Amneal Pharmaceuticals, Inc. (AMRX)
NASDAQ: AMRX · Real-Time Price · USD
12.52
-0.13 (-1.03%)
At close: Apr 24, 2026, 4:00 PM EDT
12.49
-0.03 (-0.24%)
After-hours: Apr 24, 2026, 7:16 PM EDT
← View all transcripts

J.P. Morgan 42nd Annual Healthcare Conference 2024

Jan 10, 2024

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Good morning, everybody. I'm Chris Schott at J.P. Morgan, and it's my pleasure to be introducing Amneal today. From the company, we have Chirag Patel, who is the Co-Founder and Co-CEO of the Caompany. Chirag's gonna do a presentation, and we're gonna jump into Q&A from there. With that, Happy New Year, and thanks for joining us.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah. Great. Thank you, Chris. Good afternoon. I guess it's still good morning. We're at almost good afternoon. Great to see all of you, and thank you for coming today. I'm going to start with a bit of history for whoever is new. Amneal was founded in 2002 by my brother and me. Humble beginning in Paterson, New Jersey, with our own whatever family savings we had. And today, we're proud to have built America's third-largest generics company, which we like to re-coin the term, and add the injectables and biosimilars and call it affordable medicines company. So... And 7,000 employees, multiple plants, so very great American story, and in last 20 years, we have built this, and we look forward to building this even further. So thank you.

Today I'm gonna walk you through Macro Trends first, which will give you an idea how large this market is, why the Affordable Medicines Business is sustainable, substantial, and essential for the nation. In all areas, the markets are growing, and I'll show you that. I'll give you a little bit of Amneal overview and then walk you through our growth strategy. We are very excited for all the growth areas and multiple growth vectors we have. Very excited to walk you through this brief presentation, and then we'll have Q&A. Here's the macro trends, and they're accelerating the growth, right? As we know , having the essential medicines is a right for all patients, not a privilege for few. So who's going to deliver that?

It's companies like us, and we're glad to lead, this pack and this industry and continue to lead in America. America is the largest market. We are very proud to be American company and, and keep investing for United States. We're also expanding in other markets as well, but you can see how big the market's growing, number of prescriptions patients are taking, $141 billion of products coming off the patent. So next five years, there's plenty to do. Even after that, there's plenty to do. And for companies like us, which can deliver, like our, our alignment is a competitive advantage. We can deliver all complex products. We have delivered injectables, we have delivered biosimilars, we have delivered, unit dose nasal sprays, liquid suspension, and transdermal. So we stand here to win.

When we start R&D and investment from US and FDA approvals, now it's even becoming easier to expand our markets in the international markets. So that's even larger incremental opportunities for us. And we have internal industry-leading R&D engine built over 20 years, 900 Analytical Chemists, Scientists working on it. So we got the real meat to deliver the growth, and as we have done that in last four years, we have done it for 20 years. We had a little competitive industry for a few years, back in 2018, 2019, 2020, but we're successfully we have moved to diversify the company. Here is the markets. Here are the markets that we're working on. So retail market, that is defined as the products we sell to CVS, Walgreens, Walmart, Express Scripts, so all the retail outlets.

So the prescriptions filled by retail outlet. And that market, our estimate is $25 billion today. Used to be larger. It due to pricing pressure, the buying groups consolidating, it has shrunk, which is dangerous for shortages. You see a lot of shortages coming out. You saw Cisplatin having a shortage because all the supply was concentrated 80% with one manufacturer, selling at a couple dollars or more, which is, I mean, less than $2, which is you cannot produce chemotherapy products for that kind of price. So the markets, we believe it will expand, but not to the greater. It should expand more, pricing should improve, but we are estimating $29 billion by 2030. Injectables growing more, because the hospitals are asking for more RTUs, more bags.

You can convert certain bags in a ready-to-use, which the errors are, they can have less errors, and efficiency can increase. So injectables will keep growing. Biosimilar is the biggest growth. This is IQVIA numbers, so not exactly the net number from manufacturers. But if you look at it, or if you saw Amgen's presentation yesterday, they're predicting their own 8-10 biosimilars doing $3.5 billion-$4 billion globally. So that's about $400 million-$500 million per molecule, which I believe, my estimate, the United States would be half of it. On a value, United States obviously has the highest value. So this market is going to evolve. It is going through challenges.

I've talked to many investors that are disappointed with the growth rate in biosimilars, but we have to be patient because the legislative efforts, which was successful and introduced the biosimilar bill, FDA is working with biosimilar manufacturers to develop the product more efficiently. So we can have lesser number of clinical patient, more analytical work. Can we cut down seven years of development time to five years? Can we cut down $200-$300 million or $150 million dollars development cost to $100, below $100? So we're going to do that. Our industry is going to do that. Brand companies and the payer communitypatients will eventually would have to come to the terms, as they did for generics, because the intent for the biosimilar is to bring tremendous savings.

Any force working against that, in the long term, will not be successful. So we believe in biosimilars. It will become a big market. 70 molecules are candidates for Biosimilar Competition, 70 for the next seven to eight years. So excellent market. And we have a niche specialty business, which is Parkinson's, leading Parkinson's drug, as well as a hypothyroidism drug. We will grow that business over the next several years. We're very excited to introduce IPX203, potentially this year, and we'll talk more about it. So let me now go back to the overview of Amneal and how we stack. And our mission is to become America's number one affordable medicines company. So when you combine injectables, biosimilars, and retail GX products, which are more than 270 products, we should lead the pack.

Teva would be our closest competitor. Sandoz would be our closest competitor. And then we have Indian companies that are our competitors. So we like to lead, and we have capabilities. We have the management team that can deliver. It's one of the finest. We are number one quality track record in the industry. 100+ FDA inspection, never had OAI or warning letters. We're the only one in the entire global industry to say that, 'cause we take quality completely seriously. I mean, our mother takes the same prescription drugs that we make, so it is a highly responsible business, and we invest in quality all the time.

So we now like to call ourselves a global company as well, as we have started marketing our products in India, and we are part- we partnered in Europe, partnered in Middle East, and we'll be partnering in Canada and South America very soon. So that would expand the market for us. This year looks great. Great growth, 7-8%. We affirmed the guidance this morning, and we're very excited for where we are going next. And the leverage, we will continue to delever our company from 4.6-4, and in long term, below 3x, we like to operate. Here's... If you look at what we did in four years, this was challenging times in 2019-2020.

When we went public, 18 was great, 19 came down, a lot of competition, and look what we have achieved in four years, very quietly. This revenue, every area has grown, right? Revenue growth is tremendous and sustainable. The diversification, we only have 26% of total revenue comes from OST, oral solid dosage, which tends to have more competitors as barriers to entry are easier in small molecule oral solids. But we still work on certain oral solids because there are key ones, like Asacol HD, there is a carvedilol XR. These products are very few players can come through, so we work on those. If we look at our pipeline, 90% of current pipeline is non-OST. So it's a fantastic pipeline, and it's an engine.

We keep adding more products, keep getting 30 or so approvals every year, keep launching those products successfully. We pretty much launch everything we approve that we get. So technically, it's a proven platform that we don't just get the approval and get stuck in the manufacturing issues,a and don't launch. We launch every product. And then biosimilars, existing strategy, we're in-licensing product. Oncology is our focus. We in-license 2 more products, and we will in-license more. The EBITDA, great growth, and now even it further accelerates going next five years. Cash flow, constant focus, to keep improving cash flow and paying down debt, so we can achieve our target of four times leverage and then three times in the long run. The debt situation is, we manage the refinancing, so it's now May 28. We'll be paying down debt.

We will improve our ratings and look to bring down the rates as well. The corporate structure has been enhanced as well. Here's a track record, just quickly. One thing to notice here is, if you look at the light blue. That is a base business. Everybody's worried about the base business for generics going to disappear. It doesn't. People need medicines. We are working with big three buyers, so they don't-- it just doesn't become zero. It. If you look at it, yes, it will decline, and now we are seeing lesser of a decline than the previous year. So $1.2 billion is still at $950 million over five years. But we added almost $600 million of new products. So there is always new products to be added, so it is sustainable on a generic side.

Biosimilar is small, $60 million. It will grow in 2024 and 2025 and beyond. Our value-added distribution business is doing well, and I'll explain it a little bit more. Our specialty business, very excited about IPX203, and currently, what we do with RYTARY and Unithroid. It's a, Unithroid, it's a double digit. RYTARY is about high single-digit growth. Next. So now let's each segment where the growth is coming from. So retail, we're probably the only company can say the retail GX business grew over four years, even though modest to 3.3%. Now we expect high single-digit growth, and the reason is we're introducing respiratory products. We have a Ophthalmic ortfolio. We have naloxone, which we make in Branchburg, New Jersey, and very purposeful product, so we are excited to build.

We have built the capacity to 3-4 million units this year, which is opioid reversal products, so very public need, and the government is asking for more production, and we stepped up. Next year, 2025, we should be able to make 8-10 million units, and we're constantly getting demand from states as well as CVS, Walgreens. Product is now OTC, and it will be available at multiple places, everywhere, ambulances, churches, schools, to save lives. So this is why retail will grow. On top of that, there's international growth. Injectable, we doubled our capacity, and when Amneal doubles the capacity, is a real capacity, we can produce and deliver. So we almost have and 60-70 million different dosage forms within injectable we can make. The bags, the peptide products, long-acting depots, the vials, prefilled syringes, cartridges.

So we got it all now. It's a lot of hard work over last eight, nine years, but we're very confident that we'll grow our injectable business and take the lead there as well, as we have taken the lead on retail. And the last one, biosimilars. This is exciting. It's $60 million. Obviously, this year, 2024, will grow to more than $140 million for the 3 marketed products, and then we look forward to launch additional products in coming years. We're keeping licensing as we are known for good partnerships, so we always have a partner's interest to make money for them. So together, we can bring more products with a strategic partnership with three to four players. We want to partner only with the proven players.

And with that, it's a high single-digit growth or even more going forward for multiple years. Specialty. We just in-licensed ONGENTYS, which is a complementary product, from BI, company in Portugal, 100 years old Company. It's an enzyme which improves the dopamine duration in the brain. So a L-Dopa, which is IPX203, provides the long, good-on time, longer good-on time. On top of that, this COMT Inhibitor could, for certain patients, enhance even that time further because that enzyme is helpful in increasing duration for dopamine. So very IPX203, we have completed the QT study. We are analyzing it. We'll be filing soon, and we expect the approval of IPX203, hopefully late third quarter or second half of this year. And we're ready to launch that. Very excited.

We're very close with the Parkinson's community. We've been marketing these products for over seven years, and we're really. We live patients' lives, and we want to do whatever we can. It's a polypharmacy they operate, so with a COMT inhibitor, with a CD/LD, which can last now six to eight hours. The IR, the 30-year-old technology product, it fluctuates a whole lot, so patient every day . I mean, it's the Parkinson's will stay with you for 20-30 years, so how do you live a good life every day? And then, obviously, we're working on a further expanding and improving even our own formulations. So we like our focus in Parkinson's. And then we have small add-ons, $50 million-$70 million each, but they can all add up, and they're meaningful products.

DHE auto-injector is for cluster headaches. Today, if you have cluster headache, you go to the clinic. It's the 1-10 pain scale, cluster headache is ranked 10, I think nine. It's way high. They bang their head on the wall, and it takes two, three, four hours how far the clinic is. This auto injector, they can inject it at home. Boom! And then, they can get relief from the cluster headache. So excited about the pipeline here. The current products are doing great, and we will look to in-license more products or add more on our specialty division, but very targeted. AvKARE is a distribution business which is the government business.

Government of United States, VA/DoD, requires products to be either made in United States, which fewer and fewer companies are making, and Amneal fortunately still holding the fort, and we have three large manufacturing complexes. So we're making more products for VA/DoD. This is why you see the growth, and we sell through our subsidiary, AvKARE, direct distribution to VA/DoD, long-term contracts. Some are just on FSS contracts, some are five years contract, and we have a five years pipeline. VA, that also the population is aging, and they require more prescriptions. 340B is a small distribution business, and unit dose is a good business as well. So we take many of our products and other companies' products, and we provide that in a unit dose to hospitals. So it's a very niche distribution.

We do not compete with the big three wholesalers. These are separate, the kind of value add, I call it, higher margin distribution business. And it's growing big time, like double-digit for last. Since we acquired, it's been a great acquisition. Putting all that together, the affordable medicines, we expect high single-digit growth or even more. International, as I mentioned, India, we have 250 people now marketing products in various dosage form. We believe India will grow at a very high clip because the whole economy is going from a $3.5 trillion to $5 trillion, to $7 trillion. $10 trillion is what China did in 2000 to 2020. It's happening in India with 1.4 billion population.

We feel home in India as well, 'cause we have eight manufacturing facilities and we were born in India, but then we live in America for the last 37 years. So we are best of both worlds, and we'll take advantage of that situation. And China, we have partnered for soon. They're marketing our products. In Europe, we have Orion, which is a 100-year-old Company in Finland, which we market the products together. Niche products only. We are not marketing all generics products. And then specialty, as I mentioned, growth area, EvKARE Care Growth. Here are the near-term catalyst. Our Alymsys, which is our leading biosimilar product, would do more than $100 million. Naloxone, once it's ramped up, should be a big opportunity. IPX203, big opportunity. We expect $300 million-$500 million over time.

The engine, which is retail and injectables, new product launches, happens every year, is about $100-$150 million. Every year, we launch new products, and since 2019, we have launched $600 million of new products within that category. So it's already proven, it's engine, it's sustainable, it keeps happening. And every year, these catalysts would be added. This is just a bird's-eye view. Anybody wants to look at what more detail on what products, but it's exciting portfolio we have. And on that portfolio, most of the products are made by us, our own R&D, our own product production. These are the key areas we're zoomed in focus, increasing diversification. So our- we're not just a generic company.

We're proud to be generics company, but we have now biosimilars, injectables, specialty product, value-added distribution, global market. So we like to call ourselves globally diversified company with ability to work on multiple things and deliver, and we have the track record to do that. Strong financial performance, very disciplined, very committed to get to below three and keep generating cash, pay down debt, so we can increase our free cash flow to invest in company. And you can see where we can go from here, right? When you have this platform and there's more to come. So I will end here. Sorry, I took three minutes.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

No, all good, you said. Good.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Oh, sorry.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Overview of the business. So maybe just to kick off on the Q&A. 2023 was a very strong year for the company, and just as you reflect back of what drove the fun- the operating performance, what were the real outliers in your view? And as you think forward to 2024, you know, what are you most focused on in terms of sustaining that momentum?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Thank you, Chris. So we've been working on it since 2019.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We came back, we had a couple of years of transition. So when we came back, we again, mojo came back, all the R&D, so all those products are getting approved.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So NPL is driving the growth. The government business, VA/DoD, because we have more products than you can produce for VA/DoD, and we thank somebody cares about made in United States. So that business increased. We had a biosimilar launch, successful launch. So launching against Amgen and Pfizer, we were able to take 6% market share in first six months. So we beat Pfizer in market share. So in their first six months versus our six months. And then we had a bit of a contribution from better generics market.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Than previous year. But it's quite a bit.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

It improved by two points on a... It's a, it's a large improvement. So, and that we see all these carrying forward in 2024.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

The dynamics around, I guess, the U.S. market and pricing, it's been a long process, I think, of kind of bottoming out. It certainly seems like the trends are starting to improve. How do you get comfort in the durability of what seems like kind of this more maybe reasonable dynamic or, you know, that your portfolio kind of repositioning is gonna protect you from other cycles like this in the future?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yes. For us, speak specifically about Amneal, and then I'll give you my view on the industry.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah, perfect.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So specifically for Amneal, because we diversified the portfolio, we have a deep relationship with these buying groups over 20 years. Number one in supply, right? We're 98% customer service, so hardly we cause shortages. Quality is number one. Portfolio is probably the best in the entire industry. So we're working to make longer-term contracts. Let's enter into a strategic contracts for certain category of products. We were able to convince them that: Look at these prices. When companies don't make money, they don't stay in business for a long time. So either we adjust the price and make margins, or we get out of these products, and then you are left with unreliable, unproven companies from low-cost countries. So would you want to take that chances?

When Bloomberg and Wall Street calls us, "Who caused the shortage?" We're going to give them the details, because you're not, we cannot invest in inventory. We cannot invest in capacity.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So you have to look at this pricing, and I think now, and it's not completely done and on, and but the most of the buying groups are now saying mature products do not have anywhere to go.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

They cannot go any further. They have to go up because the inflation is going up. So and for us, it's just new product launches. We're first to market. We just launched FML this morning, so it just so many of varieties of products, respiratory, unit dose, nasal sprays, naloxone. So we're fine. I mean, we have so much to keep adding.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We have so much to negotiate with the buying groups.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

And they're being responsible. Last year, they were, and we believe it will keep improving-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

for the sake of patients.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Otherwise, we'll have many shortages.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah. Excellent. On the shortage front, do you see this resolving itself anytime, or does it get worse before it gets better? Like, how are you thinking about that? And I guess, how is Amneal positioned to take advantage of that or solve the problem?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We are diligently working on oncology portfolio.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

because of shortages.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Working with groups to provide longer-term contracts-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So that we can give them 15-20 oncology products. Shortages will not get better because it takes time. There could be some kind of intervention, which it's a government. I cannot tell you when they could do certain things, but something would be needed to do that, especially for this essential medicine. And as I've been saying, and we've been advocating as a company, that America, United States, we need 100 essential or 80 essential products to be made in America, from API to finished products, for 35%-40% of market share, which is Medicare and Medicaid.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So in emergencies, we can ramp up. We have that ability to do that because our friendly countries will have issue if there are unfortunate events like wars or climates or pandemics. And for our country, we shouldn't do that. And it's not that costly to do that. The government can easily fund that. So we're trying to advocate and say, "Hey, let's not wait until the last minute.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah. Yeah. Be a little proactive on that.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

On the biosimilar business, a very good start to the portfolio and the ramp this year. What does this business look like for you in five or 10 years? Is it more products? Is it more vertically integrated? Like, how do you think about evolving it over time?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

It will be more products-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

-for sure.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Right now, we are going more deeper in oncology.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We may look at other segment, because it should be agnostic, and we would, over time, vertically integrate. So because over time, you have to control your destiny.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Also take advantage of global markets.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

But next few years, we want to pay down debt. We want to...

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We got enough good partners who like to partner with us.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay. When I think about the $200 million target on this business by 2025, how much of it's coming from biosimilar Avastin versus the other opportunities?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

I think 60, 60, 65% would be-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

-Alymsys

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

And then Filgra-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

and then Rubraca.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Well, I mean, G-CSFs are five G-CSFs.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah. Okay, perfect. I'll pause here for a second, see if anyone, any questions from the audience. Otherwise, I'll keep going here, but anyone with any questions? Going once, going twice. Okay, I'll keep going here. On 203, just remind us timelines, for the study the FDA wanted you to run here, and just how do we think about path to approval from where we sit today?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Only one question was asked. Once we-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

... submitted the answers to CRL, we basically explained all the data we had already, safety data, and put it in different formats, which the FDA wanted. They checkmarked that. "That's okay. We're fine with safety, but we'd like you to do one more thing, is to do a routine QT study in 36 patients," which we completed only on carbidopa. And we will be analyzing as of this month, and next month we'll file it. And that should give a start of the six months call.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Great. And once you get approval, how quickly can you turn this around to the other commercial side, in terms of securing access and formulary positions and really starting to go out to launch the product?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah, that's the exciting thing. So seven years with the Parkinson's community and payers community, we have built deep relationship.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

And we want to broaden this market.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

RYTARY only penetrated with movement disorder specialists, so only 5% patient take RYTARY. 95% patient take 30-year-old IR, and we believe most of them should be taking long-acting IPX203, which is even better than obviously, a one, one hour 55 one hour 55 minutes good on time per dose-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

-compared to IR. So it's significantly higher, and it's higher than RYTARY. And so we are ready. Marketing is ready. The sales team's already there with RYTARY, so we would be all over and expanding the market. And also, we're about to—first time, the RYTARY never went outside of the United States, so we're licensing in Europe, licensing in Brazil, Canada, every country, because they all have Parkinson's patient. So our goal is to create access, do good for Parkinson's patient.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Great. On your recent acquisition, Ongentys, is that the pronunciation?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Sorry.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Ongentys.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Ongentys, perfect.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

How big of an opportunity is that for Amneal?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

It currently doing $20 million or so.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We think we can double it over the next few years because we're focusing on it.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

COMT inhibitor, the more we learn about it, it's a good enzyme to assist levodopa to produce more longer-lasting dopamine. So we believe it's synergistic. It's-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We'll find out more as we just started marketing.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Sounds good.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

The Neurocrine marketed-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

for a couple of years.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yep. Excellent. Pivoting over to AvKARE. Just two-part question here: What's been driving the strength we've been seeing in this segment? And just your thoughts in terms of the future potential of this business. Is this, is this a product- is this a, you know, business that stays within Amneal longer term, or how are you thinking about that component to it?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Growth is superb-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Because limit, the manufacturing, a lot of manufacturing moved away over the last 10 years from the United States. Probably more than 60-70 plants.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

-closed, including, unfortunately, we had to close one plant in Long Island. So now very few companies have U.S. manufacturing or TA-compliant countries manufacturing. So it creates bigger opportunity for Amneal because we are vested, we can plan out 5 years, 10 years launches with government. So we see growth continue. Unit dose will expand. It's $60 million today, may go to $100 million, $120 million, so it's a great growth.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

340B is just a pure distribution, for we inherited that-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So we're not focusing. That's a low-margin business. On a strategic value, look, it's a great business for us, but it's not a core business. So if we get a proper multiple, we already made a lot of money and

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

... it's, we expand double the-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

So if we get the right multiple, we'll transact and pay off a big chunk of debt-

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

And keep focusing on doubling down on specialty, biosimilars, international, so, which are 100% our core areas.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah. So business either kind of stays within and grows nicely or-

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah, yeah.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Or sells.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Both ways very good.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Yeah.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

We're not, like, going to sell cheap.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay. Okay, perfect. Switching to the P&L for a little bit, gross margins. Just how do we think about gross margin progression from here and kind of the drivers we should think about that?

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

Yeah. I was hoping to escape without answering anything.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

No, no, we got some questions for you here.

Chirag Patel
Co-Founder, Co-CEO, President and Director, Amneal Pharmaceuticals

I almost made it five minutes.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

You got the last five minutes.

Speaker 3

So since, you know, since we came on board, since 2019, right, we focused on margin expansion in a couple areas. Number one is we spent a lot of time cleaning up the gross to net, right? So that kind of dropped down to the bottom line, number one. Also kind of driving a lot of operating expense synergies. So we insourced a lot of products from third-party manufacturers to internally. We moved some of the product supplies from the U.S. to India, to kind of leverage some of the labor. And kind of our operating expense kind of initiatives continue, right? And the third thing that we did was kind of the new product launches, right? So augmenting the portfolio with more complex products that demand higher pricing. So those were the three reasons.

For example, when you look at the gross margin of the generic segment, went from about 35% in 2019 to about 41% this year, okay? And we think that is very sustainable.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Speaker 3

Very sustainable. There may be a little room for improvement as we're accelerating new product launches, but we feel great in terms of kind of 40%+, okay? A couple of years ago, we were about 43, probably about 44.1 right now, we think. So that's probably the band, and it's very, very much sustainable. When you look at the AvKARE portfolio, so the early days, the gross margin of that was somewhere around 12%-13%. This year, they had an exceptional year. It was probably 17%.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Speaker 3

We think 15%-17% stays there.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Speaker 3

But more importantly, when we acquired AvKARE, our focus was not about the profitability of the business as a percentage of revenue, it was about driving incremental revenue, driving incremental EBITDA. So for that business, it's really kind of going after the dollars, but nevertheless, improvement and maintaining or improving that. And then the gross margins of the specialty business been at about over 80%, so that will continue. So overall, we feel great about the kind of improvement that we delivered and the sustainability of that. So we'll think about margins flat to slightly up.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay, that's helpful. Other pushes and pulls we should think about in the P&L as we go through 2024?

Speaker 3

Yes. So what happens as a management team, right? So, you know, you've seen, you know, what we have done from 2019 and consistently, right? Between 2019 and 2023, which is every single year, we increased revenues. Every single year, we increased EBITDA. Every single year, we delivered incremental cash. And that was in an environment that we had to deal with COVID, we had to deal with tremendous levels of inflation and so forth. So I think that's kind of testament to the sustainability of what we have built here. And as a public company, you need to do that, right? So consistency matters. So as we think about the one piece that we are very focused is accelerating the revenue growth and accelerating EBITDA growth.

Over the last few years, we've made a number of organic investments and inorganic. So now we look at the management team and we say, "Guys, now those investments need to translate to increased revenue growth," right?

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Mm-hmm.

Speaker 3

Also, our operating expenses have increased substantially because we had to build new commercial teams for biosimilars, who acquired some of those businesses. Now, the conversation with the management team is: Folks, you know, the rate of growth of expenses has to be reduced.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Okay.

Speaker 3

So I wouldn't say anything dramatic. And the only reason for all of those things is, as we think about 2024, and we'll give guidance at the end of February, as we always do, we're looking to accelerate revenue growth. We're trying to drive accelerate EBITDA growth versus 2023. And also because of our changing, shifting our priorities to paying down debt, we need the incremental cash to reduce, to deliver.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Does that help?

Speaker 3

But nothing dramatically. It's just gonna be evolutionary.

Chris Schott
Managing Director and Senior Equity Research Analyst, JPMorgan

Perfect. That's great. I think we're just about out of time here. Really appreciate the comments today, and thanks for joining us.

Speaker 3

Thank you. Great. Thank you so much, Chris. Thank you.

Powered by