Amneal Pharmaceuticals, Inc. (AMRX) Earnings Call Transcript & Summary

June 10, 2021

NASDAQ US Health Care Pharmaceuticals conference_presentation 40 min

Earnings Call Speaker Segments

Nathan Rich

analyst
#1

Good afternoon, everyone, and thank you for joining our session with Amneal. My name is Nathan Rich, and I follow the generic space here at Goldman Sachs. We're very pleased to welcome the management team from Amneal. We're joined by Chirag Patel, President and Co-CEO; and Tasos Konidaris, EVP and CFO. We also have Tony DiMeo from IR on the line. I think Chintu may join us as well, we'll have to see. But before we jump in, I think everybody knows the drill at this point. I'd just like to remind the audience, though, if you do want to ask a question during the session, you can either e-mail me directly at [email protected] or you can submit the question through the Q&A function on the webcast.

Nathan Rich

analyst
#2

So with that, I thought we might jump into the Q&A. Maybe starting at a high level, Chirag, in the nearly 2 years since you've come back to the company, how have you repositioned the Amneal business? And can you talk about what you kind of see as the growth opportunities across the 3 areas of the company, generic, specialty and also the distribution business?

Chirag Patel

executive
#3

Thank you, Nathan. Thank you, Goldman, for having us today. Really appreciate it. Since we came back, so first of all, we built Amneal 1.0 with lots of passion and purpose, really remarkable story. Thanks to all our colleagues, 5,000 employees back then, now 6,000. So Amneal 2.0, the way it's -- we're calling it tradition with future. So we're bringing same passion, same purpose, same mission-driven into everything we do from the R&D to execution. So now what is the difference in Amneal 2.0 is we knew the generic industry is becoming too crowded back in 2011, '12, '13, that early. So we did the Impax transaction. So now we have a specialty division. We acquired Gemini as well. So we have built up and building up a nice specialty division. We are strengthening our generics business with more injectable products, more biosimilars and lot more complex generics. So we're setting ourself apart from the simple generics since the last 5 years. And the distribution business is very niche. Since we're a U.S. player, we have U.S. facilities, we have government business. So we're focused on winning the national contracts, stockpiling, other government-related businesses as well as allows us to launch the unit dose business as well through the distribution business that we acquired. So very niche play and the distribution bit allows us to be 1 step closer to customers. So these 3 areas we're very focused. The teams are extremely excited just like Amneal 1.0. And we're firing on all cylinders.

Nathan Rich

analyst
#4

Great. And maybe, Tasos, to throw one at you. If this execution comes together, I mean, how should investors be thinking about the growth profile and the margin algorithm for the business as the company executes this Amneal 2.0 plan?

Anastasios Konidaris

executive
#5

Yes. Thank you, Nathan. I appreciate you having us here. We have not given any long-term growth numbers, right? But let me just kind of break the business into a couple of different components, and maybe that will help. So if you take the generic business, we are at scale. It's about $1.4 billion business, much more diversified today than ever before, right? So we're not exposed to 1 or 2 or 3 products that can make us or break us. Last year, in the middle of a COVID, of a pandemic, right, in a headwind, the business grew 3%. My gut feel is this year the business is going to grow 4%. And I think with the strength of the pipeline, we should be able to grow this business mid-single-digit, right? I think from a margin perspective on the generic business, 2 years ago, we were at 35%, and Chirag and Chintu said, you know what, we see low 40s, right? And then last year, we finished at 38%. And now in Q1, we were at 45%, ahead of our expectations. So my gut feel is this year we'll end up in the low to mid-40s already. So 35%, 38%, low 40s this year. And as the portfolio becomes more freshened, right, and more geared towards those complex generics that have substantially higher margins, I think I can see this business going from low 40s to mid-40s or higher, okay? That's around the generic business. So you should be able to model that. On the specialty side, this year, we lost Zomig exclusivity, even without I think the business is going to grow low single digits. But over the course of time, this -- we expect this to be a big business. Rytary is growing nicely. Unithroid is growing nicely. IPX203, we'll have the data later on this year. That drug hopefully, we will be launching it in 2020. That drug has a much better profile than Rytary. That can be a much bigger business, our specialty business than today. And that has an 80% gross margin. And we're already at scale. So we don't need to invest in commercial infrastructure. And the smaller part of our business is distribution. We know we'll do about $350 million this year at about 20% margins. I think that business -- until we figure a way to do something substantially more, I think that business can grow double-digit with margins at about 20%-plus. So all the targets -- so when you look at all of those things, you have a business whose growth profile is higher in the future than today, and it's just more sustainable and durable. Does that help?

Nathan Rich

analyst
#6

Yes. No, that's great. I think that's a really helpful overview. Now maybe to drill down into some of the segments, maybe starting with generics. I think one of the key opportunities is, obviously, to continue to bring new products to market. I think Amneal targets 30 products a year roughly, 6 to 7 of those being complex. You've given some details on the pipeline. With some of the biggest opportunities looking to be in injectables, inhalants and ophthalmology, maybe what are some of the specific products that we should be watching that you think could really -- where -- may be a limited competition or where you could really be differentiated? And in terms of coming to market that could drive that 4% growth plus or minus that you're kind of targeting for that segment?

Chirag Patel

executive
#7

So Nathan, I'll take that. But if I could disturb you, could you let my brother come in. He's been waiting in the lobby, or the operator...

Nathan Rich

analyst
#8

Yes. Operator, could you let him in. Chintu Patel.

Chirag Patel

executive
#9

So let me start with this, Nathan...

Nathan Rich

analyst
#10

Great. I think we have him joining.

Chirag Patel

executive
#11

He's on, I can see. Excellent. So right, good timing, Chintu. We were just talking about the Generics pipeline and how -- what are the 6, 7 different opportunities every year would present to us. So let's step back and look at the -- as we all know, that in Generics, we have to keep launching new products to offset all the competition and price erosion that happens every year. So to grow 3%, 4%, 5%, 10%, we have to have more new product launches than what we lose every year. So this is what we have built. We have all dosage forms, so it covers from the implants to the vaginal inserts to the inhalations, ophthalmics, injectables, transdermals, topicals, all kind of oral solids, allowing us a broader spectrum that we go after. And within that, we look for niche opportunities. And those are the product selections. Much harder to crack in, longer, all kind of complexities whether in manufacturing or analytical chemistry or bio studies or the -- now more requirements on peptides. Biosimilars has its own sets of challenges. So we'll cover that separately. But within Generics, these allows us to introduce 6 to 7 high level products every year, not saying the other 20 to 23 products will be low-value, but they will be not at the level of these 6 to 7. We're not being specific in the product names for the competitive reasons, but you should expect to see ophthalmics being launched, inhalation being launched, injectable being launched. Still, there is 1 or 2 transdermal left. And you will see certain these device-based products. So these are exciting opportunities on Generics pipeline. So we feel very confident from now to 5 years that we can introduce more new products that can offset all these competition.

Nathan Rich

analyst
#12

Makes sense. And it does seem like injectables make up a lot of the future opportunity, just kind of going back to how you broke out the pipeline in your presentations. Obviously, a bit of a higher degree of difficulty, both, I think, with the FDA as well as just in terms of kind of commercial go-to-market. Can you maybe, just at a high level, give us your perspective on sort of how you feel like -- how do you feel about the kind of probability of success of this class of product and the level of market share that you can kind of achieve on average when you do bring a product like this and how that's may be different from a traditional oral solid generic?

Chirag Patel

executive
#13

Chintu?

Chintu Patel

executive
#14

Yes. Sorry, I was in the lobby and somehow I couldn't get in, so...

Nathan Rich

analyst
#15

Yes. Okay. No problem. Sorry about that.

Chintu Patel

executive
#16

I apologize for that. So yes, our portfolio is very exciting, and injectable, it's one of the very strategic growth area for us. And within the injectable, we have further differentiations, right? We have liposomals. We have a drug device, auto-injector-based products. We have peptides product. We are one of the first company to bring liquid suspension product in injectable, which requires clinical studies or biostudies and tough formulations. Plus, now we have invested and started in a large volume bags, so we'll have the bag products. So we -- and plus, we have a separate cytotoxic plant for our onco portfolio. So these are some of the areas that are very tough when it comes to the complex injectables, especially in peptides and product people talk like iron sucrose, very tough to characterize on APIs and things like that. So last several years, we've been investing in this area. We have Adrenaclick product that -- so -- and plus, we are working on the auto-injectors. So we have good device-based knowledge in-house and we are further expanding portfolio to bring many devices, and we are working on creating our platform for a device, plus we are looking also into many 505(b)(2) programs within injectable. The path with the FDA, we have fantastic relationship. We understand the science. We have dedicated a team of over 200 people, dedicated R&D for injectable and manufacturing plants. We have added a new site also. So I think we have a good infrastructure, a good knowledge. And what we have done on certain products in peptide and all these areas is going to give us the base for the future acceleration of our pipeline. So FDA was also learning in some of these areas. We have worked with FDA in designing the pathways and the regulatory strategies around that. So we feel very comfortable and confident on our ability to bring these products to market. And our first transdermal product, for example, took 5 years and the follow-on ones took less than 2 years for approval. So I think that's a very key area. And plus we have everything organically in-house. So we are pretty confident on really materializing on our entire sterile portfolio. The ophthalmics -- most of the ophthalmics will be filed by end of the year, some will be next year, but we are covering entire gadget of ophthalmic portfolio, about 12 to 14 products. So that's also one segment of sterile product. So I think we are very comfortable and excited about the value it will create in coming years for our sterile portfolio.

Nathan Rich

analyst
#17

Makes sense. And it seems like some of the maybe hurdles around like the FDA having to familiarize -- kind of learn as they go as well, like we're maybe at a point where we're getting close to the end of that. And hopefully, you might see these new products kind of come through the system faster?

Chintu Patel

executive
#18

Yes. And FDA is giving a lot of product-specific guidances. So our execution is going to further enhance, but we have a little bit of lead over competition. We have very robust and enhanced scientific capability, especially in analytical area, lot of characterization. Liposomal is the one area where we also see good products out there. So our portfolio -- and we keep adding here, there's plenty -- 90 products in overall portfolio. We add at least 20 or 25 every year. So we keep adding new products, so we'll be able to refresh our portfolio going forward. And we see plenty of product opportunity for the next 5, 7 years.

Nathan Rich

analyst
#19

And how should we think about the durability of revenue for injectables or just maybe the complex products in general? Obviously, the degree of difficulty is higher, but we have seen a lot of other manufacturers invest in this area as well. So I guess, could you maybe just talk about how you expect these competitive dynamics to play out? And do you think that, just given the complexities with manufacturing these products, there will remain limited competition in markets longer term?

Chintu Patel

executive
#20

Yes. So one thing is the manufacturing. So for most of these complex dosage forms, we have in-house manufacturing, right? And then controlling that supply chain, even some of the critical APIs for this first-to-market complex injectable product we have in-house. So that's a very critical area, is to control your manufacturing and quality. Amneal has a very strong quality track record. And people would have limited capacity on these complex products, unlike noncomplex. It's not very easy to scale up and supply, let's say if somebody comes in, take 50% market share, that's very difficult. Many companies rely on outside CMOs. We are doing it in-house. In our example products, inhalation products, it's not so easy to scale up because that product-specific infrastructure required [indiscernible] you need to create. So it's very difficult. So even with the competition, I think the manufacturing and how much you can produce and how much you can scale would always have a longer tail on your product.

Nathan Rich

analyst
#21

That's helpful. One other kind of big opportunity I think a lot of investors are watching is just with generic Copaxone. Do you have any updates there? And just in terms of -- either nature of the conversations with the FDA or when you would expect to get a decision on that product?

Chintu Patel

executive
#22

Yes. So we are having good conversations with FDA. We are in process of responding to our pending CRL. I think we are optimistic we'll be able to resolve all the queries and launch this product in first quarter of next year.

Nathan Rich

analyst
#23

Okay. Great. And then, Tasos, maybe kind of tying the pipeline together with how that could translate into new product revenue growth. You do disclose new product revenue in your filings. I think in the first quarter, it maybe added 10% to the Generics segment. It's kind of been in that range over the past year or so. So I guess when we think about kind of benchmarking the company's success with its pipeline, is that sort of a fair target going forward to use as we think about how return -- kind of go from the pipeline that you have into what that will ultimately contribute to top line?

Anastasios Konidaris

executive
#24

Yes. So the way we think about it, right, is if we do the math and say, okay, we want the company, let's say, at this point in time to be growing, let's say, 4% or 5%, right? And we're always conservative on the price deflation, right? So we are assuming the price deflation has always been there, will continue to be there. Let's assume it's going to be 10%, right? So every -- and it's going to be on only a part of the portfolio. So every year, we're assuming we're going to lose $120 million to price deflation. Then you got to look at it in order to offset that and then try to grow the company at mid-single digits, then you're looking for a couple of hundred million dollars worth of revenue, right? So that's what Chintu and the R&D team are looking for. And that $200 million is not going to come all in this year's launches, usually come over 2 years. A big part of it is going to come from the products we're going to launch this year and the other part is going to come from the products that we launched the year before. So typically, you get a couple of years worth of control, right? And the products that we have launched in 2000 -- for example, '19 and '18, because they are much more complex, they're not declining. They tend to be fairly flat. So as a result, so when you look at the $30 million we disclosed in Q1 in growth, you multiply this by 4, you're at $120 million growth mostly from this year's pipeline, and the rest of it is going to come products that we launched late last year. So we feel really good about it. So that's how we think about this, about $120 million in year, the another $80 million from previous year's growth. And that's what we're gearing the pipeline. And over time, what's going to happen is -- and it goes to the algorithm for the business. Over time, as the portfolio becomes newer, who are less exposed to the price deflation so it becomes -- the -- it becomes easier for us, right, to overcome those headwinds. And number two, as the portfolio gets newer, our margins are growing. And that's where we're seeing that. So we can see a double benefit, increased revenue trajectory with higher margins because of this strategy. Does that help?

Nathan Rich

analyst
#25

Yes, definitely. And so you said that on the pricing front and the kind of the base business erosion, losing $120 million to price deflation. I think the guidance for this year is kind of consistent with that, like you said, in that mid-single-digit range. Is there anything to call out? I mean it has been topical with investors. We've seen in the IQVIA data, maybe a little bit more deflation. I think there's a little bit of a price spike last year in March and April around COVID. So some of it could just be a comparison to last year. But have you seen any kind of pockets of increased deflation or anything like that are worth calling out?

Anastasios Konidaris

executive
#26

I don't think so. I think maybe Chirag has additional color. What we are seeing is, what I would say, steady deflationary pressure as opposed to what happened 2017 and '18 that was structural. It was a structural imbalance. So for us, it's similar players, similar customers, and I think different companies are being impacted differently. I think we have been impacted much lesser than the average company as a function of our strategy, and it's not just the focus and the energy around the complexity of the R&D pipeline, but I think it's also will continue to drive operating expense synergies. So we negotiate with our suppliers, and there is a number of initiatives that Chintu and his manufacturing team, in terms of in-sourcing products and as a result, we're just making ourselves much more efficient.

Nathan Rich

analyst
#27

Makes sense. So nothing's changed from the buying groups or contracting cycles or anything like that?

Chirag Patel

executive
#28

No, there's nothing new in that. They're playing the same techniques, right? The Econdisc separated out. So they went out for a new bidding process that created certain disturbances in the market. But as we've been saying and all our colleagues and all peers, they're saying it's just unsustainable because every year, we have inflation, right, merit increase, other supply price increase and how can we keep providing deflationary prices to already commoditized price structure in the market. So the game ends at some point. Its just -- its not sustainable. One way or other, it's going to be the company's rationalized products and out of it, that will create shortage, increased price, all these and quality issues, we do not know yet because FDA is not inspecting plants in foreign countries at this point or even here. So all these, because when you have these such low prices, something is being sacrificed. And eventually, it comes out.

Nathan Rich

analyst
#29

Makes sense. Maybe moving over to biosimilars. You have 3 candidates in the pipeline. I think Neupogen, Neulasta and Avastin with plans to launch, I think, one a year over the next 3 years. What do you think it will take to move market share? And I guess, looking at those markets, in particular, the existing biosimilars on the market for those products have done fairly well in terms of carving out a sizable amount of share. Amneal, if you're successful, I think you'll be third or fourth to market depending on the particular product. What's the strategy to drive market share in those markets where, obviously, there's been acceptance for biosimilars. As more options come to market, how do you see the dynamics for those products changing?

Chirag Patel

executive
#30

No, it's great thing that's happening. It's everybody's learning, lot of discussions going around. So from the payer side, the provider side, there are products which are PBM driven in biosimilars. There are products that are driven by the practices like oncology practices. Ultimately, we believe the payer will have a lot of influence, just like complex generics face the same thing. The competition, we believe, will always be there. The players that launches first, second will be at the advantage. Third, fourth, your expectations have to be tapered down. To gain the market share, you have to try different strategies, which we are used to it. We have the relationship already. We're supplying to these channels, whether it's institutional providers, the PBM channels, the retail channels. We're setting up the entire infrastructure in preparation to launch these biosimilars. And we are here to stay just like complex generics and generics, we would like to be a top 3 biosimilar player in 5 years, 7 years, 10 years. It will -- takes time for us and we will be a very active player in this second wave of biosimilars and third wave of biosimilars. And it keep expanding in biologics and bringing affordability is a key in biologics products. So we are setting our infrastructure in a way that we have spent so far only $15 million cash on biosimilars. So we're -- going in cost is low, and we intend to spend smartly $30 million, $40 million per product, not $150 million to $200 million products because we know these markets are going to be competitive and we would like to get a return on our invested capital and R&D. So our strategy is different than the companies that entered earlier. And they enjoyed earlier market share gain, but how they fare out, they would phase the same challenges as we do whether the first or second may enjoy 1 or 2 years of those good growth, but then, it will become competitive. We expect competition in every biosimilars over now to next 10 years. And this is why it fits with players like us and Teva rather with Merck or any -- Biogen, it may not be their cup of tea at some point.

Nathan Rich

analyst
#31

Makes sense. I wanted to shift over to the Specialty business. Again, maybe starting high level there, too. I think the pipeline has maybe 4 main assets covering movement disorders. Obviously, Parkinson's kind of being key within that as well as endocrinology. I guess what do you see as kind of most attractive in those areas? And kind of how do you think about kind of bringing the value and kind of improving on sort of the existing therapies in those markets?

Chirag Patel

executive
#32

Excellent. So I'll take the first part, Nathan. And then Chintu will address how our technology addresses and remarkably improves the patient daily lives. So on a -- our strategy on Specialty as we acquired Impax, we acquired Gemini. We have a great setup from the marketing, from the payer coverage. The products we have so far taken requires somewhere between 50 to 100 reps, very specialty-driven within the movement disorder and within endocrinology. We are a smaller company, right? We're not a big pharma. So we're -- our R&D focus is 505(b)(2)s, which has a 50%, 60% success rate. And using the technology that we acquired from Kashiv Specialty Pharma allows us to create meaningful differences in these products. So the strategy has been that mid-tier, it's $100 million to $300 million range products. In a baseball term, some would be singles, some would be doubles and some would be triples. We haven't gone to home run or grand slam yet. We will progress slowly, but very determined way, very focused, right? So we got organic pipeline that fits our R&D budget as well as the clinical risk profile and our commercial infrastructure. On top of that, we will -- and we can talk about that later on. Strategically, we'll add on single asset companies or other companies that we can have commercial assets added on to our excellent sales force and commercial infrastructure within these 2 specialty. So that's the plan. We're paying a lot of focus, a lot of attention and we intend to spend all our excess cash and -- to do these specialty deals rather than -- I mean, rather than generics. Chintu, you want to add on technology?

Chintu Patel

executive
#33

Yes, Nathan. So with Kashiv acquisition, we have access to 2 very solid platform technologies, GRANDE and KRONOTEC, which really uniquely position us to really modify the existing molecule drug delivery because the product that we are picking does not have a fundamental issue as a molecule, but they were designed way not to optimally delivered in human body. So our GRANDE and KRONOTEC platforms gives us that advantage. So our goal is to bring a meaningful change in patient experience, improve their quality of life. So our GRANDE platform is very unique where people have talked about this gastric retentive advanced drug delivery platform, right, but our platform is very unique. It gives us 12- to 24-hour our release profile for the product, which has a site-specific absorption in part of GI. So we can bring and really solve product, which fits this criteria. So our products like CD, LD or our pyridostigmine program, they all have nothing wrong with the molecule itself, but still, it's a huge unmet need for patients because it's mainly symptomatic management of Parkinson's or PD patients or the movement disorder patients, myasthenia gravis. So with this platform, we'll be able to do many other products and having in-house dedicated team of 70, 80 scientists with this proven technology, which has been tested and proven in about over 500 patients. So it's not something that early, it's already we have a human data, we have a targeted product profile. So we feel very comfortable. So we're utilizing this. We have another program in endocrinology, T3, which is an unmet need. There is no good liothyronine product, which gives doctors and patients that tools to really prescribe additional therapy on top of the T4. And it's -- thyroid is one of the biggest disease in over 20 million patients in the United States alone. And our second platform is KRONOTEC, which mimics the physiological pattern of your body. So we are able to give at certain time and have released at certain time. It's advanced osmotic release technology. So with that and with our advanced science and our clinical regulatory expertise, we have all those things in house. So we feel very excited and upbeat about our ability to bring the specialty -- meaningful differentiated product to the market.

Nathan Rich

analyst
#34

Makes a lot of sense. And I guess, like, just a follow-up on that quickly. Obviously, when you think about kind of this platform technology, is there a potential to license that kind of outside of what just you're working as a company? Could that potentially be valuable to other manufacturers? And is that something that you would be looking to do?

Chirag Patel

executive
#35

Sure. We are looking to do that. Now we have good sets of data. So that's something we will definitely evaluate and expand upon as we even file our own products. And it can bring value to other developers where they don't have to shell out the program because it just doesn't get properly delivered in the body.

Nathan Rich

analyst
#36

Makes sense. I wanted to ask on IPX203, obviously, that's sort of the biggest kind of near-term catalysts. I think the Phase IIb data showed longer relief, both relative to kind of the immediate release treatments as well as, I think, to Rytary. I guess how do you think about the value proposition of that product potentially and how it would be physician to physician in the market?

Chirag Patel

executive
#37

So we're very excited. We're waiting for the Phase III readout. It's completed. So data is being compiled. So hopefully, in September, we should have the top line results. And if they're in -- as expected as in the Phase II, it's a remarkable meaningful difference with 2 hours, good on-time increase without troubles of dyskinesia, keeping the patients steady for almost 8 hours. Most of the patients would require the drug 2 to 3x a day instead of 4 to 5x or 6 to 7x on some higher cases. It also has a very simplified dosing regimen compared to Rytary as well. So we believe we can have general neuro prescribe the product as well as all our [indiscernible] who are the movement specialist -- movement disorder specialists continue to be fan of these products. Today, we cover 30,000 patients out of 700,000 patients on CD/LD IR treatment. So we believe we can cover much more than 30,000 patients for IPX203. And with the coverage, we have gotten adequate coverage for both the Medicare patient as well as private patient, we should be able to do meaningfully more than Rytary.

Nathan Rich

analyst
#38

Yes. And I think the other opportunity right in this market is kind of just increasing awareness and going after the relatively large patient population that's out there and not treated. I mean, can you maybe just talk about your strategy there? Is it more just educating physicians? Or is it -- can you do more kind of direct-to-consumer just to kind of increase awareness about this condition?

Chirag Patel

executive
#39

So we're working through all that. Unfortunately, we have learned all this since last 3 years with Rytary, and the teams are proactively working now to have the launch strategy. So working with Parkinson's Foundation, the awareness campaign, the marketing, the KOLs engagement, all that just like more of a branded company launch, we are preparing for IPX203, such a meaningful advantage it will provide for the PD patients. [indiscernible]

Nathan Rich

analyst
#40

A couple of questions in the few minutes that we have left. I guess, Chirag, you maybe alluded to it a little bit earlier, but I did want to ask because it's such a big topic right now. The input cost inflation, whether that, I guess, for you would be API or labor? Are you seeing any changes there? It's obviously gotten a lot of headlines. So I just wanted to ask if you have been seeing anything in your business?

Chirag Patel

executive
#41

Well, we have seen certain price increases in packaging materials, certain excipients and certain starting materials for our API manufacturing. So yes, we have seen those. And we expect them to continue every year. And therefore, this generic deflationary prices may not be sustainable for any manufacturers going forward. And we do have to push for certain inflation, we have to pass it on to our customer as well.

Nathan Rich

analyst
#42

Makes sense. And then from an M&A standpoint, I think the company has always been kind of opportunistic, especially recently about going after kind of high-value opportunities that you can kind of bolt-on easily and obviously work within the leverage that you have. Can you maybe talk about other areas that you think there could be opportunities from an M&A standpoint, whether that's more on the specialty side? Or are there other kind of adjacent businesses like AvKARE that you could go after? And maybe Tasos, turning it back to you too, how do you think about balancing M&A with also deleveraging? That would be helpful.

Chirag Patel

executive
#43

So I'll start, Nathan, on where we are focused. We're focused on the specialty products. We have excellent infrastructure on movement disorder and endocrinology. So we're looking at the companies that may be -- may have only single asset that we can acquire or certain private companies who have good specialty portfolio that fits our endocrinology movement disorder, institutional side. So those are the opportunities. As I said earlier, we want to allocate most of our excess cash and cash flow generation that we do every year into specialty side of business because we're very serious and we -- that's sort of one thing we did well in Amneal 1.0 is when we focus, we focus deep. We go deep into it. And we do need to build it both ways, have organic pipeline, which we have and we'll keep increasing it and buy these assets that fits our current specialties. Tasos?

Anastasios Konidaris

executive
#44

Yes. Thank you, Chirag. Yes, for us to do a deal, it has to be a great strategic fit, right, number one. Because that is the only way that we can reduce the execution risk, number one. And all of us know, sellers always have big prices in their head, right? So for us to justify paying anything near to that, we've got to be able to get a ton of synergy. So the only way can get a ton of synergies is something strategic and leverages our commercial infrastructure and our corporate infrastructure, so that's number one. Number two is, we're very sensitive of our leverage, right? So the last 2 years, we brought net debt-to-adjusted EBITDA from 7.3 to 5.3. If we don't do any deals, I think we're going to be mid-4s by the end of this year, right? If we do a deal, right, on a pro forma basis, we still -- my gut feel, we're still going to be below 5, right? So we are trying to trend over the course of time to below 4. That's where we're going to be. And I think the fact that we don't have any near-term maturities for another 4 years and the business is scaling up nicely, I think puts us in a good place.

Nathan Rich

analyst
#45

Great. Well, I think that's all the time we have. Chirag, Chintu, Tasos, thanks very much. I really appreciate the time, and thanks, everyone, for joining the webcast. Have a great rest of the conference.

Chintu Patel

executive
#46

Thank you very much. Thank you.

Chirag Patel

executive
#47

Thank you.

For developers and AI pipelines

Programmatic access to Amneal Pharmaceuticals, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.