Amneal Pharmaceuticals, Inc.AMRXNASDAQ
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Operator: 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.
Anthony DiMeo: 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.
Chirag Patel: 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.
Chintu Patel: 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.
Anastasios Konidaris: 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.
Chirag Patel: 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: [Operator Instructions] We will now take our first question from Matt from Goldman Sachs.
Matthew Dellatorre: 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.
Chirag Patel: 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.
Operator: Next we will have our next question from Leszek Sulewski from Truist Securities.
Leszek Sulewski: 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.
Chirag Patel: 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.
Chintu Patel: 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.
Leszek Sulewski: 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.
Anastasios Konidaris: 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.
Operator: We will now take our next question from Chris Schott from J.P. Morgan.
Ekaterina Knyazkova: 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?
Anastasios Konidaris: 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.
Chirag Patel: 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.
Operator: We will now take our next question from David Amsellem from Piper Sandler.
David Amsellem: 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?
Chirag Patel: 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.
Operator: 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: Well thank you very much everyone. Have a great day. Thanks.
Chintu Patel: Thank you.
Operator: That concludes the Amneal Pharmaceuticals Third Quarter 2025 Earnings Call. Thank you for your participation. You may now disconnect from your line.