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Question: Balaji Prasad - Barclays - Analyst
: Indeed, I hope you got some time out there. So starting with the business, you recently reported Q4 earnings, maybe take us through some of the
key highlights there. And also, is that as a segue to discuss the outlook for 2025, as you say, Chirag?
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Yeah, Balaji. So Amneal, we delivered another great growth year in '24 continuing the momentum in 2025 as well. And all segments of our business
are performing really well. So if I walk you through each segment how well it did in 2024 and why we are so bullish in '25, '26, '27, basically, we have
mapped out next seven years or so growth plan already. And the areas we're excited is that all of them.
So let's start with, we call it affordable medicine segment, which we define it as traditional generics business, biosimilars and hospital injectable
business, including bags. So those affordable medicine segment has a huge growth potential. The LOEs are coming. There's a void in biosimilars.
If you get it right and execution, affordable medicines for us and our key competitors will grow in significant manner over the next five to seven
years.
So that segment, you saw the growth in '24. We're so excited it will keep growing in '25 and beyond. And we have excellent pipeline. We launched
20 to 30 products every year in affordable segment categories. And we -- actually, our base business continues to do well as well.
And we're not seeing as much of a price erosion in traditional generics as we saw a few years ago. So all -- everything is pointing towards growth
for the entire segment, and it's a big segment where it's 92% of prescriptions in the United States.
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MARCH 12, 2025 / 3:00PM, AMRX.OQ - Amneal Pharmaceuticals Inc at Barclays Global Healthcare Conference
Biosimilars has a potential of delivering $100 billion a year savings for American patients and health care systems in 2032. And government is
completely supporting the NFDA, obviously, to ease the development of biosimilars. So it's a $6 billion biosimilar category could get to $30 billion,
$35 billion in the next five to five years. So huge growth potential there.
The second segment, specialty, we're extremely excited and pleased to report that CREXONT is outperforming our own expectations. And the
patient testimonials are just superb. It makes us feel so good. I mean our purpose as a company is to make healthy possible. And the patient
testimonials, such as the patient was not walking for five, six years properly, now able to walk.
The MDS specialist by himself has Parkinson. He just texted us saying he's moving much better than RYTARY. So now we believe that the market
is so wide. And later on, we can cover more on CREXONT, but specialty business is doing well as well. And our third segment, distribution outperformed
our expectation as well. That's a government value-added distribution, which requires made in United States, TA compliant products. Amneal is
one of the largest US manufacturer, we have an advantage to do business with VA/DoD. So was a great year and starting out '25 great as well.
Question: Balaji Prasad - Barclays - Analyst
: Exit more than 50 plus towards the end of the year.
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Yes.
Question: Balaji Prasad - Barclays - Analyst
: That's a pretty interesting, pretty exciting number out there, 20% market share, which is substantially above RYTARY. So look forward to traction
on that. But maybe taking a step about when thinking about the overall Parkinson's franchise, I mean, RYTARY will be seeing an LOE and then you
have ONGENTYS that you picked up recently and of course, CREXONT. So overall, how should we think about the Parkinson's franchise and as you
think about this commercial strategy, is there anything else which comes next to incrementally.
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Yeah. It'd be flat this year compared to last year and then grows from '26 and tremendous growth from '27.
Question: Balaji Prasad - Barclays - Analyst
: Got it. Shifting away from the Parkinson's side to the DHE auto injector, seem to be expecting an approval in 2Q and a potential launch in 2H '25.
So help us understand a bit more on the product and the opportunity as you see it?
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
So there's another niche product, right? We -- our specialty segment is defined by niche product, which big pharma typically, obviously, do not
pursue. They are somewhere between $100 million to $500 million, sometimes we may hit a really good product like CREXONT which could do
even more. The DHE auto-injector is for -- it's, again, the gold standard for the cluster headache patients as well as severe migraine patient. And
right now, they would have to go to clinic.
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MARCH 12, 2025 / 3:00PM, AMRX.OQ - Amneal Pharmaceuticals Inc at Barclays Global Healthcare Conference
It takes two, three hours to get there being administered. So tremendous pain until then. So we have come up with an auto-injector at home, they
can inject and get immediate relief in the next 20, 30, 40 minutes rather than going for three, four hours. So a tremendous need.
The KOLs are very excited about this. We are looking for exciting launch in the second half of this year.
Question: Balaji Prasad - Barclays - Analyst
: Understood. Shifting towards the biosimilar side, again, that's one place I've been really impressed with the pace that Amneal ramped up starting
from just talking about in 2020 to having three products by the end of 2022 and now like a $200 million revenue size there. What's next on the
biosimilar pipeline side of things? I know it's going to be dependent on partner discussions, but what --
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
It's a very exciting area for us, and it's in our wheelhouse. This is what we do really well, produce complex products at a large scale. And in the
beginning, we had commercial model. We did not want to invest a whole lot of money until the market stabilizes. The FDA guidance are more
amicable, more easier than what used to be, which is all happening at the same time.
Trifecta. I'm probably the only one calling this a golden era of biosimilars from now to next five, five years. And you will see people are always hung
up on HUMIRA, but there are 120 products. That was just a couple of years that brand company protected its franchise. But now you can see the
HUMIRA market share with the biosimilar players.
So competition is lower compared to before the brand companies are pretty much out except Amgen. So the competition's main competition is
Sandoz, Celltrion, Teva tech, mAbxience, Kabi, Amneal will have to integrate with R&D and manufacturing unit somewhere along the time, which
we've been very public about it, that we would look to do that this year. And that will give us additional pipeline. We're launching three products
by '27. So Xolair is a big opportunity for us.
We could be the second in the market after Celltrion. We have XGEVA, Prolia, and OBI for our current Neulasta franchise. And after that, we would
have many biosimilars if we are successful integrating the business, and we'll have full control from R&D, manufacturing, the sales and marketing,
commercial functions in the United States and our strategy is to partner in Europe with European champion, a partner in South America with
whoever specializes there, Middle East, the demand for these products are amazing. The access it creates, the volume, it grows because now it's
affordable and available and how many patients it helps and think about it.
It's just -- these are great products, never reached so many patients globally. So it's a very exciting business, and we're fully committed to making
it really big. And just like our -- on a small molecule, we are in top five, we will do the same for biosimilars.
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MARCH 12, 2025 / 3:00PM, AMRX.OQ - Amneal Pharmaceuticals Inc at Barclays Global Healthcare Conference
Question: Balaji Prasad - Barclays - Analyst
: All right. Last one on the biosimilar side is more around the partnerships on the deals. You commented that you'll be looking to add a couple of
deals every year. So -- and you rightly said that there are many, many biologics, which are expiring and not -- we have not seen that in the US. So
tell us about the environment for these deals and what kind of assets you're looking at?
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Well, we -- usually two kind of deals we look for. We are -- we have, first of all, organically really great pipeline. So we're not in a position where we
have to do this, except for integrating biosimilar business. We look at specialty assets. We are quietly building our branded oncology business,
again, specialty assets, we're launching 505(b)(2)s. You'll see us doing more in onco. And some of the biosimilars deal will continue to happen. So
those are the -- from the deals standpoint.
Question: Balaji Prasad - Barclays - Analyst
: Great. And on the injectables side of things, you again called it out within your affordable medicines segment. Help us understand the current
capacity that you have and the need for incremental capacity or how well equipped the company is towards this?
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MARCH 12, 2025 / 3:00PM, AMRX.OQ - Amneal Pharmaceuticals Inc at Barclays Global Healthcare Conference
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Yes. So we build out capacity for about 60 million to 70 million units and we are very -- our approach is very targeted, 505(b)(2)s, more complex
injectables, microspheres and long-acting depot, which we're able to peptide, right? We just got our first GLP-1 approved, the old one. So with
that, we are pretty rightsizing capacity for next four, five years. We're good.
Where we are building capacity is on our newly announced partnership with Metsera on a peptide front.
Question: Balaji Prasad - Barclays - Analyst
: And when you say that you mean generic GLPs.
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Yes.
Question: Balaji Prasad - Barclays - Analyst
: Fantastic. So let's speak about that. We still have a couple of minutes left. Let's speak about the international part of the business. And it's a very
unique model where US best pharma starts looking at that, especially on the specialty generic side, looks at the international market, which is not
frequent.
Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director
Yeah. So we're -- we have -- obviously, we're a US company. All our products are approved by US FDA, number one in quality, so it has a unique
demand in Middle East, anywhere we go in the world.
So we -- instead of setting up our own distribution centers, which will be too much and will not be that much value added. So we're partnering
with key partners. We already have almost 40 partnership with Middle East, Southeast Asia, Canada, Europe, so our products will go through our
partners who are set to distribute in these countries. We picked about 50 small molecule assets, which are already approved in the United States.
We signed up our CREXONT also is going international.
First time the International Parkinson's patient, which is more than 10 million would get access to most advanced drug formulation than the IR.
And you see the need is same. We will launch in Europe, Canada. And in India, we decided two years ago to set our own sales and marketing. Since
we operate many facilities in India, familiar with India, and India is a growing market.
India is going to almost triple in their entire economy, but also in pharmaceuticals. It's pretty small compared to US, it's $27 billion total market. It
will go to $75 billion to $100 billion over the next 10 years. So we would like to establish our footprint there that we have started just doing that.
And it's a small $15 million, $20 million business, but it will grow tremendously over the next several years. And it's branded. So you -- with not
generics, the branded unmet need we're bringing in India and certain specialty assets.
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