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

Balaji Prasad: Yes.

Tasos Konidaris: Alright. Thank you. go to the next one, please.

Operator: Sure. Our next question is from Greg Fraser from Truist Securities. Greg, your line is now open. Please go ahead.

Greg Fraser: Great, thanks for taking the question. On the generics business, among the approved products that will be launched this year, are there any that you would call out as being particularly material contributors to the $100 million plus of new product sales? And are there any generics that are pending approval that could be significant contributors to that number. Thank you.

Tasos Konidaris: Chintu, do you want to take this one?

Chintu Patel: Sure. Yes, hi. Hi Greg, yes, we have some of the products approved in their IP-driven launches. The big notable ones are the (ph) and sodium alginate and there are a few others. We have not disclosed all the upcoming launches, but we have — we are expecting to launch five new injectable products in LVP bags by second quarter. And those ones are almost two are approved another three got — that are very near to approve in a clear and space. So we are very optimistic about our new launches throughout the year, total over 30 new launches we are expecting in 2023.

Anthony DiMeo: And this is Tony. The only thing I would add, too, is you had 26 new product launches in 2022, more of a back-half weighted contribution in fiscal ’22. So that will annualize this year in addition to Chintu’s, the 30-plus launches this year. It’s a long list. We have the key growth catalyst slide — in slide seven. But as Tasos has also mentioned the contribution from new product revenue this year is over $100 million. So it’s more than double versus even — so potentially a great year for new product launches in €˜23 with a long list of products that will contribute to the top line.

Operator: Our next question is from Elliot Wilbur from Raymond James. Elliot, your line is now open. Please go ahead.

Elliot Wilbur: Yes, thanks. Two quick follow-ups. First, I didn’t catch it in your prepared commentary or the Q&A. But just any commentary around the dihydroergotamine auto-injector filing, that seems to keep getting pushed back in terms of expected timing, hard to believe it’s a molecule formulation issue. Just wondering if you can give any color there in terms of why the time lines there are being extended? And then for Tasos just a real quick question on the debt. Anything you can say about the outlook for interest expense in 2023? I know it’s kind of hard to say when you’re be in market looking to refinance. But just looking at — so far SOFR rates today and your current spread, it would seem like we’re talking about effective rate somewhere around 8%. Just wondering if that’s in the ballpark of what you’re currently thinking? Thanks.

Chirag Patel: I’ll take the DHE to impact on refinancing. So DHE autoinjector executive was from one of the CMOs and the CMO has been stuck with — not for the product related, but GMV-related issues we’ve been working on site transfer. It is a complex device-based product. So it’s taking longer than we had expected, and that is why the date has moved. Tasos?

Tasos Konidaris: Yes. Eliot, you’re thinking about the interest rate expense the right way. So probably somewhere around in the 8%. Obviously, it depends exactly what instruments we’re going to choose and you’re thinking about this the right way.

Anthony DiMeo: And then the final question, Balaji. Thank you for sending it. A final question for today. With the goal of being a top five player in biosimilars over time, is this a five-year plan, a 10-year plan? And what’s the road map to get there pipeline, et cetera?