Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q4 2022 Earnings Call Transcript

And they are keen to know to have very high-quality products, complex products, unmet need, because many of these advanced therapies do not make it to those countries. The rare diseases are hardly been talked about it. So Amneal has a great strategy, we already launched our commercial business in India with few hundred commercial people already in Mumbai. And as you know, India’s economy is growing by leaps and bounds and the cost of living, I mean, the signings of living everything is going up and we — and more people are covered in insurance as well. So really excited about that. Europe remains obviously second largest market after United States and we are partner early on expanding, and we’ll look forward to other partners as we go forward.

And countries like Brazil, we’ll look for partners as well. So very excited long answer, but it — your question was very awesome, so I had to give a long answer. So thank you Elliot.

Operator: Our next question is from Gary Nachman from BMO Capital Markets. Gary, your line is now open. Please go ahead.

Gary Nachman: Okay. Great. Just following on a couple of answers to the last question. So for IPX-203, how have conversations with FDA been going? What are you doing to prepare for that launch? You’re obviously pretty excited about it. I think you said you’re not factoring anything in the revenue guidance for this year, but is it in the spending guidance? And then ultimately, how much will it cannibalize Rytary — or will it be additive for new patients when you talk about the $300 million to $500 million peak over time. And on the international expansion. Maybe just give a little bit more color when that could start to contribute? I think you said it’s all incremental. So I want to confirm there’s nothing in the guidance for that for this year, if that’s the case?

And then lastly, on gross margin. That came in weaker than we thought in the fourth quarter. What are the big drivers behind that? And what are you assuming for gross margin trends specifically, in 2023? And how much is that weighing on EBITDA this year? Thanks.

Chirag Patel: Thank you, Gary. Chintu, would you like to give IPX-203 regulatory update?

Chintu Patel: Sure. Good morning, Gary. So IPX-203 is moving very well in a regulatory process. We are engaged with FDA and so far, it’s moving in a very positive direction, and we are very optimistic to have approval on its goal date of June 30th. And there is nothing — there has been a showstopper. So it’s in a right direction, right place on IPX-203 from FDA perspective.

Chirag Patel: Gary, your second question on the cannibalization. We don’t see it that way. We see IPX-203 as a much broader market. We’re going up to 3 million prescriptions were all 95% of them use IR. And Rytary has not penetrated with general neurologists, so we’re going for a broader market. We believe some of the Rytary patients will switch over to IPX-203, but that’s not our strategy. We are going for bigger market, much bigger penetration with the excellent pricing strategy that makes it affordable for both the medicare patients, as well as commercial patients, so very excited. On margin question, I’ll — again you said international, let me answer that before I give it to Tasos. We see that going from zero to several hundred million dollars within the next three, four, five years.

So it’s all incremental, very exciting using our own portfolios in the United States FDA approved products, command premium and respect all over the world. And we’re proud to bring all of that portfolio to partners and our own in India. We may be doing our own commercialization in certain market opportunistically as we go forward, but very exciting international expansion, and it would be — it’s embedded for the complex products that we are working on from the beginning we’re filing globally. So we do not out in timing such a biosimilars and complex injectables. Tasos?