Amneal Pharmaceuticals at Jefferies Conference: Strategic Growth Insights

On Thursday, June 5, 2025, Amneal Pharmaceuticals (NASDAQ:AMRX) took the stage at the Jefferies Global Healthcare Conference 2025, outlining its strategic shift towards complex generics, specialty products, and biosimilars. While the company emphasized positive growth prospects and innovation, it also acknowledged challenges such as reducing leverage and the loss of exclusivity for certain products.

Key Takeaways

• Amneal aims to double its revenue from $3.2 billion over the next five to ten years.
• The company is focusing on complex generics, specialty products, and biosimilars for higher margins.
• Strategic partnerships, such as with Metsera, are key to entering new markets like GLP-1.
• Commitment to US-based manufacturing and potential expansion in antibiotics.
• Financial discipline with a target to reduce leverage to below 3x.

Financial Results

• Revenue is targeted to double from a base of $3.2 billion in the next five to ten years.
• Profitability is on the rise, projected between $650 million and $675 million.
• Current leverage ratio stands at 3.9x, with a goal to reduce it to below 3x.
• Strong cash flow generation is expected as EBITDA grows and interest rates potentially decrease.
• AvKARE, a key segment, shows impressive growth with a compound annual growth rate (CAGR) of 11% to 13%.

Operational Updates

• Krexon for Parkinson’s disease is experiencing a growth rate of 6% to 7% weekly, with projected peak sales of $300 million to $500 million.
• Launch of Brickia, a DHE auto-injector for migraines, is planned for September.
• Partnership with Metsera in the GLP-1 market includes peptide supply and auto-injector capacity.
• Biosimilars pipeline includes Xolair, positioning Amneal as a potential second market entrant.
• Focus has shifted towards complex generics, specialty products, and biosimilars.

Future Outlook

• Expansion into the GLP-1 market with Metsera, targeting 20 emerging markets, including India.
• Potential expansion into antibiotics manufacturing in the US, pending legislative support.
• Aim to be among the top five biosimilars companies globally, with estimated revenue of $2 billion to $5 billion in the next five to seven years.
• Planned launches of ophthalmic, inhalation, and 505(b)(2) products.
• Krexon is expected to offset revenue loss from the anticipated loss of Rytary exclusivity in July.
• Double-digit growth expected from the Affordable Medicines segment due to biosimilars and new launches.

Conclusion

For a comprehensive understanding, readers are encouraged to refer to the full transcript available below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Jonas Schirleff, Healthcare Investment Banking team, Jefferies: To get an on time start. It’s my pleasure. I am Jonas Schirleff from the Healthcare Investment Banking team here at Jefferies. Today we will be hearing from Chirag Entasos from the Amneal Pharmaceuticals team and I will hand it over to you. Thank you very much.

Chirag Patel, Amneal Pharmaceuticals: Thank you. Thank you. Good morning everyone. Great to see you. Beautiful summer day and hopefully you guys get to go out and walk around and I think the Canadian air is also cleaned up so the outside air is feeling good right now.

So let me walk you through just a little history. Amneal was founded by my brother and I in 2002 in Peterson, New Jersey. We humble beginning and it was simple oral solids. We got our first ANDA approved in 2005 and then we started our remarkable journey, growth journey. We were a private company.

Until 2018, we were a private company and grew the company from 0 to 1,200,000,000.0 in sales, became the fifth largest generics company in The United States. Very proud of what we build, still manufacturing many products in The United States and also build new facilities in India as well to be competitive. After the initial setup and between oral solids to it says 2016 injectable, we built out transdermal facilities, topical facilities, liquid manufacturing. We acquired a Johnson and Johnson facility in Ireland to make respiratory products. And we put up injectable facilities as well in India and now we are putting one in The United States.

Specialty, this is the business segment that we acquired through acquisition of impacts in 2018. This is when we went public. The very fascinating story on a specialty. These are the products that mainly we use five zero five b two pathway and recently our two products got approved. Crexon which is number one therapy for Parkinson’s patient today in the market.

Remarkable testimonies from the patients, from the provider. Instead of taking seven, eight IR, immediate release tablets, Now you take twice a day and it keeps their symptoms manageable all day long. We’re getting rave reviews and we just launched last end of last year and already we’re about 1,500 scripts per week right now. And it’s growing at a 6%, seven % every week. So we expect Trexon to be a very big launch.

We’re still keeping our forecast the same. It’s 300 to 500,000,000 peak cells and we should get there sooner. We got great coverage as well. And we also licensed out the product throughout the world except China and Japan. And our partners in Europe will be filing very shortly and also in Canada and South America.

So Craigsson has been such a great launch already. I already mentioned the complex products that Amneal does, Aptal makes and I’ll walk you through a little bit more. They’re all categories of generics products, small molecule we have. And basically there is no dosage form that we don’t do. The multiple device based product as you know we lead the country in EpiPen which is our product called Draniclick.

We have about 37% market share. This is DHE auto injector in the specialty side follows the familiar auto injector format and I’ll walk you through for that as well. Healthcare distribution has been a great success. It’s we acquired the company in 2020 and it has grown double digit sometimes 20 plus percent every year. We expect similar year this year.

AvKARE specializes in distributing products for VA DOD enters into direct contract with them, saves money for them and also distributes products in the hospitals in a unit dose as well as there was some small general distribution. So it’s they’re based out of Kentucky. That is where we have our central distribution centers as well. Biosimilars, this is I’m sure many of you have been very curious about biosimilars. How do you have patience, but market is forming and there is no way that market cannot form.

The reason is the government knows that the savings of almost 100,000,000,000 a year can be realized if the biosimilar market forms properly. What do I mean by forms properly? Right now it takes seven years to develop the product because of the phase three requirement. If FDA gets rid of phase three requirement, it will cut down two to three years in development. Today it takes about $70,000,000 to $120,000,000 in development.

If Phase III requirement, which should not be there for biosimilar product, it would lower that to 40,000,000 to $60,000,000 So 40,000,000 to $60,000,000 4 to 5 years. Now we can work on over the time 30 products, 40 products. There are 70 molecules that have no biosimilars in development right now. Seven zero. And these are over $160,000,000,000 of market value today.

Competition has actually shrunk because of the investment it required. We have done a smart investment in biosimilars. So far we have acquired the assets like in licensed them for The United States. Going forward now it’s the right time we wanted to wait until everything is cleared from the FDA and the commercial perspective. Now we feel confident to go ahead and invest more because this business could be a few billion dollars business per year, not only in The United States, also globally.

So we’re very committed and very solid on a biosimilar footprint. And I’ll walk you through our pipeline what we have. Krexone I spoke about earlier, it’s doing well and we expect to keep doing well for Crexon. And the last one GLP-one. This is the partnership we had announced early this year or actually late last year.

This is a company called Matsera, which is now public. It’s their pipeline is looking really good and it’s a very integrated business model we come up we came up with. So we do it’s a bit almost a partnership. We do everything on CMC device selections. We do we’re two sites, one to make peptides up to four to seven tons.

And these are using the latest technology, so higher yield because we will need the higher yield, lower cost for oral solids because oral solids requires lots of tons of peptides. Injectables only requires 100 kilos, 200 kilos, so cost is not a real issue. So we’ll be producing both obviously. And then second side is we’re working on its 100,000,000 cartridge capacity, the prefilled syringes, auto injector. So that’s a partnership with Metsera and we got 20 countries licensing rights.

So we would be marketing the newer GLP-one, ultra long and oral solids in country like India, certain countries in Southeast Asia, certain countries in Middle East, Africa. So 20 emerging markets, they also need the GLP-one. So this is a brilliant setup instead of going generics, which will have tremendous competition. And by the time generics come would be 02/1930, ’thirty one, we’re working on a newer molecule, much improved. And that’s what as it becomes a consumer product, consumer healthcare product, and cost is not going to be as high as it is now because of the competition and because what consumer can afford and what the governments and private insurance can afford.

But huge market, it’s I don’t have to tell you about GLP-one market. So this is a multiple growth focus for us. We’re a growth company. We’re entrepreneurial company. We look at long term views and we invest properly because it’s not the investment for one year, two years.

It’s like biosimilars. We’ve been there for seven, eight years, we’ll be there for another ten years, twenty years. It’s a long term there and biologics production lead to even ADC production and there any other advancement that comes in biologics, we’re ready for that. And if you look at every area that grows high single digit or double digit, where Amneal goes from today’s 3,200,000,000 in cells in next five years, ten years is amazing growth for us. Here’s what we have done in last five years.

We got from 1,600,000,000.0 to 3,100,000,000.0. You can expect us to keep thinking in this line to double or even increase our revenue profitably. Our profits have gone up to 676 hundred 50 to $675,000,000. Leverage which we’re or this is why our CFO right here sitting here. We are very disciplined to reduce the leverage to below three times.

Right now it’s 3.9 times and you expect us to keep doing that. And we generate a very good cash flow And as EBITDA increases and hopefully interest rates go down, we would generate even higher cash flow. Okay. And diversity. So when we in 2019, when we were more generics company, we were more reliant on only if you see that blue column in 2019, it is mostly generics drugs and which a lot of competition came in twenty eighteen, twenty nineteen.

So you saw that blue bar fall now go down by 10% or so. But if you look at that core business, which is all the products that were approved prior to 2018, it hasn’t gone away. It’s not vanished. We still do about nine forty million nine fifty million dollars instead of $1,300,000,000 So we lost if you look at the price erosion in generics, that’s what you have. Because we pick up volume, so it doesn’t go away.

It’s essential business. The prescriptions are needed every day. Then the second column is all the new launches. And look how big it has become. And it’s going to keep becoming bigger because every year we’re filing about 25, 30 key products and launching them, new product launches.

The third one is our specialty business, which is also growing. Even though we’re losing exclusivity on Rytary, Krexone is making up more than that and will be making it up more than that. So and the last column is is AvKARE, which is growing double digit close to even 20%. And last five years CAGR eleven percent, thirteen percent, we’re very proud of it. And here are different areas.

We’re calling the new category affordable medicines. When you combine biosimilars, small molecule generics and injectables, we expect that to keep growing high single digit, even double digit because of biosimilars, ophthalmic launches, inhalation product launches, five zero five(two) product launches, there are different five zero five(two) than specialty, which we are taking like if you look at hospitals what we did is potassium phosphate. One example, it has been compounded. The drug has been compounded for a long time. Compounding doesn’t give you proper sterility.

We made the product in sterile environment, we applied it for May, got the approval and immediately hospital moved 90% of those volume. They want sterile manufacturer under GMP to supply those products. So that’s May. So we have multiple areas that we are targeting, which are mostly 95 complex in nature devices involved. This is why we in a competitive affordable medicine segment, we’re still growing.

Specialty, same story. I would walk you through a couple of these products, but Krexone, we expect a huge growth. Patent protection goes up to 2,040. ONGENTYS is adjacent therapy to Parkinson’s. So it’s a smaller product, about $20,000,000 20 5 million dollars Rytary will lose its exclusivity in July year.

So far, we don’t know who’s going to launch. And then the new approval, Brickia, it’s for DHEA auto injector and it is for the cluster headache and and severe migraine headache patients, which I’ll talk a little bit more about it. And then I have care as I said, it’s growing well. So when you put all together we’re growing this is why you saw the CAGR of eleven and thirteen percent. Here’s a little journey from a humble beginning in Pattinson, New Jersey.

It’s an American entrepreneurial story. It’s only country you can do this without any hindrance, without knowing anybody, just working hard, be committed, have great teams, right purpose and boldly innovate new areas, invest into like making transdermal drug. It takes, it’s not in licensed products. We hardly in licensed products. We make most of the products by ourselves.

And that gives us obviously higher margins and more control on our supply chain. And as you can see, we continued our we never stop on these innovation and growth. We keep thinking about new, new things and fortunately the area of business we are is very vast. It fills 92% of United States prescription. We save a lot of money for the healthcare systems.

And there’s always a new thing coming up. Right now, you may be hearing about that we don’t make any antibiotics in America. Zero. Everything comes from 90% is controlled. The key starting material that you need for antibiotics is from China.

And then there is 20% production is in Europe, about 60% comes from India, and then China supplies the finished products as well. We have 1% in The United States. So you can imagine that you are the White House and Congress or Department of Defense. They’re very concerned. So obviously we we’ve been working with them for six years.

We have given a proper proposal so how to do it. It can be done and we should be producing certain of the total volume to have capability and capacity in case something some there’s some emergency or our friendly countries cannot supply. Or there is issue with China’s negotiation, who knows, right? The magnet thing. So that if it comes properly through the legislative channel, you expect Amneal to be one of the leaders in investing in America.

We’re American company and we’ll continue to hold as much manufacturing as we can. 70% of value of our manufacturing still in The United States. Volume wise, we’re fifty-fifty. This is our global network. I’ll skip this.

And this is back to the specialty products, which I covered. Then the cracks on growth, you can see the prescription growth is amazing. And this is just because the product is doing so well. Of course we have a great sales team and marketing team. The products is speaking by itself.

And so you know there are one point one million Parkinson’s patient about six hundred and sixty thousand are on CDLD treatment. And out of that only forty thousand are on long acting like Reiteri, which is our previous product, now Crexon. So it’s about five percent, six percent are on a proper therapy. We expect and the way product is working, we can there’s no reason they should be on IR. So now we are marketing to General Neuro and we have a huge social media campaign.

We could get to 10% market share among the CDLD or 20%. We’re not going to stop because that is the product. Crexon is the one they should be on, not on IR. This is the new product, DHE auto injector. And this is so today what what is happening, there are a certain number of patient that have cluster headaches which is the worst headache of all.

They bang their heads on the wall, they have to get the treatment. So the treatment is they existing couple of treatments where this is a gold standard DHE, They go to the hospital emergency room and get IV injected and feel good. But that process could take three, four hours, including the migraine patient. We took the same drug and put it in auto injector just like GLP-one. It’s a beautiful auto injector.

Somehow we chose color pink and you just give it ten seconds on the thigh and drug is delivered. So it avoids all these transportation and while you have headache going to the emergencies, clinics, hospitals. So we believe this is a very useful innovation and we expect a good uptake for this product. And we’ll keep you posted. We’ll be launching in September and so far the feedback is really good.

This is the collaboration with MedCera, huge opportunity for us to play in a GLP-one properly, not generics. We do we’ll do some generics later on, but that’s not the priority. Right now priority is just be a solid partner with MedCerra supply, put them in a proper place with the peptide supply, which is the main key. And then we have enough capacity for oral solid and then we can make we’re building a new capacity. We have existing capacity for auto injector, but it’s not enough.

They wanted to have 100,000,000 units capacity. So we have already ordered the lines. Their lead times are twelve to eighteen months, but somehow we got in because Lilly has ordered so many, Noah has ordered so many. So it’s hard to get and we’re same manufacturers making these our lines, but somehow we got in and placed order for three lines because of our prior history with those and business we were doing with those manufacturers. But this is a very exciting project and commercialization, you know where it’s early stage where we’re evaluating markets.

They’re not the 20 countries that we got, including India will be the biggest one in that. That’s nothing to sneeze about Because that rough number right now is about fifty five million patient can afford in India to be on GLP-one. And they should be on GLP-one. That includes both diabetes and weight loss and they could afford to pay somewhere around $700 per year. So about $60 a month and that would be affordable.

And that if you can do the math, it’s big market for us. Already covered that affordable medicine segment. This is the pipeline evolution that 96% is all complex products now. We do not work on a commodity generics where you could have ten, twelve, 14, eight competitors. We have stopped working on those products for last five years almost and revamp the company as a specialty biosimilars, injectable, more complex products, device based products.

And that is why what is giving us a great growth. This is the biosimilar current pipeline that most exciting product here is Xolair. It’s only Sultrion has filed. It looks like we could be number two And then Teva is working on as well. So two to three competitors in biosimilars market, amazing product, even four competitors.

Once it gets to five, six, seven, eight, then it becomes source of product. It’s still good. And this is why you see the main players will be affordable medicines leaders like us, Teva, Sandoz. Yes, Amgen has a division, but they’re not that’s not the company for them. Then you have two Korean companies, right?

Celltrion and Samsung, big companies there. Indian one big company, Biocon. And then you have Kabi with Mapscience in Europe. And then it’s pretty much Alwotek in Iceland and you’re done. But Alwotek is partnered with Teva.

So it’s a seven, eight serious competitor would have to be vertically integrated at some point and how to work on ten, twenty products at a time to become the top five in biosimilars. And I bet top five globally will do somewhere between 2,000,000,000 to $5,000,000,000 in revenue in next five years, six years, seven years. And our aim is to be in top five. It’s amazing and production is very challenging as well. So it’s not like small molecule.

Comparatively small molecule commodity markets, there are 150 competitors and complex GX small molecule about twenty, twenty five competitors. And this one would be seven to eight competitors to work on 70 molecules. So then there are not many of them are not being worked on. So that’s a very exciting growth for biosimilar. And commercially what is happening is there’s a buy and build category, which is slow growth, You can stay there longer time.

You need certain payer coverage, not everything. And then there is PBM buying directly like Humira. You saw CBS entered into an agreement with Sanders and all of a sudden they have 15%, twenty % market share. So those are Part B products, which would be quick in market share, but lower in value. This like product like Xolair, half is buy and bill and half is PBM driven.

So it’s a classic combination. You see future product like Orencia is similar. So you would have to strategize with both. And fortunately, the small molecule, they’re our friends for a long time because we’ve been doing business with CVS and Express Script and Optum for years. So we know how to make deals with them in advance and we were just not making deals for a couple of biosimilars, right?

We have a 200, three hundred product portfolio for them. So it’s a very huge portfolio that we are offering. So we will do well there. And we’re about 60 people right now doing sales for our existing product Avastin, Neupogen, Neulasta. So we have set the commercial team for buy and build as well.

So we’re set for both sides to commercialize this product. And that could be our hope is to bring another ten, twenty, 30 by the time 02/2033 comes, plenty to work on. This is healthcare, awesome growth. They continue to grow. And VADOD, they do smart things by product directly unlike Medicare and Medicaid, they let the middleman buy the products.

You’ll be surprised the reimbursement rate. So Medicare if they’re reimbursing $1 for the generics drug, 80¢ is going to middleman and only 20¢ coming to the manufacturer. So there’s a huge imbalance. We a DoD is obviously many their direct manufacturing cost. These are our latest number.

How did we end up the Q1 at 3.9 leverage. That’s great and the debt is 2.5 now. So it’s gonna keep coming down and EBITDA will keep going up and we’re getting the credit agencies are recognizing and we’re going up on our rating which is great. I don’t have much time. These are already spoke about these key points.

We have a little about minute left. Took a little longer than I usually leave three, four minutes for question. Well, thank you very much. Have a great day.

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