Francois Brisebois: Understood. And then can you just help me understand a little bit the U.S. versus ex U.S. dynamics in terms of the growth and your assumptions and expectations. Are there challenges, maybe ex U.S. that aren’t happening in the U.S.? Just any color there would be helpful. Thank you.
Charles Gayer: Sure. Ex U.S., first of all, once we — the biggest challenge or the biggest time factor is getting market access in an ex U.S. market. And so that always takes longer, and we have countries rolling on all the time. So a number of countries in Europe, for example, like Germany, U.K. and France, we got market access a few years ago. But we’re just now getting market access in others like Spain and Italy. And so that’s one factor. Pricing is a lot lower ex U.S., so it takes four to five ex U.S. patients to add up to one U.S. patient. So our strategy is very much a volume strategy outside the U.S. And then finally, what we’re seeing in the real world in these countries where we have market access and we’ve launched is the same consistent pattern of patient adds, depending on the market — the HAE market dynamics.
Sometimes that’s patients switching from other prophylaxis. Sometimes it’s growing the prophylaxis market with a drug like ORLADEYO. At peak, we expect ex U.S. to equal about $200 million of the $1 billion in sales and what we see so far gives us confidence that we’ll get there.
Jon Stonehouse: And if [TechSiro] (ph) is an analog here right at the time that the U.S. starts to flatten out, the ex U.S. continues to grow, so you have overall growth of the brand still. So that’s what we’re expecting right now.
Francois Brisebois: Understood. Thank you very much.
Jon Stonehouse: You’re welcome.
Operator: The next question comes from Maury Raycroft with Jefferies. Please go ahead.
Maury Raycroft: Hi. Good morning, and thanks for taking my questions. Just wanted to ask a clarifying question on the seasonality this quarter. Is that for the same reason as in first quarter ’23, where there were budget issues with external charities which increase the number of patients on free drug program? Or what are you seeing this year so far?
Charles Gayer: Sure, Maury. That’s one of the situations, the Medicare issue — we’ve got a little bit of insight into that. What I’d say is it’s not solved yet. It doesn’t seem to be worse than that, but it’s not solved. We think next year, as I said earlier, with the IRA rolling in fully, we have expectations that, that budget issue will be more solved in 2025. The main reason for the dip in Q1 is the broader percentage of patients getting reauthorizations. And when that happens, we have to drop many patients back temporarily to free product. And then also in the first quarter, it’s the highest hit to gross to net, because in the commercial market, we’re helping pick up patient co-pays and the majority of that happens in the first quarter. And you’ll see a corresponding nice pop in the second quarter when we get those people back to paid.
Maury Raycroft: Got it. Makes sense. And one other quick question. what proportion of the 321 new patients are on short-term quick start? And how long on average does it take to convert these patients to long-term pay patients?
Charles Gayer: The $321 million was the net growth across the whole year. So what we did say is that we ended the year with 1,000 — sorry, 1,104 patients on either paid therapy or long-term free product. There was also a sizable chunk of patients on short-term quick start, new patients coming in. And it usually takes us — we get the product out very quickly. For most patients, we get them to either paid or from free product within about a month.
Maury Raycroft: Got it. Okay, thanks for doing my questions.
Jon Stonehouse: You’re welcome.
Operator: Your final question today comes from John Wolleben with Citizens. Please go ahead.
Unidentified Analyst: This is [Catherine] (ph) on for John. I had a question about how you’re thinking about profitability versus your earlier pipeline kind of prioritizing those? And then just a question about the data coming? Is it still coming in midyear for the PNH trial? Thanks.
Anthony Doyle: Yes. I think we’ve been very clear about our past profitability. Very excited to get to the point where we’re independent of capital markets. We’ve been seeing over the past years that convergence of the lines between revenue and OpEx. We continue to see it this year and beyond. So being able to generate an operating profit this year getting towards both cash positivity and EPS at the end of next year and then achieving it in 2026. I think it puts us in a right spot. We do that at the same time as continuing to invest in that early phase pipeline. So the two things coexist and actually the opportunity to be able to invest in whatever we can do to move as fast as we can in those periods because that early phase pipeline that we generated in — or that we announced in November is, in fact, early phase, puts us in a spot where the expenditure within the next kind of 3 years is not as meaningful as it would be when you get them to pivotal trials.
So I think the company is in a great spot. And if there’s anything we can do to accelerate, we absolutely will.
Jon Stonehouse: And there’s nothing to update on 10013, nothing has changed on the time line.
Unidentified Analyst: Thank you.
Jon Stonehouse: Welcome.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Jon Stonehouse for any closing remarks.
Jon Stonehouse: So one of the things that we’re hearing from investors is they have so many things coming at them, and it’s hard to keep up with the opportunities to invest in. And if you’re in that camp, a question you may want to stop and ask yourself is how many companies do I have in my portfolio that have a growing product, have a discovery engine that created the growing product, have a pipeline that came from the discovery engine that’s going to create another growing product or more and has an accelerated path to profitability, where we’re probably going to be cash flow positive or near that in the second half of next year. And if the answer to that is none or too few and you want to diversify your pipe, your portfolio, reach out to us. We’re happy to get you up to speed on our company and answer any questions you may have. So have a great day, and thanks for your interest in BioCryst.
Operator: The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.
