Glaukos Corporation (NYSE:GKOS) Q3 2023 Earnings Call Transcript

Tom Burns: And then as it relates to — I think the second part of your question, Joanne, which I’m not sure if that was more towards the expense side or the overall planning. But yes, we’ve been in product launch planning mode for quite some time. We’re now getting into the finer points of what that means from an expense perspective going into next year, how we balance that against other priorities. We do have a lot going on. Thankfully, we think there’s a lot of opportunity with each of those. And so we’re going to be putting quite a bit behind iStent infinite, as we enter into 2024, with hopefully, more fulsome reimbursement coverage. And then ultimately, iDose on the commercial side, while we continue to invest in our — what we think is a pretty full pipeline of rich opportunities.

Joanne Wuensch: So just to push a bit, is the 10% increase annually in 2024, a reasonable starting point? Or is it much higher than that given everything else?

Tom Burns: I think we’ll comment on that, Joanne, when we get to the next quarter’s call and we talk about our guidance in 2024 and what the operating expense profile would look like.

Joanne Wuensch: That’s all I got. Thank you.

Operator: All right. Our next call comes from the line of David Saxon from Needham. David, please go ahead.

David Saxon: Great. Good afternoon, guys and thanks for taking my questions. Maybe I’ll start with a quick one on iDose. So you guys obviously completed the inspection and mid-cycle review in August. You mentioned a draft label. So when do you expect to receive that? And when you do, is that something you’re going to share with the investment community and then aside from that, any other milestones to call out before December 22?

Tom Burns: Hi, David, I’m happy to answer that. So we would expect to receive the draft labeling in the near term, let’s call it, the next several days. And that begins the process and that process is the FDA gives their best estimate of what they think the label should be based upon the data that they’re reviewing. And then ordinarily and routinely, there is provision for response from the company to shape that label or to contest it to the extent that they disagree with the FDA’s position. So there’ll be a period of negotiation which will occur prior to the PDUFA date and the final, we hope, favorable FDA clearance. And I think as you can probably respect that, that will be something that will be done privately and that we won’t share prior to the PDUFA date targeted clearance.

David Saxon: Okay. Got it. Thanks. And so I guess no other milestones after that. And then I’ll just throw my second question in here in the document you posted, it looks like — you got a PreserFlo study starting in the first half of next year. Does this address the concerns the FDA had raised previously? And then what’s your estimate on timing to potential approval of that product. Thanks so much.

Tom Burns: Well, I’ll be happy to address them as best I can. I mean I wouldn’t — I put it as saying that we’ve taken a more, I believe, a novel approach in relooking at how we might evaluate the safety and efficacy of the PreserFlo device given our substantial experience in the area. So we’ve had those discussions. We’re finalizing an IDE with the FDA — and we are encouraged that we’ll reach a conclusion, a successful conclusion to opening up that study and beginning to study that product in the early part of next year, certainly within the first half. This will be a second bite of the apple. And I think with our informed kind of skill in the art we hope to be able to bring it to a successful conclusion. I wouldn’t comment on date too many things — we’ll enter into when we could potentially commercialize such as rate of adoption and clinical enrollment, et cetera.

But I will tell you that I feel very confident we’ll be able to start that study in the first half of next year.