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

Unidentified Analyst: Okay. Thank you. And then just a quick follow-up on LCD more as it relates to iDose. So iDose specifically mention LTV, but it looks like — I mean, that they’re asking for more — just more better data like they want 24-month published data for a broad label. Can you tell us when Glaukos would have 24-month data published for iDose? And do you think the Phase IIb data will be good enough to meet qualifications or we need Phase III data? And — and just lastly, like it seems like with eliminating the stacking, would — I mean, would that mean a physician would not be able to do an iStent plus iDose and get covered for it? Thanks for the question.

Joe Gilliam: I’ll start and Tom may want to comment on this one as well. I think as it relates to iDose, first and foremost, it’s not covered by this LCD. It’s a pharmaceutical, as you know, and at this stage is not within the purview of the LCD that was released by WPS. So I think that’s a different conversation entirely, and so we have to take that into consideration there. As you, I think, drew the line to sort of that broader evidence, I guess what I would say is I’m not sure that we will have ever — if we’re fortunate to get approval as we expect, that we’ll ever have launched a product that has more evidence behind it than iDose will at the time of the commercial launch. You’ve heard Tom reference on prior calls, the sheer number of peer-reviewed publications that we expect to have the totality of that evidence the number of patients within it as well as the long-term evidence is contained within it.

You’ll recall that we’ve already shown multiyear evidence in support of iDose out of our Phase II studies. And ultimately, we’ll expect to do the same over time out of our Phase III study. So I think the overall evidence there, we feel stacks up pretty good against any requests that may come from any payer, including the MAX.

Tom Burns: Yes. And I would just add. I mean you think about the Phase IIb data we’ve carried out now, hopefully, with some impressions now out for three years. And those three years data, as we all know, show that 70% of those patients are controlled on the same or fewer meds versus the current standard of care from a topical standpoint, Timolol, which was 46. And so the data is profound, it’s robust, and we believe that it will — in any discussions with any payers in the future will serve us admirably to be able to receive fair and prompt payment.

Unidentified Analyst: Great. That helps and again, congrats on a nice quarter.

Tom Burns: Sure.

Operator: All right. Our next question comes from the line of Matthew O’Brien from Piper Sandler. Matthew, please go ahead.

Unidentified Analyst: Hi. This is Phil on for Matt. Thanks for taking our questions. For start is on glaucoma trends specifically, what was it about August that led to that pronounced seasonality? And how has that seasonality trending in Q4 and as it relates to guidance, what’s baked into that sequential step down in revenue? Is it more a function of working down that competitive inventory ahead of these LCDs taking effect? Or is it really more a positive in front of CMS’s final rule?

Tom Burns: Yeah. I think, well, first, in the context of the third quarter, what we saw in August was perhaps a new normal in the context of seasonality, but it was a little bit of an aberration versus what we’ve seen in the last couple of years. I think it was more similar quite frankly, what we saw back in 2019 in terms of seasonality than what we’ve seen in 2020 through 2022. And it really was just a softening of demand. It was across all of our U.S. procedures, glaucoma and corneal health in a pretty similar fashion. And in both those franchises were offset by strength in both July and September, strength that, to your question, has continued in October. When you think about how that translates into our 2023 guidance, we try to take into consideration a variety of variables as we exit the year.