Anthony Doyle: The $88.9 million does include ORLADEYO or sorry, Japanese ORLADEYO revenue.
Liisa Bayko: Okay. Got it. And then any inventory changes in the quarter?
Anthony Doyle: No. We continue to be laser focused on ensuring that we have significant quantities. The cost of sales is really, really low. And so our team does a great job of making sure that we have enough for all of our territories.
Liisa Bayko: Okay. Great. And then just finally, can you maybe just talk about the pediatric expansion opportunity and just kind of qualify that in terms of potential upside? Thanks.
Charlie Gayer: Sure. I think the first point is, as Helen pointed out, there’s just a huge need amongst kids to have an oral therapy. It’s not just the kids, it’s the parents. So I think that this is a very highly anticipated product launch when it comes from the market. We think there are about — in the US, about 500 kids who may be in the consideration for prophylactic therapy. It’s an evolving space because there haven’t been prophy therapies available for kids before and then to have the first oral, it will change. So it’s up to 500 patients for prophylaxis. And then the other piece is just the halo effect, which is another way to introduce ORLADEYO to physicians and the families to patients. And so we expect it to be an important for us.
Jon Stonehouse: And as Helen said in her remarks, when you enroll faster than you thought, that’s usually a really good sign that you’ve got something that people want, and that’s exactly what happened.
Liisa Bayko: Great. Thanks.
Operator: The next question comes from Stacy Ku with TD Cowen. Please go ahead.
Stacy Ku: Hey, thanks so much for taking our questions and congratulations on the progress. So we have a few follow-ups. So first, regarding your Q1 outperformance, what do you think is contributing to this new prescription growth, just characterize these patients a bit more? Is it coming from new prescribers versus current prescribers, just from kind of your patient activation and activities? That’s the first question. And then the second is around your long-term expectations for the Japanese launch of ORLADEYO. Can you just speak a little bit more about what you’re seeing so far in early days and how you feel comfortable kind of long term for that opportunity? And then last, just on 10013. For the partnership, is the team waiting for the full 24-week results before engaging in discussions, and just to confirm, you all would still be getting those results in the middle of 2024 but you do not anticipate disclosing data to The Street? Thanks so much.
Charlie Gayer: Hi, Stacy, so the first question, just in terms of the color on the new growth, it’s very similar to what we’ve seen before. So we’re getting prescriptions from existing prescribers. We’re always adding new prescribers, as more become aware of ORLADEYO and gain confidence. The mix of patients is also very similar. The roughly 50% switching from other prophy and the other 50% best we can tell being naive to prophylactic therapy. So, very consistent and, as I mentioned earlier, consistent to what physicians expect to do in the future. They see a lot more growth coming over the next year. As far as Japan, we think still that there are fewer than 1,000 patients who have been identified in a market that could be 2,500 to even 3,000 HAE patients.
So what the team is focused on right now is driving use of prophylaxis and oral prophylaxis within the diagnosed patient community and just building awareness about ORLADEYO. Longer term, we think that as we’re there with ORLADEYO, other manufacturers are there with other prophylaxis products, there will be more patient diagnosis. And so we expect this to be a growing market for the next five or 10 years. We’re very, very enthusiastic about the opportunity in Japan.
Jon Stonehouse: And then, Stacy, on 10013, yes, we expect the data in the middle of this year. But what matters since we’re not advancing it, we’re seeking a partner to advance, it’s what do they think about the data at the end of the day. And so that’s where we’ll focus our attention.
Stacy Ku: Wonderful. Thank you so much.
Operator: [Operator Instructions] The next question comes from Gena Wang with Barclays. Please go ahead.
Gena Wang: Thank you. Maybe just one regarding the Japan since we have quite a few questions on Japan market. What is the price there? Is that also a 30% to 50% discount of the US price relative — like similar to Europe price? And the second question is regarding the pediatric trial. I noticed it is a single-arm study. What data could be approvable based on FDA feedback?
Jon Stonehouse: Charlie, you take Japan price and Helen take the…
Charlie Gayer: Gena, the Japanese price is actually the second highest price — ORLADEYO price in the world. So at the moment — and then, of course, it’s subject to exchange rate variation. But at the moment, it’s close to $200,000 per year. So it’s higher than our European prices.
Jon Stonehouse: And then Helen.
Helen Thackray: Question on the pediatric trial. It is a single arm, and that’s fairly standard now for what’s called extrapolation of the data. The point is to match exposures in the pediatric population with the exposures that are known to be effective in the adult population. So it’s safety and PK, and that’s what we’ll really be submitted to the agency.
Gena Wang: I noticed you do have also attack rate collection. Will FDA also consider that data point, any like, say, threshold that you have to achieve?
Helen Thackray: So attack rate’s always collected when you’re following patients, and we know the patient is doing well. That will be submitted as part of the data set, but the decision will be based on safety and the exposure.
Gena Wang: Okay. Thank you.
Operator: The next question comes from Francois Brisebois with Oppenheimer. Please go ahead.
Francois Brisebois: Hey, thanks. In terms of the pediatric importance here, you talked about up to 500 patients, but is there a scenario where you’d ever expect the patient to a pediatric to be on this and then turn into an adult and maybe change treatment option? Just wondering too if you can remind us all of the competition on the pediatric front.
