BioCryst Pharmaceuticals, Inc. (BCRX) Earnings Call Transcript & Summary

Good morning. Welcome to Needham's 21st Annual Healthcare Conference. I'm Serge Belanger, one of the healthcare analysts at Needham. We're happy to have the -- a big contingent of the BioCryst team with us this morning to give a presentation on BioCryst. So to start off, I'll hand it over to Jon Stonehouse, who can introduce the team and give us an overview of the company as well as some of the recent developments. So Jon?

Thanks, Serge, and thanks for inviting us to your healthcare conference. With me today is Charlie Gayer, our Chief Commercial Officer; Anthony Doyle, who's here in the office with me, our Chief Financial Officer; Nick Wilder, who is on John Bluth's team in Investor Relations; and John Bluth with Investor Relations. We're all going to be making some forward-looking statements and those statements have risks, and the risk factors can be found on our website. So let me start with the most recent news. I think it's important that we share with you, and then we can get into some of the questions just what's the status of what's going on with 9930. So as we had put in a press release last Friday, we saw elevations in serum creatinine in patients that were on 9930 in the trial. And so we consulted with numerous experts, investigators, Chair of the DSMB and others, and we made 2 conclusions. One, it was serious enough that we should pause enrollment, but we also made a decision at that time that we would continue dosing of patients that were currently in the study. And the reason for that was that the benefit of controlling, for example, their PNH outweighed the risk of elevations in serum creatinine. Now one thing I really want to stress, and this is one of the reasons we can't give you a whole lot of information, is it's a really fluid situation and things could change from day to day, from hour to hour. And so while I know there's a real desire to get updates, we can't keep -- we'd rather put our energy towards figuring out what's going on than trying to keep everybody updated to the minute. And so things like regulatory discussions, I mean, we've informed the FDA, but they could put a hold on us tomorrow, right? And today, we're dosing patients, we could find out that things change and we stop dosing patients. And so the goal is to figure out as quickly as possible what's the root cause of what's going on with the serum creatinine elevations and then figure out a path forward. And I've talked about the bookends, they're obvious if we either continue enrollment of the trial or we stop the program. And we're working as fast as we can. It's complicated. These are complicated patients. And so getting to the root is just takes time.

Great. And before I start, I just want to -- for those listening online, there is the option of asking questions via the portal. We'll be looking at that and taking questions as they come in. So Jon, right kind of an overview here, but maybe just talk about the fact that the FDA hasn't pushed you on a clinical hold yet. Is that just -- is that a positive sign or it's a sign that where the investigation is just getting underway?

Yes, I don't think we should conclude anything about the FDA at this point in time. Because of the fluidity, things can change very quickly. It was our decision to do the voluntary pause in enrollment, and we did that with input from our investigators, advisers and the like. But again, things could change at a moment's notice. And so I don't want to characterize what the FDA views right now. And I wouldn't characterize it as positive for now because it could be today, and it might not be tomorrow.

Okay. And in terms of the investigation process, maybe just if you can walk us through that?

Yes. I mean, we're trying to get to the root cause, right. How extensive is it? How severe is it? What's the cause of it? And can we manage it or not, right? Is there things that we can do from a dose reduction? Is it reversible? Is it transient, right? Is it monitorable? All of those things need to be sorted out. But you got to remember that these patients are also sick, right? The reason they're in our clinical trial is we're treating them for PNH or a renal disorder, and so there's a lot of comorbidities that go with that. There's a lot of polypharmacy that goes with that, and so sorting through that is complicated and it just takes time.

And I don't know if you have disclosed number of patients affected by this, but are they mostly PNH patients or they were also part of the basket study that you initiated earlier this year?

Yes. We haven't commented on where the patients are coming from, but we have said in an 8-K that we filed on Monday that the majority of patients that have been enrolled thus far have been in the PNH study. And that should be obvious, because we started those studies prior to starting the basket study.

Okay. So as you said earlier, there's 2 extreme outcomes, either resume enrollment or the other one is halt development of the program. Are there any other things in between that will be contemplated at the same time?

Yes. There's a bunch of options in between. But at this point in time, I don't want to get into them because what matters is getting to the root of the matter and figuring out what's going on here, and then we'll have a very good idea of what we do next.

Okay. And just thinking about impact. You have given OpEx guidance, how does that -- can we think about how that changes now or it's still too early to really look at that?

Yes. I think it's important to finish the investigation and know what we have or don't have as a result. But obviously, 9930 was a big part of the expense last year. Anthony, I think it was what, 60-plus percent?

Yes. 63% of total R&D last year was on the Factor D program.

Yes, and Anthony has guided that it's an even bigger chunk of the $440 million to $480 million this year, so it would be a significant decrease if we stop the program. You don't want to save money by stopping a major program, but it would have a big impact on our financial situation in terms of way less burn.

Okay. And earlier this -- or late last year, you completed some transactions, some royalty financings that are tied to 9930 revenues. Just trying to think ahead, and in the worst-case scenario, what happens to those funding agreements?

I think we did the deals with RP and they've been a great partner to us over the last couple of years. Those amounts are not at risk, and so we will do everything in our power to make sure that the partnership that we have with them is successful. They also have substantial revenues as our royalties associated with the revenues for ORLADEYO, which we're doing really well in. So again, too early to say until the investigation concludes. But from a kind of risk perspective as it relates to those RP amounts, there is no risk.

Okay. And one question that came in is, these elevated levels of serum creatinine weren't -- well, I don't think they were observed in the Phase Ib trial. Curious if this is a drug class effect that you'd seen in other development programs?

Yes. I think your point about previous studies is one of the complicating factors, right? The healthy volunteer study, the MAD would probably be more appropriate in the situation than a single dose. And then the Ib, where we reported out, I think, at the last point in time last year -- late last year, 15 PNH patients that were on drug, some of them close to or up to a year on therapy. And yes, we didn't see this, so that makes it more confusing honestly. And so sorting through that is really important.

Okay. And obviously, this is a pretty significant adverse event. So is it prudent to think that if the FDA doesn't issue a clinical hold in the next few weeks, this would -- it would be a positive sign going forward?

Yes, I'm not going to agree with that at all. I think, again, the fluidity of this, I mean, we're still dosing patients as of today and something could pop up that could change our outlook, and that's why the investigation is so important. And I really don't want to categorize the regulators because that can change as well.

Okay. I guess before we move on to ORLADEYO, maybe just give us an update on how enrollment had been going in these trials? And you had previously talked about timelines for readouts. Maybe just give us an overview, and obviously, like you said, it's a fluid situation so they're subject to change, especially now.

Yes. We were in the early phases of enrollment, and so we were still in the start-up phases with a lot of sites. These are -- we cast a broad net on sites around the globe, and our expectation of contributions was 1 or 2 patients per site. It wasn't like one site is going to generate a dozen patients or something like that. So we're in the very early stages of the PNH trial, which is the majority of patients enrolled thus far, and even earlier stages with RENEW in the renal study.

Okay. Before we move on to ORLADEYO, any other issue regarding this that caused confusion or misconception that you'd like to clear up?

No, I think we've been pretty clear in what we can say, right? And that is what we're doing and then how fluid the situation is. And the other thing I'd like to remind investors about is that BioCryst has got a drug that we believe is going to generate no less than $250 million in revenue this year on its way to peak of $1 billion. And Charlie and team have done a fantastic job in the first year launch, and our expectation is we'll do much better in the second year of launch, and we have a high degree of confidence in that no less than $250 million and so financially, we're in a really solid spot, and we believe in our platform. I mean, unfortunately, in our business and in drug development, there's risk. We all know that. And when you get into bigger studies, things can happen that you didn't anticipate. And so we'll see how this plays out. We'll complete -- we appreciate the patience of investors as we go through the investigation and as soon as we have clarity, we'll communicate that.

Great. Okay. Moving on to ORLADEYO. I think you guys surprised everybody. I don't know if you surprised yourself, but definitely, it was a launch that exceeded investor expectations and probably most of the analysts' expectations, including ourselves. So just maybe review why it was such a success in the first year?

Well, let me start, Charlie, because he's not a bragger, and so I'll do a little bit for him. But yes, I mean listen, Serge, you weren't the only one, right? The consensus was $30 million at the -- before we started selling, and we sold $122 million. And so we -- you said, did we get surprised? No, we didn't get surprised. We had been saying this for well over a year that when we did the market research with the profile that we had, one, a lot of patients stayed in our studies because they were doing well on our drug. And now we have long-term data that suggests that patients do really well on ORLADEYO. And two, we knew this was a switching market. And switching to an oral if you believe you have a shot at being controlled and tolerating one capsule once a day is life -- can be life-changing for some of these people. And so those 2 things are what made this success with 1 addition, and that is we have a great team that executed a really thoughtful plan, and that's where Charlie deserves a big pat on the back, and his team deserves that as well. Charlie, I don't know if you want to get into some of the details of what led to the execution and the conversion from people from injectable prophy to ORLADEYO.

I think, Jon, it's like you said. We really made sure we understood this, and so we focus on the fact that ORLADEYO is a drug that can help any HAE patient, and we were convincing physicians and patients of that. So the evidence is that half the patients on ORLADEYO today have switched from another prophylaxis product. Most of the other half switched from acute only, and that's exactly what we set out to do. And the more we communicate that to -- particularly to physicians, that gives them even more confidence in prescribing ORLADEYO. As they see our long-term data, they see how well people are doing after 96 weeks in our clinical trial. With an 86% reduction in attacks, getting down to about half of the attacks per month, patients do really well. And then we've really done a nice job on the access front and helping patients get reimbursement coverage, helping them get access to therapy. And we're hearing again and again from customers how important that is in the mix, too. So it's the great drug, the great team, the great access is what's making this happen.

Would you estimate your number of current patients on treatment or market share currently coming out of 2021?

We haven't given specifics on market share and the numbers of start forms and things like that. But Charlie, I think you can give a lot of color on where it's coming from. What do you see in month-to-month, quarter-to-quarter in terms of new starts, that kind of thing?

Yes, it's -- I mean, in 2021, it's -- we saw -- you exclude our clinical trials. We saw very consistent demand, new patient starts every single quarter. And the trends that I was just mentioning have been also consistent, so where are we getting the patients from. It's always been 50%-plus switching from other prophylaxis. So what's happening here is we are contributing rapidly to a trend that was already in place, which is the market is moving towards prophylaxis as the standard of care. And we see the opportunity for ORLADEYO to be the #1 prescribed product someday. We're not there yet, but as we talk about that $1 billion at peak sales, we believe that, that gets us to being the #1 prescribed product in the marketplace by continuing these trends.

Okay. And as you think of future growth, as you mentioned, about half are coming from the -- half of the patients are switching over from the injectables, the other half are coming from acute or no treatments. As you think of future growth, which one of these pools maybe starts drying up first? And -- or maybe it doesn't, maybe it continues to be 50-50 through the growth -- the entire growth trajectory of the product.

I would say, at least in the -- for 2022 and probably beyond, it's going to continue to be the same. We're going to pull from both. I think putting it in context in the U.S. market, when we launched about 60% -- our data showed about 60% of patients were on one prophylaxis or another. More recently, we think that's up to at least 70%, and research says that will go -- what doctors says that will go to 80%, maybe north of that. So the switching from prophy is going to continue to be a big driver, but we can keep expanding the market. So I think both pools of patients will be very important for our growth.

Yes. And I think getting them from both is really important because I do believe that the acute market will dry up at some point in time. I think the bulk of acute therapy is going to be breakthrough attacks that people have that are on prophy. And so being able to draw from both is really important because we're not the only ones driving that switching from acute therapy over to prophy. Our competition is doing the same. As more injectable therapies come out, you're going to see more of that behavior from acute to prophy. So being able to get those injectable patients on prophy to come to our drug is a critical part of our strategy and our success.

So most of the products we follow, I would say, all of them have been affected by COVID, almost all of them negatively. I know you've launched during the pandemic, so you've never known a non-COVID world for the product. But curious what you think the impact was on the launch, and what you could benefit from as we come out of -- well, we think we're coming out of the pandemic, at least restrictions are definitely easing. Just curious what kind of tailwinds that could provide?

I think you're right, Serge. We did -- we knew we were going to launch in COVID, and the team did a fabulous job preparing for that and executing in COVID. So we never make excuses about COVID. What I'll tell you, the things -- the biggest things that we missed that are starting to change is live meetings. Not sales calls, but like live events with both doctors and patients, and particularly the patients. Patients in the HAE marketplace are used to going to educational events regionally, nationally, and that hadn't happened much at all in the last 2 years. That's a big part of our focus for this year is driving patient education events, bringing patients back together so that they can learn about ORLADEYO, learn from each other. And that -- as we're able to do that, that can be a tailwind for us. And then the physician events, starting our first big National Congress at the college in November, that was the first time we'd had a big physician event since launch. We just had Quad AI about 1.5 months ago, and there will be more events, we think, more or less back to normal this year. That's really important, too, because doctors talking to each other about their experience with ORLADEYO as they learn about it. It really opens their eyes and makes them think differently about how they're going to use this product.

Okay. So it's really kind of an education and awareness, more education and awareness than anything. But did you feel there was any impact in physicians not switching patients from an injectable to ORLADEYO just because there was less physician-patient interactions than usual?

No, not really. I mean, we even heard cases where physicians were willing to prescribe because an oral drug was easier. It didn't require the same injection training or anything like that, so they could -- some doctors even prescribe remotely. I think the big thing in the HAE marketplace is patients these days, as Jon mentioned, 8 drugs in 12 years. Patients have great options, and they're doing so much better than they were a decade or more ago. So as a result, many of them don't see their doctor as often. They may come in once or twice a year, irrespective of COVID. And so a big focus for us is when those patients come in for that visit, we'll do everything we can to accelerate that. But at least when that visit happens, we want there to be a good conversation. We want the patient to ask about it. We want the doctor to present offer for ORLADEYO, and so that's a big focus for us.

Okay. And just next, I want to talk about product access and reimbursement, usually a pretty important component for any product launch. I guess, where are you at in terms of the product reimbursement? And has there been any changes starting in 2022?

We're really pleased with where we are. Our market access team has done a phenomenal job with this. We have -- as of -- the last really big win was the last major PBM established an ORLADEYO coverage policy right at the end of 2021, so that rolled in at the start of this year. So it means all major PBMs and payers nationally have coverage policies that should cover about 80% of the U.S. HAE population, which is very competitive. The biggest thing for access then is helping patients -- when ORLADEYO been prescribed. Payers never make it easy. There's prior authorizations that happen for everyone, and so that's where our service model kicks in with Empower Patient Services. And what we're hearing from doctors and from patients is, our model really makes a difference. They've been incredibly impressed with how well that team helps patients get access. So it's -- we've got the policy set, and then we make the process as you take away as much of the burden as possible. And that's becoming a big part of our overall proposition for ORLADEYO that customers appreciate.

Do you -- it's often in the first quarter, sales are impacted because of the reset of deductibles, reset of plans. Does that create an additional opportunity for switching between an injectable and maybe an oral like ORLADEYO?

I think we look at opportunities everywhere. I mean, we'll comment more on Q1 in the not-so-distant future, but we're always looking for opportunities for switching. I think the biggest thing is Q1, as you're alluding to, is we expected, and we talked about this, is that prior authorization process means that some of the patients would have to step back to free drug while the authorization was going on. So that's why we guided to expect flat to minimal growth in Q1 because of that process that we help the patients through.

Yes. And you don't want to lose patients in that process, right? So the free drug is a really critical piece to it.

And then just on pricing, I think you took a 3% price increase back in February. Just curious where the price now stands relative to the injectables, I guess, from a WACC perspective as well as all-in with the gross to net?

Yes. So the -- from a WACC perspective, ORLADEYO remains the least expensive on the marketplace. I think we're about 20% less on a WACC basis than Takhzyro at just under $500,000 a year. And then from a gross to net, Anthony's said many times, we expect to get to about a 15% to 20% gross to net. And if you exclude free product, we're essentially there right now. From discounts, copayment assistance, rebates, we're essentially there with our paid product.

You view the current price discount relative to injectables as a driver for adoption? Or are payers pushing the lower-priced product or maybe even physicians are being responsible in describing more of a lower-priced product?

It's -- different customers have different sensitivities. I think what our strategy with that was we want to make sure that patients have equal access to ORLADEYO, so patients and doctors can figure out what's best for the patient. And where our pricing came in at, payers -- payers at launch, many of them expected us to charge a premium, and so I think that, that helps with our access. But what -- for physicians and patients, what they really care about is the process, and are we reducing the burden there. And as I mentioned, we are getting great feedback that we're delivering to their expectations on helping them through the process.

I think that makes the result that much better, right? Because it's not a -- they're prescribing it because it's the least expensive, right? That's not the case at all. This drug has its own merits and benefits, and the team is doing an excellent job of execution. And we're winning on a level playing field, not some pricing advantage. I think they all view them as these are expensive drugs, and it's a level playing field.

Okay. I think the other big news for ORLADEYO earlier this year was you updated -- well, you provided 2022 guidance and updated your peak sales guidance. I think Jon had hinted that an update on that number -- upward revision was expected. But let's start with the '22 -- '22 guidance. I think you said at least $250 million. I think when it was unveiled, there was some comments that it may be a little conservative given where you were with 4Q sales. Let me just talk about the assumptions and why it's not really that conservative, given how sales numbers change from 4Q to 1Q?

Yes. Charlie, maybe I'll start and then you can jump in with the logic. I think any time you have a spectacular first year launch where you generate $122 million and then you more than double it the second year, I don't know who's saying that's conservative, but in my book, that's not conservative. But I'll let Charlie cover the -- how we get there.

Yes. How we get there, Serge, it's the trends that I've described here. So it's what we're seeing in the patient switching, that half patients switching from injectable to prophies. That's a big piece of it, the consistency of those trends. We do a lot of market research. We did that before launch. We've done that consistently. We recently presented some of that publicly where physicians -- we asked them, what do you expect to do with your patients a year from now? And they probably get ahead of themselves a little bit in terms of the market share, but they said a year from now, we expect this to be our #1 prescribed product to our existing patients. And that was a sample of 60 HAE treating physicians. So that where we are with the market access that we just talked about and the reimbursement, all of it plus then the ability to do more of these live patient programs and live physician programs, all of that goes into our expectation of no less than $250 million this year. It will still be the great majority from The U.S., but we're starting to generate sales ex-U.S. as well. And at peak, that will become an important part of our business.

Okay. So we're just thinking about different growth drivers for 2022, we just talked about a small price increase. And then with reimbursement, are there any patients currently on treatment that will switch over to paid product, and that represents part of the growth that's expected?

Yes. Serge, as I mentioned, getting that last big PBM on was key. We've talked publicly before Q3 and Q4 last year, about 1/3 of the patients on therapy were on free product, so we expect that to continue to improve and go down. It's never going to go to 0 because we're always going to have our quick start program for new patients. And then there are always going to be some patients who have insurance plans that just won't cover drugs like HAE therapies. So it's never going to go to 0, but we expect it to get -- to be a contributor to growth this year.

And in terms of reimbursement, you said you were at 80% of covered lives?

About 80%. So you look at the HAE population, about 80%, yes.

Yes. And obviously, getting to 100% is -- usually doesn't happen with most products, but are there any chunky contracts remaining out there?

At this point, we've got the big chunks. Now, it's the little ones. It's regional plans as they pop up. It's employer-sponsored plans that have a different formulary. That's a big piece of it. And so our team, we're not stopping. We're going to fight for every patient, but we'll never get to 100%. It's just -- it's -- no rare disease product does.

Okay. So at this point, gross to nets of, you mentioned 15% to 20%, should remain pretty stable even as you add the remaining plans?

Yes.

I think especially when we think about it from a reimbursed perspective, Serge, at the moment, the free drug and the success that we've had in the Quick Start program would be one of the key drivers as to why it's north of that. But as we get to peak sales, yes, that 15% to 20%, I think, is a good number.

Okay. And then let's talk about the new peak guidance of $1 billion. I think people are interested in knowing how you get to those numbers, and maybe some timelines around those numbers?

Yes. Let me start, Charlie, and then you can do the simple math for Serge. But you said it before, Serge, we've been talking about this $500 million plus for over 2 years, so -- and then we started emphasizing the plus. Because it was a really old number and we were in the market and seeing how successful we were in the market. And so our confidence level, we don't take guidance like that lightly, right, and so our confidence level is high and the math is pretty straightforward. It's not a winner take all crazy market share to get there, but I'll let Charlie explain that math.

So Serge, it starts with the U.S. market. U.S., of course, is always going to be the largest based on the size and the pricing. You've heard us talk before about 7,500 diagnosed and treated patients that we're very confident in based on work we did a few years ago using U.S. healthcare claims. So if we get to 25% to 30% market share of those diagnosed and treated patients, that gets us to about 2,000 patients, and that would be $700 million to $800 million of the peak $1 billion. And then the last $200 million or so will come from Europe and the rest of the world, where ex-U.S., it's much more about getting as many patients as possible on. But we -- as Jon said, it's not a winner take all. The price will be lower, but meaningful revenue there from ex-U.S. countries at peak.

Okay. And how do you think about future competition from new oral products? I think there's 2 of them out there that's probably more at the earlier stage, but the 2 of them, I think the most advanced -- obviously, they're still in Phase II, a lot of things can happen. They likely won't be on the market until 2025, 2026 at the earliest. But does that play into your assumptions for this $1 billion guidance?

Yes. We expect that others will come to the market. We plan for that. And so let me just spend a minute talking about how we see the competition. So as Charlie said, we did a ton of work really understanding what drives switching in the marketplace because there've been products -- there's been a lot of switching going on for the last 5 years in particular. And so what we learned is that there has to be some meaningful benefit to get somebody off of the drug that they're currently being controlled on. And so -- because they're sticky. And what we found with ORLADEYO is this idea of being on one capsule once a day is the idea of not remembering that I'm sick, right, by injecting myself or looking at my medicine in the refrigerator. So it's really life-changing for these folks. And so if you're controlled on ORLADEYO and you tolerate it and you're taking one capsule a day, what's the incremental benefit of any of the folks behind us, right? It can't be efficacy because you're controlled. If you're not controlled, you'll go to something else, right, or you'll go back to the medicine you were on before. But if you're controlled and we've seen the long-term efficacy, it's really encouraging. Then I just don't see it twice a day oral. No, right? Even an injectable that says it's got 90-some percent reduction in attacks, no, you're controlled. Why would you go to an injectable? So I think it will be really challenging for them. And I think the other piece is there's a lot of clinical trial fatigue out there. And so because there's been 8 programs that got to market, right, in 12 years, and so people aren't raising their hand to get into clinical trials as much as they were in the past because the market is pretty satisfied.

As more competition comes in, you expect payers to be more active in playing one product against the other and trying to extract better economics?

I think that's a suicide strategy for a company because, again, what we said is this isn't a winner take all. So there are segments people can take, and finding what your segment is makes sense. If you're not controlled on our drug and you're on an injectable, would twice a day oral be an option? Maybe, right? So I think there's space for everybody. And I think -- and in rare disease, that's never been a good strategy of price competition. And honestly, patients and doctors hate being told that they have to go on to a certain drug. So you don't endear the community either.

Okay. Maybe just give us an update on the European launch? And I think it's going to start making increasing -- increasing contributions to the top line. And I guess Japan is also ramping up.

Charlie, you want to take that?

So Europe, we are underway. I mean, for 2022, the great majority still of the $250 million plus will be from The U.S. And that's just based on the size, the timing of launch and the pricing. But we've launched in Germany, U.K., France. We're launching in the Nordics. We announced we've launched in Norway. We'll get all around Europe. We've built out our teams. And the European market is just -- it's very concentrated, quite efficient. It's just going to go a little slower at first, and then it's going to take about 2 to 3 European patients to add up to one U.S. patient, but that all becomes a big contributor to that part of that $200 million plus of the $1 billion at peak sales. But the early uptake, what we're hearing from customers is favorable. So we have good expectations for Europe.

How much is -- sorry. Go ahead, Jon.

I think the other piece is, each year, we're adding more countries that we filed in. We're getting more approvals and we're getting more pricing approvals, and that's just going to keep snowballing year after year after year to where we're a big international player, right? And so it takes longer than The U.S., but it's absolutely worth pursuing when you think the peak could be somewhere between $250 million and $300 million.

How much does the price vary across European countries relative to U.S. levels?

So it's like I said, Serge, is about if you use just as a rule of thumb that it's going to be -- we're going to need 2 to 3 European patients to add up to one U.S. patient, but that's okay. It's still going to be a very profitable business for us, and there's a lot of opportunity in Europe to grow the prophylaxis market. So HAE has been pretty well understood and patients are diagnosed, but there haven't been a lot of prophy options there, and that's starting to change. And like in The U.S., we have a really experienced rare disease teams in each market. Small teams but really effective teams, and they are working to transform the HAE treatment landscape with ORLADEYO.

Great. Maybe we only have a couple of minutes left, so I'll ask Anthony to just give us a financial overview before we wrap things up.

Serge, I think we continue to be in a really strong capital position. We talked about at the end of last quarter, having about $518 million in cash on hand, access to the additional $75 million through Ethereum. Jon and Charlie have talked at length about the $122 million to $250 million to $1 billion runway on revenue generation for ORLADEYO. What we'll -- what we'll continue to look at is the impact of 9930, and Jon has talked about the materiality that, that had in our -- or continues to have in our OpEx guidance, so we'll see. Once we have more information and once we've concluded the investigation, we'll have a better handle on what it means for inclusion or exclusion of 9930. But I think we're in a really good position. And the opportunity to have ORLADEYO is big for us, and we have a pipeline behind it. Whether it's -- whether that includes a 9930 or not, right? There's other molecules, other indications that we'll continue to go after.

Well, I want to thank all of you this morning for spending time with us. It was very informative. We definitely appreciate it.

Thanks, Serge.

Thanks, Serge.

Thank you, Serge.