Catalent, Inc. (NYSE:CTLT) Q1 2024 Earnings Call Transcript

Alessandro Maselli: Yes. I would just add, look, compared to pandemic levels, surely not as attractive because the portfolio is more complex, it has a lot of absorption because the volume is much lower. So the current level of the margin from COVID should be not even close to where they were in the pandemic times.

John Sourbeer: Thanks, appreciate it. And second question here also, I guess on margins, and you gave some color earlier on Sarepta margin, but I guess when you remove the raw material pass-throughs there, just on the gene therapy or drug substance business in general, how do we think about the — and you remove the other pass-throughs, how do we think about the margin profile on gene, drug substance versus fill/finish and any differentials there?

Alessandro Maselli: So look, I would tell you that across the board of the drug substance piece, and as the gene therapy, protein mAbs margin are pretty much in the same zip code when you cut out the material pass-through, clearly, right? You have such a high volume of pass-through, you would all think it gets lower, but on the pure services side, I would say that there is pretty much a good alignment across the drug substance. I would say the drug product, there’s a little bit of a different dynamic where the margin really depends — being a very high-volume commercial industrial production system is very, very dependent on absorption, right? And so the margin itself of the products, I would say of the products we run, it’s — I mean, it’s not big, the range, but there are products, like the vaccines or the GLP-1s, that because of the volume, they can drive a lot of absorption and a lot of margin uplift.

John Sourbeer: Thanks for taking the questions.

Operator: Our next question today comes from Max Smock of William Blair. Your line is open.

Max Smock: Hey, good morning. Thanks for taking our questions and congrats on the nice update. Just looking through Sarepta filing, it seems like R&D on ELEVIDYS has been about four times as much as R&D on some of their other gene therapy programs. Just wondering if, based on this, is it fair to assume that something like 75% of total Sarepta revenue for you is tied to ELEVIDYS? And then in terms of that ELEVIDYS spend, is there any detail you can give us around what your fiscal 2024 revenue outlook that’s tied ELEVIDYS to translates to from a dose perspective? I think there’s quite a bit of uncertainty still out there in terms of how much it cost to manufacture the annual — or the actual gene therapy. So any context there would be great. Thank you.

Alessandro Maselli: You take the first part.

Matti Masanovich: So from an overall perspective, we disclosed the Sarepta revenue, and you can get to the math, you can read the script, but it’s about 90% of the revenue is ELEVIDYS, so it’s 9001. So it’s the lion’s share, by far the lion’s share, of the revenue of Sarepta. We do have other programs that are being developed and are in development, and we’ll begin to grow more rapidly as we go forward. As far as doses in patients, that’s not something that we’ve commented on. And I don’t think it’s — and Alessandro, I’ll defer to you. But we fill an order that we’re given by a customer. And that customer — or that’s our — that’s what we do. Now we study the market, we do look around corners, and we do assess it. But that’s not something that I think we’re going to discuss today.

Alessandro Maselli: Well said.

Max Smock: Understood. Thank you. Just to clarify, you said 90% ELEVIDYS?

Matti Masanovich: Yeah, 90%. Yeah, you can get to that math [indiscernible]

Max Smock: Yeah. Okay. Perfect. And then just following up a clarifying one, tou mentioned a couple of minutes ago that it’s easy to reconfigure the gene therapy capacity and that capacity is pretty fungible. I just wanted to confirm, you’re saying it’s easy to reconfigure for other gene therapy programs, right? And then while that may be the case, given some of the macro headwinds that we’ve seen, which I think most people would acknowledge have had an outsized impact on the broader cell and gene therapy space, how should we think about your ability to backfill that capacity if Sarepta’s label doesn’t actually end up getting expanded? Thank you.

Alessandro Maselli: Yeah. Look, first of all, I personally don’t see these — Sarepta is not binary dynamic as you guys are depicting, either extended or not extended. But I leave it like that. I believe there is a spectrum there that is more than just binary. That being said, surely, it’s the most fixed part of infrastructure are the suites. And the suites are designed in a way that can serve a number of different processes. What define the processes are the manufacturing units that are within the suites, and they are mostly mobile. So you can reconfigure them in — pretty easily. So fundamentally, it’s one of those facilities that we have in the network which have the highest grade of easiness to reconfigure and to be redeployed towards other programs should we need to do so. At the moment, honestly, I don’t have any visibility that we have to do so because we remain focused working around the clock to satisfy the demand of Sarepta.

Max Smock: Understood. Thanks again for taking my questions and congrats again on a good quarter.

Operator: Our next question comes from Derik De Bruin of Bank of America. Your line is open.

Derik De Bruin: Hi, good morning. Thanks for taking my question. Just a — just one clarifying question to start with and I’ve got a couple of others. So what was embedded originally in your guide for 2024 for Sarepta from a dollar amount, and sort of like what’s the incremental that’s here now? Just wanted to get some math a little bit all over the place. So that’s the first part.

Matti Masanovich: From our original guidance today, it’s remained unchanged.

Derik De Bruin: It’s unchanged. So you’d already assumed that was going — great. Okay. That’s what I thought, just wanted to make sure. And how should we think about PCH margins progressing from here? A little bit lower than we thought in the quarter. How should we think about that moving?