Amneal Pharmaceuticals - Earnings Call - Q3 2025

Executive Summary

• Q3 delivered a clean top-line and EPS beat with net revenue of $784.5M vs. ~$773.8M consensus and adjusted diluted EPS of $0.17 vs. ~$0.14 consensus, while management raised FY25 adjusted EBITDA, EPS and operating cash flow guidance. Estimates from S&P Global: revenue $773.8M*, EPS $0.138*.
• Segment strength was broad: Affordable Medicines +8%, Specialty +8% (CREXONT®/UNITHROID®), and AvKARE +24% YoY, with new launches (BREKIYA®) and complex approvals (QVAR® MDI tentative) expanding 2026+ growth vectors.
• Profitability mixed: adjusted EBITDA was $160M (includes a $22.5M Xolair BLA milestone), up 1% YoY; adjusted gross margin was 42.7%, down 150 bps YoY as the company invested behind launches (CREXONT®, BREKIYA®).
• Guidance raised again: FY25 adjusted EBITDA to $675–$685M (from $665–$685M), adjusted EPS to $0.75–$0.80 (from $0.70–$0.75), and operating cash flow to $300–$330M (from $275–$305M), while revenue held at $3.0–$3.1B.
• Catalysts: Xolair biosimilar BLA filing (targeting first-two entry by 4Q26), BREKIYA® launch, tentative approval for QVAR® MDI, and a July refinancing that extended maturities to 2032 and supports net leverage reduction (3.7x LTM).

What Went Well and What Went Wrong

What Went Well

• Specialty momentum and product confidence: “One year post launch, Crexant is delivering strong results… about 80% of prescriptions are coming from IR patients… We are confident in peak U.S. sales of $300–$500 million for Crexant.”.
• Pipeline and complex launches ramping: Tentative approval for beclomethasone dipropionate HFA (generic QVAR®) marks Amneal’s first MDI respiratory product; “a significant milestone in the Company’s expansion into complex respiratory therapies”. BREKIYA® DHE autoinjector launched through Walgreens and Sterling Specialty.
• Guidance raised with disciplined balance sheet: Management lifted FY25 adjusted EBITDA, EPS and OCF while highlighting leverage progress (3.7x LTM) and the July refinancing extending maturities to 2032.

What Went Wrong

• Margin pressure YoY: Adjusted gross margin was 42.7%, down 150 bps YoY (though up 130 bps YTD), reflecting mix and commercialization investment; adjusted EBITDA grew just 1% despite 12% revenue growth, partly due to a $22.5M R&D milestone for Xolair BLA.
• Higher OpEx: SG&A rose to $137.8M from $118.7M YoY, and R&D increased to $63.4M from $61.1M, reflecting increased commercial investments and development spend.
• GAAP softness vs. prior year: Operating income declined to $70.3M from $88.8M YoY, and GAAP diluted EPS was $0.01 (vs. ~$0.00), weighed by items including an asset impairment charge and a loss on debt refinancing.

Transcript

Operator (participant)

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.

Tony DiMeo (Head of Investor Relations)

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 discussed 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, Anastasios (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.

Chirag Patel (Co-CEO)

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-1s, 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 six consecutive years, we're 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 the specialty segment, our products for Parkinson's disease continue to outperform expectations.

One year post launch, Crexant 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-$500 million for Crexant. Next, our Brachia 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 time, Medsera's broad portfolio of injectable and oral weight loss programs continues to quickly advance through the clinical phase.

Third, in biosimilars, we are on track to have six marketed biosimilar products by 2027, led by our biosimilar 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 biosimilar Xolair, and we are well positioned to be among the first two entrants in this growing market. Both in complex generics and injectables, in our Affordable Medicines segment, we continue to receive approval for meaningful new products, including risperidone injectable, sodium oxybate, and bimatoprost ophthalmic QR, 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 APCare 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 number one affordable medicines company. I'll turn the call over to Chintu now.

Chintu Patel (Co-CEO)

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 Medsera is progressing very well. Leveraging our expertise in R&D and manufacturing, we are building two state-of-the-art facilities, one for large-scale peptide production and another for advanced sterile fill-finish designed to produce pre-filled syringes, cartridges, or vials.

At the same time, Medsera'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 the Affordable Medicines portfolio, we look to launch 20-30 new products each year. So far in 2024, 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 generic innovation, including injectables, ophthalmics, inhalation, and other advanced dosage forms, essentially the most complex drug-device combinations in pharmaceuticals.

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 multi-dose 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 factor starting in 2026. For years we have been discussing the strategic portfolio shift towards 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 Medicines 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 Crexant open-label phase four 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 Crexant's clinical value and differentiation for Parkinson's patients. We continue to work on several Specialty R&D initiatives in focus areas of CNS and Endocrinology and we look forward to sharing more as these programs advance. 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.

Anastasios Konidaris (CFO)

Thank you, Chintu, and good morning, everyone. Q3 was another terrific quarter with continued and sustainable strong growth across our three 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. 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 Crexant and Unithroid. In the third quarter, as expected, APCare revenues grew 24% to $199 million, fueled by strong growth in the government channel. APCare'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 Crexant and Brachia. 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 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 APCare. Adjusted EBITDA grew 9% and adjusted EPS grew 35% year-to-year. 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 3.7 times, down from 3.9 times at the end of last year.

Overall, our capital allocation priorities remain consistent, i.e., invest in higher return organic revenue growth, number two, reducing net leverage below three times 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-$3.1 billion. We have raised the low 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-$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 Crexant, Brachia, new biosimilars such as biosimilar Xolair, and a very strong wave of new Affordable Medicines and continued growth in APCare. 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.

Chirag Patel (Co-CEO)

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 number one affordable medicines company. Let's now open the call for Q and A.

Operator (participant)

Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove your question, press star followed by two again. To ask a question, press star one. We will pause here briefly as questions are registered.

Tony DiMeo (Head of Investor Relations)

Les, if you're ready, first question.

Operator (participant)

Thank you.

Tony DiMeo (Head of Investor Relations)

All right, we'll go to the next.

Operator (participant)

Thank you. We will now take our first question from Matt from Goldman Sachs. Tasos, please go ahead.

Hey, great, thanks. 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. Just curious on your latest thinking there. We obviously saw this morning there's another bid for Medsera by Novo Nordisk at a higher price. Maybe your thoughts on that dynamic as well, and if there's any kind of meaningful difference from an Amneal perspective in terms of who ultimately acquires the company. Secondly, FDA came out with new draft guidance yesterday that essentially removes the need for comparative phase three 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. Thanks a lot.

Chirag Patel (Co-CEO)

Good morning, Matt. I guess we chose the right partner, is doing well, I guess. Obviously there are two bidders now and for us, it's really, really great. We've been working with Medsera for the last couple of years and have devoted lots of resources from science, engineering, operations, manufacturing, very close partner, great relationship, great company, and the programs are advancing well. As you know, Matt, I cannot comment on the current events between Pfizer and Novo Nordisk and either one of them. Amneal stands to win because of the higher name recognition on both brands. With our partnership, Amneal has rights to 18 countries to market the products and agreement for supply, which is very meaningful as well. Stay tuned as it progresses. We'll keep you updated.

Your second question. It's awesome. We've been experiencing that. We know whether from our partners what FDA is willing to do now since they have lots of data over the last almost more than 12, 13 years, they've seen the biosimilars, the safety data, the biosimilarity data from the clinics as well. Finally, they are in agreement to push for more biosimilar approval, cut down the cost and time by half. This is where vertical integration would play a key role because it still will take three to five years for competitors to catch up. It's great for the industry. Most importantly, it's great for the patients. It's going to create great access. FDA and HHS are behind us, and the 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.

Making those biosimilars in the U.S. will even further give the advantages for the companies that invest in America.

We're very excited.

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

Great, thank you.

Operator (participant)

Thank you. Next we will have our next question from Les Sulewski from Truist Securities. Please go ahead.

Les Sulewski (VP, Senior Equity Research Analyst)

Great. Yeah, thank you for taking my questions. Just a follow up for each question. Actually on the biosimilars front, how does that change your kind of overall strategy given this kind of FDA draft guidance, potentially finalized as it stands? On the opposing side to that, do you see potentially for the increased competition where the price erosion curves ultimately resemble the traditional generics? On that, I understand there are clauses in place with the current contract that you have. You're building out the facilities in India. How is your kind of 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 kind of safeguards in place for you to retain those? I do have a follow up. Thank you.

Chirag Patel (Co-CEO)

Thank you, Les.

Let's expand more on overall strategy for biosimilars. It would expedite the development timing, it would cut down the cost by almost half, and both are very encouraging. You still need big biologics manufacturing site, you need the liters of capacity, you need the teams of hundreds of nonlinear people manufacturing engineering to get all these done, and with the U.S. standards, with FDA and then obviously EMA follows. European standards are similar. The companies, for example Indian companies who are focused on emerging markets and 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. If Amneal increases its footprint through the vertical integration, it will give us the advantage over next five years.

Your question on the pricing, and 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 a molecule. It takes a lot of CapEx to have the infrastructure to produce those and science, science capabilities and engineering. It is, you know, it's complicated manufacturing. The pricing of biosimilars are way higher than the small molecule. Even when you hear the tagline of 80% reduction, if your investment is $40 million-$60 million, you're still doing great as long as you can execute either and have and select the molecules which are two competitors, three competitors enter first. You have advantage of insurance coverage, working with private labels, doing buy and build model. All these three, you have to have marketing setup as well, which Amneal does have. 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 billion dollar molecule. No need to just keep going after the $10 billion and $20 billion that would face 10 competitors. It is a competitive industry. It was supposed to be competitive. 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. That was the main intent when the law was passed. We remain very, very big player and will be in biosimilars for the United States market particularly. It also allows us to go global as well. Medsera, your second question, Mike. It's the same answer less 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. Stay tuned and will update you at the right time.

Chintu Patel (Co-CEO)

On a biosimilar, I like to add, let's just, on a biosimilar, like to add, point was Chirag was saying, first of all, this draft guidance is very encouraging for the entire industry. Unlike small molecules, still in large molecules there are multiple barriers of entry. The speed to market still, it's a lot longer, plus the capacity. Unlike small molecule where there was a floodgate of people filing 20, 30, 40 ANDAs, it's not possible. You know, there are 112, 115 biologics products where you know only 20 or 30 are being worked on. Still, there are, you know, manufacturing science, you know, analytical is a very strong aspect of development, and the R&D does not allow you to take 5, 10 biosimilars a year. Still, next 10 years, if you have a head start and have a vertical integration, there's so many opportunities you can do.

With these new guidance, still, you know, three to four filing is kind of max for most of the companies.

Les Sulewski (VP, Senior Equity Research Analyst)

That was very insightful and extensive color on that. I appreciate it. Thank you. Maybe just one more if I could squeeze it in for Tasos. SG&A Q3 run rate, a little bit of a pickup. Is this kind of a good proxy as we move forward? Then second, maybe high level, as you think about capital allocation, you're kind of getting into that 3x leverage range over the next couple of years. What do you think of in terms of kind of BD? Is it more transformative or kind of continuation of tuck-ins, or even on the biosimilars front, but just in general, capital allocation priorities over the next couple of years?

Chirag Patel (Co-CEO)

Thank you. Yeah, good.

More or less the answer to your first question is about the run rate of the sales and marketing expense. I think Q3 is pretty indicative. I think you can see where we are because it includes kind of full commercialization expense for Crexant, which was an additive this year compared to last year. It includes a little bit of a kind of getting the market set up for the exciting new launch of Rytary. I think that's a good run rate.

Around.

Our priorities here have not changed, and that is how do we balance kind of building capabilities and products and diversification in the thoughtful doing the right deals, and at the same time structuring the deals in a way that is affordable. That was the case. For example, you kind of go back to APCare 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.

Right.

That allowed us to deliver that business quickly. You saw the Medsera deal last year, again, thoughtful deal where the partner contributed substantial amount of cash. There are 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 rental comes up. We have been very vocal for probably the last couple of years about our desire to vertically integrate in the biosimilar space. We continue to look at that, and we'll update folks when there's something to update about. You can continue to expect discipline and doing the right deal at the right time.

Les Sulewski (VP, Senior Equity Research Analyst)

Thank you.

Operator (participant)

Thank you. We will now take our next question from Chris Schott from JPMorgan. Please go ahead.

Hey, thank you so much. This is Ekaterina on for Chris. So first just on Rytary, any line of thought of when we could see generic entry. Just wondering if you heard anything from the channel and when Teva could potentially launch and can you just remind us what you're embedding in guidance for the year and then on Crexant and then on 2026 outlook. It's obviously, you know, early but any initial thoughts on pushes and pulls investors should keep in mind for next year. Thank you.

Chirag Patel (Co-CEO)

Hey Ekaterina, I'll take the first Rytary question and then if you don't mind.

Repeating your second question on correction.

A couple things. On Rytary, we have no new indication of whatever may or may not happen there. Earlier on this month, we lost our own authorized generics with a partner. 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. 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 on the go ahead.

Chintu Patel (Co-CEO)

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

Thank you.

Tony DiMeo (Head of Investor Relations)

Thank you, Ekaterina.

Operator (participant)

Thank you. We will now take our next question from David Amsellem from Piper Sandler. Please go ahead.

David Amsellem (Managing Director, Senior Research Analyst)

Hey. Just a couple for me. Wanted to pick your brain on the biosimilar Xolair. It doesn't look like a particularly crowded market potentially. How are you thinking about that opportunity?

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, you know, retail pharmacy setting or institutional setting. Just philosophically wanted to get your thoughts on that. Lastly, on the DHE autoinjector, how are you thinking about that opportunity and what that market looks like given that it's a particularly crowded acute migraine space. Thank you.

Chirag Patel (Co-CEO)

Great, David. Good morning.

Zollo Airbiosimilars.

We are pleased that we have filed the product partner as a manufacturing capabilities right here in the U.S., and it will have additional capacity outside of the United States as well.

So we obviously would maximize the assets. We use our relationship that we have built over 20+ years to the same groups of buyers and with 300 products. We have a deep relationship with whether it's CVS, Caremark, Optum, United, Express Scripts, Cigna. We enjoy very deep relationship as well as Kaisers and Primes and other smaller private labels. One market we would be exploring is the private label, which could be very significant in a two-player market as the product by itself is growing 32% for the brand. Very excited about that. When you are first two, you typically have the bigger coverage from the PBM, so your other potential customers tend to use your products as well. We'll maximize the market opportunity for biosimilar ZOLED for sure in advance of approval, which is expected in the fourth quarter next year.

On your question, I'll continue on the market, first the Part B part. 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. I said that five 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 margins in the U.S. market makes it harder for to have a real play in biosimilars. Whoever is vertically integrated is going to benefit big time, especially companies having current capabilities of working on five to ten biosimilars per year and filing those. Those will be the winner, and those are obviously filed globally. I don't see any difference whether it's part B or part D. We're going to play in a broader biosimilars. Once the vertical integration is done, we would obviously expand the capabilities into B specific. In ADC, if you're in biologics, then you can do more biologics.

Right.

That's where we will look forward to. FDA is considering a 505(b)(2) kind of pathway for branded biologics. That could be exciting as well to bring early access to some of these life-saving drugs or critical drugs, critical medicines. We're excited on that. We'll 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, and we'll all be major competitors to not be pretty much in all segments of the market. DHE 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. They're being administered with well-proven DHE autoinject injection in the hospital.

We made it to auto injectors so they can do it at home, avoiding the going to emergency rooms, wait time, travel time. It's a very useful innovation for patients. So far, we're getting, it's very early in the evening, but getting great feedback. We get the team all engaged with the key headache centers and key KOLs. Remain, you will see our progress. I don't have any prediction. We've been saying it's $200 million pixels, so we'll update as we go.

David Amsellem (Managing Director, Senior Research Analyst)

Okay. Thank you.

Chirag Patel (Co-CEO)

Thanks David.

Operator (participant)

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

Chirag Patel (Co-CEO)

Thank you very much everyone. Have a great day.

Operator (participant)

That concludes the Amneal Pharmaceuticals third quarter 2025 earnings call. Thank you for your participation. You may now disconnect from your line.