Vaxcyte, Inc. (NASDAQ:PCVX) Q4 2022 Earnings Call Transcript

So, it’s more than just the coverage advantage. It’s also the maintenance of the no longer circulating strains. So that is a big opportunity for us in the adult space. And then your reference to the otitis media is another aspect of the potential advantage as it relates to the infant indication. So Jim, maybe you can talk a little bit about that.

Jim Wassil: Yeah. And I’d say first in the infant, VAX-31 will increase coverage against IPD by about 25% or more from what would be the standard-of-care if PCV20 makes it through the fluid stage , even more so, it’s referenced against PCV15. So, there is still a substantial impact on invasive disease. But in terms of otitis media, especially 35B serotype, there’s a lot more contribution to otitis media and these incremental strains that are in VAX-31. You get 48% increase in coverage of otitis media. And when you think about it, the incident rate is almost to the point where every kid gets at least one year in . So — and if about 35%, 40% of those are of Strep, you can see that that’s a ubiquitous disease. So, this incremental 48% could have a substantial impact obviously on medical expenses, but also on antimicrobial resistance because it’s one of the main drivers for antibiotic streps in this young age group as well.

So that’s why we’re excited about this for otitis media.

Seamus Fernandez: Thank you.

Operator: Thank you. One moment while we prepare for the next question. The next question is coming from Joy of Evercore. Your line is open.

Jonathan Miller: Hi. This is actually Jon Miller on Evercore. But I’d love to ask about manufacturing expansion that you’re talking about. Obviously, this is — you’ve talked about only being able to currently do the U.S. But what would it take to do a much larger manufacturing footprint? Is this something that you could do in-house? Would this be a larger Lonza deal? And maybe if you could put some bookends on how much a full-size manufacturing footprint might cost in various scenarios.

Grant Pickering: Yeah. Hey, Jon. Thank you for the question. We’ll tag-team this one as well. I’ll have Andrew bring it home. But just in terms of order of magnitude, I think the way people should be thinking about that U.S. adult launch related capacity in the tens of millions of doses. Whereas when you ultimately get into the full-fledged adult and infant and sort of global reach capacity, PCV demand does get into the greater than 100 million doses per year sort of territory. So, we’re talking about that sort of line of demarcation. And then as it relates to the second part of that question, I’m not quite sure how far Andrew will be able to go. But I’ll hand it to Andrew.

Andrew Guggenhime: Yeah. Jon, again, thanks for the question. We are looking at different options in terms of strategy. That includes doing it on our own facility, using Lonza, with whom we have a great and longstanding partnership and other CDMO options as well. And obviously, the magnitude, it will depend on the route we take. And when we pull the trigger, that’s something over the next 12 to 18 months, we’re likely to do, so we can ensure we have the necessary capacity to meet the demand, subsequent — few years subsequent to the launch. Probably premature at this time to kind of range the options, but we’re hoping to be in a position to do that in the not-too-distant future as we get further down the valuation.

Jonathan Miller: Okay. That makes sense. Is this a sort of thing that you expect Lonza that would have the capacity to do already if you ask them tomorrow to do it?

Andrew Guggenhime: Well, we can — as Grant noted, we can satisfy the expected demand in the adult population in the U.S. out of the existing facilities. As to whether Lonza today, that’s one of the evaluations that likely — they have basically still custom dedicated space for their clients. So, it’s likely we would need to work and partner with them to develop, build that capacity. So that’s something that we’re looking into, but it would likely be an undertaking.