Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q4 2023 Earnings Call Transcript

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Chirag Patel: Thank you, Harsher. And overall, biosimilar market is going to be large over next several years, and it becomes more healthier and healthier as new launches come in. It is going to be competitive. So, you have to be mindful on the investments, and you have to select which product you want to enter in. Our strategy has been more buy and bill or combination of buy and bill and PBM-driven, and we’ll continue to invest in those assets. Currently, we are only front-end commercial for United States. As over time we can integrate for potentially or partner more strategically, so all those avenues are open for us, but we are committed to biosimilar business. We believe it’ll be a size of – global size of about $80 billion to $100 billion by 2031, 2032, for the manufacturers.

So, that is a fantastic market for a company like us who is completely focused on affordable medicines as we lead the retail segments, pretty soon to be leading injectable segments. And now here comes the biosimilar segments, and we intend to lead and especially in the United States. IPX203, that’s good news. We expect the coverage to be right away as well as the uptake to be right away because of our experience with Rytary, the relationship with (QLs), relationship with foundations. The patients’ caretakers have started building relationship with 700 neurologists, which we never reached out before. And the purpose of IPX203, having a great market access team, MSL teams, the sales team, which have relationship over last seven to eight years, we’re very excited.

It’s a strong uptake and shouldn’t take – it’s not a new molecule that should take a longer time for going to the peak sales. So, excited about IPX203. Thank you.

Chris Schott: Thank you.

Operator: Our final question comes from Leszek Sulewski with Truist Securities. Your line is open. Please go ahead.

Leszek Sulewski: Good morning. Thank you for taking my questions. I have two just a quick follow up on Ongentys. So, taking the early performance trends of Ongentys into consideration, do you envision treating this product as a essential product relaunch? And how do you think the peak sales potential is for the product now that it’s on your platform? And then second, you highlighted focus on neurology and endocrinology to grow your branded portfolio. What opportunities do you see out there within these two therapeutic areas, and potentially outside to add to your specialty segment, and also I guess high level, how are you thinking about other chunkier BD plans? Thank you.

Chirag Patel: Yes. Hi, Les. So, Ongentys, Neurocrine had done a good job with taking that continuous platform, and it has been a smooth transition. So, we thank Neurocrine team as well. And we are now expanding the reach and the message on a complementary outcome between the Ongentys, which is a comp inhibitor, which extends the life of levodopa, therefore reducing the off time. So, it’s a classic complementary products between the – where soon to be IPX203, currently Rytary, and then with comp inhibitor, which is Ongentys. So, we expect the peak sales to keep going up. We haven’t been public, but should cross the $50 million and keep going. And then on the pipeline for in neurology, we are looking at different assets, whether they’re in phase two, phase three, and we’ll be probably announcing certain deals this year, we’re hopeful, and that would be more expanded pipeline that we are now going after the products that can generate similar to IPX203, $300 million to $500 million in revenue.

So, we’re not looking at smaller assets anymore. And on endocrinology, we have our K-114, which we’re very excited if we can get through the regulatory hurdles. It’s the much-needed products in the market with the combination with the T3 and T4. We believe that product also can be a pretty large contributor, and also looking at a couple of pipeline assets in their phase two and three in endo as well.

Leszek Sulewski: Thank you.

Operator: This concludes our Q&A. I hand back to Chirag Patel for final remarks.

Chirag Patel: Well, first, thank you to the global Amneal family for very strong performance in 2023. And our mission is clear, and it hasn’t changed since our founding, provide access to high quality, affordable, and essential medicines. We’re building momentum across our diversified pharma business. We believe 2024 will be even better as we continue to grow, expand our reach, and impact more patients than even before. Thank you very much.

Operator: Ladies and gentlemen, today’s call has now concluded. We’d like to thank you for your participation. You may now disconnect your lines.

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