Good morning, and welcome to the Amnil Pharmaceuticals' third quarter 2025 earnings call. I will now turn the call over to Amnil's Head of Investor Relations, Tony Daimio. Please go ahead.

Good morning, and thank you for joining Amnil 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 Sharag and Shintu Patel, co-founders and co-CEOs, Tasos Konideras CFO, our commercial leaders, Andy Boyer for Affordable Medicines and Joe Renda for Specialty. I will now hand the call over to Sharag.

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 given significant and sustainable top and bottom line growth. from 2019 through now amnil revenues have grown 11 percent and adjusted EBITDA has grown 13 percent 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 AMU. First, in specialty segment, Prexon for Parkinson's disease continue to outperform expectations. One year post-launch, Prexon is delivering strong results across all key indicators. Notably, about 80 percent of prescriptions are coming from IR patients, underscoring the success of our strategy to expand into the broader patient population. We're confident in peak U.S. cells of 300 million to 500 million per CREXONT. Next, our brachial 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 historically had to go to the hospital er for relief second in glp ones our strategic collaboration with medsera positions us very well to play a meaningful role in this very large therapeutic category over the time. MedSERA'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 six marketed biosimilar products by 2027 led by our biosimilars to zola for 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 zola biosimilar and we are well positioned to be among the first two 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 respiratone injectable sodium oxalate and we mark across ophthalmic qr among others we expect this segment will continue to grow driven by our diversified portfolio of complex products and state steady cadence of impactful new launches finally our healthcare 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 excess and advancing standards of care, and for providers by delivering a broader and more differentiated portfolio, and for the investor 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.

Thank you, Girard, and good morning. Continue to drive our continued strong strategic portfolio capabilities. Remain continuously strengthen our operational efficiency through digitalization, automation, while at the same time innovating in new complex in GLP once we are building continue to importantly it is not just the number of new launches but the value of these recent launches and approvals and how they position amnil for future growth focus has been on complex generics you know reading injectables of sun mix inhalation and other advanced dosage forms essentially the most calm and as a result of years of hard work and strategic for affordable medicines to highlight all of these we have a new slide in the earnings presentation of the key launches ongoing now and coming up next in the third quarter we expanded our portfolio approvals across key therapeutic areas including our first long-acting injectable respirator extended release in the mental health space sodium aoxybet and bimato bros for just yesterday 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 or most most exciting near-term opportunity is our biosimilar to zola where we submitted our bla specialty our cracks on open label facing additional initiative in focus area of cns agenda thank you 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 strengthen 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 it, 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 exporter were products launched in 2024 and 2025, which added $24 million in revenue and included a number of 505 B2s that meet real customer needs. SESAPE revenue was again very strong in Q3, up 8% year-over-year to $125 million, driven by CREXON and Unithroid. In the third quarter, as expected, outdoor revenues grew 24% to $199 million, fueled by strong growth in the government. Outcare'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 medicine products moving down the pnl two three adjusted gross margins were 42.7 percent 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 correction and breccia. It is worth noting that our third quarter adjusted EBITDA includes $22.5 million of R&D milestone payment related to the Zoller 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 percent, driven by growth of 5 percent in affordable medicines, 11 percent growth in specialty, and 8 percent growth in healthcare. Adjusted EBITDA grew 9 percent, and adjusted EPS grew 35 percent year-to-year, 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 3.7 times, down from 3.9 times at the end of last year. Overall, our capital allocation priorities remain consistent. That is, invest in high-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 that for the second consecutive quarter to update our guidance. For revenues, we continue to expect a range of $3 to $3.1 billion. We have raised the low end of our adjusted EBITDA by $10 million to a new range between $675 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 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 Craigsam, Perkeia, new biosimilars such as Zolaire, and a very strong wave of new affordable medicines and continued growth in healthcare. 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 Shirak.

Thank you, Tarsos, for the strong Q3 results and updated 2025 guidance underscores 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&A.

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.

Les, if you're ready, first question.

Thank you. All right, we'll go to the next question. Thank you. We will now take our first question from Matt from Goldman Techs. please go ahead.

Hey, great. Thanks. And congrats on the quarter. Maybe on the MetShera partnership, could you give us your latest thinking on how the acquisition by Pfizer may impact the agreement? I know you've said prior you don't expect this to change anything given there's a change in control clause and that you all collaborate 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 MetShera by Novo at a higher price um so maybe your thoughts on that dynamic as well and if there's any kind of meaningful difference uh from an annual perspective in terms of who who ultimately acquires uh the company um and then maybe 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 um in terms of how this impacts amni on the broader industry and market dynamics going forward. Thanks a lot.

Good morning, Matt. I guess we chose the right partner. MetSERA is doing well, I guess, and obviously they're two bidders now. And for us, it's really, really great. We've been working with MetSERA 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 advanced as well. As you know, Matt, I cannot comment on the current events between twice a year and over, and either one of them, Amnil, stands to win because of the higher name recognition on both brands with our partnership with, you know, Amnil 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, will keep you updated your second question it's awesome we've been experiencing that we we know whether from our partners what what FDA is willing to do now since they have lots of data over last almost more than 12 13 years they've seen the biosimilars the safety data the 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 amnios vertical integration would play a key role because it still will take three to five 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 fpa and hhs is behind us an entire cms to call out all the games that are being played by the brand companies and really promote and create a market for biosimilists and then making those biosimilists in the united states will even further give the advantages for for the companies that invest in america so we're very excited there are 117 molecules only 30 are being worked on the 90 are not being worked on and biologics as you know represents half of the value uh for the entire uh pharmaceutical spend and most of those drugs are very expensive bringing affordable access this is our mission allows them to take the leadership position. And what we've been saying is become America's number one affordable medicines company allows us to, 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 five to seven every year. I hope that answers your question on where the biosimilars are headed. Very exciting.

That's great.

Thank you. Next, we will have our next question from Lezek Zulewski from Choice Securities. Please go ahead.

Yeah, thank you for taking my questions. Just a follow-up for each question, actually. On the biosimilars front, you know, how does that change your kind of overall strategy, given this kind of draft guidance potentially finalized as it stands? And then on the opposing side to that, you know, do you see potentially for the increased competition where the, you know, the price erosion curves ultimately resemble the traditional generics? And I met Sarah, you know, I understand there are clauses in place with the current contract that you have. You're building out the facilities in India. you know how is your kind of thinking about that um sway is a new uh change of control of the company and then potentially you know your your commercialization rights in the emerging markets um are there any kind of safeguards in place for you to retain those and i do have a follow-up thank you well thank you less 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 leaders of capacity you need the There are 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 biologists 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 Amnil increases its footprint through the vertical integration, it will give us the advantage over the next five years. Then 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 genetics or $5 million, right? We're talking still about $40 million, $50 million, $60 million based on a 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 to 60 million you're still doing great as long as you can execute be there and have and select the molecules which are two competitors three competitors enter first so you have advantage of insurance coverage working with private labels he's doing buy and build model all these three you have to have marketing setup as well which amnil does have uh so that is how i see the biosimilar industry blossoming over next uh one two three four five 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 a billion-dollar molecule. Then no need to just keep going after 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. So, and then 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. Matt Serra, your second question, Mike. It's the same answer, Les, that we cannot discuss much at this point. As you know, we have a solid partnership with MetSarai, and we look forward to work with whoever the new partner is. And we're very excited, actually. So stay tuned, and we'll update you at the right time.

And Les, on a bio thing, I'd like to say, That was very insightful and extensive color on that. I appreciate it. Maybe just one more, if I could squeeze it in for Tassos. SG&A 3Q run rate, a little bit of a pickup. Is this kind of a good proxy as we move forward? And 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. know what do you think of in terms of kind of bd is it more transformative um or or kind of continuation of tuck-ins or even on the biosimilars front but just in general uh capital locations uh priorities over the next couple years thank you yeah more or less um the answer to your first questions about the the run rate of the sales and marketing expense i think q3 is pretty indicative I think you can get where we are because it includes kind of full commercialization expense for Crackson, right, 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 Rekia. So I think that's a good run rate. Around BD, 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, right? So that was the case, for example, you kind of go back to Avcare. many years ago right we acquired 65 percent of that of that business did not acquire the whole thing it was the right smart thing from a balancing perspective it also kept the management team uh engaged with a substantial skin in the game right um and and that allowed us to deliver that business quickly uh then you saw the material last year again thoughtful deal uh where the partner contributed substantial amount of costs. There's substantial grants that we are expecting 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, you know, when there's something to update and about. But you can continue to expect discipline and doing the right deal at the right time. Thank you.

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

Hey, thank you so much. This is Ekaterina on for Chris. So first, just on Raitari, any line of sight 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 26 outlook, it's obviously early, but any initial thoughts on pushes and pulls investors should keep in mind for next year?

Hey, Katarina. I'll take the first Raitari question, and then if you don't mind repeating your second question on correction. So a couple of things. So on Raitari, we have no new indication of, you know, whatever may or may not happen there. Earlier on this month, you know, 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 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 a positive, I believe, for both this year and next year.

Go ahead. Yeah, I think the second one, Katrina, 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 a continued growth in 2026 and beyond.

Thank you.

Thank you, Katarina.

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

Hey, Dan. So just a couple for me. I wanted to pick your brain on the Zolaire biosimilar. It doesn't look like a particularly crowded market, potentially. So 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 retail pharmacy setting or institutional setting. So just philosophically wanted to get your thoughts on that. And then lastly, on the DHE auto-injector, how are you thinking about that opportunity and what that market looks like, given that it's particularly crowded acute migraine space.

David, good morning. Zola at Barsim is 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 the United States as well. So we obviously would maximize the assets we use of a 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 a 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 with a two-player market as the product by itself is growing 32% for the brand. So we're excited about that. And then also there is when you're first two, you typically have the bigger coverage from the PBMs. So your other potential customers tend to use your products as well. So we'll maximize the market opportunity for Zola for sure in advance of approval, which is expected in the next fourth quarter next year. On your question, I'll continue on the market first, the part B, part D. So as you know, we've been vocal about the vertical integration as much. The licensing deals are pretty much dead. That business model will not work. And I've said that five years ago. And it's not like I'm a very genius guy. It's just like what happened in genetics. As you know, the complex genetics or genetics, the room for two margins in the United States market makes it harder, harder 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 a broader biosimilars. And obviously, once the vertical integration is done, we would obviously expand the capabilities into a B-specific, an ADC. If you're in biologics, then you can do more biologics, right? So that's where we will look forward to. And also, FTS is considering a 505b2 kind of pathway for branded biologics. So that could be exciting as well to bring early access to some of these life-saving drugs or critical drugs, critical medicines. So 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. but I don't see any difference for us and me or my major competitors to not be pretty much in all segments of the market. DHE, it is very exciting. You know the market, the CGRP, the triptons, 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 a well-proven DHE auto-injection in the hospital. We made it to auto-injectors so they can do it administered at home, avoiding the going to emergency rooms, wait time, travel time, so it's a very useful innovation. so far uh we're getting uh it's very early in the evening but uh getting a great feedback we got the team all engaged with the key edX centers uh remain uh you'll see our progress uh i don't have any prediction we've been saying is 5200 million pixels so uh we'll update as we go okay thank you Thanks, David.

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

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