Mallinckrodt plc (AMEX:MNK) Q4 2022 Earnings Call Transcript

Sigurdur Olafsson: Yeah. So, let me start by talking a little bit where the EBITDA comes from this point from the guidance this year. I think the reason why we are optimistic is, first of all, we have two new launches. Probably a bigger opportunity is Terlivaz, we will have more information throughout the year when we hear back from the P&T committees on the formulary situation that helps us. So, we are excited about it. I think we’re getting all the right sign back. But what we have promised investors that hopefully by midyear or so, we can start to talk about the potential for Terlivaz and what the launch curve will be for that product because the formulary is so important in the launch curve and how quickly. We have seven years of exclusivity for this product.

We are excited. We are working as fast as we can to deliver that to the market. But that will be a key and critical point to it. The second thing to keep in mind is the self-delivery device of Acthar, which we expect to launch in 2024. That will help us to stabilize the Acthar franchise. This is a single delivery — single dose delivery device preferred by the patients to be able to use the product by themselves and don’t need the support to deliver that. We are still expecting that to be delivered in — to launch in 2024. Obviously, there are regulatory challenges with our partners, but they are working on overcoming and we are supporting. But overall, that’s the next step. Third thing, which we’re excited about, is the EVOLVE. We are expecting to launch EVOLVE later this year.

EVOLVE will be the next generation of INOmax devices That, I think, will again help us to stabilize the INOmax franchise. We have the total care, which differentiate with the competitors that we have been open about us as any competition impacts the pricing of the product. So, bringing the EVOLVE to the market will even further help us to stabilize. And then last but not least, we are still — the jury is a little out on StrataGraft. We are excited about it. We see some uptake in that product. But this is an amazing opportunity. I think this is a new science and technology to bring to the burn units and to the burn surgeons. The key opinion leaders are excited, but it takes a little bit more time than we expected to get that into the practice in the burn unit.

So, with all these things in place, plus you have seen over the last few quarters, the stabilization of the generics, we are excited that 2023, the impact of the decline of Acthar and the impact of the decline of Amitiza and obviously, the pricing of INOmax gives us this low point, but we really have the opportunity to grow from this point onwards.

Bryan Reasons: No, that was a very short answer, Siggi. So, I think the key is mid-year when we have better visibility of the launch slope on Terlavez, I think we’ll be able to give you a better kind of jumping off point at the end of the year.

Daniel Speciale: Thanks, Rich. Any other questions?

Operator: One moment for our next question. And our next question comes from Brendan Hall of Brean Asset Management LLC. Your line is open.

Brendan Hall: Morning. I just wanted to confirm on the prior question. Is that $50 million launch for each drug or for both? Just to clarify that.

Daniel Speciale: No, that would be cumulative. Yeah.

Brendan Hall: Yeah. Got it. And the second question is on the opioid trust and prepayment. I believe there was an 18-month extension opportunity to prepay that. I wanted to know how you guys are thinking about that in concurrence with opportunities to buyback debt, and how you think about that cost to capital.

Daniel Speciale: Yeah. Sure. So, it’s a little difficult to hear you, but I think maybe just to summarize, the question was, with respect to the opioid trust and the possibility of prepayment and really just broadly thinking about capital allocation. Bryan?