Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q3 2023 Earnings Call Transcript

Leszek Sulewski: Good morning. Thank you for taking my questions. Just first on the Rytary front the script growth has been good. I call the sales page was a bit light. So just perhaps maybe walk us through some of the pricing dynamics in 3Q. Was there any discounting in the GTN front? And then secondarily on the IPX 203, can you provide a little bit more details around the feedback from the FDA regarding your Type A meeting and the study design that you expect for that? And then also how are you thinking about the commercial launch in the second half?

Tasos Konidaris: Great. Thank you, Les. I’m going to have our Chief Commercial Officer, Joe Renda answer the Rytary question and then we’ll move to my brother for IPX two or three more details please?

Joe Renda: Yes. So your question on Rytary nothing has changed with our contracting strategy. We’re still fortunate enough with Rytary to have the best coverage of any prescription product in the Parkinson’s space. We have about 70-or-so percent commercial coverage and about 60 or so percent Part D coverage. We actually — the growth we’ve seen has been in the latter part of the year. If you look at Q3 and Q4 as an example our NBRx growth is at around 20% to 22%, which is significantly higher than what we saw at the same time last year. So we are seeing both NBRx growth with Rytary as well as TRx growth. So we’ve been really pleased with the pattern that we’re seeing as we round out this year. And overall this year it looks like our growth will be higher than what we’ve seen in previous years with Rytary.

Leszek Sulewski: And last just on your point about the quarterly gross to net yes we had about $5 million $6 million of over unfavorable kind of timing gross to net adjustment related to Medicare rebates. So that’s why probably the quarterly net revenue growth is that a little less of the kind of volume growth. But that’s behind us and it was more of a onetime event.

Joe Renda : Highlight this onto IPX203 we had a very successful Type A meeting to align our path forward with FDA. So question was mainly on the safety bridge for carbidopa. And we have addressed that for the major — as we had one year of safety data on carbidopa and FDA is aligned on our data and what we had presented. And it leads to only one remaining question, because anytime carbidopa has been an old molecule there’s certain amount of carbidopa we had to do a QT breeding study. So we are doing a small routine QT study in the 30 healthy patient, which we are starting very shortly in a week’s time and we plan to complete that study and file in first half of 2024 and launched product in second half of 2024. We are ready to launch the product from the commercial and also and from the manufacturing and product is ready to go. We are very excited on IPX203 and what value it brings to the patient.

Chirag Patel : Yes, it’s a much broader value less than Rytary. We’re going after an entire 1 million patient population and 90,000 new patients come on every year unfortunately. So it’s a large market and we want to change the habits of prescription of prescribing IR to start with. Why not IPX203? It’s much better formulation. It gives a good on time, longer time — longer good on time every day meaningful or huge impact on their daily lives. So — and we have lots of obviously data to go with and we never marketed to the broader audience of a broader patient population. So that is — we are ready for the marketing strategy. We have learned a lot from Rytary launch. And obviously there’s a lot of support for this product as the clinicians have seen the results of this product.

So, extremely exciting launch coming up. And not only in the United States we are in a final negotiation in Europe because Europe only has IR. And that be much needed for Parkinson’s patient there. And globally, we’re going to push it out to our mission to provide high-quality life-changing medications to affordable access to global population. Very exciting. And we’re filing the response on a…

Leszek Sulewski : Got it. Thank you for that color. One –

Chirag Patel : Go ahead, Les. Do you have follow-up.

Operator: Sorry, I muted his line. Let me put his line back up. Sorry, Leszek, your line is now open. Please continue.

Leszek Sulewski : Can you hear me?

Chirag Patel : We can Les. Go ahead.

Operator: Yes. We can hear you now.

Leszek Sulewski : Okay. That’s seems to be a lot of feedback on line. My follow-up question was regarding your recent refinancing agreement. So can you just perhaps walk us through some of the key aspects and changes in the covenants and things of that nature? Thank you.

Tasos Konidaris : Yes. Thanks, Les. So we’re pleased to report that after as you know refinancing our term loan B, which was due May of 2025 was one of our key priorities of this year. And I think we’re very pleased with the outcome so far. So after just a lot of very positive support from our existing lenders and a number of new lenders we successfully priced and allocated about $2.3 billion, which is about 90% of our Term Loan B. And with that, the key thing was we extended the maturity by three years to May of 2028. So essentially a couple of hundred million dollars are due in May of 2025 and $2.3 billion have been pushed out to May 2028. It’s essentially 4.5 years from now which gives us a substantial amount of additional runway for the company to continue the diversification path that we began a few years ago, increasing our cash generation that I spoke of and reducing both absolute debt and net debt to adjusted EBITDA.