due to the women's health HRT, we have built out the capacity, we're building out even more capacity. We are completely in the know of the demand. We're working with HHS and FDA as well. And we would provide you more details in our February call, but it's a significant opportunity. And we are fulfilling a key need out there on Women's Health.

So day and night work has been done by our Piscataway, New Jersey team and expansion has already happened and more is coming. So significant opportunity in the base business, which we never had it before. If you can refer to the Slide 5 in our presentation that shows you that $1.2 billion of revenue on a base business in 2019 has only gone down by $200 million to $1 billion this year.

So there is no such thing as leaky buckets on these products. These are needed products. Some goes down, some go up, 300 products portfolio. Now we're predicting that our base business will grow.

Second, we have the next wave, as my brother mentioned on his script, next wave of launches, which are all in Complex Gx. We're building out a sterile manufacturing facility in New York. We got a PreCheck program. We are converting the compounded drug into approved products, such a big need for the hospitals. And we're a purpose-driven company, correct? So we are partnering with hospitals to solve that supply from India and Brookhaven, New York.

Long-acting depot injections continue to gain traction. Risperidone, octreotide is coming, inhalation, we mentioned 2 approved, more are coming, ophthalmics ramping up. So no shortage of small molecule drugs coming up in next 4 years. Biosimilars on top of that are also coming. Excited about launching denosumab, both presentation in mid next year, then XOLAIR and then continue to -- we have disclosed some of the pipeline assets that are fantastic and expect us to do more and more in Biosimilars.

Specialty is also growing because of continued growth of CREXONT. I mean we're probably not even halfway there, right? We keep growing the scripts.

And then AvKARE is growing on where it needs to grow high-growth areas such as Biosimilars, Specialty and Complex Gx, taking full advantage of our U.S. manufacturing capabilities.

And international grows because of the Biosimilars partnership internationally, we'll be doing more. India, we have launched our own label. Small business today will grow in the future. And we're further partnering in South America, Europe, Middle East, Canada, so international, which today is only $40 million, $50 million business, expect to grow significantly as well. So we're extremely excited about from now to 2030.

Your next question is from Ash Verma with UBS.

This is [ Bea ] on behalf of Ash. So one question from us.

For the iohexol, can you help us understand the overall opportunities and how that contributes to your '26 and '27 sales? And do you need the full SKU portfolio on the different dosing to maximize this launch? And then how is the conversation going with the IND on the contracting?

So on iohexol we now have filed all the SKUs and will be covering the entire breadth of the iohexol product. It is a complex product. Still, we are the only generic. We work very hard to increase our capacity and the cost efficiency. So going into 2027, we feel pretty good about iohexol as being a key growth driver. And our commercial teams are working with hospitals and other channels to increase our market share with having the full basket.

So iohexol would be a good product for us as we have the more capacity, all the SKUs, and we have strong resilient supply chain now on iohexol.

Your next question is from Matt Dellatorre from Goldman Sachs.

Congrats on the progress. Maybe on the Pfizer partnership, could you just give us an update on the status of that and share any more color on development progress, manufacturing preparedness and then also just how meaningful of an opportunity you think this could be to Amneal long-term?

And then on the Specialty side, I know you've pointed in the past to higher confidence in maybe the higher end of your long-term CREXONT and BREKIYA guidance. So just curious what your latest thinking was there.

Pfizer, excellent partnership going really well. Both teams are doing fantastic. They just had 12 people visiting our facilities, which are under construction. They are awestruck by how awesome it is, fully digitized, AI-based. The capacity is huge, obviously. It is latest and and greatest lines, fully automated through the packaging inspection. It's amazing site, amazing partnership.

We will complete the construction in late '28 to '29, we should start commercialize for Pfizer in all territories basically. And we are working through the final touches of how the future partnership would look like on our co-marketing. We have given access to 18 markets exclusively. So we're evaluating how do we market that with now Pfizer. We're interested in marketing a brand, not generic.

So that is where the Pfizer partnership and also those 2 sites we are building, we'll be able to take other business from other big pharma or even from Amneal Biologics, Kashiv's products, wherever it comes from amazing sites. So we're very excited to have this big potential, and we'll share more detail as we make great progress.

CREXONT and BREKIYA.

CREXONT and BREKIYA, Joey, would you like to chime in?

Yes, absolutely. We're really, really pleased, Matt, with the response we've seen in the market with CREXONT. We continue to add new prescribers every month, around 400 or so we're adding monthly, and our TRxs are continuing to grow at a substantial pace. So we're very confident in the guidance we've given longer term, probably to the middle part, maybe even the higher end of that guidance based on our current trends. So we're very confident there.

And BREKIYA autoinjector, as we talked about earlier, the expansion that we did earlier this year has really enabled that product to really grow. We've already doubled the expectations for tracking of how we're performing this year. We anticipate next year to probably also come close to doubling our performance from this year. So the response from the market for BREKIYA autoinjector has been very positive. And the expansion, as I mentioned, that we did enables us to get into more of the key headache prescribers that have been very, very responsive so far.

And the per patient carton use also has also been a very substantial part of that accelerated growth with autoinjector. So we actually are very confident in that probably going beyond what our current expectations are from a guidance standpoint.

Your next question is from Daniel Clark with Leerink Partners.

Just wanted to ask how you're thinking about the lanreotide opportunity in Europe here. I believe you have a pending approval. But just curious if you could frame next steps and potentially how that could impact results?

Yes, we have filed our product in Europe, and we are expecting action in the third quarter next year. And we have built capacity to address both the U.S. demand and Europe. It is a substantial product and volume in Europe. So we are very excited about the European opportunity also.

There are no further questions at this time, and we have reached the end of the Q&A Session. I will now turn the call back to Chirag Patel for closing remarks.

Well, thank you, everybody, for listening. Have a great day. Thank you.

Thank you.

Thanks everyone.

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

Good morning, and welcome to the Amneal Pharmaceuticals Second Quarter 2026 Earnings Call.

I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amneal Pharmaceuticals second quarter 2026 earnings call. Today, we issued a press release reporting Q2 results. The earnings press release and presentation are available on the IR page of 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 sections entitled Cautionary Statements on Forward-Looking Statements in our press release and presentation for factors that may impact future performance. We also discuss non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation.

On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs; Tasos Konidaris, CFO; Joe Renda for Specialty; and Jason Daly, Chief Legal Officer.

I will now hand the call over to Chirag.

Thank you. Good morning, everyone. Amneal is in the midst of the most transformative period in our company's history. We are growing as one of the America's leading Affordable Medicines businesses with an increasingly diversified and high-impact medicines portfolio, including Specialty brands, biosimilars, GLP-1s and complex generics across dosage forms such as transdermals and injectables. As we execute our strategy, we are building a larger, more impactful Amneal.

That continued momentum is reflected in our second quarter results, where the company delivered revenue of $796 million, adjusted EBITDA of $206 million and adjusted EPS of $0.30.

At the halfway point of the year, we are pleased to once again raise our 2026 outlook. This year reflects our seventh consecutive year of top and bottom line growth. As a purpose-driven company, we have a tremendous opportunity to help the next era of Affordable Medicines here in the United States and globally by expanding access for patients and providers. While Amneal has always been growth-oriented, the scale of the opportunity in front of us today has never been greater.

With that, let me touch on key growth opportunities. First, in Affordable Medicines, our base business remains strong, resilient and growing with highly relevant and in-demand therapies. In Women's Health, demand for transdermal patches increased following the revised FDA guidance late last year. We are increasing our capacity. Looking forward, our pipeline remains focused on high-value opportunities such as lanreotide where complexity, reliable supply, customer relationship and executions are key.

Second, in biosimilars, we're building a new large growth platform for Amneal. With the pending acquisition of Kashiv, we would become a fully integrated global biosimilar player from development to commercial supply. And the timing is incredibly compelling. The U.S. biosimilars market is entering a major growth cycle driven by an unprecedented wave of biologics losing exclusivity, streamlined regulatory pathways, attractive commercial structures emerging, including private labels and accelerating market adoption.

Over the next decade, 118 biologics are expected to lose exclusivity in the United States alone, with relatively limited development expected for most molecules, accordingly, we see a broad set of biosimilar opportunities with limited competition that can support reliable and repeatable value creation. Amneal is well positioned to capitalize on these opportunities. Approximately 75% of our biosimilar portfolio will be focused on targeted lower competition while 25% will address larger market opportunities. That mix gives us significant growth potential and meaningful upside.

Biosimilars align with our commercial strength as well. Through private label and customer relationship, we can bring products to market efficiently, leveraging our leading U.S. retail and institutional presence, channel access and scale. This is a national extension of our Affordable Medicines strategy. Overall, biosimilars are the next major growth area for Amneal and fit directly in our mission, expanding access, providing affordability and building a durable long-term growth platform.

Third, in Specialty, we have a differentiated branded product portfolio. CREXONT continues to gain traction and recent Phase IV data reinforces its potential to become a first-line treatment option for Parkinson's patients. Also, BREKIYA continues to see very strong uptake in its first several quarters on the market as it addresses an important unmet need for migraine and cluster headache sufferers.

Fourth, in distribution, AvKARE continues to provide diversification and access to important government and institutional channels, representing a meaningful opportunity to grow this business over time.

In summary, we are incredibly excited about the ongoing strategic evolution of Amneal and highly confident in our ability to sustain this momentum going forward.

I'll now turn it over to Chintu.

Thank you, Chirag, and good morning, everyone. I would like to thank our Amneal team for another quarter of very strong execution. Our team continues to deliver across operations, quality, supply chain, R&D, commercial execution and customer service. This consistency allows us to grow while also building towards the next generation of opportunities such as Specialty, biosimilars and GLP-1s.

Let me begin with an update on one of our manufacturing sites in India. One week ago, the Gujarat region experienced a severe rainfall and flooding, which impacted one of our facilities in India. Most importantly, all Amneal employees are safe and accounted for. We expect a limited impact on a select number of products. We look to resume operation within the next few weeks.

I will provide an update on 3 areas: first, the strength of our operating platform; second, the strategic fit and capabilities Kashiv brings in biosimilar; and third, the continued momentum across our pipeline. First, in operation, our global high-quality manufacturing and supply chain capabilities remain a core competitive advantage. If you walk into an Amneal facility today, it looks remarkably different than just several years ago. Through digitization, automation and deploying AI tools in different areas, we are unveiling our next generation of manufacturing and quality while also driving continued efficiencies.

Strategically, we have built a broad operational network with deep expertise across dosage forms. This matters more than ever. Patients, providers and all stakeholders of the health care system are focused on the quality, reliability and resiliency of the pharmaceutical supply chain. We are excited to expand our capabilities and capacity in complex dosage forms, including transdermals, sterile injectables and long-acting depots, enabling Amneal to increase our volumes and drive very meaningful near-term growth.

Our scale, leading U.S. manufacturing footprint and strong technical capabilities positions us to deliver reliable, high-quality supply while addressing important market needs and drug shortages. To that point, we are pleased to share that Amneal's Brookhaven New York site was recently selected as 1 of only 7 companies in the FDA's PreCheck Pilot Program, alongside other leading companies such as Eli Lilly and Regeneron. The program is intended to advance U.S. drug manufacturing and strengthen supply chain resiliency by allowing earlier FDA engagement on facility readiness and support access to critical medicine.

For Amneal, it is an important recognition of our robust U.S. manufacturing, particularly as we expand into sterile injectable manufacturing here in the U.S. over the next few years. Second, we are very excited about the Kashiv acquisition, which will add the in-house biologics capabilities we need to succeed in biosimilars. The end-to-end capabilities will span cell line and clone development, protein characterization, process development, clinical execution, regulatory expertise and scaled biologics manufacturing in India and U.S.

Kashiv is a biologics platform built over a decade with deep scientific expertise across monoclonal antibodies, fusion proteins, cytokines, [ microbial ] products and other complex modalities. Kashiv's drug substance capacity is expected to expand from approximately 26,000 liters by the end of 2026 to approximately 75,000 liters by 2028. With Kashiv, we will be able to do it all in biologics. Kashiv brings the science, development and manufacturing engine and Amneal brings the U.S. commercial engine with our leading retail position and channel expertise.

This is a powerful combination. Together, this combined model will allow us to advance multiple molecules at the same time, make smart portfolio decisions, move quickly and capture more economics across the value chain. With our current and future biosimilar capacity, we are well positioned to supply a meaningful share at launch with excess capacity to respond to market demand as needed.

In addition, the combined pipeline of over 20 biosimilar programs supports a meaningful number of new launches over time. We are very excited about upcoming biosimilar opportunities for XOLAIR, ORENCIA, CIMZIA and Nplate, which are attractive molecules with significant market potential and relatively limited competition. We believe each has the potential to become a meaningful growth driver.

Longer term, the pipeline extends well into the 2030s, providing substantial runway for growth. Third, turning to our Affordable Medicines pipeline. We are in the midst of the most concentrated and impactful wave of high-value new launches in our company's history. Importantly, it is not just the number of launches that matters, it is the value, complexity and durability of these products. This momentum is the result of choices we made many years ago. We deliberately prioritized complex generics and differentiated dosage forms, including injectables, ophthalmics, inhalation products, drug device combinations, 505(b)(2) opportunities and other non-oral solid dosage forms, where technical complexity and execution create long-term durable value.

Our recent approvals and upcoming launches show the strategy is working. This includes the recent approval of romidepsin in oncology, additional strengths of presentation of iohexol and ready-to-use sodium bicarbonate, our latest 505(b)(2) injectables, along with potential approval of lanreotide in Q3. Each product reflects the high-impact opportunities that we have been building towards and demonstrate the strength of our Affordable Medicines pipeline. And the wheel of innovation continues to turn with another 12 to 15 high-value complex ANDA filings planned this year, including 2 more metered-dose inhalation products.

These opportunities exemplify Amneal's core strength, strong R&D, complex manufacturing, deep customer relationships and a track record of reliable supply. We are using the same playbook that built our Affordable Medicines business and applying it to biosimilars.

In Specialty, we are pleased with the continued strong performance of CREXONT and BREKIYA. These successful product launches reflect our ability to develop new medicines, build brands and bring forward therapies that improve patient care. For CREXONT, the real-world evidence for Parkinson's patients is very compelling. We recently shared data from our first Phase IV open-label study that showed patients converting to CREXONT had 3 or more hours of "Good on" time per day versus RYTARY and other carbidopa/levodopa therapies and a meaningful improvement in system -- in symptom control.

In Q4, we are starting a new Phase IV study looking at the impact of CREXONT on treatment-naive patients recently diagnosed with PD and disease progression. More broadly, we are building on this Specialty foundation with additional R&D pipeline opportunities. While CREXONT and BREKIYA are key growth drivers today, they represent the beginning of a broader Specialty pipeline that we are advancing and we look to share more in the future. Taken together, we are well positioned for continued growth and remain laser-focused on executing across our key operational, commercial and pipeline opportunities.

I will now hand it over to Tasos.

Thank you, Chintu, and good morning, everyone. The second quarter played out as expected with revenue growth accelerating and broad-based momentum building across our business. Consequently, we are very pleased with our continued strong financial performance and ability to raise our 2026 outlook again this quarter, reflecting the strength and diversification of our business, a number of key growth drivers and the success of the business model we have strategically built over several years.

We expect this momentum to continue through the balance of 2026 and into 2027 and beyond. For the second quarter, total net revenue was $796 million, up 10%. Adjusted EBITDA was $206 million, up 12%, and adjusted EPS was $0.30, up 20%. Our results were driven by strong execution across our 3 business segments, favorable product mix and operating expense discipline.

In the second quarter, Affordable Medicines delivered revenue of $490 million, up 13%, reflecting the strength of our broad-based complex portfolio, including our Women's Health products, injectables and higher naloxone sales. In addition, new product launches added $45 million to second quarter revenue growth, including 2 recently launched products, one in ophthalmology and one in urology. Our Specialty revenue was $149 million, up 17%, driven by continued momentum in CREXONT, UNITHROID and BREKIYA, all ahead of expectations.

Moving on to AvKARE, where second quarter revenue was $157 million, down 4%, similar to the first quarter as growth in the government channel was offset by the low-margin distribution business as we expected. As we have said in the past, we remain focused on the unique value we provide in the government channel and continue to expand AvKARE's profitability.

Moving down the P&L. Our second quarter adjusted gross margin was strong at 46.2%, up 60 basis points year-over-year, reflecting favorable mix and continued operating efficiencies. Adjusted EBITDA grew 12% due to strong revenue growth, gross margin expansion and disciplined expense management. From an adjusted EPS perspective, the second quarter grew 20%, reflecting the adjusted EBITDA growth and lower interest expense.

Let me take a moment to acknowledge the strength of our first half financial performance with total revenues up 7%, adjusted EBITDA up 16%, and adjusted EPS growth of 27%. Furthermore, I'm pleased to report that we recently repriced our $2.4 billion (sic) [ $2.084 billion ] Term Loan B due in 2032 and reduced our interest expense by 50 basis points, which equates to $12 million in annual interest expense savings. Given the strength of our business, we're very pleased to raise our full year 2026 guidance against this quarter. We're increasing our revenue outlook by $50 million to $3.1 billion to $3.2 billion with high single-digit growth expected in both Specialty and Affordable Medicines. Also, we're raising our adjusted EBITDA guidance by $10 million between $750 million and $780 million, reflecting strong revenues and higher gross margin.

This guidance includes an estimated $20 million of negative impact anticipated as a result of the recent flood in our India facility, as Chintu mentioned earlier on. From an EPS perspective, we're increasing our guidance by $0.01 between $0.96 and $1.06 due to our higher profitability and lower interest expense following our most recent successful debt repricing.

From a CapEx perspective, we're increasing our expectations from about $110 million to about $150 million to capitalize on multiple near-term opportunities that we see in the marketplace, such as greater market demand for our Women's Health products and injectable expansion in the U.S. Finally, we're maintaining our operating cash flow guidance.

Turning to Kashiv for a second. We're entering the transaction from a position of strength, supported by a diverse set of growth drivers, strong cash flow and disciplined balance sheet management. This progress was further validated in April when we received a one-notch credit rating upgrade in our most recent successful Term Loan B repricing. As we have outlined, the Kashiv transaction is compelling both strategically and financially.

First, the acquisition enable us -- enables us to be a leader in the multibillion-dollar global biosimilars market that is growing rapidly. Second, we expect to capture $400 million to $500 million in financial benefits driven by tax and local incentives as well as eliminating milestone and profit-sharing obligations. Third, we see a clear path to deleveraging with net leverage below 3x by 2028. We expect the Kashiv transaction to close over the next few weeks, pending shareholder vote tomorrow and satisfaction of closing conditions.

With that, I will turn the call back to Chirag.

Thank you, Tasos. Our Q2 results demonstrate the strength of Amneal's diversified business and the momentum across our growth platforms. We are delivering strong performance today with more significant opportunities ahead than any point in our company's history.

The pending Kashiv acquisition is a natural extension of our strategy that will create a fully integrated global biosimilar platform, provide us access to a very large market opportunity and establish a major new long-term growth pillar. We are excited about the future and the substantial value creation ahead. Our goal remains clear to become America's #1 Affordable Medicines company and a leading global provider of essential medicines because innovation only matters when it reaches the patient.

With that, let's open the call for Q&A.

[Operator Instructions] Your first question is from the line of Glen Santangelo from Barclays.

Yes, just 2 quick ones for me. Chirag, I think I heard you said you're still expecting the timing for lanreotide to be 3Q. And if memory serves me correct, the biosimilar for XOLAIR, you're expecting later in the fourth quarter. And so I'm just kind of curious as to maybe what you have included in your -- in the second half fiscal '26 guide for these launches? And then my second question is really around Kashiv. I think at the time of the deal, you said you're expecting to have 6 commercial biosimilars in the market by 2027 with a $14 billion TAM. I was just wondering if you could just give us more -- an update on the timing and maybe a little bit more transparency into which launches will be more meaningful here?

So, lanreotide is on its way. That's what we feel as of today. It has official goal date in Q3. So that we have included some of the forecast number, but not probably the market...

Very conservative on that.

Conservative is included. And XOLAIR is towards very late end of the year or could spill into the January 5. So nothing is included for XOLAIR for this year. And in Kashiv BioSciences, or your question on the 6 commercial biosimilars, as you know, we market ALYMSYS, RELEUKO, FYLNETRA. We are launching Prolia and XGEVA and look forward to launch XOLAIR sometimes next year, hopefully very early. So that becomes the 6 biosimilars commercialized by next year and more to follow there on in '27, '28, '29, very exciting pipeline.

Your next question comes from Chris Scott with JPMorgan.

This is Ekaterina on for Chris. Just 2 questions from us. So first, just on tariffs, your thoughts on some of these recent headlines from the administration. How should we think about potential impact both for Amneal and the industry? And have there been any discussions between generic manufacturers and the administration since the announcement?

And then second question is just on CREXONT. It seems like another very strong quarter for the product. Just any interesting trends you guys are seeing in terms of where uptake is coming from or anything else you're kind of seeing in that market?

As you know, Amneal has a very vast manufacturing network in the United States. We always look and also expanding our capacity in the United States in sterile and patches as well. As far as the recent announcement, we look forward for more information and we'll collaborate with administration as we move forward.

Your second question on CREXONT, we're seeing 80% of the scripts coming from general neuro, which wasn't the case for RYTARY, and that continues to happen. As you know, 80% prescription are written by the general neurologist. So very exciting. The Phase IV data is exciting as well, well received and the script trend is -- keep going up every week. And it's truly a needed therapy for the Parkinson's patient, and our goal will be to make that a first-line therapy replace the immediate release product.

Your next question comes from David Amsellem from Piper Sandler.

So a couple for me. First on iohexol with the additional SKUs approved, can you talk about how big of an opportunity that could be, not just this year, but also in '27, if you can quantify that and your views on how long that could be a situation where there's limited competition?

And a similar question on lanreotide. Can you just level set for us to the extent you get approved, how long that could be a limited competition situation? And then lastly, on your Specialty business and particularly neurology, what's your appetite for adding assets where you can leverage your existing commercial infrastructure in neuro?

So iohexol is a very complex product, and it requires very good supply chain control and a manufacturing footprint. We are very excited with the new SKUs that are getting approved. We are expecting other 1 or 2 more strengths to get approved by end of the year. So I think going into next year, we'll complete the entire basket because it has multiple strength. Same time, we have increased our capacity this year, and we look forward to capitalize on the full market potential next year.

From a quantification perspective, we think this is a $50-plus million opportunity, maybe more going forward, and we have secured a very good supply chain. Regarding lanreotide, it's the same thing. It's a very complex manufacturing. As you know, it's a drug device combination. It's a peptide. It's a very unique formulation. So it has lots of multiple barriers of entry from coming into the market. We have a dedicated site and facility. We are controlling our in-house supply chain. So we are very positive and optimistic on staying a market leader upon the launch in Q3 as anticipated. So lanreotide, and we have inventory to go, we have perfected the manufacturing. So we look forward to lanreotide launch in Q3 of this year.

Great. And I'll take the second one on the Specialty M&A potential. As we have stated before, company's focus and goal will turn to the Specialty side going from next year and many years to come after that. We have a full mass and great infrastructure for small molecule and large molecule with the pending Kashiv acquisition. So we'll keep investing in our internal growth, R&D and CapEx for affordable medicines and not take our eyes off. It's a great business.

Even the existing business is growing remarkably with the new pipeline launches, the Women's Health, with the lidocaine expansion, with the injectable expansion in the United States. I mean we could not even supply more. So that is just a very positive sign. And as you know, David, that would be positive because the 90% scripts are written using generics product and always the complex products are run in shortages, and we are there to support that. So very excited about that.

And biosimilars, we have enough and we will keep expanding with CapEx. Now with excess cash and other means, we would be focusing on CNS assets. Our team is looking at it. And we are also looking at oncology assets. We'll be adding a pipeline internally and externally, and we'll share with you when we are ready.

Your next question comes from Ash Verma with UBS.

Congrats on the progress here. So I had 2 questions on both individual products. Maybe just on like lanreotide. So yes, you've been reiterating like 3Q as an approval and launch. Just help us understand if there could be like any gating items from FDA side on granting the approval? Have you had any kind of like a late-cycle review meeting recently? Any back and forth with the FDA that you can talk about? And then on iohexol, so this one, yes, so you're building out the SKU portfolio. Obviously, like is the adoption of iohexol contingent on you having first all the SKUs? Or can we start to see meaningful revenue contribution from what you have right now and then it sort of like builds out from the later dosing after that? So if you can give any comment on that, that would be great.

On the lanreotide, I'll take the first one. We responded to all the queries of FDA very -- with very comprehensive response. We are very optimistic. As of today, we haven't had any negative feedback from FDA. So we believe no news is a good news. It is under priority review, as FDA understand, it's an unmet need. So we remain very, very optimistic about 3Q launch, and we have inventory to go upon the approval of the product immediately.

On iohexol, our strategy was to get all the SKUs together. So our R&D has completed all the work. And it's not necessary to have all the SKUs, but I think we took a strategic position so that we can get a bigger bite at the market share. And also we are expanding the capacity. So in '26, iohexol does not have meaningful revenue, but in '27 onwards, it will add substantial revenue growth.

Your next question comes from Matt Dellatorre with Goldman Sachs.

Congrats on the strong quarter. Maybe stepping back a bit, Chirag, you kicked off the call highlighting how Amneal is in the most transformative period in the company's history. I think the 2 big things that come to mind here is obviously the recent biosimilars integration and also the Pfizer GLP-1 partnership. I know you discussed the biosimilar side a bit already, but maybe just walk us through what you're most focused on with respect to both of these programs over the next 6 to 12 months. And then what would you maybe highlight beyond these programs that you're most [ as you ] start paying attention to?

And then just on the Affordable Medicines side, you guys have highlighted a significant pickup in demand for estrogen patches post the recent black box removal for those types of products. Maybe just walk us through how large is that market potential there? And how much is Amneal positioned to capture?

Great. I'll start with Affordable Medicines, the existing business, as I said, we're very -- the most excited since last 7 years. We used to be -- used to have this kind of excitement in -- from 2010 to 2018, and those times have come back.

Existing -- the 2 reasons, the existing products, huge demand for the patches, estrogen patches, and we make them right here in New Jersey and expansion is underway 24/7. Our teams are working. We were fortunate to work with the equipment supplier to bring the equipment earlier, and we look to triple the capacity by next year. So it's a huge addition in revenue. Also, we are expanding lidocaine that is also in shortage.

So that demand is going up as well, the patches, hormonal -- I mean, sorry, the lidocaine patches. So with patches, with ophthalmics in high demand, with even the regular products being in a high demand and new product launches, Affordable Medicines could add -- it's a bigger range, but it could add $1 billion to $2 billion of new revenue from now to 2030.

So that we are very excited with our existing pipeline, new product launches and the in-line products. So amazing times coming up in Affordable Medicines category. Biosimilars, we've spoken enough, a huge growth opportunity. Now let's -- in Specialty, CREXONT keep expanding, BREKIYA is breaking the records and UNITHROID is Steady-Eddie growth. So we expect these 3 brands to continue to grow.

On top of it, the organic pipeline would be revealed within probably in first quarter next year. And we will also look to be active in potential partnership, acquisitions of branded products that fits our commercial infrastructure and fits our -- the category we play in and we'll keep expanding, and we may add oncology assets as well, since we have the biosimilar oncology team already, more market knowledge over the last 3 years. So that's very exciting news on Specialty, and we look to share that as we have that information.

On GLP-1 peptides, Pfizer's results are good on clinical trials and our partnerships moving extremely well. We look to expand the partnership and our -- both plants are coming up as fast as they can and should be operational 2029 and '30, and we look to start supplying in 2030. And also, we have evaluated the markets that we are -- we have given the exclusive commercial rights like India and Egypt, and those are looking good as well.

So very excited on a GLP-1 peptide opportunity. And also with this large infrastructure, it opens up for additional manufacturing of peptides as well as finished products for either other branded companies or in the future, some generics products.

On biosimilar, Matt, I just want to add in the next 6, 12 months, we are very much focused on integrating Kashiv and also advancing our pipeline on abatacept, Nplate and CIMZIA. Our goal is to -- because R&D is going to be key, and that's what Amneal is always shining. So Kashiv and enhanced R&D capabilities where we can file 3 or 4 biosimilars a year, which is potentially possible.

And new into biologics, we are also looking into different platforms within the biologics and look at some new drug device combination within the biologics to come out with kind of a 505(b)(2) biosimilar. So we are just focused on biosimilars. There are plenty of products to go advancing our pipeline and infrastructure and some of the 505(b)(2s) within the biosimilars.

Yes, I think we answered.

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

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

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

Great. Good morning, everyone, and thank you for joining us. My name is Matt Dellatorre. I'm a biopharma analyst here at Goldman Sachs. And we're very pleased to have Amneal Pharmaceuticals with us this morning, where I'm joined by Chirag Patel, Co-Founder, President and Co-CEO.

Chirag, thank you for being here.

Well, thank you, Matt. It's been a pleasure. A nice Goldman dinner yesterday, around with the CEOs and investment bankers. It was fun.

[ Quite ] the Knicks one.

Yes. That was tough.

Chirag, maybe to kick things off and to level set for anyone less familiar, maybe frame for us how Amneal is positioned. You guys just announced a major acquisition of Kashiv BioSciences, which vertically integrates your biosimilars business. So maybe just kind of frame for us what you're most excited about broadly? Your key priorities and what you view as the most meaningful growth drivers as we head into second half of the year and beyond?

Great. Now we could not be more excited. This is amazing. This year, after 7 years, we're seeing the growth in our in-line products. That usually declines 4%, 5%. And now it could be up 10%, 15%. It's a very meaningful growth driven by the hormonal patches driven by the pain patches. And fortunately, we make them in Garwood, New Jersey. So very quickly, we're able to meet the demand. So we're not all of it. We're building our capacity as fast as we can. We get the calls from pretty much all news channels. When are you going to supply more? They say the story behind it, black box warning, lifted American Cancer Society estrogen does not cause cancer.

So the menopause period women are -- that is a huge, from 45 to 65 age of women there. Now used to -- maybe 5% of them used to take estrogen patches every week. That is forecasted to be 30%, 40%. So you can see the multiple fold. So we are tripling our capacity, maybe quadrupling it in a few months, but we'll be supplying more from this August.

So in line is great. our launches to date are excellent and your main question and we'll go more in deep, but biosimilar, that entire new pillar of growth, along with our small molecule where we lead is amazing. All we have to do is execute. We got the pipeline of 20 biosimilars, our own R&D, our own manufacturing, multiple plants, we have a plant in Chicago focusing on E. coli, plant in Piscataway, focusing on mAbs, India, mAbs, R&D center, U.S., India, just the same playbook we use for Amneal's growth. We are using it for [indiscernible] growth.

And massive market. It's 100-plus products. You could launch over the next 7, 8 years. That only 20 or so are being worked on because not many players are in the industry now left to focus on biosimilar. So we are -- it's a race to win and we're completely poised to take the part and be U.S., probably the top 3. Globally, we have a partner model, so we don't know where we will end up, but significant revenues will come from global markets as well. And we have launches and filing lined up over the next 4 years. And already, what comes after 4 years is also being worked on. Very exciting growth area.

Great. Yes, maybe let's dive a little bit further into the biosimilars market. Clearly, you guys did that deal and -- so you're positive on not only your portfolio but also the space more broadly. I guess, how do you kind of see the market evolving now over the next 5 to 10 years with some of the regulatory changes we've seen with FDA no Phase IIIs and kind of more alignment on the payer side, which you guys have highlighted in the past for instance, private labels. I guess kind of just kind of high-level frame for us maybe how you see the market evolving over the next 5 to 10 years?

Yes. So what is shifting now is private label, which is the PBM, same customer we deal with in a small molecule. So we have a relationship over 20 years. And we're one of the trusted supplier for more than 300 medicines to those channels.

So trust in Amneal is there. They know will deliver a quality product and on time. So now it is -- if you look at number of competitors in the pipeline assets, they are less than 3, maybe 4, except for KEYTRUDA, OPDIVO, all if you do a research and analysis on bunch of products, which could be from $1 billion to $10 billion, whatever range is, but below $5 billion, you see less competition and some of the complex molecule, fusion protein that we are able to crack through Kashiv has 2 competitors like Orencia is only 2 known competitors. That's our next products in filing.

Xolair so far, it's only 3. And these are the very important molecule for us to go after. So 75% of our portfolio is going to be niche, where we define niche as less than 4 competitors, less than 3 would be ideal because 3 major customers. So 70% or so, 7-0, is moving into private label. So what happens is now when you launch and when you have a patent settlement, you already have a market. You're not waiting for 1, 2 years to create a kind of quasi branded market. We don't need to do that. and volume matters because that PBM's job to convert from branded to biosimilars. And that is really important for biosimilar industry to thrive.

So that is one -- the biggest factor that it wasn't there and all kinds of -- I don't want to use the word, but I'll use it, the games are being played between the rebates CMS, the PBMs, the brand companies, you saw that in HUMIRA, it was biosimilars where pretty much nonexistent for a first year of launch. And then slowly now, they are more than 50%, 60% market share. So I see future biosimilar is getting pretty much 70%, 80% market share of total volume and volume is expanding private label plus buy-and-build.

So you can do multiple things as Amneal's commercial engine is set to do multiple things. And regulatory, yes, it cut down 2 years now, at least, maybe 3 if you are really good and almost 50% less cost. So on average, it would be global development. Our average is about $75 million, maybe $60 million, we can get to. Other companies may be higher, used to be $150 million. [indiscernible] number of players [indiscernible] a lot of infrastructure. They could come in. It will take time. So it's a race right now. The sooner we get to the more complex biologics, we'll be always leading the pack as the more in KEYTRUDA you may see 14 players.

So it's an amazing and a lot of access you're creating. So you feel good that patient benefits big time and global access as well.

And just to touch on the private label, you guys still view that as an attractive segment of the market because you give up a little bit of price, but what you gain in volumes kind of more than offsets.

Yes. What we gain in the volume as well as we have now less sales and marketing expense. So overall, it's not a bad deal.

So similar margins potentially even on...

Similar, yes. And it depends, right? If you're 2 players, then you will have higher margins. 4, 5 less.

Yes. Interesting. Maybe with the deal you guys also gave long-term guidance, which included projected biosimilar revenues of about $1.2 billion by 2030, which I think everyone viewed as quite strong. But on the call, you guys mentioned that you were being conservative, which we like.

Maybe walk us through how you reach that number in terms of which key products. We know Xolair and Orencia are definitely going to be key to that. But just kind of which products are going into that and how you're thinking about, I guess, potential share and pricing, which you touched on, I guess, a few minutes ago. And then maybe frame for us kind of the upside scenario, if that's the base case on.

Yes, that's -- so we have existing products, which do about $100 million. Then we have [indiscernible] we're launching those of settlement agreement with them. So this year launched approved products. So that should add a good amount of revenue starting from next year. Xolair, absolutely a winner. Market is expanding. We already are in discussion with the private label as well as have the whole game plan for buy-and-build as well.

Xolair will do well. And then follow that with Orencia, which would be sometime late '28, mid-'28, and then that is the only 2 player market. So that should add significant contribution. And then we have Nplate, which is E. coli-based product coming from Chicago, that should be sometime in late '28 as well. So that should -- it's only single player. There's nobody in Nplate. Yes, hospital plays slightly count increases Amgen's product.

And then we have undisclosed product, which is -- could be a major one. If we break through, we're waiting for the FDA's comment back, but that is a big winner. We have worked -- [ Harsher ] has worked 7 years on it, characterizing probably more than 70 enzymes. It's a tough one, but..

You would potentially be only single player...

We are advanced. Yes, yes. For a long time, we could be a single player if we correct through this. So we're not talking too much until we hear from FDA and ready to go. So those products, along with international revenue added on those products should get there.

Great. That's really helpful. Maybe shifting to the commercial business. You talked about the affordable medicine segment already a little bit. You all highlighted the ADHD momentum and...

Yes. But affordable medicines, just as I soon add our respiratory product portfolio. So we have a cluster of growth within affordable medicines. So this -- we're not a tablet capsule company. We're more of a respiratory. We got a long-acting depots. We just launched risperidone. We have octreotide in the pipeline. So these are major driver.

We launched 505(b)(2) bags, which are taking the compounded version and turning into the FDA-approved products, which FDA loves because it comes from the sterile GMP manufacturing rather than compounded. The hospital love it too. We just launched or will be launching Romidepsin, which was being compounded, and it was cytotoxic product. Teva was there with RTU since 2017. They had to pull out for some stability reasons.

We cracked the stability. It took us a couple of years, and we have a great science team. And now we are in the market. FDA approved that product within like 6 months because of the need in the hospitals. So these kind of it is a completely unique portfolio and highly diversified. And the tailwind is behind us in small molecule as well, so many LOEs, so much diversity we have built on a hospital business, respiratory business, ophthalmic business, patch business. So this -- we're very excited about that segment as well while we grow biosimilars.

So continued momentum there, high single-digit type. Mid-to high single digits...

It would be more than.

And then layer biosimilars after that. You guys are also kind of -- I mean, this year and next, I think, on the kind of small molecule side are particularly -- it's a particularly rich period of launches for you all?

Yes. I didn't mention the lanreotide.

Yes, yes. Maybe -- yes, maybe starting with that one. I think you guys have flagged a Q3 approval.

Yes, yes. So far, everything is looking like Q3 or earlier and it should be a very good market until somebody else comes in. For a couple of years, we already have so much demand have spoken to customers and ready to go. This is a dedicated facility, our own. We built it for lanreotide. So it doesn't require a huge footprint, but it requires a dedicated facility.

The nature of the product, the viscosity, the device, it's -- we designed the whole thing over the past 7 years.

Did that end up being one of like your biggest product within...

No, no, luckily, we have -- we have other big products as well. But it could be...

People think it's going to be.

Or it could be. I hope it just becomes. So I don't want to throw the numbers out, but it's going to be very significant. And so that's lanreotide. We have Iohexol. Other strengths are coming, which is, again, only GE and us. If there are any supply disruptions, right, it's GE alone, and this is a much needed product.

So we have now a couple more strengths coming in. The supply chain is very, very tricky. So we have it somewhat figured out. We're still working more to have a bit of a higher volume. And we'll go after certain markets where GE hasn't locked dow customers.

So both lanreotide and Iohexol be the only generic on the market for the foreseeable future?

Yes, yes, yes. That is true.

And how are you thinking about the durability of that? Is that should we think like multiple years, I think you...

Yes, I don't know about lanreotide, how quickly Cipla can come back. But Iohexol, we don't hear anybody coming in. Again, this is we've been working on supply chain and figuring it out for 10 years. So -- we always work on toughest projects at Amneal, and that is paying off. Sometimes it may take some time. But this is where you need the value, you need more affordable access. And that is what we bring in.

Yes. Great. You did touch on this a little bit already, but your current biosimilars portfolio outside of kind of the Kashiv acquisition. I guess, how are you thinking about the Prolia, XGEVA launches? Obviously, those -- there are there are other players on the market now. So you guys have kind of, I think, set expectations a little bit lower for those in the sense that they're not going to probably take huge share, but please correct me if I'm wrong.

Well, we'll wait until we disclose the creative strategy. You got to find an angle, right?

Okay. So then maybe tied to that...

It will have meaningful contribution for it.

It will have meaningfull -- okay...

Yes.

Okay. And then in terms of the Xolair launch, obviously, there's a lot of excitement about that. You guys will be one of the first 2 players. It could be one1 of your biggest products probably through 2030 in biosimilars. I guess, what do you view as kind of like the critical points of execution for capturing that market? Is there anything that kind of sticks out?

No, first, we hurdle is the Piscataway plant, FDA is visiting from July 14, so they will be there a few days is guiding us through and inspecting. So that's the first hurdle in getting through and settlement, IP settlement, would be the second hurdle. We don't see issue, but we'll see which month because we do not infringe. Our patent landscape is very strong. So that -- and after that, it just supply, and we already have advanced -- in advanced talk with some of the customers ready to go.

Yes. Maybe switching gears to the Specialty segment. You have 2 kind of key launches going on right now, CREXONT and Brekiya, which I think on the 1Q call, you guys highlighted continued momentum. I guess, as we think about those launches over maybe the coming quarters, kind of the trajectory as you kind of head towards those long-term targets of -- I think you've highlighted $300 million to $500 million for CREXONT and then $50 million to $100 million for Brekiya. What's kind of the most critical aspects of the commercial strategy? And is it evolving now that we're a years -- couple of years, I guess, into the CREXONT?

15 months in CREXONT. Yes. And 23,000 patients already on the therapy. It took 8 years to get to 42,000 patients for RYTARY. So this is moving very fast and 80% conversion is coming from IR. So there's a huge market, there's 700,000 patients to go after. And from IR to CREXONT. This should not be on IR. So we're running multiple trials to prove that. We already had Phase IV results read out recently. Even on RYTARY, it's 3 hours, good on time, on top of RYTARY. And top of IR is even longer. And it's -- that's what the patient needs the consistency. They're not the peaks and valley, peaks and valleys. So they all kind of bad things happen for Parkinson's patients. And we're very committed for Parkinson's.

Dream is to make CREXONT a first-line therapy. That could be right, hundreds of thousand patients on starting on CREXONT. There's no need to start on IR and then move to CREXONT. So we're working on it right now. Tremendous like patient providers, everybody is talking about CREXONT. So we should be able to achieve our target hopefully, higher side of the $300 million to $500 million. It looks like international will start as well. So we have approval now in India and Europe is coming soon.

Europe, they're saying they would be able to do a whole lot as well. They ran another study in Europe. So Europe never had a long-acting CD/LD. This is the first time.

Because RYTARY is not...

RYTARY is not -- it was only in the United States. So the patient for 40 years has been taking IR. We're launching it everywhere through partners. India, we're launching with us and another major Indian player and demands is everywhere. So they should do really well. CREXONT. A great molecule. It's an amazing technology we use.

Brekiya, I think we are going to double what we said. There is a 50 to 100, it could be 100 to 200. And the reason is it's such a useful innovation. In cluster headaches, severe migraine, you go to the clinics, the pain level is almost 10 out of 10, you're banging on the head. I mean your head is banging on the wall and everywhere, it just. We have a couple of our own employees suffer through it. Actually, our own Head of Marketing has severe migraine issue on a Brekiya here. So them to then go to the emergency room, that could be a couple of hours wait and then get the same DHE injection administered at the hospital. Now we made it an auto injector.

They keep the box of 4 brands when they have the episode, boom, self-administered like Mounjaro. And in 15, 20 minutes, relief is provided. So they sleep better. There's -- they know the treatment is right there. We don't need to go to emergency rooms. So very well received by the entire migraine community and cluster headache community. -- continue to have more demand than we thought.

Maybe just kind of wrapping up the specialty segment. What are your guys' latest expectations for RYTARY generic? Is that -- is that still just TBD? These are just 3 quarters that we're...

Yes, TBD. Specialty, we are very excited, right? Because we got CREXONT, huge growth and potential. Brekiya, huge growth and potential. We have over UNITHROID like Synthroid, it's steady eddie, it keeps growing. Then we have a couple of smaller products, which are there. And then we have one undisclosed program, which we'll disclose it by probably once we file it. And that's for men's health, which is also in the news lately Yes. So we got a good product there. And then we have...

We think of that as in the kind of neuroendocrine bucket? Or is it -- we'll see it soon enough...

Yes. Often we don't talk about men's health that much. So -- and then we have a couple of other products, which we haven't disclosed because we usually disclose ones probably after Phase II. We do invest now almost $30 million to $50 million every year. which sounds small, but with the world of AI and our teams being in U.S. and India, that $50 million goes long ways. and we would keep investing in R&D every year. We love that [ data ].

And there's a lot of these niches between let's call it, a $300 million to $500 million revenue potential that big pharma will not be it leaves it out for us. And maybe sometimes, we hit a big one.

And just to touch on that men's health, when you said you'll announce that when you file the...

Yes, we filed NDA.

NDA. So it will be going into Phase...

No, no, it's going to be filed...

It will be filed post...

We're going to file it probably end of this year -- so we'll then announce it. It could be launched by end of '27, so not too far.

You mentioned Mounjaro a minute ago. So maybe shifting to your obesity program with Pfizer. You all have been very enthusiastic about this. I think when we spoke post the quarter. You all kind of highlighted that the partnership could be potentially even expanded in terms of longer term I guess kind of maybe just level set us where the partnership stands today and how far along you are with the manufacturing facility build-out.

Great. So Pfizer, we have been in active discussion. Both teams are working together already. First priority was the execution. They are superbly impressed with Amneal's team because we're not a typical CDMO or CMO. We are same as them, the manufacturer, which takes everything with passion. how they did it on their vaccine. We're doing it over here, which they never had the infrastructure for GLP except for the build and finish side.

So they're working very -- and Metsera some of the members out there as well, whom we have worked over the last 3 years. So manufacturing GLP, the peptide is a key. That facility, there are 2 facilities. One is at a small scale, which is coming online very soon, and only dedicated for Pfizer's product, Pfizer Metsera. And then another bigger facility, which should be done by end of next year as well for API.

So these 2 will -- and that API is considered biologics because of 41 ammino acids, over 40 is biologic designation. The 40 is small molecule. They get 5 more years of exclusivity, right? It's years exclusivity for -- I think Lilly is fighting on one of their filing. Yes, 7 years versus 12. So the Pfizer recent data is awesome. And it's -- we always believe that this is going to become more of a consumer product.

So the more lesser side effect, longer-lasting with how much of other complication like cardiovascular or others would be the winner because it -- I don't have to sell GLP, right? Everybody knows and what it does. It's tremendous. In India, they just launched its -- you can't even get it. And people are paying for it for the branded products. Generics becomes a dimer dozen because it's so many players will make it. Sell it at such a cheap price.

So our play was always to partner with branded company, which we did with Metsera,.Luckily Pfizer bought them. So now we are with the big guy, and we have a great relationship with them and we'll announce probably in a couple of months the updates on the agreement. We may co-market in some of the big market because Pfizer has a team right now, we have the exclusive right in India and other 17 countries. But some of them will co-market -- we're always up for what product can do. Probably we can maximize product. Yes, we'll do it together.

Yes. it's a very good relationship and moving really well. And the 2 giant facility, we could use it for other futuristic peptide products as well.

Extra capacity, okay.

Yes. Extra. First is dedicated to Pfizer, whatever is Pfizer doesn't use, we can use it for us. The peptide is moving as you know in this field.

But you guys are not interested in kind of focusing on generic? It would be it would be kind of...

Generics come ways. Generics will be 2036 something and by the day, Wegovy who's going to use it, right? It's old with a lot of side effects.

Maybe kind of tying the Pfizer is one of your maybe key people don't really give you credit for it yet. It's early, but it is one of the key kind of growth levers as we look at that...

From 2030 onwards. So we do not have it in our guidance.

You don't have it on your guidance.

No. No. This is all -- if we do it earlier, it would be added benefit. We just -- we would we are always conservative. We like to beat and raise. That's been a public company lesson for us. We like that.

In the past, you all have highlighted kind of this nice way to think about it, which is every roughly $1 billion in...

Well, that is -- let's wait until how the contract gets updated because we could expand the time line, right? The price environment has become challenging. That was back then, I think, calculation when monthly price would be $800 and now, I think it's $400 going down. for the treatment in U.S. and Europe.

So we'll uptake, but we have supply, we make money from supplying, and we share gross profit royalties as well. And then we make money from our own 18 markets. So those are who we share only small royalty back to Pfizer. The rest remains with us. So it's pretty good economics on both sides. And right now, we're negotiating. So we'll update as we finish the negotiation.

I see and then as you think about India and some of those other emerging markets, obviously, there seems to be a lot of demand now, but they're still relatively small, I guess, how do you -- how big do you see those getting? Like are you just imagining kind of...

I think, look, for our size, all these 18 countries become our portion. I don't know what Pfizer is going to bring in. But if we do somewhere between $300 million to $500 million annually, the great profitability not bad Yes. and it depends on what next product, Pfizer Metsera portfolio will produce. We have rights for all that portfolio. Maybe amylin combination, I'm not sure, maybe a broad drug on an oral that is still R&D. Yes. it's pretty good -- it's very...

Yes. Maybe just to wrap up kind of post the deal, obviously, you guys are investing heavily in biosimilars. You have the Pfizer partnership we just talked about. How capital allocation strategy post this deal. Obviously [indiscernible] You guys...

Yes. So capital [indiscernible] was straightforward. We would want to operate under 3x leverage. We're at 3.5%, maybe temporarily go to 3.6%, but very soon, we get down to under 3. Once we are 3, the rest of the free cash flow, which could be significant, $300 million, $400 million, $500 million a year as EBITDA is rising, all investment, most of it is going to go on a specialty.

This after investing into the we invest in R&D and biosimilars every year, CapEx. So that will continue. But we don't need to buy anything in...

As you highlighted, you have a specialty pipeline.

Yes, yes. And we'll do some M&A as well starting in licensing. So very excited about that. We have a multi-decade strategy. So this will continue.

Great. Thank you. Thank you very much for being with us today, and congrats on all the progress, and we look forward to monitoring all the updates.

Yes, please. Thank you very much.

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 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 leader. 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 longstanding 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. Going 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 built 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 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 3 to 5 biosimilars developments annually and offers end-to-end biologics capabilities from clone 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 have purposely structured this deal to balance upfront value and success-based consideration to ensure alignment of interest. 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 attaining certain regulatory approval milestones as well as potential royalties 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 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 the combined company's net debt leverage ratio at the end of 2026 to be 3.7x adjusted EBITDA, only a slight increase to the 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 annual 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 continued 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 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 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 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, access expands and cost lowers, 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 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 Kashiv, 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. 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 built a 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 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. Kashiv adds scientific expertise and in-house development from cell line through approval, along with scaled biologics manufacturing across a 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 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 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. 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 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 IV data, which showed CREXONT as having more than 3 hours good downtime versus RYTARY, 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. This 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 AvKARE, 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% 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 3.5x 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 shared 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 deal 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 and 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 especially 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 doubled 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 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 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 2030s. 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.

Congrats on the deal. I know this was a long time coming, so very exciting. Maybe 2 questions, if I may. First, just on the commercial strategy for the new expanded portfolio. I see you have both the mega blockbusters like OPDIVO 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 disclose more and the pipeline expands?

And then I realize you're primarily focused on the U.S. market, but can you just remind us how you are thinking about the 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 2 to 3 specific things that you're most excited about and which you think could drive upside to this long-term guidance that you're giving today?

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 the disclosed 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 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 each has its own reason why we have selected. Just to 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 work 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 Kashiv has executed over the last 25 years. We will bring the same rigor to execute this big platform on the biologics.

Your second question on how do I 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 Scripts, Cigna, Optum, UnitedHealth. 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 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 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, be a champion in America as we have a stated, goal is America's #1 affordable medicines company, and we are on our way to get there, maybe 2030, '32, we have multi-decade strategy. So we are completely focused and internationally, great partners. We look forward to work with them.

New -- 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, it -- the women's health, 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 would become a first-line therapy because they've been using 40 years old technology platform. The product was made 40 years ago, IR product, Sinemet, 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 the daily lives. So very excited about CREXONT and seeing a great outcome on Brekiya. It's a much needed product, useful product for cluster headache patients and severe migraine patients.

The third, GLP-1 partnership with Pfizer. As we all know, GLP market is going to keep growing. It's going to become life setting. So tremendous capacity would be -- 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, a 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 prices that's been out there in -- just started in India and rest of the world.

And we believe this is consumer products, everybody would want less side effect, 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. CMS has 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 bispecifics, 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.

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

Congrats on the transaction. So you noted the capacity scaling from 26,000 liters 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 liters? And then second, on the gross margin profile, maybe just walk us through the puts and takes around 1Q 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 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, we will be in manufacturing Piscataway, New Jersey and also the backup site 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. So we keep expanding U.S. manufacturing, and we only have a site in Chicago with Kashiv acquisition, 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 liter -- another 25,000 liters as we need, we are 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 and 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 how we have thought 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 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. specially, 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 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 at 200 -- we're aiming at a 200 basis points expansion. And that's going to come -- 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 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 -- 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 were here 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 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 3 to 4 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.

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 economics 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 #2 and #3. If you can just -- can you just repeat question number one 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 start with the first one. So insider ownership of Kashiv, you can see it essentially in our proxy, which has been owned by the Amneal Group, which has been also a big shareholders at Amneal since the beginning of time. So ownership includes of the Amneal Group, includes both our CEOs who've always been transparent of that as well as people who have been investors in Kashiv and -- investors of Kashiv and also at Amneal 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 #1, hopefully.

Number two is no CFO that I know likes to provide long-term guidance because it's a Catch-22 as lot of things can happen over the course of time. Having said that, and you got to -- 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 had 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 expand 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 and 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 ambiguity. So this is what's behind why provide those targets. And also you got to assume we're being prudently conservative, right? No management team, at least that I know, wants to put out numbers which they are at risk of 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 a combination. It's a combination of both. I don't have the exact percentages, 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 this and biosimilars will 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 10%. We expect this to continue and add on -- the additional add-on we expect 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 plus the acquisition and it's conservative in nature. So hopefully, that addressed some of your questions.

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...

So...

Footprint 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 -- 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 patent 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's going to just be a handful of players? Or will this remain a more fragmented market as a whole?

And the second one for me is just on a specific product on lanreotide, the Somatuline 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 of a product 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. Rest of the brand companies have moved out of favor for biosimilars, as you know, they are more obviously back to the innovative medicines.

So that leaves Sandoz obviously clear global leader at this point and a great company. Celltrion is coming in, is a -- from -- a South Korean company, which is expanding in the United States and globally and building a large vertically integrated platform. Samsung is 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 mAbxience ownership and their own, we see them as a vertically integrated player.

So the way it would expand is -- 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 settlement. All those things would take 5, 7 years.

So -- and you can't see like in a small molecule, you have 50 companies 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 regulated markets, which is a different ball game than you've been producing biologics for the emerging markets, because the requirements of FDAs are much at higher standards than those other countries. And Amneal builds everything first with U.S. in mind.

So yes, there will be more competitors. The large molecules like KEYTRUDA, OPDIVO, 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 in niche molecules where we will see 2 to 3 competitors. So that's how we see the competitive landscape, maybe 8 to 10 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 3 to 5 per year. Chintu, do you want to add anything?

I mean there's a lot of high barriers of entry, and science, it's much more complicated than the small molecules. It will cost 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, it takes 5, 7 years for a new player 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 these 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.

And lanreotide, Chris, is -- the market dynamics changed. There was -- Cipla was 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 the approval and they're working on it, and we could be the first, again, the -- I'm sorry, it's a small molecule, generic lanreotide 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 pending 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 its opportunity.

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

Just a couple for me. 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 -- 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 in 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. And I'm guessing you kind of realize 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 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 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 it to Tasos for the second question. So the first one, partnering versus full economics or vertically means vertically integrated. Yes, it is complex. This is why it took 10 years for Kashiv to build this platform with significant investment. So this is why we believe it be competitive light compared to obviously the small molecule.

And why you can take the large 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 delivered and produced. 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 biosimilar 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, Glen, that it would -- the partnering would -- is great. And in international market, we look to partner and Kashiv 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. We got to do a lot more than that because the real, real complications is the 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 can -- may have a follow-up, but let me pass it to Tasos.

Glen, 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 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, this kind of notion of kind 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 absorbing a strategic deal, which is going to have some dilution next 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, fund 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 thought of it, and try to give you guidance for 2027, 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, that gives 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, this has been discussed before. So the first one, how do you think about the lanreotide 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 time line in 3Q? And what will be the gating items for the launch?

And then my second question on gross margin. So I think like it was discussed before the annual -- like in annual term, it's about like 45%, but in 1Q, I think this quarter it is about 48%. Does that mean 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, [indiscernible] The lanreotide, 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 Tasos on the gross margin.

Yes. Our Q1 gross margin follows for a while. 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 be able the sustainability of 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 with 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%, 45%, maybe a little better compared to about 43% last year. Hopefully, 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.

All right. Good morning, everyone. Thank you for joining us for our next presentation. We're excited to be hosting Amneal Pharmaceuticals. Chirag Patel to my left is the Co-Chief Executive Officer and President of the company. In the front row, we got Joe Kates, who does all things finance. And to his left, my right, would be Tony DiMeo, who heads the Investor Relations function that I think many of you know.

So we're excited to have you here. Thank you for joining us. Why don't we just jump right into it? I probably should have mentioned, I'm Glen Santangelo. I'm the analyst at Barclays that covers the stock. We launched in December with an outperform rating. Amneal is new coverage for us here at Barclays. So we're pretty excited about it. So thank you for joining us.

Maybe a good place to start is we're week, 1.5 weeks off your 4Q results. I mean you wrapped up a very successful 2025. Maybe that's a good place to start and just give people just a quick recap of 2025 and those 4Q results and set the table for 2026 with your guidance. And I don't know if there was anything that surprised you -- I mean there was a lot that maybe surprised you the upside, anything to the downside that might have surprised you coming out of fiscal '25.

Great. Thank you, Glen. Thank you for hosting Amneal here and inviting me here. So the journey for 2025 actually started in 2019. We call it Amneal 2.0. When my brother and I, we successfully ran a private company from founding of Amneal in 2002 to 2018, when it went public, we came back in August '19, and we started strategizing how do we -- what do we do for Amneal 2.0.

And it obviously takes time for us, we had to make sure our base business keeps growing. We did that. We introduced new products and then invested in a different R&D, more complex R&D, which is -- which paid off and diversified the company as well. We bought a distribution company, especially for VA and DoD, which is doing fantastic AvKARE in 2020.

So with all that diversification, what you saw and continue to invest in specialty. So got CREXONT approved, Brekiya launch, couple of biosimilars launched. So all these activities over the last 6 years, the platform is now even more set from where it goes from '26 to 2032. And we have a whole road map to '35, but '32, we're very excited. So '25 amazing year on all aspects. We obviously meet and raise our guidance, which we like conservative and go forward.

The Affordable Medicines group, which we call it instead of calling generics, it's generics, injectable and biosimilars. We call that Affordable Medicines group, which is growing. It has grown 5% over the last 5 years. Now we expect to grow in high single digit or even more when we have successful biosimilar launches. So which we will talk more about it.

Specialty segment is growing despite of LOE, authorized generics of RYTARY. CREXONT has been a superb launch. The product is outperforming everybody's expectation because what it delivered, the absorption it delivered, the crossing of a blood-brain barrier, the patients are taking it twice a day instead of 4, 5, 6, 8 capsules a day and it provides them a stable "Good On" time. So it's been an awesome year, and we also won the Best Company to Work For award last year from BioSpace, which was always given to big pharma. First time they chose a leading Affordable Medicines company. So we're very proud of that as well.

Okay. Maybe just before we dive into the different segments. On that conference call, you also announced some changes to AvKARE in that portion of your business. And you touched on Affordable Medicines. You touched on specialty. You didn't really touch on that segment. Maybe just to round out the conversation for people why you made that decision, and then we'll dive in.

Right. So when we acquired AvKARE, the 50% revenue came from VA/DOW (sic) [ VA/DoD ] channel, which is the most profitable channel we have. And that is where we are growing. It's value-added generics and injectables will soon be biosimilars and branded products. So 20 million lives at VA/DOW (sic) [ VA/DoD ] the veterans are aging. So we have 2 benefits there. And most of the profit comes from that channel.

There was a second part of channel, which we did not really care, which competes with traditional wholesalers at 2%, 3% margin. That's a low-margin business, pure distribution. They take Gilead's product and distribute. That's not the business we are in. So that is the one we are deemphasizing. It's only nothing like $350 million in top line. Bottom line is not even $10 million, $15 million. So we're not going to invest behind that. So that's where you're seeing this, but remarkable growth on all the core areas of the business, including AvKARE, government distribution.

Okay. All right. Let's dive right into Affordable Medicines. You talked about there's 3 different businesses in there are generics, injectables and biosimilars. And when we look in 2025, a little bit of a mix of things going on, right? The trends in biosimilars and injectables were down, but in the traditional generics business, that was pretty strong. So maybe if you can unpack the different segments within that -- within the Affordable Medicines business to help us -- to help the investors think about all the underlying trends and what's impacting that business.

Right. So all 3 are large segments. All 3 are essential medicines, which 92% of prescriptions are filled using generics product, right? So let's take the small molecule retail channel. where we lead, we're #3 in the nation, soon to be #2, which is the business we do with CVS, Walmart, Walgreens, all the channels and Express Scripts and Optum. That segment has continued to grow because we're launching ophthalmics products. We have an entire line of transdermal. So right now, recently, Dotti, the estradiol patch is in shortage. We are one of the largest supplier because FDA removed the black box warning.

So the demand went up by quadruple and transdermal is not easy to just increase the production. But we're doing -- we're working day and night to supply more Dotti. So the ophthalmics launches are coming up as well. We already launched 15 or so. The more are coming. We have 2 inhalation products are approved, ProAir and QVAR. So that entire inhalation portfolio now you will see over the next 5 years, which will provide growth to this retail channel.

So we pretty much do everything in retail channel, about 260 products includes topicals, liquids, transdermal patches, inhalation, respiratory products. We have the ophthalmics, as I said, tablets, capsules. So we got the full line that the retailers need and one of the best pipeline in the industry, a lot of first-to-market products in that category.

Second category is injectable, which it's a timing of launches. We are focused on very complex injectables like long-acting depot, iohexol, right? This is the first time anybody introduced competing with GE. Lanreotide is going to be approved hopefully very soon here. So these are the -- and we have the whole pipeline. We also took certain products in a bag manufacturing, the ready-to-use bags. So they were being compounded. We made them FDA approved. So entire pipeline in injectable is set for growth.

And third, the biosimilar, which will provide the highest growth, but we would need to do certain M&A to have our own development manufacturing. And obviously, U.S. will market directly and the rest of the world would be marketed by partners. So very exciting in Affordable Medicines category. Huge growth.

Can we talk about biosimilars for a second? You have a couple of launches on the way with denosumab and the Xolair approval later this year. How do we think about the growth in 2026? I mean I think Prolia is maybe not expected to be as big as Xolair and Xolair will probably more benefit '27. How do we think about what we saw, some deceleration in '25 with maybe stabilization in '26 and reacceleration in '27. Is that the right way to think about it or not?

Yes, yes. Because we had these ASP-driven products, which always comes in pressure. So we did well with those, and they're a little bit under pressure, Avastin, Neupogen, Neulasta. And now denosumab is being launched second half of this year. that would accelerate the revenue growth. And then Xolair in '27 would accelerate further growth.

And if we are successful announcing the M&A transaction, you'll see the more and more launches in '28, '29, '30 every year new launches and every year new filing. And the pipeline is so large, opportunities are total 110 products, but we at Amneal along with our partner -- potential partner is about 27 products in pipeline would be -- could be announced. And that builds the entire portfolio, and we now become vertically integrated top 5 companies in biosimilars for a long time to stay.

Yes. So when you think about the guidance, right, I mean, 7% to 8% growth this year, but high single digits sort of longer term, which is maybe reflective of that pipeline?

Yes. And it could be more. If we are successful in executing on biosimilar, this is the golden time. It's not just me, my friend, Richard Saynor says the same thing. It's who executes, how fast, will win. And you need to have R&D, manufacturing because it's a very complex manufacturing, multiple bioreactors huge science team, the analytical team. Now FDA has made it easier. You saw yesterday's announcement, that is a second announcement. So they took out pretty much need for Phase III, now took out unnecessarily the bridging studies between different RLDs.

And can you talk about the margin tailwind that this will potentially create in this segment? How should we think about that?

It's increasing the margin. We already saw our margins going up this '25; '26 we expect another 100 basis points to go up. And we will keep ahead in margin as long as we have our own manufacturing and distribution and R&D for biosimilars in the United States.

Okay. Can we talk about -- let's maybe transition over to specialty and let's talk about RYTARY, right? We're expecting some generic competition this year. Could you maybe talk about the timing of how you think that sort of plays out and how you sort of layered that into the guidance for this segment for 2026?

Yes. So we have layered in as April 1 potential launch. Anything delayed any -- we would obviously benefit. But most exciting thing is CREXONT, which is outperforming in year 1. It converted 80% of IR patients out of 25,000 patients are on CREXONT already in 1 year. It took RYTARY about 6, 7 years to get to 25,000 patients.

So the demand is so much because what product is doing. And we made it very affordable access for the product. So we learned that from RYTARY that 38% scripts were being rejected. So this time, our goal was less than 10% rejection or nothing. So we made it -- we want to become America's leading Affordable Medicines company. We believe that innovations must reach the patients because there are potentially 700,000 patients and CREXONT has a potential becoming a first-line therapy because how it's performing and how it's formulated. And what we are seeing the real life examples, real life. It's -- so very excited. We have guidance is $300 million to $500 million for now.

Yes, that's maybe where I want to go next. Maybe we can talk about CREXONT maybe because it's clearly filling in a big hole left by RYTARY, right? Giving you some significant growth. And just to put some numbers around it for those that may be familiar, I think it was $63 million in revenues this year, but doubling next year. And you talked about peak sales number of $300 million to $500 million, right, which maybe could prove conservative over time, who knows.

But could you talk about this product and maybe what you think differentiates it versus compared to some of the other immediate-release and extended-release products on the market and why you feel like it's -- you're seeing such huge demand, maybe even above your own expectations?

Yes. It's -- so we kind of own the Parkinson's field. We've been -- we probably spent the most time over the last 14, 15 years, which I'm counting the impacts years. And the scientists learned, obviously, they first came up with RYTARY and then what were the pitfalls of RYTARY. So they designed the new formulation with different polymers, the different bilayer they came up with it and also they increased the IR in initial dosing. So it's IR/ER combination.

So patient gets the kick just like IR, but then it's stable for 8, 9 years. And the absorption at an exact proper place in the small intestine as well as the blood-brain barrier, it's crossing much effectively. So even we thought the patient would take 3 times a day, are taking 2 times a day. And starting early, which is -- we just launched another trial too because the product is approved for naive patients as well. So we are studying -- first of all, our Phase IV data came, which is 3.13 hours of "Good On" time. It's like every pump with capsule. So it's amazing what we are seeing on the field as well as the data is showing.

The second trial would take the naive patient and then study them over 2 years, 3 years, 4 years and compare that with the IR. There's a data available for IR, how the disease progresses if they just use IR versus using CREXONT. And we also have out-licensed this product in Europe. They'll be launching it soon. In India, we are launching it by ourselves. And then Middle East, everywhere in the world, Canada, South America, we have licensed it out. So it will add additional revenue for CREXONT.

Okay. In your prepared remarks, you touched on Brekiya a little bit. I mean this is meaningful, not as big as CREXONT, but still meaningful. Obviously, you've also talked about peak sales of, I think, $50 million to $100 million. Could you maybe touch on this product at all and the outlook for 2026?

Yes. So this is another useful innovation Amneal came up with because there are about 200,000 cluster headache patients, and there are many more severe migraine patients. They would go to the emergencies and clinics, emergency rooms, clinics to get DHE through the injections. We made it auto-injector and brought it home for them. So they are saying this is a 10 out of 10 pain. And the horror story, they're banging on the wall and their heads and they just go crazy. And in that, you have to go to emergency, wait there, nobody wants to do that. Now there is a psychological safety, product sitting in the refrigerator. They can -- it's auto-injector like Mounjaro, you just boom, take it home, take it at home. And the uptake is amazing. It surprised us. It's 3x more than we thought because it's what the useful nature of the product. And there are so many patients suffer through these.

Does that make you rethink your peak sales number potentially?

Not yet, not yet. We're going to be modest in our -- but we're so happy that the patients are benefiting. Our own employees stood up in a town hall and said, she had the episode and she took Brekiya in 30 minutes, she never felt better like that.

Great. Awesome. All right. Well, maybe just in the interest of time, let's move on to AvKARE, and we don't need to spend much time here. You already sort of talked about it. I thought it was kind of interesting, right, in that you're getting out of some of the less profitable businesses that had an impact on your revenues, but a positive impact on your profitability, and we'll segue to guidance in a second, right? But when you look at your revenues are coming in 2026, maybe a little bit lower than what everybody thought, but the EBITDA is much better right, on the profitability and what's remaining. So you could just maybe talk through that transition and how people should be thinking about AvKARE in 2026, given the change?

Right. So the core business, which is obviously the Affordable Medicines growing 7%, 8%. And depending on the timing of launches, we could do better. The second one is the specialty, which already grew from '24 to '25 from $440 million to $529 million. We're saying it would be steady this year because we will lose LOE for -- we're assuming on April 1, but still is staying steady.

These are the high-margin businesses. And then AvKARE, the government business is doing well. They have a little bit flattish year because they had a big launch Entresto last year, which now the competition is there, but they're launching new products, but we expect that to continue to grow over many years. And that's very core to us. We love that direct distribution. Many of Amneal's product because VA and DOW (sic) [ DoD ] requires TAA compliant. So made in U.S.A. is a big advantage for us. So we can provide many products from our U.S. clients to directly without the wholesaler margins to VA and DOW sic [ DoD ].

Okay. Can we maybe segue to the Metsera deal? I don't know to what extent you may be...

It is Pfizer now.

Well, I was going to get to that. I was going to say there was already some interest in it and the spotlight has intensified now with the Pfizer transaction. And so I don't know if you've started to think about quantifying the opportunity and maybe what attracted you to the deal to begin with? And are you more excited now because of the Pfizer transaction? Or is it still the same? Like how should we be thinking about how impactful this can be?

Yes, it's very impactful. So how -- it's an interesting question you asked. So we wanted to go in GLP-1, and we did not want to just be a generics GLP-1 player. We have a lot of talent in the company, lots of scientists, peptide experts. So we approached our friends at Metsera back then, and I know Clive really well for years and so I have all these capabilities and talent, CMC, clinical support, oral solid formulations, device selection and drug device combination, peptide manufacturing, and we can make it cost effective because we could bring this from India rather than making it in the United States, which will be very expensive in a long time.

So we partnered with Metsera and it is such a comprehensive partnership. And as you know, Pfizer now acquired. Pfizer is continuing to work with our team, and we're very excited to be a very helpful partner for Pfizer. I know they're big guys. They have a lot of capabilities, but there are things we can provide. And right now, the partnership is going in a great spirit on both sides.

This is obviously future down the road as we think about contributing to that growth algorithm.

It's huge, right? Because -- just Zepbound was launched in India. So the total deal is in the 2 phases we have. We have a right to market in 18 countries, including India. So we have exclusive rights for Pfizer products now. It used to be Metsera, which is very lucrative for us, which India and other emerging markets.

In India, Zepbound is running out of products. So it's that much in demand. So globally, it will be in demand. The prices, as you know, the price points are going to come down. And at that point, having a technology which produces the cost-effective peptides and have these highly automated fill and finish total from start to end packaging lines, which we have 3 of them being installed right now, 2 cartridge line, 1 auto-injector line. It is really needed for the global supply. So we -- with Pfizer and us, we're very excited. Well, we are more excited than, I guess, they're, but they're very excited as well.

Just 2 more quick ones as we're starting to run out of time. Let's talk about the balance sheet, over $300 million in cash. I mean, manageable leverage. How should we think about sort of capital allocation in 2026 and beyond? I mean, anything that sticks out to you opportunistically or what you'd like to do?

Well, we continue to invest in the company, right? We have our own R&D, which is about $180 million to $200 million we invest, Capital expenditures we continue to invest. Outside, as we have said, this year, priority is vertical integration for biosimilars and which hopefully we'll be announcing that shortly.

Okay. Well, we're out of time. So what I want to do is I just want to give you the last word to sort of close this out. It felt like we've come off a very successful 2025. We got a lot of momentum in Affordable Medicines. Within specialty, we're overcoming the LOE of RYTARY. We got CREXONT and Brekiya that is sort of picking up the slack. You've made some changes on the profitability side of AvKARE. I mean, what else have we not talked about that you want to mention to investors? And what's the final word you want to leave with the investors here today?

Well, thank you, Glen. Well, we're very zoomed in focusing on the execution of massive portfolio that we have and looking forward to successfully integrate biosimilars and become a top 5 players for the United States. So that's a huge opportunity for us. And we do have a couple of candidates on our specialty side of R&D, which how it moves forward, we'll be announcing towards the end of the year or beginning of next year.

So all segments are doing really well. And there is some growth in international markets, India being direct market and then through partnership in Europe and rest of the world. So that would become meaningful maybe after 3, 4, 5 years.

Okay. All right. Perfect. Chirag Patel, Co-CEO of Amneal Pharmaceuticals. We'll leave it there. Thank you very much.

Good morning, and welcome to the Amneal Pharmaceuticals Fourth Quarter and Full Year 2025 Earnings Call.

I'll now hand the call over to Amneal's Head of Investor Relations, Tony DiMeo. Go ahead, please, sir.

Good morning, and thank you for joining the Amneal Pharmaceuticals Fourth Quarter 2025 Earnings Call. Today, we issued a press release reporting Q4 results. The earnings press release and presentation are available at amneal.com.

Certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled cautionary statements on forward-looking statements for factors that may impact future performance.

We also discuss non-GAAP measures. Information and use of these measures and the reconciliations to GAAP are in the earnings release and presentation.

On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs, Tasos Konidaris, CFO; our commercial leaders; Andy Boyer for Affordable Medicines; Joe Renda for Specialty; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

Thank you, Tony, and good morning, everyone. 2025 was a defining year of excellent execution and portfolio expansion at Amneal. As a diversified biopharmaceutical company across specialty complex products, injectables and biosimilars, we're building category leadership positions in large and growing markets. In 2025, revenue grew 8%, adjusted EBITDA increased 10%, adjusted EPS rose 43%. 2025 marks our sixth consecutive year of growth in our industry, that consistency of growth stands out.

What's most exciting is not only what we have achieved so far, which we are truly proud of but the even greater opportunity that lies ahead. We entered 2026 with a strong foundation and exciting strategic growth opportunities, whether we are advancing the standard of care with innovative therapies like CREXONT or expanding access to affordable complex medicines, our mission is clear, to become America's #1 affordable medicines company.

Since our founding over 20 years ago, Amneal has always been driven by the deep passion and responsibility to serve the millions of patients who rely on our medicines every day and we're just getting started.

Let me begin with our largest segment, Affordable Medicines. The business continues to grow year after year, driven by an expanding portfolio of complex differentiated and durable products. 2025 was an exceptional year for approvals and launches, particularly in complex generics and injectables. These launches are not onetime events. They are multiyear value drivers. As a result, we expect meaningful acceleration in our affordable medicine segment, revenue growth in 2026 and '27.

In Injectables, we are executing with a clear ambition to become a top 5 player in the U.S. institutional market. Over the years, we have significantly expanded our R&D and manufacturing capabilities, adding the technical capabilities required for long-term leadership. Our strategy focuses on providing differentiated offerings for hospitals, including ready-to-use specialty injectables. With over 40 products and a pipeline of differentiated launches, we expect this business to scale substantially over time.

In biosimilars, we're building a long-term growth engine. We began with in-licensing and creating a strong commercial platform. In December, we received approval for our denosumab biosimilars, our fourth and fifth products. With biosimilar Xolair in the review, we remain on track to have 6 biosimilars in the U.S. market by 2027. Strategically, our goal remains to be vertically integrated in biosimilars across development, manufacturing and commercialization, which we believe is essential for long-term success.

From a macro perspective, the opportunity is remarkable. Over the next decade, about 234 millions of biologic cells will lose exclusivity, more than double the prior 10 years. And only about 10% of those products have biosimilars in development. This creates a significant long-term opportunity to dramatically expand patient access and drive very meaningful growth for our company.

Next, on GLP-1, our collaboration with Pfizer is progressing well and both teams are working together. We are here to assist Pfizer in a meaningful way. This initiative builds on what we do best: develop, manufacture and commercialize complex medicines at scale and position us to play a meaningful long-term role in one of the largest and fastest-growing therapeutic categories in health care.

Now let's turn to the Specialty segment. We're very pleased with the uptake of CREXONT. At the end of 2025, our 23,000 patients were on therapy, reflecting over 3% market share one year post launch. For context, RYTARY reached roughly 42,000 patients and 6% market share 10 years after launch. In December, Interim Phase IV data reinforced that what physicians and patients are already seeing, CREXONT delivers more "Good On" time than other therapies. We remain confident in peak U.S. sales of $300 million to $500 million for CREXONT which we believe is setting a new standard of care for Parkinson's patient.

In the fourth quarter, we launched Brekiya, a first and only auto-injector for severe migraine and cluster headache patients. For many of these patients, the prior option was an emergency room visit. Brekiya gives them control, delivering the same hospital medication in a ready-to-use auto-injector. Brekiya is our next growth catalyst in specialty with expected peak sales of $50 million to $100 million.

Lastly, health care continues to provide diversification and strategic advantage through government and distribution channels, health care strengthens our direct access to key end markets and provides an efficient path for new launches, including bio seamless, complex generics and specialty products. Overall, we are building a diversified biopharmaceutical company that expands access and provides new therapies for patients and delivers consistent growth for investors.

With that, I'll turn it over to Chintu.

Thank you, Chirag, and good morning. I will begin with gratitude and thank the global Amneal team for their dedication and hard work, which continue to drive our company's success. The formula for strong execution remains the same: operational excellence, robust innovation and the differentiated portfolio.

First, on operations, our global manufacturing network and leading technical capabilities remain a core strategic advantage. We continually enhance efficiency through digitization, automation, and AI, which will drive cost efficiencies.

In GLP-1s, our collaboration with Pfizer is progressing very well. Our manufacturing build-out of two new GLP-1 facilities remain on target, one for large-scale peptide production and one for advanced sterile fill-finish manufacturing designed to support all dosage forms. We are well positioned to participate meaningfully in the long-term GLP-1 market with the scalable and flexible manufacturing platform.

In Affordable Medicine, we look to launch 20 to 30 new products each year. Importantly, it is not just the number of launches, but the value and complexity of these products that matter. In that regard, in 2025 was an exceptionally strong year. For years, we have strategically prioritized the development of complex generics, including injectables, ophthalmics, inhalation products and other advanced drug device combinations. As a result, we are now in the midst of one of the most concentrated and impactful waves of high-value affordable medicine launches in Amneal's history.

During the fourth quarter, we meaningfully expanded our portfolio with a series of important late 2025 approvals and launches across multiple areas. Highlights included risperidone extended-release, our first long-acting injectable, sodium oxybate, Bimatoprost and cyclosporin in ophthalmic, the first generic for iohexol and multiple other injectables for hospitals, including several epinephrine products. Notably, we also announced approval and now launching our first two innovation products: beclomethasone dipropionate and albuterol sulfate. This reflects a decade of hard work by the team and marks our new entry into inhalation, which is new growth platform starting this year.

With this level of activity, we are reaching an inflection point in complex innovation. Today, we have 59 ANDA spending with 64% classified as complex products and 52 more products in development with 94% complex. We look to file 10 to 15 key complex programs in 2026, including several more injectables and inhalation programs. This complex portfolio evolution positions us very well for sustainable growth.

In biosimilars, we continue to build our business deliberately over time. Our next major milestone is biosimilar Xolair, which represents our sixth potential biosimilar and our largest opportunity to date. Xolair was one of the first blockbuster allergy biologics, and we expect to be among the first biosimilars in this over $4 billion U.S. market next year. We are very proud of the progress we have made in building a biosimilar business. As Chirag noted, we see a very significant opportunity ahead with the upcoming wave of biologics LOEs. Success in this space will require vertical integration from cell line development and R&D to manufacturing and commercial capabilities. That is what will be needed to be a long-term leader in biosimilar.

In Specialty, CREXONT continues to perform exceptionally well and believe it has the potential to become the standard of care for all people living with Parkinson's disease. For decades, the foundation of treatment has been immediate release carbidopa/levodopa, a therapy that dates back to 1970s. IR CD-LD is limited by fluctuating symptom control, frequent dosing and significant off time as the disease progresses. CREXONT represents a meaningful advancement in therapy designed to address these long-lasting limitations by delivering more consistent system control with fewer daily doses.

In 2024, we initiated a phase IV real-world study of approximately 225 patients converting them from RYTARY, IR CD-LD and IR CD-LD with COMT inhibitors to CREXONT. In December, we shared the first interim results from this open-label study which demonstrated clear and clinically meaningful differentiation, patients treated with CREXONT experienced substantially more "Good On" time less of time and longer intervals of continuous "Good On" time. Importantly, patients converted from IR to CREXONT showed over 3 hours more "Good On" time per day, a result that is highly meaningful for Parkinson's patients.

We look to generate further evidence to demonstrate CREXONT's effectiveness and expect to share more data for 2026 and 2027. In addition, internationally, we have filed the products in a number of key countries, including India, Canada and in Europe.

Beyond CREXONT, we plan to expand our specialty portfolio over time with products in areas like CNS and others, where differentiated delivery, real-world performance and patient convenience matter. Brekiya auto-injector is a clear example, combining a proven therapy with differentiated drug delivery system that improves how patients receive care. Specialty represents a multiproduct growth engine for Amneal, and we'll share more on our pipeline as it evolves.

In summary, we are executing well, driving operational excellence advancing innovation and expanding a differentiated portfolio across affordable medicines, specialty and biosimilars. The progress we made in Q4 reinforces our confidence in the path ahead.

With that, I will turn it over to Tasos.

Thank you, Chintu, and good morning, everyone. The fourth quarter completed another terrific year for Amneal with strong top and bottom line growth as Q4 revenues grew 11%, adjusted EBITDA grew 13% and adjusted EPS grew 75%. Our consistent performance reflects our strategic choices, relevancy of our broad portfolio, prudent capital allocation and strong execution.

In addition to strong top and bottom line growth, we also delivered strong full year operating cash flow of $340 million, reduced net leverage to 3.5x and our successful refinancing extended maturities to 2032 and substantially reduced interest costs. So all in all, an excellent finish to the year. Over the next few minutes, I'll cover in more detail on our fourth quarter and full year 2025 results and move on to our 2026 guidance.

Starting with the fourth quarter. Total company revenues grew 11% to a record $814 million. First, our affordable medicines segment was essentially flat to $437 million, reflecting the timing of key products and new launches. Second, Specialty revenues were very strong again in Q4 up 38% year-over-year to $167 million due to strong demand across our key brands such as CREXONT, RYTARY, UNITHROID and some small initial sales of our newest branded product, Brekiya auto-injector for cluster headaches. Third, Health care revenues grew 24% to $211 million driven by strong growth in the government channel. Our Q4 revenues continued to benefit by approximately $50 million associated with one significant new product lines which accounted for approximately $100 million in new revenue for the full year 2025.

Fourth quarter adjusted EBITDA of $175 million grew 13%, driven by top line growth and limited operating expense growth. Q4 earnings per share of $0.21 grew 75% due to adjusted EBITDA growth and lower interest expense due to our favorable refinancing earlier in 2025.

Let me now shift to our full year 2025 performance where we exceeded all our financial guidance metrics. Total company revenue of $3 billion increased 8% driven by growth across all of our business segments as Affordable Medicines grew 4%, Specialty grew 19% and Health care grew 12%. We're also very pleased by the growth of our adjusted gross margin, which expanded by 50 basis points to approximately 43%. It's worth noting that Health care's 2025 adjusted gross margin increased in excess of 400 basis points due to our concerted efforts to prioritize profitability. On the bottom line, full year 2025 adjusted EBITDA grew 10% to $688 million, and adjusted EPS grew 43% to $0.83.

In addition to our strong financial performance in 2025, we feel great about the actions we have taken to strengthen our balance sheet. First, we have reduced net leverage from 7.4x in 2019 to 3.9x at the end of 2024 and finally, to 3.5x at the end of 2025. Second, we fully refinanced our debt last summer. And in January of this year, we repriced our term loan B to further lower interest rate expense. As a result, our weighted average cost of debt is down from 10% in 2024 to about 6.8% in 2026, and maturities have been extended out to 2032. Accordingly, interest expense in 2025 was $217 million compared to $256 million in 2024 and as importantly, we expect a further reduction in 2026.

I'll now turn to our full year 2026 guidance, which in summary reflects another year of growth across all financial metrics. In summary, we expect top line growth between 1% and 4%, adjusted EBITDA growth between 5% and 10%, and adjusted EPS growth between 12% and 24%. Let me provide a bit more detail on each of our guidance metrics, starting with total company revenue of $3.05 billion to $3.15 billion, up 1% to 4%, as I mentioned. We expect the growth to be driven by our largest business segment, Affordable Medicines where we expect growth between 7% and 8%. This is an acceleration from 4% growth in 2025, but in line with our prior 3-year average. Our growth expectation is rooted in the robust cadence of new product launches we received from the FDA in the last couple of months. As a result, we're entering 2026 with the highest number of product approvals which derisks our growth expectations.

In our Specialty segment, we expect 2026 revenues to be about flat to 2025. This temporary pause in growth simply reflects the continued growth of CREXONT and our other brands been offset by the expected generic erosion, RYTARY. As we look forward to 2027 and beyond, we expect our specialty business to resume its strong growth trajectory as the growth of CREXONT and our multiple other branded products overcome the loss of exclusivity of RYTARY.

In our Health Care segment, we expect revenue between $625 million to $700 million in 2026 compared to $745 million in 2025 and $663 million in 2024. While the year-over-year revenues will be down in 2026 our expected profitability is flat year-over-year as we continue our successful efforts to focus on the more profitable segments of the business. For some of the newer audience on our call, it's worth noting that it has been about 6 years since we acquired 65% of Health Care, and over that time, top and bottom line have increased by over 3x. We're very excited about Health Care's growth potential given the strong fundamentals of expanding population of more than 20 million veterans and federal government workers as well as the growing portfolio of new launches such as biosimilars, complex generics and specialty products. Overall, Health Care remains a highly strategic direct platform for Amneal, and we expect it to continue generating substantial profits and cash flow over time.

Moving down the P&L. We expect 2026 adjusted gross margins of over 44%, which reflects approximately 100 basis points of gross margin expansion driven by the continued mix shift in our business as the higher margin parts of our business are growing faster. As a result, we expect 2026 adjusted EBITDA between $720 million and $760 million, up between 5% and 10%. From an EPS perspective, we expect 2026 adjusted EPS between $0.93 and $1.03, which reflects 12% to 20% earnings growth driven by strong adjusted EBITDA growth and lower interest expense.

Now in terms of quarterly phasing for 2026, we expect a gradual build over the year for a couple of reasons. First, the revenue associated with many new affordable medicines launches as well as correction will build throughout the year. And second, some launch-related investments are more front-end loaded to support key launches such as our Brekiya auto-injector.

Moving on to cash. We expect robust 2026 operating cash flow between $325 million to $375 million compared to approximately $340 million in 2025 and CapEx of approximately $110 million or 3% of revenue. Lastly, we're pleased to be added to the S&P SmallCap 600 Index a month ago, which reinforces the consistency of our operating and financial performance over time. We believe this inclusion enhances our visibility with the investment community and continued expansion of our institutional investor base.

In summary, we entered 2026 in our strongest position yet and with a wind in our backs. We expect sustained top and bottom line growth supported by our diversified portfolio and multiple growth drivers, including new branded launches such as CREXONT and Brekiya, new biosimilar launches and a very strong wave of new affordable medicines. Combined with our disciplined focus on profitable growth, operating efficiencies and strong balance sheet, we see a clear path for substantial value creation.

With that, I'll turn the call back to Chirag.

Thank you, Tasos. Our strong 2025 results and 2026 guidance reflect the momentum across our diversified business. We remain focused on the disciplined execution of our strategy as we progress towards coming America's leading affordable medicines company.

Let's now open the call for Q&A.

[Operator Instructions] We now have our first question here from Chris Schott from JPMorgan.

Congrats on all the progress. Maybe just to start out on CREXONT, post the Phase IV data for the product, can you just elaborate a little bit more on the response you're seeing in the market from these results? And maybe as part of that, as we think about 2026, how should we think about either revenue or market share targets for the product? And I just have one follow-up after that.

So well, I'll start and have my brother added on to this as well. So the Phase IV, it's interim result showing 3.13 hours of "Good On" time, which is what we've been hearing from physicians and the experience of patients. So it's a huge uptick. 80% of the IR patients are converting to CREXONT. And the Phase IV continues. Chintu will give more details on it, and we also have another study, which he will share as well.

Market share, we would double it in '26, more than double the revenue. And as we march towards the first goal is to reach 100,000 patients and second goalpost would be to reach 200,000 patients, reminding you, total is 700,000 patients on CD-LD treatment.

Chintu, why don't you add more on the clinical studies, please.

Yes. Chris, so we are very excited about our interim results, which we shared for 50 patients throughout '26 and early '27, we will be sharing remainder, which is the total study was about 225 patients, and the data is looking pretty promising. And we have done -- as I mentioned, converting patients first time from different therapy, not on just the IR CD-LD, we have done conversion from the RYTARY, from IR with COMT inhibitor and CREXONT is clearly showing substantial benefits of "Good On" time compared to all those therapies. So we are very excited. We have a lot more data coming, and I think that will further enhance CREXONT's position in the market, plus we are looking at another Phase IV. At the right time, we will also disclose the Phase 4, which continue to generate the data.

And what we are excited about is the difference is making in patient lives. And that -- we have so many testimonies from the patient and the doctors. So I think when the product is doing well, obviously, it will reflect in the sales and the revenue and uptake. So we are very pleased and a lot more coming in '26 and '27 with new data.

Great. And just one maybe quick follow-up on Health Care. Can you just -- I just want to make sure I understand the 2026 guidance relative to 2025. So can you just talk a little bit more about the growth you're expecting in that kind of higher-margin government channel versus the distribution business? And just like roughly what type of gross margins we can think about -- kind of -- for that franchise for the year?

Yes, I can take that, Chris. This is Tasos. Yes, as I mentioned before, kind of stepping back, right? This business, when we acquired 65% of Health Care, since then, we have more than tripled the revenue, gross margins and EBITDA. So it's great because we were able to leverage both the unique assets Amneal brought to the transaction as well as the inherent growth in that business.

So as we talked about, so when you look at 2025 versus 2024, right? So in 2025, the total revenue of Health Care was about $745 million and in 2024, the revenue was $663 million. So that grew about -- total, about 12%. About 50% of the revenue is between about 40% of the revenue kind of goes into the government channel, 60% of the revenue goes in the distribution channel. So when you think about this 12% growth, 2025 versus 2024, the distribution part of the business declined, okay, while the government business grew, okay? And the distribution declined, it was purposefully done because that's what we talked about it because we decided to not chase businesses with 1 or 2 gross margin. okay?

So as a result of that kind of what I would say is pivoting, right? Into the -- kind of leaning hard into the government channel, the gross margin of our Health Care business grew over 400 basis points. So the gross margin in 2025 of Health Care was $147 million compared to about $100 million in 2024. And the operating income in 2025 was $94 million compared to $57 million. So essentially, '25 versus '24, revenue up 12%, gross margin up 41%, operating income up 65%. So a great performance.

So now as we look into 2026, there's two things that are happening. We continue to expect the distribution business to be declining. But because it's such a low profitability part of the business, it doesn't hurt the bottom line. The government business is going to be down slightly, not because of anything fundamental that is happening. But in 2025, with such an extraordinary growth because we had this one generic products, essentially, generic Entresto. That essentially we're the only ones in the market. That product had $100 million worth of revenue, as I mentioned before in 2025. In 2026, as it always happens it will have some additional competition. So that's why in 2026, revenues declining is down because of our pivot away from distribution, number one, and not having kind of that exclusivity, if you want to call that of generic Entresto impacted the government business as well.

So that's what's going to drive the decline and what we like to call it almost like a reset level for 2026. But the bottom line is not going to be impacted because for a couple of reasons: a, there is other more profitable parts of the business. We will be allocating resources. We'll also be leaning on some of the operating expenses. So these are the dynamics that are happening in Health Care, which essentially creates this reset revenue in 2026 before we resume top line and bottom line growth in 2027 and beyond. So I know I said a lot, Chris, let me know if that was helpful.

Moving on, we now have Matt Dellatorre from Goldman Sachs.

Maybe on the Pfizer GLP-1 obesity partnership, could you just share your latest update on the status of that partnership? And then how should we think about potential outcomes? For example, what -- if they do end up buying you out, would that be a complete return of all rights and economics? Or are there other scenarios where, for instance, maybe you don't manufacture for a developed market, but you keep emerging market rights? And then if it is a complete buyout, what would be the plan for the new facilities in India and the cash you would receive? And then I had one follow-up.

So with Pfizer, our collaborations continues such as we had it with Metsera, both teams are working together. Facilities actually accelerated in manufacturing. And we -- several levels of C-level meetings have been already conducted with Pfizer. So we expect nothing much to change. Right now, it's all waiting for the starting the Phase III and getting the products and the demand is global and we have built a building, such a remarkable, highly automated, fill-and-finish facility with latest and greatest equipment. So Pfizer is very excited about that.

And also, we are making great progress on our Peptide manufacturing, which you know is in shortages with solid phase technology, and we are also introducing hybrid in the future. So our teams are working with Pfizer on those aspects as well. And we continue to have the marketing rights for 18 countries, including India and Southeast Asia. So we're excited about the entire partnership, and there are no plans to think about right now. It's moving great.

Okay. Awesome. That's exciting. And then maybe just on business development. Could you share your latest thoughts on the strategy, areas of interest and capacity and then how you're thinking about the potential vertical integration of biosimilars?

Yes. So as we've been saying it since last couple of years, time is now to do the vertical integration. Biosimilar opportunities are [ awesome ], regulatory is streamlined and we are very familiar with the market. So very excited that's where the capital allocation will go first. And then as I said previously, 2027 and onward, we'll be more focused on specialty assets and keep building our pipeline there.

And remember, the -- organically, we are very strong in our R&D pipeline. So we keep our pipeline full. More complex products, a great team in-house we have. So we'll continue to invest in our own R&D, our own CapEx, which is strategically we've been investing and very excited about the future and next 5 years, going to be tremendous growth than what we have even witnessed in last 5 years.

Moving on, we now have David Amsellem from Piper Sandler.

Just a few for me. I wanted to get your thoughts on the generic Omnipaque opportunity and what has been built into your '26 expectations regarding that opportunity, talk about barriers to competition, potential approval of additional strengths. And the extent to which you think that's going to be a limited competition product for the foreseeable future. So I know that's a bunch, but that's number one.

And then secondly, I had a question on Xolair. Kind of similar set of questions, but I wanted to get your thoughts on the extent to which that could be a limited competition market. I believe there's only two or three others. So talk about how big of an opportunity that could be in '27 and beyond.

Great. Thank you, David. On Iohexol, the supply chain is -- it's complicated. They will be entering the market. GE has the huge market share. So we'll be making inroads. The hospitals we have spoken to, they're very excited. But expect that as a ramp-up because of the difficulty in the supply chain. So over the years, as we introduce more strength, it will pick up. So great achievement from our R&D team and complexity of manufacturing, both we have achieved. So excited over time on Iohexol.

On Xolair, we're very excited right now with Celltrion and us in '26, large market, growing market, very well said about we expect 65% to 70% to go through the private label, which gives us immediate bump in the cells rather than ramp up over market share over 1, 2, 3 years. So exciting opportunity. And as you know, Amneal is well positioned to do business with these large buying groups as we have been doing business with them over 20 years great relationship, #1 pipeline in the country for them, and they appreciate our high integrity, the quality standards we have. So we expect tremendous partnership with these private label side of the business, which I expect about going forward would be almost 70% would go through private label which would make the biosimilar penetration very effective. It would not have to wait for 3, 4 years to get to 30%, 40% market share. It would jump to higher market share immediately in year 1 and 20%, 30% will continue on buy and bill, which we are well positioned as well. So very excited on solar as well.

Chintu, you wanted to add anything on Iohexol?

Yes, David, So on Iohexol your question on additional strength. So by end of the year, we will have approval for the missing trends. So by end of the year, we'll have the entire Omnipaque, all the strength. It's a very large opportunity for us. We have been working on strengthening our supply chain and increasing our capacity. So '26, we will start but '27 onwards, it would be a meaningful revenue contribution. And from a competition perspective, it is a tough product supply chain perspective, manufacturing, it's unique bottle. So all those things put together, I think we don't foresee a lot of competition and multiple strengths. So we are very excited. And by end of the year, we'll have all the strength approved.

Moving on. We now have Les Sulewski from Truist Securities.

First one on CREXONT. Can you quantify the persistence at perhaps month 3 or 6 versus your internal expectations and versus RYTARY? Any sort of signal around discontinuation? And how should we think about the gross to net evolving as you brought in access? And what's kind of a steady-state gross to net you're expecting at peak? And then second on the DHE auto-injector, what's the early patient profile? Is it migraine versus clusters and the switches from prior DHE exposure versus naive?

CREXONT versus RYTARY. Obviously, CREXONT is performing much better as RYTARY, it took almost 10 years to get to 6% market share. First year, we have 3% market share, 23,000 patients on it. testimonials are amazing, and we've received letters and -- our office literally -- written letters from patient providers are -- physicians are so excited about the product as well. And now our aim is to make that first-line therapy over time so nobody -- no patient has to take the whole [ filament ], which is giving them a lot of fluctuations every 1.5 hours, 2 hours. So this is clearly a 7, 8 hours, a "Good On" time every day. So amazing stories, no comparison with RYTARY. It is -- we're doubling or more than doubling market share this year, so we'll reach 6-plus percent this year, which would be above RYTARY.

And we learned -- on the pricing side, we learned everything we had about 35% of patients that could not fill that prescription due to the pricing on RYTARY. We have really worked on it and have us put the pricing out there that, that number has been reduced now. And our gross to net runs is typical in this category, about 40% to 45%. We're very excited about CREXONT.

Brekiya, Joe, you want to -- it is also -- the Brekiya is for cluster headache as well as severe migraine. So we're treating two segments and only excitement is amazing. Joe Renda is here, he just came back from our national sales meeting. Would you like to shed some light on Brekiya?

Sure. Yes. Thanks so much for the question. And yes, the response from the field team so far has been fantastic on both CREXONT and Brekiya auto-injector because what we're seeing in the market from the key KOLs has been very favorable. I would say with regards to your question about CREXONT with persistence and adherence, it continues to improve as we continue to see more and more patients on the product. And right now, it's surpassing that of RYTARY. And we continue to -- we anticipate to see that continue to go up because we're seeing patients return to therapy at a higher rate with CREXONT than they did with RYTARY. So that's been very favorable.

With Brekiya auto-injector, our strategy has been to focus on the key migraine treatment centers across the United States and key KOLs and the response has been beyond our expectations so far. So we've been very pleased. We're about 90 days into the launch. And having come back now from our sales and marketing meeting -- our national meeting this week, I'm maybe more further convinced that we're going to continue to drive growth for both of those products. The team is trained and ready, and we're going to be executing this year. So excited about that. Thank you.

And checking the Q&A list now, and we are now all clear. And with that, I'll go ahead and hand it back to Chirag Patel for some final remarks. Go ahead, please.

Well, thank you, everyone, for joining the call today. Have a great Friday and weekend. Thank you.

Thanks, everyone.

Thank you. Thanks, everyone.

Thank you, gentlemen. And this concludes today's call. Thank you all for joining. You may now disconnect your lines, and have a great weekend.

Good afternoon, everybody. I'm Chris Schott at JPMorgan, and it's my pleasure to be introducing Amneal today. From the company, we have the company's Co-CEO, Chirag Patel, who's going to be doing a presentation and they're going to jump into a Q&A session from there. But Chirag, happy New Year.

Thank you. Haier, Chris. Thank you very much for joining us. I put today. But great to see you. I'm very excited to be here. And thank you again, JPMorgan, for wonderful conference here. So we're going to jump right into it. We have a lot to share and I'm going to start just a little history about the founding of Amneal, very humble beginning. My brother is here as well. This time, he comes -- we're co-CEOs, co-founders.

Our father helped us with his knowledge and he's also a pharmaceutical scientist. And that's where our humble beginning started in 2002 in Paterson, New Jersey. So we're a U.S. company dedicated to America, and we have a huge mission, which will get there. And obviously, it's much needed in the society as well. In 23 years, we have delivered so much savings. 175 million prescriptions are filled with Amneal's products today.

Number one, in quality, we -- that's our highest priority all the time. All complex dosage homes we have. So we make products from transdermals to in-house injectable to respiratory to topicals, liquid, obviously, oral solids, less and less, and biosimilars now, which we partner in. So it's excellent opportunity great founding, and we won the best company to work for from BioSpace, which usually won by the Lilly's and nose and big pharma, Amneal on it first time. So it's a fantastic company to -- it's the people make it happen, and we're so proud to win that award.

So our mission is we've been very public. We're focused on we call it affordable medicine segment, which consists of retail generics, injectables and biosimilars, And we'll talk more about each segment as we go forward. We're probably ranked #3 or 4 today, and we should be #1 by 2030 and remain there.

And that -- this is for America. So 98% revenue. So all of it is United States. So we're zooming focus in the United States, but we're slowly expanding through partnership in Europe and other parts of the world.

This is the evolution. This is what we have done. As you know, retail generics got very competitive from companies from China, India, like hundred of competitors, 3 buyers. It really became highly competitive in in 2017, '18 when FDA started approving so many ANDAs. So one product could have 15 approval, 20 approvals, it's race to the bottom.

So that we have moved out of it. Only 25% of our revenue is on retail, oral solid. We're more into complex GX where you see less competition. And those products are very complicated drug device combination, long-acting [ depot, ] respiratory, injectables, complex injectables portfolio. ready-to-use bags that avoids the hospital errors. So that is -- it's not only affordability we are providing, we're also providing solution for our customers. So that is exciting.

And then biosimilars, we launched 3, about to launch 2 denosumab presentation, ex-GanProlia. So that would be biosimilars, and I'll speak about biosimilars as we go forward.

AvKare has been a great distribution company, value-added distribution to VA DoD, the second largest in VA DoD is almost 18 million now for a recipient in VA DoD. They're aging. So a number of prescriptions are also going up for them. and we bring affordable products for government as well, and it's direct distribution.

Specialty branded, there we were [indiscernible]. We just published Phase I data what we've been hearing from the physicians and patients that how well that product is doing. So we're very excited about proving that in Phase I, and it's the best oral medicines in Parkinson's -- maintaining Parkinson's disease in the world.

We have our partner in Europe as well, running further trial and they'll be launching in Europe. We launched in South America, Canada, all over the world. So this is the excellent innovation, and we're very, very proud of what we have done for the Parkinson's patient. And we get a lot of letters. We get a lot of on calls from the patient that they couldn't walk. Now they're walking, going to the grocery store and playing with grandchildren.

So it's been an amazing discovery will continue -- not a discovery. It's -- our formulation is so well that it absorbs at the right places and crosses the blood brain barrier to produce more levodopa for the patient. So that is -- has been amazing, and we will share more specialty branded products story as we go forward.

And GLP-1 peptide that our partnership with Met Sera is working out really well. Now it's with Pfizer, and we look forward to work with Pfizer. We already started speaking with them. It's a fantastic 2 plants we are building dedicated for Pfizer in India, one for manufacturing peptide. It could manufacture up to 3 to 5 tons using hybrid processes; and second is auto-injector and which could be cartridges, could be PFS capacity up to $100 million. So global supply, it's additional supply for Pfizer, and we are there to assist Pfizer in all our capacity to make the product very successful.

With that, let's just a reminder how we have progressed over the last 6 years. We doubled the revenue, doubled the EBITDA. Net leverage is down from 7.4% to 3.7% now, but it will even further go down. Our EBITDA is crossing at a high end of 685 plus.

So it's tremendous progress. Pipeline is really focused on high value. It's not a number of products, it's what each product is doing, and you will see more and more biosimilars as well. Very excited about the next 5 years as well. Every year is a growth year.

And why? Because of all these areas, it's so essential to have generics medicine affordable medicines, biosimilar. You look at the retail generics is competitive, so not growing in dollars as much. Injectable is still growing. Huge growth in biosimilars, we'll talk about it separately. The branded side, we could come up with new products, niche products that big pharma doesn't focus on it and keep growing that entity and GLP-1 from 29, 30, 2029, 30 starts setting top and bottom line revenue for us. excellent areas we are in, multiple growth drivers,

And we expect all of them to grow high single digits or more. and all about execution, affordable medicines category, we could double the business over the next few years with biosimilars, new complex injectables, it's a really good business. And so much LOEs are double than last 5 years. So $234 billion product of wealth of branded products going up patent. So it's a huge opportunity.

And in biosimilars is that 130 candidates. Only 20 people talk about it. They're smaller ones, $500 million, $1 billion, $1 billion in half. But if you can develop it cost effectively, execute it properly, have right COGS, launch it globally, U.S. being the main market; it's huge growth in that segment as well. So it's -- and it's needed for the country, it's needed for the patients. As you know, 92% of prescriptions are filled with generic products or biosimilar products.

Specialty also, we expect higher growth. Branded products, we'll see what happens to our pipeline assets, but they could just keep adding. We do about $540 million in 2025 for specialty, it will keep growing. EmCare is such a nice niche business. We value added for government keep growing. And total, company is growing. So it's excellent.

So let's talk about Craxon. The first year of launching, we already have 22,000 patients on Traxon. It took 6, 7 years to get to 22,000 patients for Rytary. And it already achieved 3.2% market share. It took right early 6, 7 years and eventually [indiscernible] achieved 6% market share, we'll be 6% most likely this year in 2026.

It's patient feedback, doctors' feedback, how -- what products doing, the good on time, the Phase I, you can see on the right side, it's the best in the industry. You can compare any product, and it's oral. So 3.13 good on-time over IR, which is about 80% of prescriptions of IR . about 10% could be IR in combination with COMT inhibitor. We beat that as well by 2.31 hours.

And this -- think about the Parkinson's patient, and caregiver, huge difference. As I said, it's -- we get a lot of thank you letters and we meet our own product rita by 1.8 hours. So then this is showing. We've been getting calls. Certain doctors have said of a Crexon clinic. So it's amazing, and we are very confident about our projections of peak sales, $300 million to $500 million. And it's a great product, and we'll continue to research more in Parkinson's category.

Another branded product that we have just launched very useful innovations. Obviously, these are done by companies that our size, affordable medicines and who have science as well. So this is when there's cluster headache, there's a severe migraine patients go to the emergencies. They could drive for whatever 30 minutes, 1 hour, then wait an emergency and it's such a massive headache, and then they get DHE order injector.

We're delivering that at-home auto-injector just like Manzaro [ Zeon ], you just take it at home and only FDA-approved auto-injector. So we -- it's in just 2 months, the feedback from the cluster headache centers, severe migraine centers, it's very positive, what we have done for the patients, saving the emergency visit. It's a cost effective as well for the insurance company. So they're authorizing these use.

Then come to our original business foundation. We've been filing a certain number of products, getting approval, growing it. Now we see high single digit. It was a low 4% growth. Now we see 8%, 9% growth in complex GX because of respiratory approvals because of more ophthalmic products being approved, drug device combination, complex injectables. So with -- and this doesn't count biosimilars, that's a separate within affordable medicine.

So we're launching 20, 30 key products, high quality. The customers are -- where you can call customers that will tell you who is the #1 favorite company, it will be Amneal in complex GX or any GX products. So we're proud to serve our customers.

Here, we're not going to go through all of these, we're so excited. We put it out this, the pipe -- the products that have been approved lately and what are going to be approved in next few quarters. It's the most exciting pipeline in complex GX. It took us a little time to get back and get restarted as we came back in 2019, and now we're very confident, very happy where it's going and it's going to keep growing with new products every year, you should expect list like this. And they are higher values.

In generics, when you make $20 million, $40 million, that is a good product. This is just the United States. We don't even sell outside of United States. Some of them we may sell in Europe, we have a partner or in India. So excellent, I mean, you see -- I mean, I'm not going to go through the well-known brands, huge opportunity, very excited about the even biosimilar as well.

Denosumab, as we talked about, RolexGiva, Romi Dassen; we are the first company came up with a radiopharmaceutical approval, iohexol only GE is the biggest supplier. Now Amneal. It will take time to build it up as the API is expensive, we don't have volume yet. We will -- and we'll get more strength approved.

FDA is approving our ready-to-use products very fast as well because they're compounded products, we're turning them to be to approved product like sodium bicarbonite just got a prod today. We brought sodium phosphate. So there's a lot of protection phosphate we brought. So a lot of products we're bringing, which are compounded typically in approved route. And hospitals are very appreciative of that.

Moving to the biosimilars, I know everybody is shocked with what happened in first inning of biosimilar, first 2, 3 innings, if you use the baseball terms because it was a new thing, it was FDA just published guidelines, the gold rush, the branded companies jumped in. They thought the pricing would stay very high. The lot of people invested, a lot of money like Humira, you saw 12 approvals, [indiscernible].

So the old development, you saw multiple approvals. They've spent $200 million, $250 million per product. to get in 7 years to get to the finish line. Now it is less than 5 years, you can develop the products from start to launch it could be $50 million to $75 million if you're really smart about it, which mine does very cost-efficient job. And it's a global product. adoption is 80% plus. It used to be 5%, 10%, 20%. Private label, all 3 big insurance company PBMs are doing private label, so they can move the volume just like generics immediately.

So for example, ZoLED, we are very excited about that in early 27 launch, And we're speaking with private label side as well, they can move the volume immediately. So you do not need to detail the product like a quasi brand. So it's huge opportunities, but it requires complexities are higher as well. So only 7, 8 series played for the United States remained.

Sandoz is a leader who will be there in a few years. We would -- we look forward to vertically integrate, have our own R&D and manufacturing. So that's the key target for us in 2026. and then have a much broader pipeline, a global pipeline.

And we will partner as well. So it's -- if you think about it, if you have 3 to 5 competitors only, those products are going to do commercially really well. And now the channels for conversion is controlled by the payers. So everything is going positive, and many players unfortunately have dropped out. They couldn't stay in the business for 10 years, smaller companies. So there's only a few large companies left, 2 Korean, right? Salten, Samsung, you got Biocon from India, Sandoz, you got mabsience, Kabi, Amni. Obviously, Amgen will stay in. Pfizer looks like it's not interested in biosimilar, obviously. Biogen has given up.

So you will see very few players, and it takes years to develop this platform, develop the product, it's making your drug substance and drug product and you need infrastructure and a lot of science. So it's not hyper competitive. Maybe can compare hyper -- not hypercompetitive right now, less than 10 competitors. In the future, it could be probably 15 to 20 competitors, but that's 5, 7 years ahead. So we're trying to take advantage now to be a very key player in biosimilar.

This is our pipeline that's been disclosed. This presentation is also posted on our website, but excellent progress, and we'll keep making it. And commercially, we're well set for the United States to market these products.

I talked about [indiscernible] collaboration. We look forward to expanding this and very excited, obviously, with Pfizer name. Their capabilities, capacity, the volume is going to be much lower than larger than we had anticipated with Metsa. So excellent opportunity for us going forward.

Just pointing out this chart, is so interesting because every year, I used to hear 2019-'20, the leaky bucket, the generics revenue will go away. We used to do, if you see this blue, $1.2 billion 2019, those generics products still doing $1 billion today because they're needed product, essential medicines, players come in, go out, you have some quality supply. It's over 6 years, we have lost 20%. So that's not bad. You're 4%, 5% price erosion, but you keep launching new products. And now we have moved up the value chain. So it's excellent progress. Expect us to keep performing this way and more.

Just summing it up, a bold company, clear mission, long time were co-CEOs, we are here to stay and make this bigger and bigger, and we do want to be America's #1 affordable medicines company. And we are well over we're committed as well. And it's -- obviously, financial growth is going to be there. Two, we're very proud of what we are doing.

Q&A. I think Sorry, 1 minute.

Excellent. Well, thank you very much for the comments here. Yes. Maybe just to kick off, bigger picture question. How do you think about the evolution of the Amneal portfolio over the past few years? So how far along are we in this kind of transformation process with what you're trying to do with the business, if you want to...

The transformation process is -- I think it's 70%, 75% there already for the complex biosimilar we would have to integrate and start and so that would be the focus in the next 5 years. And specialty is as we make progress, we will share that.

Okay. Great. And I guess on that same front, as the company scales, should we think about the balance of investment across the businesses staying kind of where it is now? Or would you see meal, for example, leaning more into an area like branded specialty where there could be some very large products really attractive margins, et cetera?

Yes. So the first goal this year is to vertically integrate in biosimilars, move R&D investment more from complex GX to more biosimilar as well. And then we do about $50 million or so internal R&D on branded side, which we expect will go up. And then from '27 and onwards is mostly going to be the specialty assets because that is where it's unlimited growth.

And the new ways of developing products with AI, and we've been at it for the last few years, and my brother can add more to it. He sees on to this. He's more R&D manufacturing quality, I do the rest. But thank you for coming this time. So he's younger for this, I give time.

But I think you can come up with a branded product, not discovery from the beginning with all the tools available and where regulatories has moved up maybe $100 million, $150 million. I don't think you need $3 billion for many of these products that we can do that.

We have 1,000 scientists. We have worked on 400 products. We have a lot of knowledge. And we have added now branded R&D people as well more and more. You want to add something?

So our main focus is going forward on how we provide more towards even more complex area besides complex GX, as Chirag mentioned, biosimilar in specialty. And we have a division in specialty where we are focused on affordable innovation because that's the key. How do we use the AI and other technological tools and efficiency where even the branded product -- because we believe that any innovations we do should be accessible to everyone. That's our purpose, and that's the mission of our organization.

So yes, you will see a shift more towards complex areas. We will reduce our GX spend below 50% in our R&D. The 50% or plus will go towards more specialty and biosimilars.

Great. Croxon. It's been a great launch. Maybe just share just some of your learnings from the ramp so far. Kind of what's working kind of directionally, where do you see this going?

So we were very fortunate to get a label with naive patients because we showed that and now it's showing up more and more. But we still have to convince doctors on a patient to start with Craxon.

Our goal and mission is to replace IR. I think IR should just go away. It's 50 years old technology used on and off all the time. Craxon should become standard of care. That's what we are working towards. It will take us a few years to get there. Our partner in Europe will go on a similar way. And then it's a much larger opportunity. And then the new innovations will come after that. But this is a gold standard.

But so far, so good, and this AI is really helpful. We're able to do the marketing and reach the provider more efficiently with even lower budgets. I mean, we're still spending properly, but we can reach -- and AI is so good to identify what connected TV, whether they watch Hulu or HBO Max, and here you go, Craxon shows up. And what we have seen is when they seek Craxon message, is 6.7x more likely to prescribe Craxon. Now we're talking about general neuro, which we never marketed for Rytary. So 80% of the patients are coming from general neuro, the IR patient to Craxon, which is fantastic. That's a huge market, right, like 600,000 patients.

And just to add that we continue to provide a lot more data in coming years on a recon and how beneficial for the naive patient. So we'll have a lot more Phase II data in this year in 2026. We are also -- will be starting another Phase I to show the true benefit because we believe that it's a game changer for the Parkinson's treatment, especially for the patient, and it will be hugely benefit. So you'll see a lot more data over the next 2, 3 years, continue to provide the proof of what we've been telling.

That's great. And I know you just recently shared some of the initial Phase I data. What's the feedback you've been getting from physicians?

The physicians already were calling us, thanking us and said, this is what we are seeing leasing all the stories and now -- it's there. And we'll continue to do another 100 patients been enrolled as well. So it's a 200-patient trial. So it's sizable. And we're -- as my brother said, we're launching a naive patient trial. -- also Phase IV. So we'll continue to produce more data.

And it's affordably priced. So about like 6,000 a year for a patient that were attractive. We have a very great commercial coverage. And that's why we are talking about affordable innovation and affordable access.

We think about uptake in 2026, just any rough expectations we should be keeping in mind the revenue or market share ?

We were doubling it. We did about $60 million, $65 million last year, this year, $120 million plus -- and market share about 5, 6 SP999 Already right at level.

We already exited at 3.2%.

Yes. And then just on the peak sales. $300 million to $500 million. Is that still that the right peak sales? Or is that...

Right now we're keeping it. Let us go through this year evolution next year and then we may have just...

But a few years ago, we were questioning the low end of the range. Now it seems like be higher. It's going to be higher Yes, exactly. that seems like it's doing well. Last 1 is on retire. -- generic timing there? Any update SP-2 I don't know. I mean...

So far there on launch. So -- we do expect sometime this year. .

Okay. Moving over to the generic business. You've had a number of approvals in the last few months. So I know you're expecting a few more in 1Q. Just of those opportunities, what are you most excited about, which is the growth? So...

As you can see, like we are most excited about ophthalmic portfolio. We have many good ophthalmic boutique products that's going to drive a lot of value. We have entire franchise of epinephrine. So all single-dose, multi-dose we are leader on Adrenalin. We have the entire now franchise of the epinephrine. And we are very excited about the inhalation, the 2 inhalation approval, which creates the pathway for any more. We have publicly is also the SMT technology platform.

So I think the launches of Q1 and Albitral, along with ophthalmic product launches, which is coming up and OTC and our respite Depot because we are excited about the launches, but what it does for the future because it's always the tough to get the first one. So now you crack the code. Now the next core would be much more easier.

So I think the entire inhalation our long-acting depot pipeline, our drug device combinations in a specially complex injectable. So these are the -- some of the product. Sodium oxybate is a meaningful opportunity for us in 2026 also which is -- we already launched that product this month. So these are some of the highlights.

Great. And just any initial thoughts on what growth can look like for the generic business in 2026?

High single. Yes. So it's affordable medicines. You can use that term would be great because Yes. get used to that. SP49946718 Maybe just shifting to biosimilars a little bit. On first, maybe Prolia and XGEVA, -- just thoughts on how those markets are shaping up and how attractive those are going to be for Amneal.

There's only a couple of launch already...

That's it. And we know how the channel is working. So we're working on it. We're very excited. We have 2 different BLA, 1 for Prolex.I think we're the only company that has 2 separate -- so we can manage the products properly in the channel. And we're excited. It's a sizable product for us. It's a huge product, but combined...

Yes. And of those 2, how are you thinking about the differences, I guess, between...

Onco will do by Yes. on health. SP49946718 And maybe just similarly on ZoLa, biosimilar.

Yes, that's first quarter 2, we're very excited. That is just Seltron has approval. I think they're launching in fourth quarter 26. We're right after them. We're already speaking with private label. That's a huge opportunity Yes. and it's a growing market. Solar as a product is growing.

You mentioned this integration of the biosimilar business. Can you just let a little bit what does your biosimilar business we're looking at 5 or 10? What is this looking like for ML...

We'll be top 3, probably 30 or so product already launched multiple in pipeline, grid manufacturing capabilities and capacity the United States and India. We follow that model all the time. dual filing, global supply, key player in -- for the U.S.

And then we partner geographically like Europe, we're not going to put boots on the ground. That's not the model we have. We'd rather focus on product, science, manufacturing. There's plenty of things to do rather than having a sales and marketing 80 countries not our cup of tea.

And plus, those are great partners. And if you go Brazilian champion, you've got European champions, Signor good friends. And then you find Southeast Asia, somebody Middle East. So it's -- you'll see substantial revenue increase within this segment of biosimilar and affordable medicines is why I'm saying we would more than double the whole revenue. It's huge opportunities, right?

Just the cost of vertically integrating, how should we think about what that's going to mean for your...

So we are very, very disciplined, right? The hard work to get to 3.6%. We're going to stay disciplined. -- the leverage, the net leverage could go up to 3.8% temporarily fine. But be a smart deal and more accretive right away from '27.

Excellent. A couple -- let me just move on to Netcera collaboration. First, just any color you can provide in terms of conversations you've had with Pfizer and how you're thinking about that relationship?

Albert [ norm ] since 2012, we changed the miles already forward to working with [indiscernible]. We're here to -- I told them we're here to make you successful and product successful is capacity. So it's going well. We have several meetings already and more coming up. China and I will go see Alberta as well in nearby New York.

If Pfizer decided to do their own manufacturing, what does that mean for Amneal?

It's giant. They will do their own file peptide, they don't have manufacturing of peptides they need a partnership and they need additional volume as well. So as I said, we got cost efficient global supply and plus we have rights to 18 countries marketing rights. So we're marketing in India, Indonesia and Malaysia. So we got good countries, emerging markets.

Pretty exciting opportunity for you.

It is. It is. I think it's working out well. It was a write back.

Absolutely. Absolutely. Just kind of continue along AdCare, so just maybe stepping back to 2025. Can you just talk about dynamics we saw over the course of the year? And kind of as you enable the growth going forward? Just how are you thinking about that...

Now they're entering into biosimilars will take a couple of years for them to ramp it up, specialty products. The generics products are keep coming. So they're focused more on government channel, higher margins. because it's value-added, they're developing products, investing versus pure distribution, which is like 3%, 4% margin. So -- and the unit dose in hospitals. So it will keep growing. But it won't grow double digit all the time. It's now we are saying high single digit. But yes.

And thoughts on that business more broadly, how that fits into the portfolio. It's been a great investment. It's 1 well for you. Is this one, I think in the past, you said that maybe that the right buyer there be an opportunity to monetize it? Is that still the thought? Or is it...

Not immediately, but down the road, if somebody is consolidating the area, and then we are open for it, right? It's -- we've got multiple growth bikes. But we love the business. It's run by the team that owns still 35% of the business. So that is the expert. We just provide more products from our U.S. plants.

Excellent. As we report to 2026, can you talk through pushes and pulls and since more more pushes than pulls, but just...

Yes. I mean I have Tasso is ahead of late flight. So I was covering your questions. my own business...

As you can imagine, every year, there are multiple things that are happening. But this year, we are entering, I feel having been here 6 years, we're entering a new year more so in a position of strength than any other year in the last 6 years. And that is driven by a substantial amount of new products approvals we have had the last 3, 4 months. So that dramatically reduces the risk level of the forward year revenue and EBITDA.

So I feel good about it. You have the typical price erosion, which we have had the last few years of 4% to 5%. So that is nothing new for us, and it has been stable. So that's always there, we always account for that. Then they give new product approvals that are coming in. So we talked about it, really excited about the new inhilation products that are coming in after 10 years of work by our R&D colleagues. So that's going to be an upside. That's going to be definitely a growth driver, not only for 2026 and beyond a number of 505(b)(2)s biosimilars that we talked about it.

So new product approvals is definitely, we have to win in our box more so than any other prior year. On -- from a gross margin perspective, we should see 50, 60 basis points improvement, and that's a combination of the higher-margin products and the operating efficiencies we're getting. Operating will continue to invest $180-or-so million in R&D. So year-over-year, that will be neutral.

Our operating expenses and the investments in sales and marketing the level of growth should not be as in prior years because we have built the commercial teams now for the neurology and the other products and G&A will continue to go up 5%, 6%. So at the end of the day, for 2026 should grow faster than the revenue. We will continue to generate a tremendous amount of cash that should continue to improve our balance sheet.

And EPS will grow double digit, no question about it because our interest expense after the latest refinancing that we did a few months ago and the repricing that we did last week, will allow for 20, 25 plus EPS growth rate next year this year.

Great. Maybe last question for me. Just as leverage comes down, I know you touched on a little bit of this. What are you most focused on, on capital deployment and on the business development front?

So biosimilar is the first priority. And then we would be looking at either branded assets, mainly and within Parkinson's or within oncology. And it could be a Phase III, it could be approved. So multiple choices, is a huge opportunity in our wheel house. right, and then keep growing that business. It's a fantastic business. We got the group now we've been doing it for almost 8 years now.

So I think on that branded specialty piece that's pay more '27?

'27, '28 onwards because we have enough of our in-house development in biosimilars, complex GX. So that's in our pipeline. We may do some partnership with a trusted partner, but mostly the deals are going to be. And we will have good -- I mean EBITDA is going up we will operate the company just below 3x levered. The rates are awesome 300 basis points plus LIBOR or SOFOR. So that's what that's a disciplined approach.

And so still, if we have higher EBITDA, the cash flow is there. As equity grows, right, the equity price, we can use shares as well at some point. So very excited about the next few years.

We're just out of time here. Thank you so much for all the comments. Thank you.

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

Good morning, and thank you for joining Amneal Pharmaceuticals' third quarter 2025 earnings call. Today we issued a press release reporting Q3 results. The earnings press release and presentation are available at amneal.com. Certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance.

We also discuss non-GAAP measures. Information on use of these measures and reconciliation to GAAP are in the earnings release and presentation. On the call today are Chirag and Chintu Patel, co-Founders and co-CEOs; Tasos Konidaris, CFO; our commercial leaders, Andy Boyer for Affordable Medicines; and Joe Renda for Specialty.

I will now hand the call over to Chirag.

Thank you, Tony. Good morning, everyone. We are pleased with our strong third quarter performance, which represents another consecutive quarter of growth, with revenues of $785 million and adjusted EBITDA of $160 million. At Amneal, we focus on delivering innovative and affordable medicines that make a difference for patients and providers.

Since our founding in 2002, we have strategically expanded from generics into specialty, injectables, biosimilars, GLP-1, and complex medicines. This portfolio diversification has driven significant and sustainable top and bottom line growth. From 2019 through now, Amneal revenues have grown 11% and adjusted EBITDA has grown 13% on a CAGR basis. With growth in each of the last 6 consecutive years, we are very confident our momentum will continue in the years ahead.

Today there are multiple growth drivers that are shaping the future of Amneal. First, in Specialty segment, CREXONT for Parkinson's disease continue to outperform expectations. One year post-launch, CREXONT is delivering strong results across all key indicators. Notably, about 80% of prescriptions are coming from IR patients, underscoring the success of our strategy to expand into the broader patient population. We are confident in peak U.S. sales of $300 million to $500 million for CREXONT.

Next, our BREKIYA autoinjector for migraine and cluster headache has now launched. This is the first and only product allowing patients to self-administer with the same medication used in hospitals. It addresses an unmet need for patients who have historically had to go to the hospital ER for relief. Second, in GLP-1s, our strategic collaboration with Metsera positions us very well to play a meaningful role in this very large therapeutic category over the time. Metsera's broad portfolio of injectable and oral weight loss programs continue to quickly advance through the clinical Phase. Third, in biosimilars, we are on track to have 6 marketed biosimilar products by 2027, led by our biosimilars to Xolair. With the U.S. market over $4 billion for this key allergy and asthma product, this represents our largest current biosimilar opportunity.

Last month we submitted our BLA for Xolair biosimilar, and we are well positioned to be among the first 2 entrants in this growing market. Both in complex genetics and injectables, in our Affordable Medicine segment, we continue to receive approval for meaningful new products, including risperidone injectable, sodium oxybate, and Bimatoprost Ophthalmic Qvar among others. We expect this segment will continue to grow driven by our diversified portfolio of complex products and steady cadence of impactful new launches. Finally, our health care segment continues to provide diversification, stability, and growth, with a broad portfolio for government, distribution, and unit dose channels.

In summary, our growing portfolio is creating meaningful value for patients by expanding access and advancing standards of care, and for providers by delivering a broader and more differentiated portfolio and for investors by driving consistent growth and margin expansion. Over time we have strategically evolved from generics to innovative and complex medicines and our current chapter of growth is the most exciting one yet. As we grow and expand our portfolio, we are advancing towards our strategic goal of becoming America's #1 affordable medicines company.

I'll turn the call over to Chintu now.

Thank you, Chirag, and good morning. As always, I will begin by thanking the global Amneal family. Your unwavering dedication and commitment continue to drive our success. The recipe for continued strong performance is clear: operational excellence, robust innovation, and strategic portfolio expansion. First, in operations, our global manufacturing network and leading capabilities remain a core strategic advantage. We continuously strengthen our operational efficiency through digitalization, automation, and cost discipline, while at the same time innovating in new complex dosage forms to expand our reach. Furthermore, with one of the largest U.S. pharmaceutical manufacturing footprints, Made in America remains a key differentiator for Amneal in the industry.

In GLP-1s, our collaboration with Metsera is progressing very well. Leveraging our expertise in R&D and manufacturing, we are building 2 state-of-the-art facilities, one for large scale peptide production and another for advanced sterile fill-finish designed to produce prefilled syringes, cartridges, or vials. At the same time, Metsera's injectable and oral clinical programs continue to show strong efficacy and product profiles with timelines bringing us closer to entering this fast-growing market.

In Affordable Medicines portfolio, we look to launch 20 to 30 new products each year. So far in 2025 we have launched 17 new products, with approvals for 13 more to launch in the future. Importantly, it is not just the number of new launches but the value of these recent launches and approvals and how they position Amneal for future growth. For years, our focus has been on complex generics innovation, including injectables, ophthalmics, inhalation, and other advanced dosage forms, essentially the most complex drug-device combinations in pharmaceutical. And as a result of years of hard work and strategic focus, we are in the midst of a concentrated wave of Affordable Medicines new product launches coming to market in the near term.

To highlight all of these, we have a new slide in the earnings presentation with the list of some of the key launches ongoing now and coming up next. In the third quarter we expanded our portfolio with several important approvals across key therapeutic areas, including our first long-acting injectable risperidone extended-release in the mental health space, sodium oxybate for narcolepsy, and Bimatoprost for glaucoma, as well as new otic and injectable products like multidose epinephrine for hospitals.

Just yesterday we were pleased to receive tentative approval for our first metered dose inhalation product beclomethasone dipropionate generic for Qvar. This is the first of several new inhalation products expected in the coming years as inhalation is a new growth vector starting in 2026. For years we have been discussing the strategic portfolio shift towards the complex products, and with so many meaningful launches, we are at an inflection point.

Looking ahead, we have 69 ANDAs pending, of which 64% are complex products and 44 additional products in development of which 95% are complex products. We continue to focus our R&D on high-growth, high-impact products across dosage forms such as inhalation, microspheres, liposomes, and 505(b)(2) specialty injectables. With this strategic portfolio expansion and robust pipeline, we are reshaping our Affordable Medicine business and expect our strong momentum to drive meaningful growth and value creation for years to come.

In biosimilars, we remain focused on building our leadership position over time. Our most exciting near-term opportunity is our biosimilar to Xolair, where we submitted our BLA in September, ahead of schedule. Alongside Xolair, we are advancing other key programs including denosumab, with multiple new biosimilar launches expected in 2026 and 2027. In Specialty, our CREXONT open-label Phase 4 study is progressing very well. We are very pleased with early results and look forward to sharing additional data later this year on real-world "Good On" time performance that further supports CREXONT's clinical value and differentiation for Parkinson's patients. We continue to work on several specialty R&D initiatives in focus area of CNS and endocrinology, and we look forward to sharing more as these programs advances.

In summary, we are driving operational excellence, advancing our innovation agenda, and expanding our portfolio to deliver robust growth and leadership across our business areas. I will hand it over to Tasos.

Thank you, Chintu, and good morning, everyone. Q3 was another terrific quarter with continued and sustainable strong growth across our 3 business segments. The resilient and consistent growth is a testament to our strategic choices, diversified portfolio, and robust execution. In addition, we further strengthened our balance sheet with strong cash flow generation, reduced net leverage ratio, and increased our expected full year bottom line guidance. So all in all, an excellent quarter.

As I usually do, I'll start with our Q3 and year-to-date results, move on to our balance sheet, and our updated 2025 guidance. Starting with the third quarter, total company revenues grew 12% to $785 million. Our Affordable Medicines revenue grew 8% year over year to $461 million, reflecting strong performance across our broad portfolio of more than 280 products.

Key contributors to our growth this quarter were products launched in 2024 and 2025, which added $24 million in revenue and included a number of 505(b)(2)s that meet real customer needs. Specialty revenue was again very strong in Q3, up 8% year over year to $125 million, driven by CREXONT and UNITHROID. In the third quarter, as expected, AvKARE revenues grew 24% to $199 million, fueled by strong growth in the [ government channel ]. AvKARE's growth continues to be driven by strong underlying demographics as well as providing substantial savings to the government with timely access to innovative and very often newly available Affordable Medicines products.

Moving down the P&L. Q3 adjusted gross margins were 42.7%, down 150 basis points year over year. However, margins on a year-to-date basis are up 130 basis points. We view our year-to-date gross margins growth as indicative of our underlying performance, and we're confident of growing our full year gross margin compared to 2024. The expansion of gross margin is primarily driven by the innovation and strength of new product launches as well as our relentless focus on driving operating expense efficiencies.

Third quarter adjusted EBITDA of $160 million grew 1% driven by top line growth, higher gross profit, and higher commercial costs in support of CREXONT and BREKIYA. It is worth noting that our third quarter adjusted EBITDA includes $22.5 million of R&D milestone payment related to the Xolair BLA filing. Lastly, Q3 earnings per share of $0.17 grew 6% versus prior year on the back of lower interest expense.

Let me now shift to our year-to-date performance where total revenue increased 7% driven by growth of 5% in Affordable Medicines, 11% growth in specialty, and 8% growth in AvKARE. Adjusted EBITDA grew 9% and adjusted EPS grew 35% year-to-date. The drivers of our year-to-date growth are very similar to those of the third quarter.

Turning to the balance sheet. As a reminder, we're very pleased to complete our full debt refinancing in July which reduces interest costs substantially and extends debt maturities from 2028 to 2032. Also, net leverage at the end of Q3 was 3.7x, down from 3.9x at the end of last year. Overall, our capital allocation priorities remain consistent, that is, invest in higher-return organic revenue growth; number two, reducing net leverage below 3x over the course of time; and finally, remain strategic with business development opportunities that enhance our growth profile and value creation.

Moving on to our financial guidance. We're pleased for the second consecutive quarter to update our guidance. For revenues, we continue to expect a range of $3 billion to $3.1 billion. We have raised the lower end of our adjusted EBITDA by $10 million to a new range between $675 million and $685 million, and we have raised the full range of adjusted EPS by $0.05 to a new range between $0.75 and $0.80. Lastly, we expect continued strong operating cash flow between $300 million to $330 million this year and further year-over-year debt and net leverage reduction. Looking to 2026 and beyond, we continue to expect top and bottom line growth supported by our diversified portfolio and multiple growth drivers including CREXONT, BREKIYA, new biosimilars such as Xolair, and a very strong wave of new Affordable Medicines and continued growth in AvKARE. Furthermore, our focus on profitable growth, operating expense synergies, and lower Interest costs are strong catalysts for strong shareholder value creation.

With that, I'll turn the call back to Chirag.

Thank you, Tasos. Our strong Q3 results and updated 2025 guidance underscore the continued momentum across our diversified business. We remain confident as we advance this chapter toward becoming America's #1 affordable medicines company.

Let's now open the call for Q&A.

[Operator Instructions] We will now take our first question from Matt from Goldman Sachs.

Congrats on the quarter. Maybe on the Metsera partnership, could you give us your latest thinking on how the acquisition by Pfizer may impact the agreement? I know you said prior you don't expect this to change anything, given there's a Change in Control clause and that you all collaborated with Pfizer in the past. So just curious on your latest thinking there. And then we obviously saw this morning there's another bid for Metsera by Novo at a higher price. So maybe your thoughts on that dynamic as well. And if there's any meaningful difference from an annual perspective in terms of who ultimately acquires the company.

And then maybe secondly, FDA came out with new draft guidance yesterday that essentially removes the need for comparative Phase III efficacy studies for biosimilars. Just curious on your thoughts in terms of how this impacts Amneal and the broader industry and market dynamics going forward.

Matt, I guess we chose the right partner. Metsera is doing well, I guess. And obviously there are 2 bidders now. And for us, it's really great. We've been working with Metsera for last couple of years and have devoted lots of resources from science, engineering, operations, manufacturing. Very close partner, great relationship, great company, and their programs are advancing well.

As you know, Matt, I cannot comment on the current events between Pfizer and Novo, and either one of them, Amneal stands to win because of the higher name recognition on both brands with our partnership where Amneal has rights to 18 countries to market the products and agreement for supply, which is very meaningful as well. So stay tuned. And as it progresses, we'll keep you updated.

Your second question, it's awesome. We've been experiencing that. We know from our partners what FDA is willing to do now since they have lots of data over last almost more than 12, 13 years, they have seen the biosimilars, the safety data, their biosimilarity data from the clinics as well. So finally, they are in agreement to push for more biosimilar approval, cut down the cost and time by half. And this is where Amneal's vertical integration would play a key role because it still will take 3 to 5 years for competitors to catch up. So it's great for the industry. Most importantly, it's great for the patients. It's going to create great access. And FDA and HHS is behind us, and entire CMS, to call out all the games that are being played by the brand companies and really promote and create a market for biosimilars. And then making those biosimilars in the United States will even further give the advantages for the companies that invest in America.

So we're very excited. There are 117 molecules, only 30 are being worked on, 90 are not being worked on. And biologics, as you know, represents half of the value for the entire pharmaceutical spend. And most of those drugs are very expensive. Bringing affordable access, this is our mission, allows Amneal to take the leadership position. And what we've been saying is become America's #1 affordable medicines company, allows us, in the future if we get the vertical integration done as soon as possible, to have bigger, broader portfolio of 20 to 30 biosimilars and keep adding 5 to 7 every year. I hope that answers your question on where the biosimilars are headed. Very exciting.

Next we will have our next question from Leszek Sulewski from Truist Securities.

Just a follow up for each question, actually. On the biosimilars front, how does that change your overall strategy given this draft guidance potentially finalized as it stands. And then on the opposing side to that, do you see potentially for the increased competition where the price erosion curves ultimately resemble the traditional generics? And on Metsera, understand there are clauses in place with the current contract that you have. You're building out the facilities in India. How is your thinking about that sway the new change of control of the company and then potentially your commercialization rights in the emerging markets? Are there any safeguards in place for you to retain those? And I do have a couple of follow-ups.

Thank you, Les. So let's expand more on overall strategy for biosimilars. So it would expedite the development timing, it would cut down the cost by almost half. And both are very encouraging. But you still need big biologics manufacturing site, you need the [ liters ] of capacity, you need the teams of hundreds of analytical people, manufacturing, engineering to get all these done and with the U.S. standards, so with FDA and then obviously EMA follows European standards are similar. So the companies, for example, Indian companies who are focused on emerging markets in biologics for years -- for 20 years -- they would have to build a brand new infrastructure that is for the United States and develop the products from the beginning for the United States. So if Amneal increases its footprint through the vertical integration, it will give us the advantage over next 5 years.

Then your question on the pricing and competitors, yes, competitors will enter. But it's still expensive. We're not talking about $2 million development of complex generics or $5 million, right? We're talking still about $40 million, $50 million, $60 million, based on the molecule. And still it takes a lot of CapEx to have the infrastructure to produce those and science capabilities and engineering. So as you know, it's complicated manufacturing. The pricing of biosimilars are way higher than the small molecule. So even when you hear the tagline of 80% reduction, if your investment is $40 million to $60 million, you're still doing great. As long as you can execute, be there, and select the molecules which are 2 competitors, 3 competitors enter first so you have advantage of insurance coverage, working with private labels, doing buy and build model, all these 3, you have to have marketing setup as well, which Amneal does have. So that is how I see the biosimilar industry blossoming over next 1, 2, 3, 4, 5, I see it up to 10 years. Even with the competition, it's a great marketplace. As dollars are large, complications are very much there, and there are many molecules to go after.

Now you can select $500 million molecule, you can select $1 billion molecule, then no need to just keep going after to the $10 billion and $20 billion that would face 10 competitors. So it is a competitive industry. It was supposed to be competitive. And it will create huge value for the patient and providers and complete backing of U.S. government, which is fantastic to push this, rightfully so. And that was the main intent when the law was passed. So we remain very, very big player and will be to win biosimilars for the United States market particularly, and it also allows us to go global as well.

Metsera, your second question, it's the same answer, Les, that we cannot discuss much at this point. As you know we have a solid partnership with Metsera, and we look forward to work with whoever the new partner is, and we're very excited, actually. So stay tuned and we'll update you at the right time.

And Les, just on a biosimilars I'd like to add a point to what Chirag was saying, first of all, this draft guidance is very encouraging for the entire industry. But unlike small molecules, still in large molecules there are multiple barriers of entry. So the speed to market still it's lot longer. Plus the capacity, unlike small molecule where there was a floodgate of people filing 20, 30, 40 ANDAs, it's not possible. There are 112, 115 biologics products where only 20 or 30 are being worked on. So still there are manufacturing, science, analytical is a very strong aspect of development, and the R&D does not allow you to take 5, 10 biosimilars a year. So still next 10 years if you have a head start and have a vertical integration, there's so many opportunities you can do. And with these new draft guidance, still 3 to 4 filing is max for most of the companies.

Maybe just one more if I could squeeze it in for Tasos. SG&A 3Q run rate, a little bit of a pickup. Is this a good proxy as we move forward? And then second maybe high level. As you think about capital allocation, you're getting into that 3x leverage range over the next couple of years. What do you think of in terms of BD? Is it more transformative or continuation of tuck-ins or even on the biosimilars front, but just in general capital allocations priorities over the next couple of years.

Les, the answer to your first questions about the run rate of the sales and marketing expense, I think Q3 is pretty indicative where we are because it includes full commercialization expense for CREXONT, which was an additive this year compared to last year. It includes a little bit of a getting the market set up for the exciting new launch of BREKIYA. So I think that's a good run rate.

Our priorities here have not changed, and that is, how do we balance building capabilities and products and diversification in a thoughtful, doing the right deals, and at the same time structuring the deals in a way that is affordable. So that was the case, for example, you go back to AvKARE. Many years ago, we acquired 65% of that business, did not acquire the whole thing. It was the right, smart thing from a balance sheet perspective. It also kept the management team engaged with a substantial skin in the game. And that allowed us to delever that business quickly. Then you saw the Metsera deal last year. Again, thoughtful deal, where the partner contributed substantial amount of cash. There's substantial grants that we are expected to receive from the India government, and the CapEx is over the course of time. And that's the way we're thinking about this. The right deal comes up. We've been very vocal for probably the last couple of years about our desire to vertically integrate in the biosimilar space. So we continue to look at that, and we'll update folks when there's something to updating about. But you can continue to expect discipline and doing the right deal at the right time.

We will now take our next question from Chris Schott from J.P. Morgan.

This is Ekaterina on for Chris. So first just on RYTARY, any line of sight of when we could see generic entry. Just wondering if you heard anything from the channel on when Teva could potentially launch. And can you just remind us what you're embedding in guidance for the year? And then on CREXONT -- and then on '26 outlook, it's obviously early, but any initial thoughts on pushes and pulls investors should keep in mind for next year?

Ekaterina, I'll take the first RYTARY question and then if you don't mind repeating your second question on CREXONT. So a couple of things. So on RYTARY, we have no new indication of whatever may or may not happen there. Earlier on this month, we launched our own authorized generics with a partner. So this was part of a well-documented settlement years ago, and we are receiving the majority of potential profits that may come up on that authorized generic. So overall, the delay of Teva has always been a positive for us. And it's going to be positive I believe for both this year and next year.

Yes. I think the second one, Ekaterina, is the 2026 as we mentioned in our script, momentum is already here. The approvals we listed it on Page 11 of the company presentation, it tells you that the excitement over the new product launches. Current business is performing really well. So we expect continued growth in 2026 and beyond.

We will now take our next question from David Amsellem from Piper Sandler.

So just a couple for me. Wanted to pick your brain on the Xolair biosimilar. It doesn't look like a particularly crowded market potentially. So how are you thinking about that opportunity? So that's number one.

Number two, can you just give us a better sense of how many biosimilars you're looking to file annually and specifically how you're thinking about Part B versus say Part D products and where your priorities lie in terms of whether it's a retail pharmacy setting or institutional setting? So just philosophically wanted to get your thoughts on that. And then lastly on the DHE autoinjector, how are you thinking about that opportunity, and what that market looks like, given that it's particularly crowded, acute migraine space?

David, Xolair biosimilars, we're pleased that we have filed the product. Our partner has manufacturing capabilities right here in the United States, and it will have additional capacity outside of United States as well. So we obviously would maximize the assets. We use our relationship that we have built over 20-plus years to the same groups of buyers and with 300 products. So we have a deep relationship with whether it's CVS, Caremark, Optum, United, Express Script, Cigna. We enjoy very deep relationship as well as Kaisers and Primes and other smaller private labels.

So one market we would be exploring is the private label, which could be very significant in 2-player market as the product by itself is growing 32% for the brand. So very excited about that. And then also there is when you are [ first to ], you typically have the bigger coverage from the PBM, so your other potential customers tend to use your products as well. So we'll maximize the market opportunity for Xolair for sure in advance of approval, which is expected in the fourth quarter next year.

On your question on -- I'll continue on the market first, the Part B, Part D. So as you know, we've been vocal about the vertical integration is must, the licensing deals are pretty much dead. That business model will not work, and we I've said that 5 years ago, and it's not like I'm a very genius guy. It's just like what happened in generics. As you know, the complex generics or generics, the room for 2 margins in the United States market it makes it harder; harder for to have a real play in biosimilars. So whoever is vertically integrated is going to benefit big time, especially companies having current capabilities of working on 5, 7 biosimilars per year and filing those. Those will be the winner. And those are obviously filed globally.

So I don't see any difference whether it's Part B, Part D. We're going to play in broader biosimilars. And obviously, once the vertical integration is done, we would obviously expand the capabilities into bispecific and ADC. If you're in biologics, then you can do more biologics. So that's where we will look forward to. And also FDA is considering a 505(b)(2) pathway for branded biologics. So that could be exciting as well to bring early access to some of these lifesaving drugs or critical drugs, critical medicines. So we're excited on that. We will play on Part B, Part D, private label, the smaller customers, the insurance coverage. We will be everywhere. I don't see any difference for us, Amneal or major competitors, to not be pretty much in all segments of the market.

DHE, it is very exciting. You know the market, right. CGRP, the triptans. But there are almost -- our internal analysis we have put it out there. 132,000 patients fail those first- and second-line therapies. So they're being administered with the well-proven DHE autoinjection in the hospital. We made it autoinjectors so they can administer at home avoiding going to emergency rooms, wait time, travel time. So it's a very useful innovation for patients. And so far, we're getting -- it's very early in the inning but getting great feedback. We've got the team all engaged with the key headache centers and key KOLs. So remains -- you'll see our progress. I don't have any prediction. We've been saying the $50 million to $100 million peak sales. So we'll update as we go.

Thank you. There are no questions waiting at this time. I will pass the conference back over to Chirag Patel for any additional remarks.

Well thank you very much everyone. Have a great day. Thanks.

Thank you.

That concludes the Amneal Pharmaceuticals Third Quarter 2025 Earnings Call. Thank you for your participation. You may now disconnect from your line.