BCRX

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 8:30 a.m. ET President and Chief Executive Officer - Charlie Gayer Chief R&D Officer - Dr. Sandeep Menon Chief Financial Officer - Babar Ghias Operator: Hello and welcome to the BioCryst Second Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. It is now my pleasure to introduce Nick Wilder. Nick Wilder: Good morning and welcome to BioCryst's Second Quarter 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. 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 2 of the presentation. In addition, today's conference call includes non-GAAP financial measures. 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. Charles Gayer: Thanks, Nick. During the second quarter, 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 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 and 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. Despite the manufacturing delay, we have already received 47 prescriptions for ORLADEYO pellets through July 31, which is well ahead of the total we expected for all of 2026. 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 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. On the payer side, the heavy part of reauthorization season is now behind us and we continue to make incremental improvements with the paid rate, which 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 and 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. 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 the third quarter of 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 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. 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 Ib 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. 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. 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 in the way. 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. With that said, let me turn over to the financial results. Total revenue for the second quarter of 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 peak 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. 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 and that is a true reflection of the benefit 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. The increase in R&D is driven by ongoing Phase III activities for navenibart 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. 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 $450 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, cash equivalents and investments. And 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 2 very important catalysts, one of which adds to our growth profile in the near term. 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. 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, 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 delevering the balance sheet and/or buybacks. Moving on to financial guidance. Given closing of the navenibart EU license, we are raising our total revenue guidance to the range of $690 million to $715 million. 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 June 29. 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. And while the new BioCryst, I would say, is still in an evolutionary phase, one thing that has remained constant is our 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. Operator: [Operator Instructions] Your first question comes from the line of Laura Chico with Wedbush. Laura Chico: Just 2 for 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? And then just one on the Netherton 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? Charles Gayer: Great. Laura, I'll take the first question. Sandeep can address the second one on Netherton. Yes, 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 TAKHZYRO. The overall retention for ORLADEYO 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. And our overall view on ORLADEYO growth, we're very positive about. Sandeep, do you want to address the Netherton? Sandeep Menon: Yes. 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? As you have seen in our healthy volunteer data, the safety has been well tolerated and the drug distribution that has been part of the epidermis where all the action is. So 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. Charles Gayer: And Laura, just as far as enrollment in the trial, yes, 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 will inform next steps for the program. Operator: Our next question comes from the line of Gavin Clark-Gartner with Evercore ISI. Gavin Clark-Gartner: Just following up on the Netherton side. I guess what are your expectations for how a placebo arm could potentially perform? Like we have some of the SPEVIGO 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. So I guess I'm just curious how you're piecing together this and contextualizing what a good result is on the efficacy side. Sandeep Menon: Yes. 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 the Netherton syndrome. 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. So any relief for improving signs and symptoms for Netherton would be a big advance based on our discussions with the patients and the KOLs. 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. And so obviously the placebo is -- there will be some placebo response, but then there is the disease itself has its own waxing and waning. It's a very variable disease in general. Operator: Our next question comes from the line of Stacy Ku with TD Cowen. Stacy Ku: We have a couple. So 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 you expect with the pediatric launch? I understand your comments on the injectable kind of share with new patients, but just help us understand kind of how ORLADEYO would continue to progress in a steady fashion. That's one. And then two, maybe talk about the new specialty pharmacy setup. 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 U.S. launch for ORLADEYO, maybe how the second half might look relative to the first 2 quarters? So that's the second question. And then just a very quick follow-up on Netherton. Given that you are in Part 4, any early comments you're willing to share on Part 3? Charles Gayer: All right. On the clinician additions, you might recall from the past, we had talked about approximately 60 physicians per month prescribing ORLADEYO. We were a little bit above that so 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. 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. 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 did look at experience bringing in prophy 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 and 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. And our guidance, as Babar said, is still the same $625 million to $645 million for the year. And I don't even need to pass this over to Sandeep on sharing anything on Part 3. No, it's too few patients, too short a time. We're really pleased with how Part 4 is enrolling and we look forward to having data at the end of the year. Operator: And our next question comes from the line of Timur Ivannikov with Cantor. Timur Ivannikov: This is Timur Ivannikov on for Steve. So 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, but there was also a 9% price increase. And you mentioned increased paid rate. So what does this imply about volume growth year-over-year in the quarter? Charles Gayer: Sure, Timur. It's basically half and half. So you might recall that on the 9% price increase, we previously said we net about 4.5% and then obviously we improved the paid rate a bit. So the overall was about half volume, half kind of price and reimbursement. Operator: Our next question comes from the line of Jess Fye with JPMorgan. Unknown Analyst: This is [ Sylvia ] on for Jess Fye. 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? And what kind of prophy 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 advances and in the scenario where it doesn't just to help us understand the flex factors there? Babar Ghias: Yes. So I would say that from a BD perspective, the objective is to build a really high-value pipeline validated biology proof of principle. As I mentioned that naturally we are not going to stress our balance sheet so we're not looking at large company acquisitions that will put stress. We are very laser-focused on delivering on our catalysts. So it could be the clinical mid-stage assets and with an emphasis on clinical assets. That's where we think we can do a real impact. So that's from a BD perspective how we're thinking about the world. And like I said, we are cash generating self-sufficient so we don't necessarily looking at the large capital raises to fund our BD or R&D operations. From an OpEx standpoint, I think the outlook is really strong. 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. And when we are ready to provide that guidance, we are anticipating that the costs will continue to go down because we will be past the Birmingham facility closure. We will be past like closing out internal programs. So looking ahead, it's basically Netherton and navenibart expenses. And 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. Operator: Our next question comes from the line of Serge Belanger with Needham. Serge Belanger: 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? And 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's 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'll need to expand beyond the 1,500 unique prescribers you currently have? Charles Gayer: Yes. 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 and so 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, but the early signs there are good as well. 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. 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. So the pattern on that really hasn't changed and pediatrics can only further help that. Operator: And our next question comes from the line of Brian Abrahams with RBC Capital Markets. Brian Abrahams: Two for me. Maybe first on navenibart just with the enrollment completion and upsizing in that study. 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? And then secondly, it seems like with ORLADEYO, you're in 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. Charles Gayer: Sure, Brian. Let's do the navenibart and I'll take the first part and you take the second part, Sandeep. Just on the upsizing, no, it had nothing to do with anything about powering. 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. And so I think it's a reflection of the team as well as the profile of the product. Do you want to just talk about the overall powering? Sandeep Menon: Yes. So the overall powering, we are already overpowered for the trial 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 of how much value the patient -- the physicians are adding to this kind of a modality and the dosing regimen. Charles Gayer: 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. 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 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? 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 1 and 2 years was above what we saw in our adult trial in Apex 2. So we'll see if that plays out in the real world. Operator: Our next question comes from the line of Maury Raycroft with Jefferies. Maurice Raycroft: Congrats on the quarter. For the new patient prescription momentum being maintained in 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? Charles Gayer: Sure. Yes, 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, but it was also great to see that continued consistent strong demand. And then 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. Maurice Raycroft: 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? Charles Gayer: Yes, 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 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. Our long-term goal is 85%. But I always say that if we get to 85%, our goal will then go up and we feel good about it. 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. For some of them, it takes longer. And so the typical pattern is 1 or 2 percentage is lost over the second half of the year 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 and 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. Operator: Our next question comes from the line of Jon Wolleben with Citizens Bank. Jonathan Wolleben: Just talking about the pediatric opportunity. You've talked a little bit before about 500 diagnosed patients and 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 are you guys getting out there in the community? How do you think about the ramp and then also the diagnosed population as you get out there and talk about it more? Charles Gayer: Yes. Again I mean, 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 prophy 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 prophy patients onto oral prophy, 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 500 grows. Early signals are positive, but we're going to need another many quarters to really see how this plays out. Jonathan Wolleben: Do you expect to continue giving us pediatric prescription data going forward? 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 is the demand directionally going in pediatrics. 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, but we probably won't give the numerical number going forward. 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. Before you buy stock in BioCryst Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and BioCryst Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. 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— Total net revenue of $218.3 million and ORLADEYO® net revenue of $158.2 million — — Operating profit of $98.5 million and Non-GAAP operating profit of $113.2 million — — Maintained Full Year 2026 ORLADEYO revenue guidance of $625 to $645 million and increased total revenue guidance to $690 million to $715 million — — Began shipping ORLADEYO oral pellets to pediatric patients on August 3 — — Completed enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart — RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2026 (GLOBE NEWSWIRE) --  BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the quarter ended June 30, 2026, and provided a business update. “We were pleased to deliver strong revenue growth and positive free cash flow again in the second quarter, reflecting our continued focus on expanding the reach of ORLADEYO while advancing our prioritized pipeline programs,” said Charlie Gayer, President and Chief Executive Officer of BioCryst. “We are especially excited to have begun shipments of the ORLADEYO oral pellet formulation – an important milestone for children living with hereditary angioedema – and we are fully committed to making the launch a success. “Across our pipeline, we completed enrollment in our pivotal navenibart trial and continued to advance BCX17725 toward early clinical data in patients by year-end. As we announced in June, we have rationalized our internal R&D efforts to better align our cost structure with our shift toward external innovation to build our pipeline. These changes will allow us to more efficiently allocate capital toward compelling assets where we have differentiated clinical and commercial expertise. “Building on this momentum, we remain focused on cost discipline while directing our capital and energy toward opportunities where we can have the greatest impact. This positions BioCryst exceptionally well to continue delivering growth, strong profitability, and lasting value for patients and their families as well as our shareholders.” Business & Corporate Updates To support the growing scale of ORLADEYO across both adults and pediatrics, BioCryst has engaged CareMed to serve as its new commercial pharmacy partner. CareMed is a full-service specialty pharmacy that provides expert care to patients living with rare diseases, and will become BioCryst’s sole source specialty pharmacy for ORLADEYO shipments to patients beginning in Q3 2026. New patient prescriptions maintained momentum in Q2 2026, driving ORLADEYO revenue of $158.2 million (+1% y-o-y; +10% y-o-y on a comparable basis excluding European revenue). Initial product shipments of ORLADEYO oral pellets to patients began the week of August 3, marking a new paradigm in the treatment of HAE in pediatrics. Prescription demand is strong: 47 prescriptions have been written year-to-date. Over half of these prescriptions have completed the prior authorization process and have a high approval rate. Patient enrollment in ALPHA-ORBIT, the ongoing pivotal study of navenibart in hereditary angioedema, was completed in June. Navenibart is an investigational, long-acting plasma kallikrein inhibitor being studied with every three-month and every six-month subcutaneous dosing. The program remains on track to report top-line results from both doses in Q3 2027. The company is studying BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, in a Phase 1 trial. The company is dosing in Part 4 of this trial, which will enroll up to 12 patients for three months, and expects to report data from this part by the end of 2026. In June, the company announced the discontinuation of its internal discovery programs and closure of its Birmingham facility by the end of 2026 to sharpen its scientific focus on external innovation. In July, the company appointed David W. Jenkins, MA, PhD, as Chief Scientific Officer, strengthening the company's research leadership and external innovation strategy. Second Quarter 2026 Financial Results Total revenues were $218.3 million (+34% y-o-y; +45% y-o-y on a comparable basis excluding European revenue). In May 2026, the company announced that it entered into a licensing agreement with an Irish affiliate of Neopharmed Gentili for exclusive rights to commercialize navenibart in Europe. The company received upfront consideration of $70.0 million and is eligible to receive up to $275.0 million in future regulatory and sales milestone payments and tiered royalties on net sales ranging from 18% to 30%. The company recognized $55.7 million of revenue related to this licensing agreement in the second quarter of 2026 with the balance to be recognized over the next few years. Research and development expenses, excluding stock-based compensation expense, were $46.5 million (+37% y-o-y) for the second quarter of 2026. The increase was primarily due to costs associated with the navenibart ALPHA-ORBIT study following the acquisition of Astria in the first quarter of 2026. Sales and marketing expenses, excluding stock-based compensation expense, were $33.9 million (-26% y-o-y, +2% y-o-y on a comparable basis excluding European sales and marketing expenses) for the second quarter of 2026. General and administrative expenses, excluding stock-based compensation expense, were $20.8 million (-30% y-o-y, -2% y-o-y on a comparable basis excluding European general and administrative expenses and transaction-related costs) for the second quarter of 2026. The company recorded a GAAP operating profit of $98.5 million for the second quarter of 2026. On a non-GAAP basis, the company recorded an operating profit of $113.2 million. Additional details on individual adjustments are included in the accompanying financial tables. During Q2 2026, the company generated positive cash flow even when excluding the upfront consideration received from the navenibart licensing agreement. As a result, cash, cash equivalents, restricted cash and investments totaled $354.0 million at June 30, 2026. The accompanying tables provide GAAP and non-GAAP financial information for the three and six months ended June 30, 2026. Non-GAAP measures include adjustments, as applicable, for the sale of the European ORLADEYO business on October 1, 2025 (including transaction-related costs), stock-based compensation, and expenses incurred in connection with the acquisition of Astria on January 23, 2026. Management believes that the presentation of these non-GAAP figures provides greater transparency into the financial results of core, ongoing operations and improves comparability across reporting periods by excluding items that are non-recurring or other items that may vary significantly from period to period. Financial Outlook for 2026 The company maintained its outlook for full year 2026 global net ORLADEYO revenue of $625 million to $645 million. The company raised the full year 2026 total revenue outlook, including RAPIVAB® (peramivir injection) and revenue from the licensing of navenibart European rights, to $690 million to $715 million. In June, the company improved its outlook for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to $420 million to $440 million, due to the announced plans to discontinue internal discovery programs and close the Birmingham facility. Conference Call and Webcast BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com. About BioCryst Pharmaceuticals BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of potential first-in-class or best-in-class therapeutics for rare diseases. For more information, please visit www.biocryst.com or follow us on LinkedIn. Non-GAAP Financial Measures The information furnished in this release and the accompanying tables includes non-GAAP financial measures that differ from measures calculated in accordance with generally accepted accounting principles in the United States of America (“GAAP”), including financial measures labeled as “non-GAAP.” As noted under “Second Quarter 2026 Financial Results” above, we believe providing these non-GAAP measures, which show our results with certain items adjusted, is valuable and useful since they can provide greater transparency into the financial results of core, ongoing operations and improve comparability across reporting periods. These non-GAAP measures also correspond with the way we expect investors and financial analysts to compare our results. Our non-GAAP measures should be considered only as supplements to, and not as substitutes for or in isolation from, our other measures of financial information prepared in accordance with GAAP. A reconciliation between each non-GAAP financial measure and its respective closest equivalent GAAP financial measure is provided in the tables below. We also provide our non-GAAP operating expense outlook for full year 2026, which refers to our expected GAAP operating expense, excluding stock-based compensation, restructuring and transaction-related costs. We have not provided a reconciliation against the comparable forward-looking GAAP measure because we are unable to predict with reasonable certainty the full amount of stock-based compensation expense or restructuring or transaction-related costs for the full year 2026 without unreasonable effort. Stock-based compensation expense is uncertain and depends on various factors, including our future hiring and retention needs, as well as the future fair market value of our common stock, which is difficult to predict and subject to change. In addition, we are unable to predict with reasonable certainty the full amount of restructuring and transaction-related costs as the related costs are dependent on various factors that have not yet or have only recently occurred. The actual amount of stock-based compensation, restructuring and transaction-related costs for the full year 2026 could have a material impact on GAAP reported results for the guidance period. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding future results, performance or achievements, such as expected full year 2026 revenue and operating expenses, expectations related to future profitability, expectations regarding pipeline development, including expected data reporting timing, potential future milestone payments or royalties, expectations regarding BioCryst’s strategic shift to prioritize external innovation, including as it relates to future growth, value creation and opportunities, and expectations related to the closure of BioCryst’s Birmingham research facility and wind-down of internal discovery programs, including statements about the expected timing and financial impact. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst’s ability to successfully progress its pipeline development plans as described herein, including meeting the expected timelines; BioCryst’s ability to successfully transition to its new sole source specialty pharmacy for ORLADEYO shipments to patients and to continue to successfully commercialize ORLADEYO, including the successful launch of the ORLADEYO oral pellet formulation; uncertainties related to BioCryst’s ability to successfully execute its plan to close the Birmingham research facility and wind-down its internal discovery programs, including the timing and costs of such action; ongoing and future preclinical and clinical development of product candidates may take longer than expected and may not have positive results; the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; the results of BioCryst’s partnerships with third parties may not meet BioCryst’s current expectations, including that our partners may fail to reach performance milestones or achieve certain royalty thresholds under our license agreements; statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and BioCryst’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. This list is not exclusive. To see a more comprehensive list of risks, please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements. BCRXW Contact: Investors:[email protected] Media:[email protected] BIOCRYST PHARMACEUTICALS, INC.CONSOLIDATED FINANCIAL SUMMARY(In thousands, except per share) Statements of Operations (Unaudited) Balance Sheet Data (in thousands) Reconciliations of Non-GAAP Income from Operations (in thousands)

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance was driven by consistent demand for ORLADEYO capsules and a 45% year-over-year increase in total revenue, excluding divested European operations. Management completed a strategic pivot by discontinuing internal drug discovery and closing the Birmingham research unit to reallocate resources toward external asset acquisition. The pediatric launch of ORLADEYO pellets is exceeding expectations with 47 prescriptions received before official shipping began, representing nearly 10% of the known diagnosed pediatric market. Operational efficiency improved through the transition to CareMed as a sole-source pharmacy partner, selected for its ability to scale alongside the growing HAE portfolio. Market dynamics show that new injectable competitors are primarily impacting existing injectable therapies like TAKHZYRO, while ORLADEYO's patient retention remains stable. The paid therapy rate reached 84%, a slight improvement over the previous year, reflecting successful navigation of the heavy reauthorization season. Full-year 2026 ORLADEYO revenue guidance is maintained at $625 million to $645 million, assuming long-term growth trends remain intact despite the pediatric manufacturing delay. Top-line data for the navenibart ALPHA-ORBIT pivotal study is expected in the third quarter of 2027, with the study remaining blinded to collect a full year of safety and efficacy data. The company expects to report proof-of-concept data for BCX17725 in Netherton syndrome by the end of 2026, with enrollment currently on track. Management is targeting a leaner operating model with non-GAAP operating costs guided to $420 million to $440 million, benefiting from the closure of legacy R&D facilities. Future business development will prioritize high-quality, mid-stage clinical assets with validated biology, funded through existing cash flow rather than large capital raises. The company recognized $55.7 million in revenue from an upfront payment related to the navenibart European license agreement with Neopharmed Gentili. A one-time strategic decision to exit internal discovery is expected to generate meaningful long-term cost savings as legacy R&D expenses wind down through the end of the year. Cash and investments ended the quarter at over $350 million, with the company achieving positive cash flow even when excluding one-time licensing proceeds. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that while new injectables are entering the market, they are mostly capturing share from other injectables rather than oral therapies. ORLADEYO retention patterns remain consistent with historical trends, as patients who do well on the drug tend to be very 'sticky'. The BCX17725 program targets KLK5, which management believes is the specific driver of Netherton syndrome, unlike other systemic modalities. While some placebo response is expected due to the disease's natural variability, any improvement in signs and symptoms would be significant given the lack of approved therapies. Early data shows the availability of oral pellets is encouraging physicians to consider prophylaxis for a broader range of the pediatric population. A portion of the initial 47 pediatric prescriptions came from physicians who had not previously prescribed ORLADEYO, suggesting a 'halo effect' for the brand. The company is focused on 'quality over quantity' for new assets and intends to maintain a flexible balance sheet that allows for potential debt deleveraging or share buybacks. Management emphasized they do not feel the need to 'unnecessarily stress' the balance sheet for acquisitions given their current cash-generating profile.

This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Completed enrollment of the largest blinded hereditary angioedema (HAE) trial ever for Navenabar ahead of schedule, with top-line data expected in Q3 2027. Orladeo oral pellets for pediatric HAE patients started shipping, with 47 prescriptions received by July 31, exceeding full-year 2026 expectations. Total revenue increased 45% year-over-year on a comparable basis, driven by strong Orladeo growth and the Navenabar European license upfront payment. Non-GAAP operating profit reached $113.2 million in Q2, reflecting strong profitability and disciplined cost management. Improved payer approval rate for Orladeo to 84%, up from 83% a year ago, despite a competitive landscape. Strategic shift to external innovation and closure of internal discovery programs is expected to reduce operating costs, with guidance lowered to $420-$440 million. Strong balance sheet with over $350 million in cash, generating positive cash flow even excluding the license upfront payment. Manufacturing delay for Orladeo oral pellets impacted the pediatric launch timeline, though early demand is strong. Competition from new injectable HAE therapies is causing some patient switches away from Orladeo, particularly to newer products. The company discontinued internal discovery programs and closed its Birmingham facility, which may limit internal pipeline innovation. Navenabar's pivotal study will remain blinded for 12 months, delaying top-line data until Q3 2027, which is later than initially expected. Orladeo's paid rate is expected to decline by 1-2% in the second half of the year due to new patient mix, potentially impacting revenue growth. The transition to a new sole-source pharmacy (CareMed) may cause temporary disruptions in Orladeo shipments, though long-term benefits are anticipated. The company's BD strategy focuses on external assets, which carries execution risks and may not yield immediate pipeline additions. Warning! GuruFocus has detected 3 Warning Signs with BCRX. Is BCRX fairly valued? Test your thesis with our free DCF calculator. Q: Can you elaborate on your business development priorities? Does this look more like bolt-on acquisitions to the clinical pipeline or partnerships, and what kind of profile businesses does this look like? A: (CFO Barbara Gas) From a BD perspective, the objective is to build a high-value pipeline with validated biology and proof of principle. We are not looking to stress our balance sheet with large company acquisitions. We are laser-focused on delivering on our catalysts, with an emphasis on clinical mid-stage assets where we can have a real impact. We are cash-generating and self-sufficient, so we don't need large capital raises to fund BD or R&D operations. Looking ahead to 2027, operating expenses will continue to go down as we move past the Birmingham facility closure and internal program wind-down. Even as we bring in BD assets, BioCryst is committed to delivering profitable growth and remaining cash flow positive. Q: Just following up on the Netherton side, what are your expectations for how a placebo arm could potentially perform, and how are you contextualizing what a good result is on the efficacy side? A: (Chief R&D Officer Dr. Sandeep Menon) BCX 17,725 has the potential to be the first systemically administered and targeted drug for Netherton syndrome, targeting KLK 5, which is exactly what is needed. These patients have no approved therapies, so any relief or improvement in signs and symptoms would be a big advance based on our discussions with patients and physicians. There will be some placebo response, but the disease itself has its own waxing and waning, as it is a very variable disease in general. Q: Can you talk through the clinician additions this quarter versus historical averages, and what kind of halo effect you expect with the pediatric launch? Also, can you talk about the new specialty pharmacy setup and any early comments on part 3 of the Netherton trial? A: (President and CEO Charlie Geyer) We previously talked about approximately 60 new physicians per month prescribing Orladeo, and we were a little bit above that. Of the 47 pediatric prescriptions, a number were prescribed by physicians who had not yet prescribed Orladeo, which is a good early sign. On the CareMed transition, we chose them for their ability to scale with our growth and their experience with proactive programs. We don't expect the switch to affect Orladeo long-term. (Dr. Sandeep Menon) On part 3 of the Netherton trial, there were too few patients and too short a time to share anything meaningful. We are pleased with how part 4 is enrolling and look forward to having data at the end of the year. Q: For Orladeo, can you provide some color on the volume growth in the quarter? It sounds like you grew revenues 10% year over year, but there was also a 9% price increase and an increased paid rate. What does this imply about volume growth year over year? A: (CFO Barbara Gas) It's basically half and half. On the 9% price increase, we previously said we would net about 4.5% of that. Combined with the improved paid rate, the overall growth was about half volume and half price/reimbursement. Q: Regarding the pediatric launch, you mentioned initial numbers are tracking ahead of expectations. Does that change your outlook for that opportunity, and should we expect paid Rx rates to be similar on the pediatric side? Also, can you capture the patients who have yet to try Orladeo with your current base of prescribers? A: (CEO Charlie Geyer) We are encouraged by the early demand for pediatrics, but it's too early to call. We expect the paid rate to at least be in the range of what it's been for capsules, with a different payer mix split between commercial and Medicaid. The early signs are good as the pellets slot right into our existing contracts. The fact that demand has continued to be consistent and strong, plus we are adding new prescribers, shows there is still plenty of opportunity. New prescriptions are coming strongly from existing prescribers as well as new ones, and pediatrics can only further help that. Q: With the enrollment completion and upsizing of the Navenabar study, was the upsizing based on higher-than-expected interest or observations on dropouts? Should we assume this is almost entirely adults? Also, are there ways to further improve patient retention ahead of potential competitor launches? A: (CEO Charlie Geyer) The sizing had nothing to do with powering; it was purely about patient and investigator interest. It was the largest blinded trial ever in HAE, yet it enrolled just as quickly as other recent smaller trials. (Dr. Sandeep Menon) We are already overpowered for the trial, so there are no concerns. The interest from investigators is a positive sign for the value physicians see in this modality and dosing regimen. (CEO Charlie Geyer) On retention, we are pleased with the overall rate. Patients either do quite well on Orladeo and are very sticky, or they don't and move on. We will be looking at pediatric retention, as in the clinical trial Apex-P, long-term patient retention at 1 and 2 years was above what we saw in the adult trial. Q: For the new patient prescription momentum maintained in the second quarter, is that only driven by new pediatric patients, or can you provide more context on the contribution from new adult versus pediatric patients? A: (CEO Charlie Geyer) The 12-and-up population for Orladeo capsules had demand very consistent with what we've seen over the last couple of years, which was expected. The pediatrics are off to a great start and are just upside on top. We will see how that progresses over the next few quarters. Q: Does the paid rate at 84% only include the adult population, and how do you expect it to continue increasing for the third and fourth quarters? A: (CEO Charlie Geyer) Yes, that only includes the adult population because we didn't have the pellets out yet in Q2. The paid rate also includes patients who are completely uninsured, about 4% of that 16% who are getting free product. Our long-term goal is 85%, but if we get there, the goal will go up. Typically, in the second half of the year, the paid rate tends to drop off a little because the patient mix is driven more by new patients who don't get to 84% as quickly. We usually lose a percentage or two in the second half and gain it back For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in BioCryst Pharmaceuticals, Inc.? Here are five stocks we like better. ORLADEYO revenue rose 10% year over year to $158.2 million in Q2, while pediatric oral-pellet shipments began with 47 prescriptions by July 31. BioCryst maintained its 2026 ORLADEYO revenue outlook of $625 million to $645 million. BioCryst completed enrollment in the pivotal ALPHA-ORBIT trial of long-acting injectable navenibart for hereditary angioedema, with top-line results expected in Q3 2027. Its BCX17725 study for Netherton syndrome is also enrolling and remains on track for early data by the end of 2026. The company reduced 2026 non-GAAP operating-cost guidance to $420 million-$440 million after deciding to end internal drug discovery and close its Birmingham research facility by the end of 2026. BioCryst ended the quarter with more than $350 million in cash, equivalents and investments and plans to focus future innovation efforts on external partnerships. BioCryst Pharmaceuticals (NASDAQ:BCRX) reported second-quarter results marked by growth in ORLADEYO revenue, the start of shipments for its pediatric oral-pellet formulation, and completion of enrollment in its pivotal navenibart trial for hereditary angioedema, or HAE. President and CEO Charlie Gayer said the company completed the integration of Astria Therapeutics during the quarter and increased cash generation through revenue growth and spending discipline. BioCryst also decided in June to discontinue its internal drug-discovery programs and close its Birmingham research facility by the end of 2026, shifting its research strategy toward externally sourced innovation. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control ORLADEYO revenue totaled $158.2 million in the second quarter, rising 10% from a year earlier on a comparable basis that excludes BioCryst's divested European business, Chief Financial Officer Babar Ghias said. Total revenue increased 45% year over year on the same comparable basis. Ghias said total revenue also included $55.7 million recognized from the upfront payment under the company's European navenibart licensing agreement with Neopharmed Gentili. → 3 Drone Stocks That Should Soar After the Summer Slump BioCryst began shipping ORLADEYO oral pellets for pediatric patients during the week of the call. Gayer said the company had received 47 prescriptions through July 31, despite a manufacturing delay, a figure that exceeded its previous expectation for total pediatric prescriptions during 2026. Prior authorizations had been completed for about half of those patients, with what Gayer described as a strong early approval rate. The company said the initial pediatric prescription count represented close to 10% of an estimated 500 diagnosed children in the applicable age range. Gayer added that physicians have expressed enthusiasm for prescribing the oral formulation and that the availability of an oral prophylactic option could expand use among pediatric HAE patients. He said BioCryst believes there may be as many as 1,200 diagnosed children in the age population, though the company expects it will take several quarters to assess market development. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure For patients age 12 and older using ORLADEYO capsules, new prescription demand during the quarter remained consistent with historical trends. Gayer said BioCryst continued to add slightly more than its historical average of about 60 new prescribing physicians per month. BioCryst's paid rate for ORLADEYO reached 84% at quarter-end, compared with 83% a year earlier. The figure applied only to the capsule population because pediatric pellets were not yet available during the second quarter. Gayer said the company typically sees the rate decline by one or two percentage points in the second half as new patients enter treatment, before recovering during the following year's reauthorization season. Management said approximately half of ORLADEYO's year-over-year revenue growth reflected volume, while the other half reflected price and reimbursement. The company had previously discussed a 9% price increase, of which it said it nets about 4.5%. BioCryst selected CareMed as its sole-source specialty pharmacy for ORLADEYO shipments. The pediatric pellet prescriptions are already shipping through CareMed, while patients 12 and older are expected to transition during August. Gayer said the company selected CareMed because of its ability to scale as BioCryst's HAE portfolio and patient population grow. He acknowledged that a pharmacy transition can involve operational challenges but said the company does not expect the change to affect ORLADEYO's long-term performance. On competition in the HAE prophylaxis market, Gayer said newer injectable products have primarily affected use of existing injectable therapies, particularly TAKHZYRO. He said ORLADEYO retention has remained in line with historical patterns, with patients who respond well to the treatment generally remaining on therapy. Chief Research and Development Officer Dr. Sandeep Menon said BioCryst completed enrollment in June for ALPHA-ORBIT, its pivotal trial of navenibart, an investigational long-acting injectable plasma kallikrein inhibitor for HAE prophylaxis. The company expects to report top-line data in the third quarter of 2027. The study will remain blinded to collect one year of safety and efficacy data, as agreed with the Food and Drug Administration. Menon said this design will allow BioCryst to evaluate efficacy at both six and 12 months, reflecting navenibart's potential every-six-month dosing regimen. Management said the trial was expanded because of patient and investigator interest, rather than concerns about statistical power or patient discontinuations. Menon said the study is already overpowered. BioCryst also said its proof-of-concept study of BCX17725 in Netherton syndrome is enrolling well and remains on track to produce early patient data from Part 4 of the Phase 1b study by the end of 2026. Gayer said the company expects enrollment to reach up to 12 patients by year-end. Menon described BCX17725 as a potential first systemic, targeted treatment for Netherton syndrome, a severe skin condition with no approved therapies. The drug targets KLK5, which BioCryst identified as implicated in the disease. He noted that Netherton syndrome can be variable and involve waxing and waning symptoms, and said the company will need the full data set to evaluate pharmacokinetics, pharmacodynamics and clinical efficacy. BioCryst reported non-GAAP operating profit of $113.2 million for the quarter and ended the period with more than $350 million in cash, cash equivalents and investments. Ghias said the company generated positive cash flow even excluding the upfront proceeds from the Neopharmed Gentili agreement. The company reduced its 2026 non-GAAP operating-cost guidance to $420 million to $440 million, from a previous range of $454 million to $470 million. Ghias attributed the lower outlook to the planned shutdown of internal discovery operations and the Birmingham facility closure. 2026 total revenue guidance: Raised to $690 million to $715 million. 2026 ORLADEYO revenue guidance: Maintained at $625 million to $645 million. 2026 non-GAAP operating-cost guidance: Maintained at $420 million to $440 million. Ghias said BioCryst intends to pursue external business-development opportunities focused on high-value, clinically validated assets, particularly early- to mid-stage programs. He said the company does not intend to pursue large acquisitions that would unnecessarily strain its balance sheet, while maintaining a commitment to profitable growth and positive cash flow. BioCryst Pharmaceuticals, Inc is a clinical‐stage biotechnology company headquartered in Durham, North Carolina, that focuses on the discovery and development of novel, oral small‐molecule medicines for rare and serious diseases. Since its founding in 1986, the company has leveraged structure‐based drug design to advance a pipeline of targeted therapeutics designed to address underlying disease mechanisms rather than just treat symptoms. The company's first commercial product, Orladeyo (berotralstat), is an oral kallikrein inhibitor approved for the prophylactic treatment of hereditary angioedema (HAE) in both the United States and Europe. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "BioCryst Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

BioCryst Pharmaceuticals (BCRX) came out with quarterly earnings of $0.3 per share, beating the Zacks Consensus Estimate of $0.14 per share. This compares to earnings of $0.15 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +114.29%. A quarter ago, it was expected that this drugmaker would post earnings of $0.06 per share when it actually produced a loss of $0.03, delivering a surprise of -150%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. BioCryst, which belongs to the Zacks Medical - Drugs industry, posted revenues of $218.25 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 18.26%. This compares to year-ago revenues of $163.35 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. BioCryst shares have added about 15.6% since the beginning of the year versus the S&P 500's gain of 13%. While BioCryst has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for BioCryst was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.05 on $163.52 million in revenues for the coming quarter and -$2.58 on $676.48 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Heron Therapeutics (HRTX), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 10. This pharmaceutical company is expected to post quarterly loss of $0.02 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Heron Therapeutics' revenues are expected to be $42.4 million, up 14% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioCryst Pharmaceuticals, Inc. (BCRX) : Free Stock Analysis Report Heron Therapeutics, Inc. (HRTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Second-quarter revenue rose 34% year over year to $218.3 million, topping analyst expectations of $183.3 million, according to Fiscal.ai data. Orladeyo generated $158.2 million in revenue during the quarter, contributing around 72% of the total revenue. The firm recognized over $55 million in revenue tied to its licensing agreement in Europe for Navenibart. BioCryst Pharmaceuticals (BCRX) raised its full-year revenue guidance after another strong quarter, highlighting continued growth for its hereditary angioedema (HAE) treatment therapy and the launch of a new oral pellet formulation for children. “We are especially excited to have begun shipments of the Orladeyo oral pellet formulation – an important milestone for children living with hereditary angioedema,” said Charlie Gayer, President and Chief Executive Officer of BioCryst. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox HAE is a rare genetic condition that causes episodes of swelling in different parts of a child’s body, including the face, hands, and feet. BCRX shares rose as much as 7.2% before shedding some of the gains. It is currently trading 3% higher. Second-quarter revenue rose 34% year over year to $218.3 million, topping analyst expectations of $183.3 million, according to Fiscal.ai data. Earnings came in at $0.3 per share, ahead of Street estimates of $0.12. This was also Biocryst’s fifth straight quarterly earnings beat. Orladeyo generated $158.2 million in revenue during the quarter, contributing around 72% of the total revenue. The firm recognized over $55 million in revenue tied to its licensing agreement in Europe for its other investigational hereditary angioedema therapy, Navenibart. BioCryst also raised its full-year 2026 total revenue outlook to $690 million to $715 million, up from its previous estimates of $635 million to $660 million. It maintained Orladeyo revenue guidance of $625 million to $645 million. Beyond Orladeyo, BioCryst said its investigational therapy BCX17725 for Netherton syndrome, another rare genetic condition affecting the skin, hair and the immune system, remains on track to generate early patient data by the end of 2026. Retail sentiment surrounding BCRX on Stocktwits flipped to ‘bullish’ from ‘bearish’ over the past 24 hours, amid a 92% increase in message volumes. One user expects a buyout of the company in the $18 to $22 per share range, implying a 138% premium over the current price. Another user expects the stock to climb above $15. The stock has gained more than 24% so far this year. Also read: Eli Lilly CEO Bets On Weight-Loss Medicine Retatrutide As Next Growth Driver, Says Firm’s Future Has ‘Never Been Brighter’ For updates and corrections, email newsroom[at]stocktwits[dot]com. Arnab Paul has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: CRM, NOW, INTU, ADBE: Software Stocks Slide After Figma Flags Surging AI Costs RDW Stock Surges Overnight On Blockbuster Earnings: Retail Wants ‘Valuation Rebalance’ Now RKLB Stock Slips Overnight: Rocket Lab Prepares To Retry 92nd Launch After Last-Minute Electron Abort

Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. BioCryst Pharmaceuticals (BCRX) is back in focus after first quarter results combined higher revenue with a very large reported loss, alongside a fresh licensing deal for navenibart in Europe and reaffirmed full year revenue guidance. See our latest analysis for BioCryst Pharmaceuticals. At a share price of $8.58, BioCryst’s 90 day share price return of 30.99% and year to date gain of 14.40% contrast with a decline of 17.02% in the 1 year total shareholder return. This suggests that momentum has recently picked up after a tougher stretch. If earnings swings and new licensing deals have your attention, it can be useful to scan other healthcare related opportunities using our 32 healthcare AI stocks With revenue guidance intact, a large reported loss and a fresh navenibart deal on the table, is BioCryst’s recent share price pullback setting up an undervalued rare disease stock or is the market already pricing in future growth? Analysts following BioCryst see a big gap between their fair value of $21.40 and the last close at $8.58, and they tie that gap directly to the rare disease pipeline and the Astria Therapeutics deal. Read the complete narrative. Curious what kind of revenue runway, margin profile, and future earnings multiple would need to hold for that fair value to make sense? The narrative leans on a specific mix of ORLADEYO performance, new indications, and longer term earnings power that the market is not fully pricing in yet. Result: Fair Value of $21.40 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this depends on ORLADEYO continuing to carry most of the revenue load, as well as on early stage programs like BCX17725 and DME avoiding clinical or regulatory setbacks. Find out about the key risks to this BioCryst Pharmaceuticals narrative. There are mixed signals on value and risk so far, so take a closer look at the full picture and weigh both sides with the 3 key rewards and 2 important warning signs If BioCryst has raised fresh questions for your portfolio, do not stop here. Broaden your watchlist with other focused stock ideas built from clear, bottom up data. Target potential mispricings by scanning for quality companies that screen as undervalued using our 47 high quality undervalued stocks Strengthen portfolio resilience by concentrating on businesses with healthier finances through the solid balance sheet and fundamentals stocks screener (44 results) Get ahead of the crowd by filtering for lesser known opportunities in our screener containing 21 high quality undiscovered gems This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include BCRX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]