Executive readout · one minute
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Earnings call · FY2026 Q2
Executive readout · one minute
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Management tone
Confident
Net tone +62 · low hedging
Forward guidance
2 guided metrics
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From the 8-K filed Aug 5, 2026.
| Metric | Period | Guided | Basis |
|---|---|---|---|
|
ORLADEYO revenue
Initiated
full year 2026
|
$625M – $645M | — | |
|
Non-GAAP operating expense
Raised
full year 2026
|
$420M – $440M | Non-GAAP |
How the reported period landed and where the business moved.
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this week. And obviously that should probably make prescribers more comfortable too. We have to kind of see what the ongoing trend is. And so it's a little too early to call, but certainly the early signals are very positive. As far as the paid rate, we expect it to at least be in the range of what it's been for capsules. The payer mix will be a little bit different, obviously, because we're not going to have Medicare. So it's going to really be a split between commercial and Medicaid, but the early signs there are good as well. And the pediatric pellets slot right into our contracts that we already have. So it's not like a new lift to get these things on formulary. As far as the ongoing opportunity, yeah, I think the fact that demand has continued to be as consistent and strong as it's been over the last couple of years, plus we're adding new prescribers, just shows that there's still plenty of opportunity out there. And we see that in our market research as well. We also see that new prescriptions are coming very strongly from existing prescribers, as well as obviously these new prescribers that are opening up. So the pattern on that really hasn't changed, and pediatrics can only further help that.
Thank you. And our next question comes from the line of Brian Abrams with RBC Capital Markets.
Hey, good morning. Thanks for taking my questions. Two for me. Maybe first on Nevenibar, just with the enrollment completion and upsizing in that study, just wondering if I guess the upsizing was based on just like higher than expected interest or on any kind of observations on dropouts, the types of patients you're seeing there and sort of any implications for powering. And should we assume this is almost entirely adults with just a few adolescents? And then secondly, it seems like you're with Oral Odeo, you're in a nice steady state with regards to patient retention. Just wondering if there may be any ways you can further improve on that just ahead of potential competitor launch, anything that you might see in upcoming competitor Oral Pro-Free results that could adjust your strategy there just in anticipation of potential additional competitive entrant. Thank you.
Sure, Brian. Let's do the Novena Bart, and I'll take the first part. you take the second part, Cindy. Just on the upsizing note, it had nothing to do with anything about powering. It was purely about patient and investigator interest. And as we mentioned, it was the largest blinded trial ever in HAE, yet it enrolled just as quickly as other recent trials that were smaller. And so I think it's a reflection of the team, excuse me, as well as the profile of the product? Do you want to just talk about the overall powering?
Yeah, so the overall powering, we are already overpowered for the trial, so we don't have any concerns. In this case, it was just a function of more interest from the investigator, so that actually, you know, is a very, very positive sign for all of us in terms of the uptake of how much value the patient, the physicians are adding to this kind of modality and the dosing regimen.
And then as far as patient retention, You know, I think one of the things we always look at is just our operations and how we're performing, and we think that there might be a few things there that we can further improve, but we're pleased with the overall rate of retention. And it really comes down to what we said before, which is patients either do quite well on Orland Ayo, and then they're very sticky, or they don't, and they move on. And so, you know, that's what our market research shows. That's what our real-world evidence shows, and we expect that to continue. One thing we will be looking for is in the pediatric indication, what is the retention there? And that's going to take us some quarters to really see that in the real world. But in the clinical trial in APEX-P, we saw that long-term patient retention at one and two years was above what we saw in our adult trial in APEX-2. So we'll see if that plays out in the real world.
That's really helpful. Thanks so much.
Thank you. So, and our next question comes from the line of Maury Raycroft with Jeffries.
Hi, good morning. Congrats on the quarter, and thanks for taking my questions. For the new patient prescription momentum being maintained in second quarter, is that only driven by the new pediatric patients or prescriptions, or can you provide more context on how we can quantify this and understand contribution from new adult patients versus pediatric patients?
Sure. Yeah, the 12 and up population for Rolodeo capsules, demand was very consistent with what we've seen over the last couple of years. So that was what we expected, but it was also great to see that continued consistent strong demand. And then the pediatrics, off to a great start, that's just upside on top, and we'll see how that progresses over the next few quarters.
Got it. Okay. And then just clarifying with the paid rate at 84%, does that only include the adult population? And wondering if you can comment on just how you expect the paid rate to continue increasing for third quarter and fourth quarter?
Yeah, that does only include the adult population because we didn't have the peds, the pellets out there yet in Q2. And just a reminder, the paid rate also includes patients who are completely uninsured. So that's about 4% out of that 16% that are getting free product. So we feel like we're making great progress and continuing to chip away. Our long-term goal was 85%, but I always say that if we get to 85%, our goal will then go up and we feel good about it. Typically, and I've said this before, in the second half of the year, the paid rate tends to drop off a little bit because the patient mix is driven more by new patients coming in who tend not to get to that 84% quite as quickly. For some of them, it takes longer. And so the typical pattern is, you know, percentage or two is lost over the second half of the year. And then we gain it back in the reauthorization season next year. So I think The end of Q2 is a great point to measure progress, and that's why we pointed it out this year, where we picked up a percent versus last year. Next year, I would expect us to be at or above where we were at the end of Q2 this year. Got it.
Thanks for taking my questions. Thank you. Our next question comes from the line of John Wollobin with Citizens Bank.
Hey, thanks for taking the question. Just talking about the pediatric opportunity. you've talked a little bit before about 500 diagnosed patients and with 10% already seeking prescriptions. Can you talk a little bit about that early dynamic of those where families coming in and asking about oral a day, or you guys getting out there in the community? How do you think about the ramp and then also the diagnosed population as you get out there and talk about it more?
Yeah, again, I mean, John, it's really exciting what we've seen. You pointed it out is close to 10% of that 500 number. What we are seeing in our market research is that physicians, A, are very enthusiastic about prescribing Erlodeo pellets to kids, and B, the availability of an oral prophy makes them think about prescribing to more of their pediatric population in general. And so the early signs are that we could not only get more of the existing prophy patients onto oral prophy, but also grow the market, expand the market, because there should be more like 1,200 kids diagnosed in this age population. And so we're going to be watching for signs that that 500 grows. Early signals are positive, but we're going to need another many quarters to really see how this plays out.
Do you expect to continue giving us pediatric prescription data moving forward?
No, I don't think we'll give you the exact number going forward. We'll give you the overall color on how is demand in general, and we'll probably say how's the demands, you know, directionally going in pediatrics, but we just wanted to give, and you hit the point, it's close to 10% of that 500 number, and so we thought it was significant to talk about it at this point, but we probably won't give the numerical number going forward.
Got it. Thanks, Charlie.
Thank you. I'm showing no further questions. Ladies and gentlemen, we'd like to thank you for participating. This does conclude today's program, and you may now disconnect.
SEC filing · Item 2.02
Filed Aug 5, 2026 · complete as-filed document
SEC periodic report
Filed Aug 5, 2026 · complete as-filed document