Amneal Pharmaceuticals - Q4 2025

Transcript

Operator (participant)

Thank you all for your patience. The conference call titled Amneal Pharmaceuticals Fourth Quarter and Full Year 2025 Earnings Call will begin shortly. During the presentation, you'll have the opportunity to ask a question by pressing star followed by the number one on your telephone keypads. Again, please stand by and we will begin in a few minutes. Good morning. 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.

Anthony DiMeo (Head of Investor Relations)

Good morning. Thank you for joining 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 reconciliations to GAAP are in the earnings release and presentation. On the call today are Chirag and Chintu Patel, Co-founders and Co-CEOs, Tasios 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.

Chirag Patel (Co-Founder and Co-CEO)

Thank you, Tony. Good morning, everyone. 2025 was a defining year of excellence, 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. 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 enter 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 number one 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. 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 one-time events. They are multi-year value drivers. As a result, we expect meaningful acceleration in our Affordable Medicine segment, revenue growth in 2026 and 2027.

In injectables, we are executing with a clear ambition to become a top five 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 begin with in-licensing and creating a strong commercial platform. In December, we received approval for our biosimilars, our fourth and fifth products. With biosimilar XOLAIR under review, we remain on track to have six 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 micro 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, in GLP-1s, 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 healthcare. Now, let's turn to the Specialty segment. We're very pleased with the take of CREXONT.

At the end of 2025, about 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-$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-$100 million. Lastly, AvKARE continues to provide diversification and strategic advantage. Through government and distribution channels, AvKARE strengthens our direct access to key end markets and provides an efficient path for new launches, including Biosimilars, 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.

Chintu Patel (Co-Founder and Co-CEO)

Thank you, Chirag. 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 a 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 this scalable and flexible manufacturing platform. In Affordable Medicine, we look to launch 20-30 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, 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 cyclosporine in ophthalmics. 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 inhalation 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 ANDAs pending, with 64% classified as complex products and 52 more products in development, with 94% complex. We look to file 10-15 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. We expect to be among the first biosimilars in this over $4 billion US 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 symptom control with fewer daily doses. In 2024, we initiated a phase 4 real-world study of approximately 225 patients, converting them from RYTARY, IR/CD-LD, and IR/CD-LD with comp inhibitors to CREXONT. In December, we shared the first interim result from this open label study, which demonstrated clear and clinically meaningful differentiation. Patients treated with CREXONT experienced substantially more good on-time, less off-time, and longer intervals of continuous good on-time. Importantly, patients converted from IR to CREXONT showed over three 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 over 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 multi-product 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 Biosimilar. The progress we made in Q4 reinforces our confidence in the path ahead.

With that, I will turn it over to Tasios.

Anastasios Konidaris (EVP and CFO)

Thank you, Chirag, 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 3.5 times, and our successful refinancing extended maturities to 2032 and substantially reduced interest costs. All in all, an excellent finish to the year. Over the next few minutes, I'll cover in more detail 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, AvKARE 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 launch, which accounted for approximately $100 million in new revenue for the full year 2025.

Fourth quarter adjusted EBITDA over $175 million, grew 13%, driven by top-line growth and limited operating expense growth. Q4 EPS 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 AvKARE 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 AvKARE'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 most 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%-4%, adjusted EBITDA growth between 5%-10%, and adjusted EPS growth between 12%-24%.

Let me provide a bit more detail on each of our guidance metrics, starting with total company revenue of $3.05 billion-$153 billion, up 1%-4%, as I mentioned. We expect the growth to be driven by our largest business segment, Affordable Medicines, where we expect growth between 7%-8%. This is an acceleration from 4% growth in 2025, but in line with our prior three-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 de-risks 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 being offset by the expected generic erosion of RYTARY. 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 AvKARE 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 six years since we acquired 65% of AvKARE, and over that time, top and bottom line have increased by over 3x. We're very excited about AvKARE'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. AvKARE 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%-20% earnings growth, driven by strong adjusted EBITDA growth and lower interest expense. In terms of quarterly phasing for 2026, we expect a gradual build over the year for a couple reasons. First, the revenue associated with many new affordable medicines launches, as well as correction, will build throughout the year.

Second, some launch-related investments are more front-end loaded to support key launches such as Brekiya auto-injector. Moving on to cash. We expect robust 2026 operating cash flow between $325 million-$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 enter 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 balances, we see a clear path for sub-substantial value creation. With that, I'll turn the call back to Chirag.

Chirag Patel (Co-Founder and Co-CEO)

Thank you, Tasios. 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 becoming America's leading affordable medicines company. Let's now open the call to Q&A.

Operator (participant)

Thank you. As a reminder for our audience, if you would like to ask a question, you may do so by pressing star followed by one on your telephone keypads. Again, that is star followed by one on your telephone keypads, please. We now have our first question here from Chris Schott from JPMorgan. Go ahead, please. Your line is now open.

Chris Schott (Managing Director)

Great. Thanks so much for the questions, and 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? Maybe as part of that, as we think about 2026, how should we think about either revenue or market share targets for the product? Just have one follow-up after that.

Chirag Patel (Co-Founder and Co-CEO)

Excellent. Well, I'll start and have my brother added on to this as well. The phase IV, its interim result showing 3.13 hours of good-on-time, which is what we've been hearing from physicians and the experience of patient. It's a huge uptake. 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 patient, and second goal post will be to reach 200,000 patient. Reminding you, total is 700,000 patient on CD/LD treatment.

Anastasios Konidaris (EVP and CFO)

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

Chintu Patel (Co-Founder and Co-CEO)

Yeah, hi, Chris. Good morning. We are very excited about our interim results, which we will share for 50 patients. Throughout 2026 and early 2027, we will be sharing remainder, which is the total study was about 225 patient, and the data is looking pretty promising. We have done, as I mentioned, converting patient first time from, you know, 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 benefits, substantial benefits of good on time compared to all those therapies. We are very excited. We have a lot more data coming, and I think that will further enhance CREXONT's position in the market. We are looking at another phase IV.

At the right time, we will also disclose that phase IV, which continue to generate the data. What we are excited about is the difference is making in patient lives. That's because we have so many testimonials from the patient and the doctors. I think when the product is doing well, obviously it will reflect in the sales and the revenue and uptake. We are very pleased, and a lot more coming in 2026 and 2027 with new data.

Chris Schott (Managing Director)

Great. Thanks so much. I just want maybe a quick follow-up on, just on AvKARE. I just wanna make sure I'm understanding the 2026 guidance relative to 2025. Can you just talk a little bit more about the growth you're expecting in that kinda 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 forthe year? Thank you.

Anastasios Konidaris (EVP and CFO)

Yeah, I can take that. Chris, good morning. This is Tasios. Yeah, as I mentioned before, kinda stepping back, right? This business, when we acquired 65% of AvKARE, since then, we have more than tripled the revenue, gross margins and EBITDA. It's great because we were able to leverage both the unique assets Impax brought to the transaction, as well as the inherent growth in that business. As we talked about, when you look at 2025 versus 2024, right? In 2025, the total revenue of AvKARE was about $745 million, and in 2024, the revenue was $663 million. That grew about total, about 12%.

About 50% of the revenue is about 40% of the revenue kinda goes into the government channel, 60% of the revenue goes in the distribution channel. When you think about this 12% growth, 2025 versus 2024, distribution, the distribution part of the business declined, okay? While the government business grew, okay? The distribution decline, 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? As a result of that, kinda what I would say is pivoting, right, into the kinda leaning hard into the government channel, the gross margin of our, of our AvKARE business grew over 400 basis points.

The gross margin in 2025 of AvKARE was $147 million, compared to about $100 million in 2024. The operating income in 2025 was $94 million, compared to $57 million. Essentially, 25 versus 24, revenue up 12%, gross margin up 41%, operating income up 65%. Great performance. 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 gonna be down slightly, not because of anything fundamental that is happening, but in 2025 was such an extraordinary growth because we had this one generic product, essentially generic Entresto, that we essentially were 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. That's why in 2026, revenue is declining, is down because of our pivot away from distribution, number one, and not having kinda that exclusivity, if you wanna call that, of generic Entresto impacting the government business as well. That's what is gonna drive the decline and what we like to call it, almost like a reset level for 2026. The bottom line is not gonna be impacted because for a couple reasons: A, there is other more profitable parts of the business who will be allocating resources, who will also be leaning on some of the operating expenses.

These are the dynamics that are happening in AvKARE, which essentially creates this reset revenue in 2026 before we resume top line and bottom line growth in 2027 and beyond. I know I said a lot, Chris, let me know if that was helpful.

Chris Schott (Managing Director)

That was perfect. Thank you so much. Appreciate it.

Anastasios Konidaris (EVP and CFO)

Welcome.

Operator (participant)

Thank you for that question, Chris. Moving on, we now have Matt Dellatorre from Goldman Sachs. Go ahead, please. Your line is now open.

Matt Dellatorre (VP and Equity Analyst)

Great. Good morning, guys, and thanks for the question. Maybe on the Pfizer GLP-1 obesity partnership, could you just share your latest update on the status of that partnership? How should we think about potential outcomes? You know, for example, would 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, you know, for instance, maybe you don't manufacture for developed market, but you keep emerging market rights? If it is a complete buyout, what would be the plan for the new facilities in India, and then the cash you would receive? I had one follow-up. Thank you.

Chirag Patel (Co-Founder and Co-CEO)

Good morning, Matt. 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-levels meetings have been already conducted with Pfizer. We expect nothing much to change. Right now, it's all waiting for the starting the phase III and getting the products, and you know, the demand is global, and we have built, building such a remarkable, highly automated fill and finish facility with latest and greatest equipment. Pfizer is very excited about that. Also, we are making great progress on our peptide manufacturing, which, you know, is in shortages with solid phase technology, and we're also introducing hybrid in the future. Our teams are working with Pfizer on those aspects as well.

We continue to have the marketing rights for 18 countries, including India and Southeast Asia. We're excited about the entire partnership, there are no plans to think about right now. It's moving great.

Matt Dellatorre (VP and Equity Analyst)

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

Chirag Patel (Co-Founder and Co-CEO)

Yeah. 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. Very excited that's where the capital allocation will go first. Then, as I said previously, 2027 and onward will be more focused on Specialty assets and keep building our pipeline there. Remember, organically, we are very strong in our R&D pipeline, we keep our pipeline full. More complex products, a great team in-house we have, 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.

Next five years is going to be tremendous growth than what we have even witnessed in last five years.

Matt Dellatorre (VP and Equity Analyst)

Great. Thank you.

Chirag Patel (Co-Founder and Co-CEO)

Thank you, Matt.

Operator (participant)

Thank you for that. Thank you for that question, Matt. Moving on, we now have David Amsellem from Piper Sandler. Go ahead, please. Your line is now open.

David Amsellem (Managing Director and Senior Research Analyst)

Hey, thanks. Just a few for me. 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. I know that's a bunch, but that's number one. Secondly, I had a question on XOLAIR. Kind of similar set of questions, 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. Talk about how big of an opportunity that could be in 27 and beyond. Thank you.

Chirag Patel (Co-Founder and Co-CEO)

Great, thank you, David. On iohexol, you know, the supply chain is 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. Over the years, as we introduce more strength, it will pick up. Great achievement from our R&D team and complexity of manufacturing, both we have achieved. Excited over time on iohexol. On Xolair, very excited right now. It's Celltrion and us, in 2026, large market, growing market, very well set about.

We expect 65%-70% to go through the private label, which, you know, gives us immediate bump in the sales rather than ramp up our market share over 1-3 years. 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. Number one pipeline in the country for them, and they appreciate our high integrity, the quality standards we have. 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 three, four years to get to 30%-40% market share. It would jump to higher market share immediately in year one, and 20%-30% will continue on a buy and build, which we are well positioned as well. Very excited on XOLAIR as well. Chintu, you wanted to add anything on iohexol?

Chintu Patel (Co-Founder and Co-CEO)

Yeah, David. On iohexol, you had a question on additional strength. By end of the year, we will have approval for the missing strength. 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. 2026, we will start, but 2027 onward, it would be a meaningful revenue contribution. For competition perspective, it is a tough product, supply chain perspective, manufacturing, it's a unique bottle, you know, so all those things put together, I think, we don't foresee a lot of competition and multiple strengths. We are very excited, and by end of the year, we'll have all the strength approved.

David Amsellem (Managing Director and Senior Research Analyst)

Okay, great. That's very helpful. Thank you.

Operator (participant)

Thank you, David. Moving on, we now have Les Sulewski from Truist Securities. Go ahead, please. Your line is now open.

Leszek Sulewski (Research Analyst)

Good morning. Thank you for taking my questions. First one on the CREXONT. Can you quantify the persistence at perhaps month three or six versus your internal expectations and versus RYTARY? Any sort of signal around this continuation, and how should we think about the growth to net evolving as you brought in access, and what's kind of the steady-state growth to net you're expecting at peak? Second, on a DHE auto injector, what's the early patient profile? Is it migraine versus clusters, and the switches from prior DHE exposure versus naive? Thank you.

Chirag Patel (Co-Founder and Co-CEO)

Thank you, Les. Good morning. CREXONT versus RYTARY, obviously, CREXONT is performing much better as RYTARY 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 get letters that our office, literally written letters from patient. Physicians are so excited about the product as well. Now our aim is to make that a first-line therapy over time, so nobody, no patient has to take the old Sinemet, which is giving them a lot of fluctuations every hour and a half, two hours. This is clearly a seven to eight hours, a good on time every day. Amazing stories, no comparison with RYTARY.

We're doubling or more than doubling market share this year, so we'll reach 6+% this year, which would be about RYTARY. We learned on the pricing side, we learned everything. We had about 35% of patients could not fill their prescription due to the pricing on a RYTARY. We have really worked on it and have us put the pricing out there. That number has been reduced now, and our gross tonight runs typical in this category, about 40%-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. We're treating two segments, and all the excitement is amazing. Joe Renda is here. He just came back from our national sales meeting.

Would you like to shed some light on this?

Joe Renda (SVP and Chief Commercial Officer)

Sure. Thanks so much for the question, and 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. Right now, it's surpassing that of RYTARY, and we anticipate to see that continue to go up because we're seeing patients return to therapy on a higher rate with CREXONT than they did with RYTARY. 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. We've been very pleased. We're about 90 days into the launch. Having come back now from our sales and marketing meeting, our national meeting this week, I'm even more further convinced that we're gonna continue to drive growth for both of those products. The team is trained and ready, and we're gonna be executing this year, so excited about that.

Leszek Sulewski (Research Analyst)

Thank you.

Operator (participant)

Thank you, Les. Checking the Q&A list now, and we are now all clear. With that, I'll go ahead and hand it back to Chirag Patel for some final remarks. Go ahead, please.

Chirag Patel (Co-Founder and Co-CEO)

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

Joe Renda (SVP and Chief Commercial Officer)

Thanks, everyone.

Chintu Patel (Co-Founder and Co-CEO)

Thank you. Thanks, everyone.

Operator (participant)

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