Q2 2026 BioCryst Pharmaceuticals Inc Earnings Call

August 5, 2026

Speaker #1: Hello, and welcome to the BIOCRYST Q2 2026 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session.

Operator: Hello, welcome to the BioCryst Q2 2026 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand has been raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Nick Wilder.

Operator: Hello, welcome to the BioCryst Q2 2026 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand has been raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Nick Wilder.

Speaker #1: To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising that your hand has been raised.

Speaker #1: To withdraw your question, please press *11 again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Nick Wilder.

Speaker #2: Good morning, and welcome to BIOCRYST's Q2 2026 corporate update and financial results conference call. Participating with me today are President and CEO Charlie Gayer, Chief R&D Officer Dr. Sandeep Menon, and Chief Financial Officer Babar Ghias.

Nick Wilder: Good morning, welcome to BioCryst's Q2 2026 corporate update and financial results conference call. Participating with me today are President and CEO, Charles Gayer, Chief R&D Officer, Dr. Sandeep Menon, and Chief Financial Officer, Babar Ghias. A press release and slide presentation about today's news are available on our investor relations website. Today's call contains forward-looking statements, including statements regarding future results, unaudited, and forward-looking financial information, as well as the company's future performance and/or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance, or achievements to be materially different from any future results or performance expressed or implied in this presentation. For additional information, including a detailed discussion of these risks, please refer to slide two of the presentation. In addition, today's conference call includes non-GAAP financial measures.

Speaker #2: A press release and slide presentation about today's news are available on our investor relations website. Today's call contains forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and/or achievements.

Speaker #2: These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance, or achievements to be materially different from any future results or performance expressed or implied in this presentation.

Speaker #2: For additional information, including a detailed discussion of these risks, please refer to slide 2 of the presentation. In addition, today's conference call includes non-GAAP financial measures.

Speaker #2: For our reconciliation of these measures against the most directly comparable GAAP financial measure, please refer to the earnings press release available on our investor relations website.

Nick Wilder: For a reconciliation of these measures against the most directly comparable GAAP financial measure, please refer to the earnings press release available on our investor relations website. I'll now turn the call over to Charlie.

Speaker #2: I'll now turn the call over to Charlie.

Speaker #3: Thanks, Nick. During the Q2, we continued to execute effectively on the commercial and development fronts. We completed the integration of Astria Therapeutics, and we further increased our cash generations through the growing revenue and discipline spending.

Charles Gayer: Thanks, Nick. During the Q2, we continued to execute effectively on the commercial and development fronts. We completed the integration of Astria Therapeutics, we further increased our cash generations through growing revenue and disciplined spending. That increase in cash flow, bolstered by our strategic decision to wind down internal drug discovery, will enable us to build a balanced pipeline of rare disease assets through external innovation, as Sandeep and Babar will describe. Sandeep will also provide more color on navenibart, where we completed enrollment of the largest blinded HAE trial ever and did it ahead of schedule. Our proof of concept trial for BCX17725 in Netherton syndrome is also enrolling well, we look forward to having data by the end of the year. This week, we also have exciting news for HAE families as ORLADEYO oral pellets started shipping to kids.

Speaker #3: That increase in cash flow bolstered by our strategic decision to wind down internal drug discovery, will enable us to build a balanced pipeline of rare disease assets through external innovation as Sandeep and Babar will describe.

Speaker #3: Sandeep will also provide more color on Nevenabar, where we completed enrollment of the largest blinded HEE trial ever and did it ahead of schedule.

Speaker #3: Our proof-of-concept trial for BCX-17725 and Netherton syndrome is also enrolling well, and we look forward to having data by the end of the year.

Speaker #3: This week, we also have exciting news for HEE families as Orlando Oral Pellets started shipping to kids. Despite the manufacturing delay, we have already received 47 prescriptions for Orlando Pellets through July 31, which is well ahead of the total we expected for all of 2026.

Charles Gayer: Despite the manufacturing delay, we have already received 47 prescriptions for ORLADEYO pellets through 31 July. This is well ahead of the total we expected for all of 2026. Prior authorizations are complete for about half of these patients. So far, the approval rate has been strong. We have a lot to learn about ongoing prescription rates of paid therapy, and real-world outcomes for kids taking ORLADEYO, but we are thrilled to be delivering this much-needed therapy. Our market research in Q2 showed that preference for and satisfaction with ORLADEYO were up for both patients and physicians compared to 1 year prior. This played out in market demand as new prescriptions for ORLADEYO capsules in Q2 were consistent with our history and expectations. We also activated new prescribers at a rate in line with historical trends.

Speaker #3: Prior authorizations are complete for about half of these patients, and so far, the approval rate has been strong. We have a lot to learn about ongoing prescription rates, rates of paid therapy, and real-world outcomes for kids taking Orlando, but we are thrilled to be delivering this much-needed therapy.

Speaker #3: Our market research in Q2 showed that preference for and satisfaction with Orlando were up for both patients and physicians compared to one year prior.

Speaker #3: This played out in market demand as new prescriptions for Orlando capsules in Q2 were consistent with our history and expectations. We also activated new prescribers at a rate in line with historical trends.

Speaker #3: On the payer side, the heavy part of reauthorization season is now behind us, and we continue to make incremental improvements in the paid rate, which ended the quarter at 84% compared to 83% one year ago.

Charles Gayer: On the payer side, the heavy part of reauthorization season is now behind us. We continue to make incremental improvements to the paid rate. It ended the quarter at 84% compared to 83% 1 year ago. Finally, we are pleased to partner with CareMed as our new sole source pharmacy for ORLADEYO shipments to patients. The sole source model has been a cornerstone of our strategy since launch. Because our HAE portfolio and the number of patients that we serve is growing, we chose CareMed for their ability to scale operations with our growth. All ORLADEYO pellets prescriptions for kids are shipping from CareMed, and the 12 and up population will transition over the course of this month. We look forward to serving these patients together. I'll turn the call over to Sandeep to describe our pipeline developments.

Speaker #3: Finally, we are pleased to partner with CareMed as our new sole-source pharmacy for Orlando shipments to patients. The sole-source model has been a cornerstone of our strategy since launch, and because our HEE portfolio and the number of patients that we serve is growing, we chose CareMed for their ability to scale operations with our growth.

Speaker #3: All Orlando Pellets prescriptions for kids are shipping from CareMed, and the 12-and-up population will transition over the course of this month. We look forward to serving these patients together.

Speaker #3: I'll turn the call over to Sandeep to describe our pipeline developments.

Speaker #4: Thank you, Charlie. I'm pleased to share that in June we completed enrollment of our pivotal study, Alpha Orbit for Nevenabar, our investigational long-acting injectable plasma calcareen inhibitor for HEE prophylaxis.

Sandeep Menon: Thank you, Charlie. I'm pleased to share that in June, we completed enrollment of our pivotal study, ALPHA-ORBIT for navenibart, our investigational long-acting injectable plasma kallikrein inhibitor for HAE prophylaxis. We are excited about the potential for this product to transform the injectable segment of the market with its differentiated profile. We expect to announce the top-line data for this program in Q3 2027. Because navenibart's extended dosing regimen includes every 6 months dosing, we will keep the study blinded to reach 1 year of safety and efficacy data as agreed by the FDA, putting us in a unique position to evaluate the efficacy at 6 and 12 months. I'd like to also address our June decision to discontinue internal discovery programs and close our research unit in Birmingham.

Speaker #4: We are excited about the potential for this product to transform the injectable segment of the market with its differentiated profile. We expect to announce the top-line data for this program in the Q3 of 2027.

Speaker #4: Because Nevenabar's extended dosing regimen includes every 6-month dosing, we will keep the study blinded to reach one year of safety and efficacy data as agreed by the FDA, putting us in a unique position to evaluate the efficacy at 6 and 12 months.

Speaker #4: I'd like to also address our June decision to discontinue internal discovery programs and close our research unit in Birmingham. Since I've joined BIOCRYST, we have completed a comprehensive review of our programs' capabilities and strategic options to ensure we are positioned for future success.

Sandeep Menon: Since I've joined BioCryst, we have completed a comprehensive review of our programs, capabilities, and strategic options to ensure we are positioned for future success. After a careful consideration, our team concluded that expanding our access to external innovation is the best way to allocate resources and accelerate the development of a stronger pipeline. This decision has no impact on our clinical programs, including BCX17725, which remains on track for early clinical data in patients from part 4 of our phase I-B study by the end of this year. We remain excited about the potential to bring forward a treatment for patients with Netherton syndrome, a rare, severe skin condition with no approved therapies. We will continue to be active in our search for external assets.

Speaker #4: After a careful consideration, our team concluded that expanding our access to external innovation is the best way to allocate resources and accelerate the development of a stronger pipeline.

Speaker #4: This decision has no impact on our clinical programs including BCX-17725, which remains on track for early clinical data in patients from Part 4 of our Phase 1b study by the end of this year.

Speaker #4: We remain excited about the potential to bring forward a treatment for patients with Netherton syndrome—a rare, severe skin condition with no approved therapies. We will continue to be active in our search for external assets.

Speaker #4: The decision to end internal research broadens our scope to build a balanced pipeline of differentiated assets across clinical stages in areas of high end met need where we can leverage our scientific, clinical, and commercial strengths.

Sandeep Menon: The decision to end internal research broadens our scope to build a balanced pipeline of differentiated assets across clinical stages in areas of high unmet need where we can leverage our scientific, clinical, and commercial strengths. I will now transition to my colleague, Babar.

Speaker #4: I will now transition to my colleague Babar.

Speaker #2: Thanks, Sandeep. Our second fiscal quarter reflected continued momentum across the business, steady growth in Orlando, substantial progress across our clinical pipeline, as you heard, and very importantly, a key step forward in resolving the manufacturing issue to get our pediatric launch underway.

Babar Ghias: Thanks, Sandeep. Our second fiscal quarter reflected continued momentum across the business, steady growth in ORLADEYO, substantial progress across our clinical pipeline, as you heard, and very importantly, a key step forward in resolving the manufacturing issue to get our pediatric launch underway. It was also another quarter that reflected our financial strength with strong operating profitability and a cash position that leaves our balance sheet in excellent shape to execute on our go-forward strategy. In my remarks today, I will be referring to some non-GAAP figures which are adjusted for revenues and expenses related to our former European ORLADEYO business, stock-based comp, and expenses related to the acquisition of Astria. You can find additional details for adjustments and reconciliations in the press release. We believe the non-GAAP figures provide a better underlying view of our business on a forward-looking basis.

Speaker #2: It was also another quarter that reflected our financial strength, with strong operating profitability and a cash position that leaves our balance sheet in excellent shape to execute on our go-forward strategy.

Speaker #2: In my remarks today, I will be referring to some non-GAAP figures, which are adjusted for revenues and expenses related to our former European Orlando business stock-based comp and expenses related to the acquisition of Astria you can find additional details for adjustments and reconciliations in the press release.

Speaker #2: We believe the non-GAAP figures provide a better underlying view of our business on a forward-looking basis. With that said, let me turn over to the financial results.

Babar Ghias: With that said, let me turn over to the financial results. Total revenue for Q2 2026 increased 45% year on year on a comparable basis. That is excluding the European divestiture. I would draw your attention to ORLADEYO revenue of $158.2 million in the quarter, which grew 10% year on year on that same comparable basis. New patient demand remains strong, and as we build on our understanding of the ped market dynamics with real-world outcomes, we feel confident that it will continue to augment our growth. Market research results continue to deliver the same consistency of findings regarding the value of ORLADEYO, and we naturally see that play out in our day-to-day commercial execution. Still adding new prescribers, we see consistent long-term patient retention to past trends.

Speaker #2: Total revenue for the Q2 of 2026 increased 45% year-on-year on a comparable basis. That is excluding the European divestiture. I would draw your attention to Orlando revenue of $158.2 million in the Q1, which grew 10% year-on-year on that same comparable basis.

Speaker #2: New patient demand remains strong, and as we build on our understanding of the paid market dynamics with real-world outcomes, we feel confident that it will continue to augment our growth.

Speaker #2: Market research results continue to deliver the same consistency of findings regarding the value of Orlando. And we naturally see that play out in our day-to-day commercial execution.

Speaker #2: Still adding new prescribers, we see consistent long-term patient retention to past trends, and now with the reauthorization season largely complete, we achieved a slight increase in our paid rate over last year but which is important and impressive at the same time because you may recall we had already made a substantial improvement on that metric last year.

Babar Ghias: Now with the reauthorization season largely complete, we achieved a slight increase in our pay rate over last year, which is important and impressive at the same time because you may recall we had already made a substantial improvement on that metric last year. That is a true reflection of the benefits of ORLADEYO for HAE patients. Our total revenue for the quarter also includes $55.7 million recognized in the quarter from the upfront payment of our navenibart European license agreement with Neopharmed Gentili. I'm also very pleased to share that we are seeing stable operating costs across our business. As you can see from our press release, our non-GAAP G&A and sales and marketing expense categories for both the 3-month and the 6-month period remained relatively flat compared to prior periods.

Speaker #2: And that is a true reflection of the benefits of Orlando for HEE patients. Our total revenue for the Q1 also includes $55.7 million recognized in the Q1 from the upfront payment of our Nevenabar European license agreement with Neopharmed Gentilly.

Speaker #2: I'm also very pleased to share that we are seeing stable operating costs across our business. As you can see from our press release, our non-GAAP GNA and sales and marketing expense categories for both the 3-month and the 6-month period remained relatively flat compared to prior periods.

Speaker #2: The increase in R&D is driven by ongoing phased reactivities for Nevenabar, as you would expect. As a result of these trends, we posted a strong non-GAAP operating profit of $113.2 million for the Q1.

Babar Ghias: The increase in R&D is driven by ongoing phase III activities for nivolumab, as you would expect. As a result of these trends, we posted a strong non-GAAP operating profit of $113.2 million for the quarter. Importantly, we have taken deliberate steps to further sharpen our cost structure going forward. As we stated in our June news release, we are shifting our R&D strategy towards an external innovation model, discontinuing our internal discovery programs, along with the announced closure of our Birmingham facility by the end of this year. The result is a leaner, more focused operating model that is expected to generate meaningful cost savings as legacy R&D costs continue to come down.

Speaker #2: Importantly, we have taken deliberate steps to further sharpen our cost structure going forward. As we stated in our June news release, we are shifting our R&D strategy towards an external innovation model discontinuing our internal discovery programs along with the announced closure of our Birmingham facility by the end of this year.

Speaker #2: The result is a leaner, more focused operating model that is expected to generate meaningful cost savings as legacy R&D costs continue to come down.

Speaker #2: This enables us already to improve on our non-GAAP operating cost guidance range for the remainder of the year which we brought down from the earlier range of $450 to $470 million to $420 to $440 million.

Babar Ghias: This enabled us already to improve on our non-GAAP operating cost guidance range for the remainder of the year, which we brought down from the earlier range of $454 million to $470 million to $420 million to $440 million. The financial discipline continues to positively impact our balance sheet. We ended the quarter with just over $350 million in cash equivalents, and investments. Importantly, we generated positive cash flow in the quarter, even setting aside the upfront proceeds from the license agreement. Simply put, our balance sheet has never been in a stronger position. On that front, let me address from a financial standpoint our strategy going forward. We have a business that continues to generate strong profitability and cash flow growth. We have two very important catalysts, one of which adds to our growth profile in the near term.

Speaker #2: The financial discipline continues to positively impact our balance sheet. We ended the Q1 with just over $350 million in cash, cash equivalents, and investments, and importantly, we generated positive cash flow in the Q1 even setting aside the upfront proceeds from the license agreement.

Speaker #2: Simply put, our balance sheet has never been in a stronger position. On that front, let me address, from a financial standpoint, our strategy going forward.

Speaker #2: We have a business that continues to generate strong profitability and cash flow growth. We have two very important catalysts, one of which adds to our growth profile in the near term.

Speaker #2: So from a BD perspective, we don't feel any need to unnecessarily stress our balance sheet. As Sandeep alluded earlier, with the shift to external innovation, it allows us to build a more balanced pipeline of clinical assets across all stages.

Babar Ghias: From a BD perspective, we don't feel any need to unnecessarily stress our balance sheet. As Sandeep alluded earlier, with the shift to external innovation, it allows us to build a more balanced pipeline of clinical assets across all stages. These could be early to mid-stage clinical programs where we will have much more transaction structure flexibility. Ultimately, the objective for us is not about the quantity, but rather the quality of the clinical programs that add to our overall growth profile. We are in a very unique position relative to other companies of our size in that we can finance BD and R&D, deliver profitable growth with excess cash flow, remain flexible to consider de-levering the balance sheet and/or buybacks. Moving on to financial guidance. Given closing of the nivolumab EU license, we are raising our total revenue guidance to the range of $690 million to $715 million.

Speaker #2: These could be early to mid-stage clinical programs where we will have much more transaction structure flexibility. But ultimately, the objective for us is not about the quantity, y, but rather the quality of the clinical programs that add to our overall growth profile.

Speaker #2: We are in a very unique position relative to other companies of our size in that we can finance BD and R&D, deliver profitable growth with excess cash flow, remain flexible to consider delevering the balance sheet and/or buybacks.

Speaker #2: Moving on to financial guidance. Given closing of the Nevenabar EU license, we are raising our total revenue guidance to the range of $690 to $715 million.

Speaker #2: Despite the delay in the pediatric launch, we feel long-term Orlando trends are intact and are hence maintaining our full-year 2026 Orlando revenue guidance of $625 million to $645 million.

Babar Ghias: Despite the delay in the pediatric launch, we feel long-term ORLADEYO trends are intact and hence maintaining our full year 2026 ORLADEYO revenue guidance of $625 million to $645 million. On non-GAAP operating costs, we are maintaining the range at $420 million to $440 million that we announced on 29 June. Over the last 12 months, our business has gone through a number of critical transactions. Sale of Europe, followed by the Astria acquisition, a CEO transition, and now the recent Birmingham decision. While the new BioCryst, I would say, is still in an evolutionary phase, one thing that has remained constant is a strong operating performance record throughout. For that, I'm deeply grateful to our team for their unwavering focus on what matters most, advancing ORLADEYO and our pipeline to deliver critical life-changing medicines to patients. With that, operator, we are now ready for questions.

Speaker #2: On non-GAAP operating costs, we are maintaining the range at $420 to $440 million that we announced on June 29. Over the last 12 months, our business has gone through a number of critical transactions.

Speaker #2: Sale of Europe followed by the Astria acquisition, a CEO transition, and now the recent Birmingham decision. And while the new BIOCRYST I would say is still in an evolutionary phase, one thing that has remained constant is a strong operating performance record throughout.

Speaker #2: For that, I'm deeply grateful to our team for their unwavering focus on what matters most. Advancing Orlando and our pipeline to deliver critical, life-changing medicines to patients.

Speaker #2: With that, operator, we are now ready for questions.

Speaker #3: Certainly. As a reminder, to ask a question, please press star 11 on your telephone. And wait for your name to be announced. To withdraw your question, please press star 11 again.

Operator: Certainly. As a reminder, to ask a question, please press * one on your telephone and wait for your name to be announced. To withdraw your question, please press * one again. One moment please. Your first question comes from the line of Laura Chico with Wedbush.

Speaker #3: One moment, please. Your first question comes from the line of Laura Chico with Wedbush.

Speaker #4: Hey, good morning. Thanks very much for taking the me. One, it looks like a very solid Orlando performance this Q1. I know one of your competitors had indicated their prophylactic product was seeing switches from a range of patients.

Laura Chico: Hey, good morning. Thanks very much for taking the questions. Just two from me. One, it looks like a very solid ORLADEYO performance this quarter. I know one of your competitors had indicated their prophylactic product was seeing switches from a range of patients. Just curious maybe, Charlie or anybody else want to comment, any anecdotal evidence with respect to ORLADEYO persistence in the period, I guess. Are you seeing more pressure from competitors? Just one on the Netherton program. I think you mentioned enrollment is proceeding. Are you approaching the completion of recruitment? Just kind of curious if you could elaborate on any challenges or learnings that you've made so far. Thanks very much.

Speaker #4: I'm just curious, maybe Charlie or anybody else want to comment? Any anecdotal evidence with respect to Orlando persistence in the period, I guess? Are you seeing more pressure from competitors?

Speaker #4: And then just one on another term program. I think you mentioned enrollment is proceeding. Have you are you approaching the completement of recruitment and just kind of curious if you could elaborate on any challenges or learnings that you've made so far?

Speaker #4: Thanks very much.

Speaker #5: Great. Thanks, Laura. I'll take the first question, Sandeep can address the second one. Another term. Yeah, obviously, we have new competitors out there, new injectables, and what we're seeing is what we expected from all of our market research is that the injectables are primarily affecting existing injectables, particularly Taxyro.

Charles Gayer: Great. Thanks, Laura. I'll take the first question. Sandeep can address the second one on Netherton. Obviously, we have new competitors out there, new injectables, what we're seeing is what we expected from all of our market research, is that the injectables are primarily affecting existing injectables, particularly Cinryze. The overall retention for ORLADEYO is the same pattern as Babar mentioned in his statement. Of course we lose some patients, what now happens is we tend to lose them to the newer products as opposed to the older products, which is exactly what we expected. Our overall view on ORLADEYO growth, we're very positive about. Sandeep, do you want to address the Netherton?

Speaker #5: The overall retention for Orlando is the same pattern as Babar mentioned in his statement. So of course, we lose some patients, and what now happens is we tend to lose them to the newer products as opposed to the older products, which is exactly what we expected.

Speaker #5: And our overall view on Orlando growth, we're very positive about. Sandeep, do you want to address the other terms?

Speaker #6: Yeah. Thank you for the question. So we are on track for completing our POC data that will be coming end of this year. And what are we seeing?

Sandeep Menon: Thank you for the question. We are on track for completing our POC data that will be coming end of this year. What are we seeing? As you have seen in our healthy volunteer data, the safety has been well tolerated, the drug distribution has been part of the epidermis where all the action is. At this point, that is the only thing we can comment on. We are still waiting for more data to come in terms of the holistic understanding of the PK/PD and the clinical efficacy endpoints.

Speaker #6: As you have seen in our healthy volunteer data, the safety has been well tolerated. And the drug distribution has been part of the epidermis, where all the action is.

Speaker #6: So, at this point, that is the only thing we can comment on. We are still waiting for more data to come in, in terms of the holistic understanding of the PK, PD, and the clinical efficacy endpoints.

Speaker #5: And Laura, just as far as enrollment in the trial, yeah, it's been going strong and we're confident that we'll have that up to 12 patients at the end of the year.

Charles Gayer: Laura, just as far as enrollment in the trial, yeah, it's been going strong and we're confident that we'll have that up to 12 patients at the end of the year, and that'll inform next steps for the program.

Speaker #5: And that'll inform next steps for the program.

Speaker #6: Yeah.

Sandeep Menon: Yeah.

Speaker #4: Perfect. Thanks, guys.

Laura Chico: Perfect. Thanks, guys.

Speaker #3: Thank you. And our next question comes from the line of Gavin Clark Gardner with Evercore ISI.

Operator: Thank you. Our next question comes from the line of Gavin Clark-Gardner with Evercore ISI.

Speaker #7: Hey, guys. Thanks for taking the question. Just following up on the Netherton side, I guess, what are your expectations for how a placebo arm could potentially perform?

Gavin Clark-Gardner: Hey, guys. Thanks for taking the question. Just following up on the Netherton side. I guess, what are your expectations for how a placebo arm could potentially perform? We have some of the Strivego data showing a bit of an improvement from baseline. We have the Daiichi data, which showed maybe a little bit of a decline on placebo. I guess I'm just curious how you're piecing together this and contextualizing what a good result is on the efficacy side. Thank you.

Gavin Clark-Gartner: Hey, guys. Thanks for taking the question. Just following up on the Netherton side. I guess, what are your expectations for how a placebo arm could potentially perform? We have some of the Strivego data showing a bit of an improvement from baseline. We have the Daiichi data, which showed maybe a little bit of a decline on placebo. I guess I'm just curious how you're piecing together this and contextualizing what a good result is on the efficacy side. Thank you.

Speaker #7: We have some of the Spivigo data showing a bit of an improvement from baseline. We have the Daiichi data, which showed maybe a little bit of a decline on placebo.

Speaker #7: So I guess I'm just curious how you're piecing together this and contextualizing what a good result is on the efficacy side. Thank you.

Speaker #6: Yeah, for us, the way we are thinking about BCX17725, it has the potential to be the first systemically administered and a targeted drug for Netherton syndrome.

Sandeep Menon: Yeah. For us, the way we are thinking about BCX17725, it has the potential to be the first systemically administered and a targeted drug for Netherton syndrome, and the rest of the modalities and other things that have been in use, they are not impacting the implicated target that is exactly needed for Netherton syndrome. This is the KLK5, which is what we are targeting. For us, when we look at these patients, they have no approved therapies. Any relief or improving signs and symptoms for Netherton syndrome would be a big advance based on our discussions with the patients and the QoL. That's what we keep on learning. We will have a better understanding of the totality of the data that will come at the end of the year. Obviously the placebo, there will be some placebo response.

Speaker #6: And the rest of the modalities and other things that have been in use, they are not impacting the implicated target that is exactly needed for Netherton syndrome.

Speaker #6: So this is the KLK5, which is what we are targeting. So for us, when we look at these patients, they have no approved therapies.

Speaker #6: So any relief or improving signs and symptoms for Nethertons would be a big advance based on our discussions with the patients and the KOLs.

Speaker #6: So that's what we keep on learning, and we will have a better understanding of the totality of the data that will come at the end of the year.

Speaker #6: And so, obviously, with the placebo, there will be some placebo response. But then, the disease itself has its own vaccine and waning.

Sandeep Menon: The disease itself has its own waxing and waning. It's a very variable disease, in general.

Speaker #6: It's a very variable disease in general, so.

Gavin Clark-Gardner: Sounds good. Thank you.

Gavin Clark-Gartner: Sounds good. Thank you.

Speaker #7: Sounds good. Thank you.

Speaker #3: Thank you. And our next question comes from the line of Stacey Goo with TD Cowan.

Operator: Thank you. Our next question comes from the line of Stacy Ku with TD Cowen.

Speaker #8: Hey there. Thanks so much for taking our questions. We have a couple. So first, as we think about Orlando, maybe just can you talk through the clinician additions?

Stacy Ku: Hey there. Thanks so much for taking our questions. We have a couple. First, as we think about ORLADEYO, maybe just can you talk through the clinician additions this quarter versus historical averages? What kind of halo effect might you expect with the pediatric launch? I understand your comments on the injectable kind of share with new patients, just help understand how ORLADEYO is continuing to progress in a steady fashion. That's one. Two, maybe talk about the new specialty pharmacy set up. Is there any expectation setting when it comes to the transition? Should it be really smooth? Just help us think about the cadence of the US launch for ORLADEYO, maybe how H2 might look relative to Q1 and Q2. That's the second question. Just a very quick follow-up on Netherton.

Speaker #8: This Q1 versus historical averages. What kind of halo effect might you expect with the pediatric launch? I understand your comments on the injectable kind of share with new patients.

Speaker #8: It would just help understand kind of how Orlando is continuing to progress in a steady fashion. So that's one. And then two, maybe talk about the new specialty pharmacy setup.

Speaker #8: Is there any expectation setting when it comes to the transition? Should it be really smooth? Just help us think about the cadence of the US launch for Orlando.

Speaker #8: Maybe how the second half might look relative to the first two Q1s. So that's the second question. And then just a very quick follow-up on Nethertons.

Speaker #8: Given that you are in part four, any early comments you're willing to share on part three? Thanks so much.

Stacy Ku: Given that you are in Part IV, any early comments you're willing to share on Part III? Thanks so much.

Speaker #5: All right. Thanks, Stacey. On the clinician additions, you might recall from the past, we had talked about approximately 60 new physicians per month prescribing.

Charles Gayer: All right. Thanks, Stacy. On the clinician additions, you might recall from the past, we had talked about approximately 60 new physicians per month prescribing ORLADEYO. We were a little bit above that. ORLADEYO continues to gain in the market. From the halo of pediatrics, obviously it's still early, but of those 47 prescriptions, a number of them were actually prescribed by physicians who had not yet prescribed ORLADEYO. That's a good early sign. Like I said, there's a lot to learn about pedes now that we have product in the market, but we're off to a really good start. On the new SP transition to CareMed, the biggest decision was, as I mentioned, the ability to scale with us as we grow.

Speaker #5: Orlando, we were a little bit above that. So it's Orlando continues to gain in the market. From the halo of pediatrics, obviously, it's still early, but of those 47 prescriptions, a number of them were actually prescribed by physicians who had not yet prescribed Orlando.

Speaker #5: So that's a good early sign. Like I said, there's a lot to learn about peds now that we have product in the market, but we're off to a really good start.

Speaker #5: On the new SP transition to Caremed, the biggest decision was, as I mentioned, the ability to scale with us as we grow. But in the process, we also looked at experience bringing in active programs, and Caremed has a lot of experience doing that.

Charles Gayer: In the process, we also did look at experience bringing in active programs, and CareMed has a lot of experience doing that, and we've kind of been impressed with their track record. Anytime you do a switch like this, there can be bumps. This whole switch is just starting this month. We don't expect it to affect ORLADEYO long term, but we'll have to just kind of see in the quarter. We think long term, this is going to be great for patients. Our guidance, as Babar said, is still the same, $625 to $645 for the year. I don't even need to pass this over to Sandeep on the sharing anything on Part III. No, it was too few patients, too short a time.

Speaker #5: And we've kind of been impressed with their track record. Anytime you do a switch like this, there can be bumps. And this whole switch is just starting this month.

Speaker #5: We don't expect it to affect Orlando long-term, but we'll have to just kind of see in Q1. We think long-term, this is going to be great for patients.

Speaker #5: And our guidance, as Babar said, is still the same: $625 to $645 million for the year. And I don't even need to pass this over to Sandeep to share anything on part three.

Speaker #5: No, it was too few patients, too short of time. We're really pleased with how part four is enrolling, and we look forward to adding data at the end of the year.

Charles Gayer: We're really pleased with how Part IV is enrolling, we look forward to having data at the end of the year.

Speaker #8: Thank you so much.

Stacy Ku: Thank you so much.

Speaker #3: Thank you. And our next question comes from the line of Timur Ivanakov with Cantor.

Operator: Thank you. Our next question comes from the line of Timur Ivanenko with Cantor.

Speaker #6: Thank you. Thank you. This is Timur Ivanakov on for Stacey's house. So our question is for Orlando, what are you hoping you could provide some color on the volume growth in the Q1?

Timur Ivanenko: Thank you. This is Timur Ivanenko on for Steve Houss. My question is for ORLADEYO. I was hoping you could provide some color on the volume growth in the quarter because it sounds like you grew revenues 10% year over year, there was also a 9% price increase, you mentioned increased paid rate. What does this imply about volume growth year over year on the quarter? Thank you.

Timur Ivannikov: Thank you. This is Timur Ivanenko on for Steve Houss. My question is for ORLADEYO. I was hoping you could provide some color on the volume growth in the quarter because it sounds like you grew revenues 10% year over year, there was also a 9% price increase, you mentioned increased paid rate. What does this imply about volume growth year over year on the quarter? Thank you.

Speaker #6: Because it sounds like you grew revenues 10% year over year, but there was also a 9% price increase. And you mentioned increased pay rate.

Speaker #6: So what does this imply about volume growth year over year in the Q1? Thank you.

Speaker #5: Yeah, sure, Timur. It's basically half and half. So you might recall that on the 9% price increase, we'd previously said we net about four and a half of that.

Charles Gayer: Sure, Timur. It's basically half and half. You might recall that on the 9% price increase, we previously said we net about four and a half of that. Obviously we improved the paid rate a bit. The overall was about half volume, half kind of price and reimbursement.

Speaker #5: And then obviously, we improved the pay rate a bit. So the overall was about half volume, half kind of price. And reimbursement.

Speaker #6: Great. Thank you.

Timur Ivanenko: Great. Thank you.

Timur Ivannikov: Great. Thank you.

Speaker #3: And our next question comes from the line of Jess Phi with J.P. Morgan.

Operator: Our next question comes from the line of Jess Fye with JPMorgan.

Speaker #8: Hi, this is Sylvia on for Jess Phi. Two questions from us. Can you elaborate on your business development priorities? Does this look more like bolt-on acquisitions to the clinical pipeline or partnerships?

[Analyst] (JPMorgan): Hi, this is Silvan On for Jeff Phi. Two questions from us. Can you elaborate on your business development priorities? Does this look more like bolt-on acquisitions to the clinical pipeline or partnerships? What kind of profile businesses does this look like? The second question I have is, can you walk through the OpEx outlook for 2027 and beyond in the scenario where Netherton advances and in the scenario where it doesn't, just to help us understand the flex factors there? Thank you.

Silvia Luo: Hi, this is Silvan On for Jeff Phi. Two questions from us. Can you elaborate on your business development priorities? Does this look more like bolt-on acquisitions to the clinical pipeline or partnerships? What kind of profile businesses does this look like? The second question I have is, can you walk through the OpEx outlook for 2027 and beyond in the scenario where Netherton advances and in the scenario where it doesn't, just to help us understand the flex factors there? Thank you.

Speaker #8: And what kind of profile businesses does this look like? And the second question I have is, can you walk through the opex outlook for 2027 and beyond in the scenario where Netherton's advances and in the scenario where it doesn't just to help us understand the flex factors there?

Speaker #8: Thank you.

Speaker #5: Yeah. So I would say that from a BD perspective, the objective is to build a really high value pipeline validated biology proof of principle.

Babar Ghias: Yeah. I would say that from a BD perspective, the objective is to build a really high-value pipeline, validating biology proof of principle. As I mentioned, that naturally we are not going to stress our balance sheet, so we are not looking at large company acquisitions that would put stress. We are very laser-focused on delivering on our catalysts. So it could be clinical mid-stage assets and with an emphasis on clinical assets. That is where we think we can do a real impact. So that is from a BD perspective, how we are thinking about the world. Like I said, we are cash-generating, self-sufficient, so we do not necessarily looking at large capital raises to fund our BD or R&D operations. From an OpEx standpoint, I think the outlook is really strong.

Speaker #5: As I mentioned, that naturally, we are not going to stress our balance sheet. So we're not looking at large company acquisitions that would put stress.

Speaker #5: We are very laser focused on delivering on our catalyst. So it could be a clinical mid-stage assets. And with an emphasis on clinical assets.

Speaker #5: That's where we think we can really make an impact. So, that's from a BD perspective how we're thinking about the world. And like I said, we are cash-generating and self-sufficient.

Speaker #5: So we don't necessarily looking at large capital raises to fund our BD or R&D operations. From an opex standpoint, I think the outlook is really strong.

Speaker #5: We haven't really given 2027 guidance, but as you may recall, that when we lowered our guidance, that was at the middle of the year that we were making this decision.

Babar Ghias: We have not really given 2027 guidance, but as you may recall that when we lowered our guidance, that was at the middle of the year that we were making this decision. When we are ready to provide that guidance, we are anticipating that the cost will continue to go down because we will be past the Birmingham facility closure. We will be past closing on internal programs. So looking ahead, it is basically Netherton and navenibart expenses. As you can imagine, that navenibart expenses will be coming down as well as that program reaches its completion. So going forward, the operating expense guidance, absent any new BD deals, will be really strong. Having said that, it is our objective that even as we bring BD assets in, BioCryst is committed to delivering profitable growth. So that is a key imperative for us to remain profitable and cash flow positive.

Speaker #5: And when we are ready to provide that guidance, we are anticipating that the cost will continue to go down because we will be past the Birmingham facility closure.

Speaker #5: We will be past closing our internal programs. So, looking ahead, it's basically Netherton and Novena Bard expenses. And as you can imagine, Netherton expenses and Novena Bard expenses will be coming down as well as those programs reach their completion.

Speaker #5: So going forward, the operating expense guidance absent any new BD deals, will be really strong. Having said that, it is our objective that even as we bring BD assets in, BioCRYST is committed to delivering profitable growth.

Speaker #5: So that is a key imperative for us to remain profitable and cash flow positive.

Speaker #3: Thank you. And our next question comes from the line of Serge Bellinger with Benham.

Operator: Thank you. Our next question comes from the line of Serge Belanger with B. Riley Securities.

Speaker #6: Hi, good morning. Thanks for taking my questions. First one regarding the pediatric launch. Charlie, I think you mentioned that the initial numbers were tracking ahead of your expectations.

Serge Belanger: Hi, good morning. Thanks for taking my questions. First one regarding the pediatric launch. Charlie, I think you mentioned that the initial numbers were tracking ahead of your expectations. Just curious if that changes your outlook for that opportunity, and whether we should expect the paid RX rates, which I think resides around 80% right now, to be similar on the pediatric side. Then, I guess second question, just looking at slide 6, where you highlight 1,600 patients are currently on therapy, 3,500 other ones have tried the product since launch. So I assume there is another 3,000 to 4,000 patients that have yet to try the ORLADEYO at this point. Are you able to capture these other patients via the current base of prescribers, or you will need to expand beyond the 1,500 unique prescribers you currently have?

Speaker #6: Just curious if that changes your outlook for that opportunity. And whether we should expect the paid Rx rates which I think resides around 80% right now to be similar on the pediatric side.

Speaker #6: And then I guess second question, just looking at slide six where you highlight 1,600 patients are currently on therapy. 3,500 other ones have tried the product since launch.

Speaker #6: So I assume there's another 3,000 to 4,000 patients that have yet to try ORLADEYO at this point. Are you able to capture these other patients via the current base of prescribers, or will you need to expand beyond the 1,500 unique prescribers you currently have?

Speaker #6: Yeah, thanks, Serge. Yeah, as far as the peds, like I said, we're encouraged by the early demand since we just have product going out to patients this week.

Charles Gayer: Yeah. Thanks, Serge. As far as the peds, like I said, we're encouraged by the early demand, since we just have product going out to patients this week, and obviously that should probably make prescribers more comfortable too. We have to kind of see what the ongoing trend is. It's a little too early to call, but certainly the early signals are very positive. As far as the paid rate, we expect it to at least be in the range of what it's been for capsules. The payer mix will be a little bit different, obviously, because we're not going to have Medicare, so it's going to really be a split between commercial and Medicaid. The early signs there are good as well, and the pediatric pellets slot right into our contracts that we already have.

Speaker #6: And obviously, that should probably make prescribers more comfortable, too. We have to kind of see what the ongoing trend is, so it's a little too early to call, but certainly the early signals are very positive.

Speaker #6: As far as the paid rate, we expect it to at least be in the range of what it's been for capsules. The payer mix will be a little bit different.

Speaker #6: Obviously, because we're not going to have Medicare, it's really going to be a split between commercial and Medicaid. But the early signs there are good as well.

Speaker #6: And the pediatric pellets slot right into our contracts that we already have, so it's not like a new lift to get these things on formulary.

Charles Gayer: It's not like a new list to get these things on formulary. As far as the ongoing opportunity, I think the fact that demand has continued to be as consistent and strong as it's been over the last couple of years, plus we're adding new prescribers, just shows that there's still plenty of opportunity out there, and we see that in our market research as well. We also see that new prescriptions are coming very strongly from existing prescribers, as well as obviously these new prescribers that are opening up. The pattern on that really hasn't changed, and pediatrics can only further help that.

Speaker #6: As far as the ongoing opportunity, yeah, I think the fact that demand has continued to be as consistent and strong as it's been over the last couple of years plus we're adding new prescribers just shows that there's still plenty of opportunity out there.

Speaker #6: And we see that in our market research as well. We also see that new prescriptions are coming very strongly from existing prescribers as well as obviously these new prescribers that are opening up.

Speaker #6: So the pattern on that really hasn't changed. And pediatrics can only further help that.

Speaker #3: Thank you. And our next question comes from the line of Brian Abrams with RBC Capital Markets.

Operator: Thank you. Our next question comes from the line of Brian Abrahams with RBC Capital Markets.

Speaker #7: Hey, good morning. Thanks for taking my questions. Two for me. Maybe first on Novena Bard just with the enrollment completion and upsizing in that study.

Brian Abrahams: Hey, good morning. Thanks for taking my questions. Two from me, maybe first on navenibart, just with the enrollment completion and upsizing of that study. Just wondering if, I guess the upsizing was based on just higher than expected interest or on any kind of observations on dropouts. The types of patients you're seeing there and sort of any implications for powering, and should we assume this is almost entirely adults with just a few adolescents? Secondly, it seems like with ORLADEYO, you have a nice steady state with regards to patient retention. Just wondering if there may be any ways you can further improve on that, just ahead of potential competitor launch. Anything that you might see in upcoming competitor oral prophy results that could adjust your strategy there, just in anticipation of potential additional competitive entrant. Thank you.

Speaker #7: Just wondering if I guess the upsizing was based on just like higher than expected interest or on any kind of observations on dropouts. The types of patients you're seeing there and sort of any implications for powering and should we assume this is almost entirely adults with just a few adolescents.

Speaker #7: And then secondly, it seems like with Orladeyo, you're in a nice steady state with regard to patient retention. Just wondering if there may be any ways you can further improve on that, just ahead of a potential competitor launch.

Speaker #7: Anything that you might be that you might see in upcoming competitor oral trophy results that could adjust your strategy there just in anticipation of potential additional competitive entrant.

Speaker #7: Thank you.

Speaker #6: Sure, Brian. Let's do the Novena Bard and I'll take the first part. You take the second part, Cindy. Just on the upsizing though, it had nothing to do with anything about powering.

Charles Gayer: Sure, Brian. Let's do the navenibart, I'll take the first part, you take the second part, Cindy. Just on the upsizing note, it had nothing to do with anything about powering. It was purely about patient and investigator interest. As we mentioned, it was the largest blinded trial ever in HAE, yet it enrolled just as quickly as other recent trials that were smaller. So I think it's a reflection of the team, excuse me, as well as the profile of the product. Do you want to just talk about the overall powering?

Speaker #6: It was purely about patient and investigator interest. And as we mentioned, it was the largest blinded trial ever in HAE. Yet it enrolled just as quickly as other recent trials that were smaller.

Speaker #6: And so I think it's a reflection of the team excuse me. As well as the profile of the product. Do you want to just talk about the overall powering?

Speaker #7: Yeah, so overall, in terms of powering, we are already overpowered for the trials, so we don't have any concerns. In this case, it was just a function of more interest from the investigators, so that actually is a very, very positive sign for all of us in terms of the uptake and how much value the physicians are adding to this kind of modality and dosing regimen.

Sandeep Menon: Yeah. The overall powering, we are already overpowered for the trial, we don't have any concerns. In this case, it was just a function of more interest from the investigators. That actually is a very, very positive sign for all of us in terms of the uptake of how much value the physicians are adding to this kind of a modality and the dosing regimen.

Speaker #6: And then as far as patient retention, I think one of the things we always look at is just our operations and how we're performing and we think that there might be a few things there that we can further improve, but we're pleased with the overall rate of retention.

Charles Gayer: As far as patient retention, I think one of the things we always look at is just our operations and how we're performing, we think that there might be a few things there that we can further improve. We're pleased with the overall rate of retention, it really comes down to what we said before, which is patients either do quite well on ORLADEYO, then they're very sticky, or they don't, they move on. That's what our market research shows, that's what our real-world evidence shows, we expect that to continue. One thing we will be looking for is in the pediatric indication, what is the retention there? That's going to take us some quarters to really see that in the real world.

Speaker #6: And it really comes down to what we said before, which is patients either do quite well on Orladeyo and then they're very sticky, or they don't.

Speaker #6: And they move on. And so that's what our market research shows. That's what our real-world evidence shows, and we expect that to continue. One thing we will be looking for is, in the pediatric indication, what is the retention there?

Speaker #6: And that's going to take us some quarters to really see that in the real world. But in the clinical trial, in apex P, we saw that long-term patient retention at one and two years was above what we saw in our adult trial in apex two.

Charles Gayer: In the clinical trial in APEX-P, we saw that long-term patient retention at one and two years was above what we saw in our adult trial in APEX-2. We'll see if that plays out in the real world.

Speaker #6: So we'll see if that plays out in the real world.

Speaker #3: That's really helpful.

Brian Abrahams: That's really helpful. Thanks so much.

Speaker #7: Thanks so much.

Speaker #3: Thank you. And our next question comes from the line of Mauri Raycroft with Jefferies.

Operator: Thank you. Our next question comes from the line of Maury Raycroft with Jefferies.

Speaker #8: Hi, good morning. Congrats on the quarter and thanks for taking my questions. For the new patient prescription momentum being maintained at second quarter, is that only driven by the new pediatric patients or prescriptions or can you provide more context on how we can quantify this and understand contribution from new adult patients versus pediatric patients?

Maury Raycroft: Hi, good morning. Congrats on the quarter, thanks for taking my questions. For the new patient prescription momentum being maintained at Q2, is that only driven by the new pediatric patients or prescriptions, or can you provide more context on how we can quantify this and understand contribution from new adult patients versus pediatric patients?

Speaker #6: Sure. Yeah, the 12-and-up population for ORLADEYO capsules, demand was very consistent with what we've seen over the last couple of years. So that was what we expected.

Charles Gayer: Sure. Yeah, the 12 and up population for ORLADEYO capsules demand was very consistent with what we've seen over the last couple of years. That was what we expected, but it was also great to see that continued consistent strong demand. The pediatrics off to a great start, that's just upside on top, and we'll see how that progresses over the next few quarters.

Speaker #6: But it was also great to see that continued, consistent, strong demand. And then the pediatrics is off to a great start—that's just upside on top.

Speaker #6: And we'll see how that progresses over the next few quarters.

Speaker #8: Got it. Okay. And then just clarifying with the paid rate at 84%, does that only include the adult population? And wondering if you can comment on just how you expect the paid rate to continue increasing for third quarter and fourth quarter.

Maury Raycroft: Got it. Okay. Then just clarifying with the paid rate at 84%, does that only include the adult population? Wondering if you can comment on just how you expect the paid rate to continue increasing for Q3 and Q4.

Speaker #6: Yeah, that does only include the adult population because we didn't have the peds, the pellets out there yet in Q2. And just a reminder, the paid rate also includes patients who are completely uninsured.

Charles Gayer: Yeah, that does only include the adult population because we didn't have the peds, the pellets out there yet in Q2. Just a reminder, the paid rate also includes patients who are completely uninsured. That's about 4% out of that 16% that are getting free product. We feel like we're making great progress and having continuing to chip away. Our long-term goal was 85%, I always say that if we get to 85%, our goal will then go up. We feel good about it. Typically, I've said this before, in the H2, the paid rate tends to drop off a little bit because the patient mix is driven more by new patients coming in who tend not to get to that 84% quite as quickly. For some of them, it takes longer.

Speaker #6: So that's about 4% out of that 16% that are getting free product. So we feel like we're making great progress and continuing to chip away.

Speaker #6: Our long-term goal was 85%, but I always say that if we get to 85%, our goal will then go up. And we feel good about it.

Speaker #6: Typically, and I've said this before, in the second half of the year, the paid rate tends to drop off a little bit because the patient mix is driven more by new patients coming in who tend not to get to that 84% quite as quickly.

Speaker #6: For some of them, it takes longer. And so, the typical pattern is that a percentage or two is lost over the second half of the year.

Charles Gayer: The typical pattern is a percentage or two is lost over the H2, then we gain it back in the reauthorization season next year. I think end of Q2 is a great point to measure progress, that's why we pointed it out this year, where we picked up 1% versus last year. Next year, I would expect us to be at or above where we were at the end of Q2 this year.

Speaker #6: And then we gain it back in the reauthorization season next year. So I think end of Q2 is a great point to measure progress.

Speaker #6: And that's why we pointed it out this year where we picked up a percent versus last year. Next year, I would expect us to be at or above where we were at the end of Q2 this year.

Speaker #8: Got it. That's helpful. Thanks for taking my question.

Maury Raycroft: Got it. That's helpful. Thanks for taking my questions.

Speaker #3: Thank you. Our next question comes from the line of John Wolubin with Citizens Bank.

Operator: Thank you. Our next question comes from the line of Jon Woloshin with Citizens JMP.

Speaker #5: Hey, thanks for taking the question. Just talking about the pediatric opportunity, you've talked a little bit before about 500 diagnosed patients and with 10% already seeking prescriptions.

Jon Woloshin: Hey, thanks for taking the question. Just talking about the pediatric opportunity, you've talked a little bit before about 500 diagnosed patients with 10% already seeking prescriptions. Can you talk a little bit about that early dynamic if those were families coming in and asking about ORLADEYO, or you guys getting out there in the community? Then also the diagnosed population as you get out there and talk about it more?

Jon Wolleben: Hey, thanks for taking the question. Just talking about the pediatric opportunity, you've talked a little bit before about 500 diagnosed patients with 10% already seeking prescriptions. Can you talk a little bit about that early dynamic if those were families coming in and asking about ORLADEYO, or you guys getting out there in the community? Then also the diagnosed population as you get out there and talk about it more?

Speaker #5: Can you talk a little bit about that early dynamic if those were families coming in and asking about Orlando or you guys getting out there in the community?

Speaker #5: How do you think about the ramp and then also the diagnosed population as you get out there and talk about it more?

Speaker #8: Yeah, again, I mean, John, it's really exciting what we've seen. You pointed it out as close to 10% of that 500 number. What we are seeing in our market research is that physicians A, are very enthusiastic about prescribing Orlando pellets to kids.

Charles Gayer: Yeah, again, Jon, it's really exciting what we've seen. You pointed it out, it's close to 10% of that 500 number. What we are seeing in our market research is that physicians, A, are very enthusiastic about prescribing ORLADEYO pellets to kids, and B, the availability of an oral prophylaxis makes them think about prescribing to more of their pediatric population in general. The early signs are that we could not only get more of the existing prophylaxis patients onto oral prophylaxis, but also grow the market, expand the market. Because there should be more like 1,200 kids diagnosed in this age population. We're going to be watching for signs that 500 grows. Early signals are positive, but we're going to need another many quarters to really see how this plays out.

Speaker #8: And B, the availability of an oral Profi makes them think about prescribing to more of their pediatric population in general. And so the early signs are that we could not only get more of the existing Profi patients onto oral Profi, but also grow the market, expand the market because there should be more like 1,200 kids diagnosed in this age population and so we're going to be watching for signs that that 500 grows.

Speaker #8: Early signals are positive, but we're going to need another many quarters to really see how this plays out.

Speaker #5: Do you expect to continue giving us pediatric prescription data moving forward?

Jon Woloshin: Do you expect to continue giving us pediatric prescription data moving forward?

Jon Wolleben: Do you expect to continue giving us pediatric prescription data moving forward?

Speaker #8: No, I don't think we'll give you the exact number going forward. We'll give you the overall color on how is demand in general and we'll probably say how's the demand directionally going in pediatrics.

Charles Gayer: No, I don't think we'll give you the exact number going forward. We'll give you the overall color on how is demand in general, and we'll probably say how's the demand directionally going in pediatrics. You hit the point. It's close to 10% of that 500 number, and so we thought it was significant to talk about it at this point, but we probably won't give the numerical number going forward.

Speaker #8: But we just wanted to give—and you hit the point—it’s close to 10% of that 500 number. And so we thought it was significant to talk about it at this point.

Speaker #8: But we probably won't give the numerical number going forward.

Speaker #5: Got it. Thanks, Charlie.

Jon Woloshin: Got it. Thanks, Charlie.

Jon Wolleben: Got it. Thanks, Charlie.

Operator: Thank you. I'm showing no further questions. Ladies and gentlemen, we'd like to thank you for participating. This does conclude today's program, and you may now disconnect.

Speaker #3: showing no further questions. Ladies and gentlemen, we would like to thank you for participating. This does conclude today's program and you may now disconnect.

Q2 2026 BioCryst Pharmaceuticals Inc Earnings Call

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