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 a big contingent of the BioCryst team with us this morning to give a presentation on BioCryst. 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. Jon.
Thanks, Serge, and thanks for inviting us to your healthcare conference. With me today is Charlie Geyer, our Chief Commercial Officer. Anthony Doyle, who's here in the office with me. Our Chief Financial Officer, Nick Wilder, who's on John Bluth's team in investor relations, and John Bluth with investor relations. We're all gonna be making some forward-looking statements, and those statements have risks, and the risk factors can be found on our website. 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 99-30. As we had put in a press release last Friday, we saw elevations in serum creatinine in patients that were on 99-30 in the trial.
We consulted with numerous experts, investigators, chair of the DSMB and others, and we made two conclusions. One, it was serious enough that we should pause enrollment. We also made a decision at that time that we would continue dosing of patients that were currently in the study. 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 wanna 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. Things could change, you know, from day to day, from hour to hour.
You know, while I know there's a real desire to get updates, we'd rather put our energy towards figuring out what's going on than trying to keep everybody updated to the minute. Things like regulatory discussions, I mean, we've informed the FDA, but they could put a hold on us tomorrow, right? You know, today we're dosing patients, we could find out that things change and, you know, we stop dosing patients. The goal is to figure out as quickly as possible what's the root cause of what's going on with these serum creatinine elevations and then figure out a path forward. I've talked about the bookends, they're obvious. We either continue enrollment of the trial or we stop the program.
We're working as fast as we can. It's complicated. These are complicated patients, and getting to the root just takes time.
Great. Before I start, 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. Jon, provide kind of an overview here, but maybe just talk about the fact that the FDA hasn't put you on clinical hold yet. Is that just a positive sign or it's a sign that the investigation is just getting underway?
Yeah. I don't think we should conclude anything about the FDA at this point in time. You know, because of the fluidity, you know, 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, advisors and the like. Again, things could change at a moment's notice, and so I don't wanna characterize what the FDA views right now. I wouldn't characterize it as positive for now 'cause it could be today and it might not be tomorrow.
Okay. In terms of the investigation process, maybe just if you can walk us through that.
Yeah. 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? You know, and can we manage it or not, right? You know, 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 gotta remember that these patients are also sick, right? They, you know, the reason they're in our clinical trial is we're treating them, you know, for PNH or a renal disorder. So there's a lot of comorbidities that go with that. There's a lot of polypharmacy that goes with that. Sorting through that is complicated and just takes time.
I don't know if you have disclosed the 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?
Yeah. 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. That should be obvious because we started those studies prior to starting the basket study.
Okay. As you said earlier, there's two extreme outcomes. Either resume enrollment or the other one is halt development of the program. Are there any other thing in between that would be contemplated at the same time?
Yeah. There's a bunch of options in between. But at this point in time, I don't wanna get into them because, you know, what matters is getting to the root of the matter and figuring out what's going on here. Then we'll have a very good idea of what we do next.
Okay. Just thinking about impact, you have given OpEx guidance, how does that, you know, can we think about how that changes now or it's still too early to really look at that?
Yeah, I think it's important to finish the investigation and know what we have or don't have as a result. Obviously BCX9930 was a big part of the expense last year. Anthony, I think it was, what? 60%+.
Yeah. 63% of total R&D last year was on the Factor D program.
Anthony has guided that it's an even bigger chunk of the $440 million-$480 million this year. You know, it would be a significant decrease if we stop the program. You don't wanna 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. Earlier this year or late last year, you completed some transactions, some royalty financings that are tied to BCX9930 revenues. Just trying to think ahead and, you know, 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. We will do everything in our power to, you know, make sure that the partnership that we have with them is successful. They also have substantial revenues or royalties associated with the revenues for ORLADEYO, which we're doing really well in. You know, again, too early to say until the investigation concludes.
From a kind of risk perspective as it relates to those RP amounts, you know, there is no risk.
Okay. 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 1b trial. Curious if this is a drug class effect that you've seen in other development programs.
Yeah. I think your point about previous studies is one of the complicating factors, right? The healthy volunteer study, you know, the MAD would probably be more appropriate in this situation than a single dose. The Phase 1b where, you know, we reported out, I think, at the last point in time last year, late last year, you know, 15 PNH patients that were on drugs. Some of them close to or up to a year on therapy. Yeah, we didn't see this. That makes it more confusing, honestly.
Sorting through that is really important.
Okay. Obviously, this is a pretty significant adverse event. Is it prudent to think that, you know, if the FDA doesn't issue a clinical hold in the next few weeks, it would be a positive sign going forward?
Yeah. I'm not gonna agree with that at all. I think, again, the fluidity of this, I mean, we're still dosing patients, you know, as of today. You know, something could pop up that could change our outlook, and that's why the investigation is so important. I really don't wanna categorize the regulators because, you know, that can change as well.
Okay. Just before we move on to ORLADEYO, maybe just give us an update on how enrollment had been going in these trials. You had previously talked about timelines for readouts. Maybe just give us an overview. Obviously, like you said, it's a fluid situation, so they're subject to change, especially now.
Yeah. We were in the early phases of enrollment. You know, we were still in the startup phases with a lot of sites. These are, you know, we cast a broad net on sites around the globe, and, you know, our expectation of contributions was one or two patients per site. It wasn't like one site's gonna generate, you know, a dozen patients or something like that. 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, you know, pretty clear in what we can say, right? That is, you know, what we're doing and then how fluid the situation is. You know, the other thing I'd like to remind investors about is that, you know, BioCryst has got a drug that we believe is gonna generate no less than $250 million in revenue this year on its way to peak of $1 billion. You know, Charlie and team have done a fantastic job in the first year of launch, and our expectation is he'll do much better in his second year of launch. You know, we have a high degree of confidence in that, no less than $250 million. So financially, we're in a really solid spot.
You know, we believe in our platform. I mean, unfortunately, in our business and in drug development, there's risk. You know, we all know that. When you get into bigger studies, things can happen that you didn't anticipate. We'll see how this plays out. We appreciate the patience of investors as we go through the investigation. 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 analyst expectations, including ourselves. Just maybe review why it was such a success in the first year.
Well, let me start Charlie, 'cause he's not a bragger. I'll do a little bit for him. Yeah, I mean, listen, Serge, you weren't the only one, right? You know, the consensus was $30 million before we started selling, and we sold $122 million. We know, you said, you know, did we get surprised? No. We didn't get surprised. We had been saying this. You know, for well over a year that when we did the market research with the profile that we had, you know, one, a lot of patients stayed in our studies 'cause they were doing well on our drug. Now we have long-term data that suggests that, you know, patients do really well on ORLADEYO.
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 can be life-changing for some of these people. Those two things are what made this a success, with one addition, and that is we have a great team that executed a really thoughtful plan. That's, you know, where Charlie deserves a big pat on the back, and his team deserves that as well. Charlie, I don't know if you wanna get into some of the details of what led to the execution and the conversion from people from injectable prophy to ORLADEYO.
I think, Serge , it's like you said. We really made sure we understood this. We focus on the fact that ORLADEYO is a drug that can help any HAE patient, and we're convincing physicians and patients of that. You know, 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. You know, 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 an attack per month. Patients do really well.
We've really done a nice job on the access front in helping patients get reimbursement coverage, helping them get access to therapy. We're hearing again and again from customers how important that is in the mix too. It's the great drug, the great team, the great access that's making this happen.
What do you estimate your number of current patients on treatment or market share currently, coming out of 2021?
Well, we haven't given specifics on market share and the numbers of start forms and things like that. Charlie, I think you can give a lot of color on where it's coming from.
Yeah.
You know, what do you see in, you know, month-to-month, quarter-to-quarter in terms of new starts, that kind of thing?
Yeah. I mean, in 2021 we saw if you exclude our clinical trials very consistent demand, new patient starts every single quarter. The trends that I was just mentioning have been also consistent. Where are we getting the patients from? It's always been 50% plus switching from other prophylaxis. 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. You know, we see the opportunity for ORLADEYO to be the number one prescribed product someday. We're not there yet.
As we talk about that $1 billion at peak sales, we believe that gets us to being the number one prescribed product in the marketplace by continuing these trends.
Okay. As you think of future growth, as you mentioned, 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 entire growth trajectory of the product.
You know, I would say at least in the, you know, for 2022 and probably beyond, it's gonna continue to be the same. You know, we're gonna pull from both. I think put 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, you know, our research says that'll go with doctors that will go to 80%, maybe north of that. So the switching from prophy is gonna 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.
Yeah. 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 gonna be breakthrough attacks that people have, you know, that are on prophy. 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. You know, our competition is doing the same. As more injectable therapies come out, you're gonna see more of that behavior from acute to prophy. You know, being able to get those injectable patients on prophy to come to our drug is a critical part of our strategy and our success.
Yeah. 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 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 knew we were gonna launch in COVID, and the team did a fabulous job preparing for that and executing in COVID. We never make excuses about COVID. What I'll tell you the biggest things that we miss 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 two 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.
that as we're able to do that can be a tailwind for us. 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 a month and a half ago, and there'll 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 really opens their eyes and makes them think differently about how they're gonna use this product.
Okay. It's really kind of a education and awareness, more education and awareness than anything. 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, you know, injection training or anything like that. So they could, you know, some doctors even prescribed remotely. I think the big thing in the HAE marketplace is patients these days, you know, as John 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. You know, a big focus for us is when those patients come in for that visit, we'll do everything we can to accelerate that.
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 ORLADEYO. So that that's a big focus for us.
Okay. This next, wanna 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?
Yeah. 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. That rolled in at the start of this year. 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 patient when ORLADEYO has been prescribed, payers never make it easy. There's prior authorizations that happen for everyone. That's where our service model kicks in with EMPOWER Patient Services.
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. It's that we've got the policy set, and then we make the process so 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 know, there's often in the first quarter, sales are impacted because of 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, you know, flat to minimal growth in Q1, because of that process that we help the patients through.
Yeah. You don't wanna lose patients in that process, right? The free drug is a really critical piece to it.
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 WAC perspective as well as all-in with the gross to net.
Yeah. From a WAC perspective, ORLADEYO remains the least expensive on the marketplace. I think we're about 20% less on a WAC basis than TAKHZYRO at just under $500,000 a year. Then from a gross to net, Anthony's said many times we expect to get to about a 15%-20% gross to net. You know, if you exclude free product, we're essentially there right now from a you know, discounts, co-payment 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 and prescribing more of the lower priced products?
You know, it's different customers have different sensitivities. I think what our strategy with that was we wanna make sure that patients have equal access to ORLADEYO so patients and doctors can figure out what's best for the patient. Where our pricing came in, you know, payers at launch, many of them expected us to charge a premium. I think that helped with our access. For physicians and patients, what they really care about is the process and are we reducing the burden there. 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 that they're prescribing it 'cause 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. We're winning on a level playing field, not some pricing advantage. I think they all view them as, you know, 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 John had hinted that an update on that number, upward revision was expected. Let's start with the 2022 guidance. I think you said at least $250 million. I think when it was unveiled, there was you know, some comments that it may be a little conservative given where you were with Q4 sales. Let me just talk about the assumptions and why, you know, it's not really that conservative, given how sales numbers change from Q4 to Q1.
Yeah. Charlie, maybe I'll start, and then you can jump in with the logic. I think anytime 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. I'll let Charlie cover the how we get there.
Yeah. How we get there, Serge, it's the trends that I've described here. It's what we're seeing in the patients switching, you know. That half the patients switching from injectable prophys. That's a big piece of it, the consistency of those trends. You know, 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?" 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 number one prescribed product to our existing patients." That was a sample of 60 HAE treating physicians. That's where we are with the market access that we just talked about and the reimbursement, all of it plus then, you know, 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 you know, we're starting to generate sales ex-U.S. as well. At peak, that'll become an important part of our business.
Okay. Just thinking about different growth drivers for 2022, we just talked about a small price increase. With reimbursement, are there any patients currently on treatment that will switch over to paid product and that represents the part of the growth that's expected?
Yeah. You know, Serge, as I mentioned, the getting that last big PBM on was key. We talked publicly before Q3 and Q4 last year, about a third of the patients on therapy were on free product. We expect that to continue to improve and go down. It's never gonna go to zero.
Because we're always gonna have our Quick Start program for new patients. You know, there are always gonna be some patients who have insurance plans that just won't cover drugs like HAE therapies. It's never gonna go to zero, but we expect it to get to be a contributor to growth this year.
In terms of reimbursement, you said you were at 80% of covered lives?
About 80%. You look at the HAE population, about 80%. Yeah.
Yeah. Obviously, getting to 100 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, you know, employer sponsored plans that have a, you know, different formulary. That's a big piece of it. Our team, you know, we're gonna fight for every patient, but, you know, we'll never get to 100%. It's just no rare disease product does.
At this point, gross-to-net of 15%-20% should remain pretty stable even as you add the remaining plans?
Yes.
I think especially when we think about it from a reimbursement 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. As we get to peak sales, yeah, that 15%-20%, I think is a good number.
Okay. Let's talk about the new peak guidance of $1 billion. People are interested in knowing how you get to those numbers and maybe some timelines around those numbers.
Yeah. Let me start, Charlie, and then you can do the simple math for Serge. You know, you said it before, Serge. We've been talking about this $500 million plus for over two years, so we started emphasizing the plus because it was a really old number and, you know, we were in the market and seeing how successful we were in the market. Our confidence level. We don't take guidance like that lightly, right? Our confidence level is high and the math is pretty straightforward. You know, it's not a winner-take-all crazy market share to get there, but I'll let Charlie explain that math.
Serge, it starts with the U.S. market. U.S., of course, is always gonna 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. If we get to 25%-30% market share of those diagnosed and treated patients, that gets us to about 2,000 patients, and that would be $700 million-$800 million of the peak $1 billion. The last 200 or so will come from Europe and the rest of the world, where you know, ex-U.S., it's much more about getting as many patients as possible on. But you know, 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. How do you think about future competition from new oral products? You know, I think there's two of them out there. There's probably more at the earlier stage, but the two of them, I think the most advanced are obviously they're still in Phase 2. 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?
Yeah. We expect that others will come to the market. We plan for that. Let me just spend a minute talking about how we see the competition. As Charlie said, we did a ton of work, really understanding what drives switching in the marketplace because, you know, there's been a lot of switching going on for the last five years in particular. 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. Because they're sticky and what we found with ORLADEYO is this idea of being on one capsule once a day, you know, is the idea of, you know, not remembering that I'm sick, right?
By injecting myself or looking at my medicine in the refrigerator. It's really life-changing for these folks. 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 'cause you're controlled. If you're not controlled, you'll go to something else, right? You go back to the medicine you were on before. 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, you know, 90% some reduction in attacks, no, you're controlled. Why would you go to an injectable? I think it'll be really challenging for them.
I think the other piece is there's a lot of clinical trial fatigue out there. You know, 'cause there's been, you know, 8 programs that got to market, right? In 12 years. You know, people aren't raising their hand to get into clinical trials as much as they were in the past because the market's pretty satisfied.
As more competition comes in, do you expect payers to be more active in playing one product against the other and trying to extract better economics?
You know, I think that's a suicide strategy for a company 'cause again, what we said is, this isn't a winner take all. There are segments people can take and finding what your segment is, you know, makes sense. If you're not controlled on our drug and you're on an injectable, would an oral twice a day oral be an option? Maybe. Right? 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 onto a certain drug. You don't endear the community either.
Okay. Maybe just give us an update on the European launch, and I think it's gonna start making increasing contributions to the top line. I guess Japan is also ramping up. Charlie, you wanna take that?
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, you know, the timing of launch and the pricing. But we've launched in Germany, U.K., France, we're launching in the Nordics. We've 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 gonna go a little slower at first, and then it's gonna take about two to three European patients to add up to one U.S. patient.
That all becomes a big contributor to that, you know, part, that $200 million plus of the $1 billion at peak sales. The early uptake, what we're hearing from customers, is favorable. We have good expectations for Europe.
How much is-
I think-
Sorry, go ahead. Go ahead, Jon.
No, I think the other piece is, you know, each year we're adding more countries that we filed in, we're getting more approvals, and we're getting more pricing approvals. That's just gonna keep snowballing year after year after year to where we're a big international player, right? 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?
It's like I said, Serge, it's about if you use just as a rule of thumb that it's gonna be we're gonna need two to three European patients to add up to one U.S. patient. That's okay. You know, it's still gonna be a very profitable business for us, and there's a lot of opportunity in Europe to grow the prophy market. 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. Like in the U.S., we have really experienced rare disease teams in each market. Small teams, but really effective teams. They are working to transform the HAE treatment landscape with ORLADEYO.
Great. I think 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.
Yeah. 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 Athyrium. You know, John and Charlie have talked at length about the $122 million-$250 million to $1 billion runway on revenue generation for ORLADEYO. You know, what we'll continue to look at is the impact of BCX9930, and Jon's talked about the materiality that that had in our or continues to have in our OPEX guidance. We'll see. You know, 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 BCX9930.
You know, I think we're in a really good position. You know, the opportunity to have ORLADEYO is big for us, and we have a pipeline behind it, whether that includes BCX9930 or not, right? There's other molecules, other indications, that we'll continue to go after.
Okay. Well, I wanna thank all of you this morning for spending time with us. It's very informative. We definitely appreciate it.
Thanks, Serge.