This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk06: pipeline for this disease are affecting just the downstream inflammation. So we expect to see healing of the skin and improvement of the disease from that perspective, as well as preventing then the downstream inflammation that causes other effects in the disease.
spk11: And one of the things you see in rare diseases like this where there's nothing to treat it is there are way more patients than you originally estimated, and that's really exciting as well.
spk02: Thank you. The next question comes from Gina Wang with Barclays. Please go ahead.
spk05: Thank you for taking my questions. I also want to add my congrats on the strong quarter. So, you know, with revised guidance, just wondering, where do you see the main increase? Would that be mainly from on-demand patient, untreated patient, or continue to be from the switchover patient? And then for the pipeline assets, just wondering, were you at some point sharing the preclinical data?
spk11: On which program, Gina?
spk05: The lead asset, the pipeline asset, the 17725.
spk08: Okay, got it, got it. Gina, I think what I showed today, we're thrilled that we are getting over 50% of patients from prophylaxis switches, and then we're also getting the on-demand patients and even treatment naive. We expect that to continue, and the market research that I showed on slide 12 shows is specific to patients on injectable prophylaxis. And you can see from that that 50% of those patients have a preference specifically for oral prophylaxis therapy, and three out of four of those patients are willing to switch. And so what I would expect is the same dynamics to continue, about half the patients coming from prophy and then the other half coming from on-demand and treatment-naive treatments.
spk07: While it's great to see that, you know, growth this year and growth next year is going to come from that growth in patient demand, the increase in the guidance for this year, a lot of that's driven by the operational activity that Charlie explained. So it's great to see both things happening simultaneously.
spk11: Helen, you want to take the?
spk06: Yeah, so in terms of sharing preclinical data, we – And we would, of course, publish data in the future as we have excellent results for our pipeline programs. In terms of the Netherton syndrome program, John mentioned earlier the data that we have in an animal model showing changes in the skin. We also have animal model information showing the extreme potency with this molecule. So we would expect to share data supporting both potency and effect. But for the purposes of today, I think it's important to know that we have sufficient information to be ready to proceed to First in Human, and we're very excited about this program's potential.
spk11: Yeah, and we're going to have human data by the end of next year, so you're going to start to get a sense of activity and dose by the end of next year, both in this program and the DME of OralSTAT program, which is super exciting.
spk02: Thank you. Again, if you have a question, please press star and then one. Our next question comes from Marie Raycroft with Jefferies. Please go ahead.
spk10: Hi, good morning. I'll add my congrats on the quarter and thanks for taking my question. Just to follow up on the paid patients improvement this quarter, you said you could potentially get to 85% paid patients over the next few years, but it sounds like you're doing better than expected on this front. At this point, are you able to provide more clarity into when you could achieve the 85% of patients on paid track?
spk08: Hey, Maury. I think the real key with the 85% is that's part of our growth to the $800 million in the U.S. as we achieve a billion dollars in peak sales. We previously mapped out a path to that by 2029. We'll try to get there as quickly as we can, but if we get there by 2029, we will achieve that billion dollars. And based on what we've talked about today, it's increasingly clear that we're going to get there. What I'm particularly excited about, and I noted this in my comments, is the fact that we're at 82% paid already for the commercial segment, which is our biggest segment. And that just shows that we're going to get there. It's just a matter of time.
spk11: And Charlie, is it fair to say that next year could be a really interesting year with Medicare patients in particular? And we don't want to project what we think will happen, but there's a possibility that we could make real progress there as well.
spk08: That's right. There's an opportunity to hopefully get a lot of the Medicare patients that have not been able to afford co-payments and that's led them to be on free product with the full introduction of the IRA next year and the max out-of-pocket for patients going to $2,000. That could be an opportunity that creates more affordability and thus more paid patients.
spk10: Got it. That's helpful. And just to clarify, for the 74.4% for this quarter, you expect that to be consistent for the rest of this year or could that potentially improve some as well?
spk08: We will always try to improve it. The time where we can make the biggest progress is during the big reauthorization season in Q1. And we did a great job in Q1, and then some of that great job bled into the early part of Q2. The rest of the year will be driven more by new patient prescriptions coming in, the opportunity to convert long-term free product over to paid will be less than it was in the first part of the year. Kind of the seasonal cycle that we should expect going forward.
spk10: Got it. Okay, thanks for taking my questions.
spk02: The next question comes from Stacy Ku with TD Cowan. Please go ahead.
spk04: Wonderful. Thanks so much for taking our questions and congratulations on the progress. So we have a few follow-ups. First, appreciate your detailed market research. Our KOLs and survey also tell us that additional injectable entrants are very unlikely to impact oral prophylactic options in HAE. So curious if Charlie or Jinky can discuss long-term where they expect the oral share to stabilize versus the injectable share. That's the first question. And then the second question is, is a question on clinician outreach. So Charlie, can you talk about the progress this year? How many new prescribers are adopting Orladeo? And what percentage are still in the early days of prescribing? Just remind us our goals for this year and what target you might have for next year. And then last, a quick follow-up, just can you elaborate a little bit more on the ex-US versus US split in Q2? Thanks so much.
spk08: Sure. So on the long-term oral share, I mean, Orladeo obviously is the only oral drug on the market, and once a day, you can't get better than that. And we talked about our path to the billion dollars in 2,000 paid patients in the U.S., and so 2,000 out of over 11,000 total patients, you can imagine Orladeo is going to get to at least about 20% share. We'll see what happens with other products in the future, but we're very confident in our overall growth. As far as prescribers, we continue to see new prescribers coming on board. And we've talked before about our Tier 1 doctors that cover about 50% of the market, sort of 500 to 600 doctors there, and then the bigger Tier 2 group. Q2, we got equal number of prescriptions from both of those groups. So very continues to be very balanced. And we had, um, uh, a very similar number of new prescribers to what we've seen in, in recent quarters. And as far as kind of, um, uh, adopters in the tier one group, we're now to the point where over 70% of them have prescribed. And we keep chipping away at that number. We may never get to 100% with them, but we're going to get close. And all the metrics we see is doctors across the board intend to do more.
spk11: Hey, Charlie, on that 30%, can you talk about how things like more prophy medicines come into the market and the noise of prophy going up can be an opportunity and the PEDS opportunity as well?
spk08: It's a great point John brings up. So we have two big opportunities. One, we do expect... other competitive injectable products to launch. One may come as soon as the end of this year. And with that, there's just going to be more conversation around switching patients, more treatment options, maybe lower burden treatment injectable products. And so we're going to take advantage of that because we have the product that patients want with an oral once-daily therapy. And then PEDS that we intend to file next year, that is an opportunity in itself, but also there's the halo effect from that. It's a genetic disease. They're families, and then they're doctors, where this may become their first real experience with Orlodeo, and starting with the kids, and then they maybe move on to the rest of the family. So both of these are opportunities over the next couple of years for us.
spk11: Yeah, for these KOLs that tell us, you know, it's not broke, don't fix it, if they've got a pediatric patient on injectable, it's going to be pretty hard for them to not want to switch to an oral. So we think that's a real opportunity to have that conversation with them. And then ex-U.S., Charlie?
spk08: Yeah, ex-U.S., what we see is the same consistent pattern of demand. We see many of the ex-U.S. countries moving increasingly towards prophylaxis. For market access reasons, they may never get to quite the same levels of the U.S., But we're seeing PROFI become the standard of care for patients and Orladeo to be growing very strongly. And patient retention, too, has been very consistent with what we're seeing in the U.S. So Europe, Japan, Canada, Eastern Europe, we're starting to launch now with our partners in Latin America a lot of opportunity and a lot of excitement about Orladeo coming to the market.
spk04: Wonderful. Thank you.
spk02: And the next question comes from John Wallenben with JMP Securities. Please go ahead.
spk09: Hey, good morning. Congrats, and thanks for taking the question. Just a couple more for me on the market sizing updates. I'm assuming in that 8,500 you guys gave us, that's including acute and prophylactic patients, but wondering if you had any sense of reasons why that other 2,600 or so are not being treated, and then do you have any sense today of what percentage of treatment IA patients are going to Orlodeo first?
spk08: Sure, John. Of the AD500, that includes patients that are in HAE-specific medicine. So when we do this analysis, we look at all the prophy products. We also look at all the acute, the modern prophy products, I should say, so Orlodeo plus the injectables, and then the acute therapies. So that's what's included there. You saw the data where we're attracting 17% of Orlodeo patients launched to date have come from the treatment naive. And what that tells us is that that treatment naive group is going to increasingly become a treated group. Some of those patients are probably just becoming aware of their disease or their physicians are starting to become more aware. about HAE, and so again, it may never reach 100% of those patients treated, but we expect more and more of them will be treated, and it's a great opportunity to help more patients.
spk09: Okay, but you don't have a sense from market research or what you're seeing in claims, like a new patient coming in the system is preferring Orladea or Texairo?
spk08: I knew I was missing one part of your question. We do. Orlodeo gets, we have at least 50% of those patients in our market research get Orlodeo first before other prophylaxis products.
spk09: That's helpful. Thanks, Charles.
spk02: The next question comes from Sergey Bellinger with Needham & Company. Please go ahead.
spk03: Hi, good morning, and congrats on another solid early zero quarter. First one, given the nice growth we've seen over the first half of 2024, can you tell us a little bit about where you are in terms of market share in the market? And then maybe for Charlie, regarding the prescriber survey, we've seen a pretty drastic increase in the likelihood of prescribing year over year. Just curious, what do you think drove that increase over such a short period of time. And if I'm not mistaken, you've conducted a survey, I think, every year. Just curious how it is, how predictive it is for future use and uptake of Rolodeo. Thanks.
spk08: Sure. As far as share goes, Serge, I'll point you back to the 2,500 prescriptions we had at the end of last year. Some of those, of course, are repeat patients who had dropped off and come back, but I think that's a pretty good marker, roughly, of where we are. So depending on how you want to do the math, either of treated patients or of the total market, we're probably nearing 20% market share, roughly, a little bit below that, but growing very strongly. And then as far as kind of the, you know, the indicators of increased prescribing and the Physician confidence. I think it's it's what I said in my remarks. They're just they're Experienced they're learning more about the data and they're seeing it in their patients so I think the best way for a physician to learn about this drug is to try it in their patients and And see how well the patients respond and that's why you know of current prescribers Now, 52% of them say they are extremely likely to prescribe more because they are seeing the response in their patients. And, you know, we do these surveys every quarter, and we always ask physicians, what are you going to treat your patients with over the next 12 months? And what we've seen over the last year is that the drug they see to grow over the next 12 months is Orlodeo. that is where they see the most growth in the marketplace. And I think it's because of what they're seeing with results in their patients.
spk02: This concludes our question and answer session. I would like to turn the conference back over to Jim Stonehouse for any closing remarks.
spk11: Yeah, I'd just like to wrap it up by saying, again, what I said before. It was an absolutely amazing quarter. It's two in a row now. The momentum we have, we see no signs of it slowing down. We're now having revenue over $100 million per quarter. And you should ask yourself, why is this happening? It's because this drug really works, right? When a patient... Sees control. They have the same kind of control they had with any other prophy medicine they were on before, and they get it with a once daily oral medicine. And that is why we're seeing this great success. And then the last thing I'd say is thanks to the commercial team for just having an outstanding performance and continuing to build the momentum in this company. Thank you.
spk02: This concludes our question and answer session. would like to thank everybody for joining today's presentation you may now disconnect Hello. Thank you. Thank you.
spk00: Thank you. music music you you
spk02: Good day and welcome to the Biochrist second quarter 2024 earnings call. All participants.
Disclaimer